Nutzenbewertungsverfahren
Archiv

Hier finden Sie alle Verfahren der Frühen Nutzenbewertung, die vor mindestens 9 Monaten abgeschlossen wurden. Für nähere Information, wählen Sie hier den gewünschten Wirkstoff alphabetisch aus.

A

› Abemaciclib (in combination with an aromatase inhibitor)

Subject:

Active Substance: Abemaciclib
Name: Verzenios^®
Therapeutic area: Breast cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.11.2018
Final decision by G-BA: 02.05.2019
This decision remains valid until: 31.12.2022

Final decision:

a) as initial endocrine therapy

a1) for postmenopausal women: No additional benefit proved.
a2) for pre- and perimenopausal women: No additional benefit proved.

b) with endocrine therapy pre-treated

b1) for postmenopausal women with progress after endocrine therapy: No additional benefit proved.
b2) for pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

› Abemaciclib (in combination with fulvestrant)

Subject:

Active Substance: Abemaciclib
Name: Verzenios^®
Therapeutic area: Breast cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.11.2018
Final decision by G-BA: 02.05.2019
This decision remains valid until: 15.03.2020

Final decision:

a) as initial endocrine therapy

a1) for postmenopausal women: No additional benefit proved.
a2) for pre- and perimenopausal women: No additional benefit proved.

b) with endocrine therapy pre-treated

b1) for postmenopausal women with progress after endocrine therapy: No additional benefit proved.
b2) for pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

› Abemaciclib (re-assessment: breast cancer, HR+, HER2-, combination with fulvestrant)

Subject:

Active Substance: Abemaciclib
Name: Verzenios^®
Therapeutic area: Breast cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 03.09.2020
This decision remains valid until:: 01.12.2021

Final decision:

a) as initial endocrine therapy: no additional benefit proved
b) with endocrine therapy pre-treated
b1) for postmenopausal women: hint for a minor additional benefit
b2) for pre- and perimenopausal women: no additional benefit proved

› Abiraterone acetate

Subject:

Active Substance: Abiraterone acetate
Name: Zytiga^®
Therapeutic area: Prostatic neoplasms
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2011
Final decision by G-BA: 29.03.2012

Final decision:

Best supportive care population: Hint for considerable additional benefit
Docetaxel-treated patients: No additional benefit proved

› Abiraterone acetate (new therapeutic indication: prostatic neoplasms, first-line treatment)

Subject:

Active Substance: Abiraterone acetate (new therapeutic indication: prostatic neoplasms, first-line treatment)
Name: Zytiga^®
Therapeutic area: Prostatic neoplasms (chemotherapy not yet indicated)
Company: Janssen-Cilag GmbH

Time table:

Start: 15.01.2013
Final decision by G-BA: 04.07.2013

Final decision:

Indication for a considerable additional benefit

› Abiraterone acetate (new indication: metastastic hormone sensitive prostate cancer (mHSPC))

Subject:

Active Substance: Abiraterone acetate
Name: Zytiga^©
Therapeutic area: Prostatic neoplasms
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.12.2017
Final decision by G-BA: 07.06.2018

Final decision:

Indication for a considerable additional benefit

› Acalabrutinib (chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, 1^st line)

Subject:

Active Substance: Acalabrutinib
Name: Calquence^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved

› Acalabrutinib (chronic lymphocytic leukaemia (CLL); monotherapy, 1^st line)

Subject:

Active Substance: Acalabrutinib
Name: Calquence^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved

› Acalabrutinib (chronic lymphocytic leukaemia (CLL); at least one prior therapy)

Subject:

Active Substance: Acalabrutinib
Name: Calquence^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 05.08.2021

Final decision:

a1) Patients with neither 17p deletion nor TP53 mutation and who can be treated with a chemo-immunotherapy and for whom the patient-individual therapy is rituximab in combination bendamustine (BR): No additional benefit proved
a2) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with chemo-immunotherapy and for whom the patient-individual therapy is not rituximab in combination with BR: No additional benefit proved
b) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemo-immunotherapy due to other reasons: Hint for a considerable additional benefit
c1) Patients with at least 2 prior therapies and for whom the patient-individual therapy is idelalisib in combination with rituximab or rituximab or rituximab in combination with BR: Hint for a minor additional benefit
c2) Patients with at least 2 prior therapies and for whom the patient-individual therapy is not idelalisib in combination with rituximab or rituximab or rituximab in combination with BR: No additional benefit proved

› Aclidinium bromide [repealed]

Subject:

Active Substance: Aclidinium bromide
Name: Eklira^® Genuair^® / Bretaris^® Genuair^®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: Almirall Hermal GmbH

Time table:

Start: 01.10.2012
Final decision by G-BA: 21.03.2013

Final decision:

No additional benefit proved

› Aclidinium bromide (re-assessment)

Subject:

Active Substance: Aclidinium bromide (re-assessment)
Name: Eklira^® Genuair^®/Bretaris^® Genuair^®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.10.2015
Final decision by G-BA: 15.01.2016

Final decision:

Adult patients with COPD with an intermediate (or higher) severity of disease:
-Patients with stage II: No additional benefit proved
-Patients with stage III and < 2 exacerbations per year: Indication for a considerable additional benefit
-Patients with stage IV and <; 2 exacerbations per year : No additional benefit proved
Patients with a higher severity of disease with ≥ 2 exacerbations per year: No additional benefit proved

› Aclidinium bromide/ formoterol

Subject:

Active Substance: Aclidinium bromide/ formoterol
Name: Duaklir^® Genuair^®/Brimica^® Genuair^®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.02.2015
Final decision by G-BA: 16.07.2015

Final decision:

Stage II: Indication of a minor additional benefit
Stage III (with < 2 exacerbations per year): Indication of a considerable additional benefit
Stage IV: No additional benefit proved
Stage III/IV (with ≥ 2 exacerbations per year): No additional benefit proved

› Afamelanotide (erythropoietic protoporphyria) [repealed]

Subject:

Active Substance: Afamelanotide
Name: Scenesse^®
Therapeutic area: Erythropoietic protoporphyria (EPP)
Pharmaceutical company: Clinuvel (UK) Limited

Time table:

Start: 15.02.2016
Final decision by G-BA: 04.08.2016
The decision remains valid until: 21.01.2020

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Afatinib [repealed]

Subject:

Active Substance: Afatinib
Name: Giotrif^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.11.2013
Final decision by G-BA: 08.05 2014
The decision remains valid until: 21.01.2020

Final decision:

Patients without pre-treatment and ECOG performance status 0 or 1 and

EGFR mutation Del19: Indication of a considerable additional benefit
EGFR mutation L858R: Hint for a minor additional benefit
Other EGFR mutations: Indication of a lesser benefit than the comparative therapy

Patients without pre-treatment and ECOG performance status 2: No additional benefit proved
Pre-treated patients (one ore more chemotherapies): No additional benefit proved

› Afatinib (re-assessment)

Subject:

Active Substance: Afatinib (re-assessment)
Name: Giotrif^®
Therapeutic area: Non-small-cell lung carcinoma (NSCLC)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.05.2015
Final decision by G-BA: 05.11.2015

Final decision:

Patients without pre-treatment and ECOG performance status 0 or 1 and

EGFR mutation Del19: Indication of a major additional benefit
EGFR mutation L858R: No additional benefit proved
Other EGFR mutations: No additional benefit proved

Patients without pre-treatment and ECOG performance status 2: No additional benefit proved
Pre-treated patients (platin-based chemotherapy): No additional benefit proved

› Afatinib (new indication: non-small cell lung carcinoma of squamous histology)

Subject:

Active Substance: Afatinib (new indication: non-small cell lung carcinoma of squamous histology)
Name: Giotrif^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC) of squamous histology
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 01.05.2016
Final decision by G-BA: 20.10.2016

Final decision:

No additional benefit proved for any patient subpopulation

› Afamelanotide (re-assessment: erythropoietic protoporphyria)

Subject:

Active Substance: Afamelanotide
Name: Scenesse^®
Therapeutic area: Erythropoietic protoporphyria (EPP)
Pharmaceutical company: Clinuvel UK Limited

Time table:

Start: 01.01.2021
Final decision by G-BA: 01.07.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Aflibercept (new indication: colorectal cancer)

Subject:

Active Substance: Aflibercept
Name: Zaltrapi^®
Therapeutic area: Metastatic colorectal cancer
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.03.2013
Final decision by G-BA: 15.08.2013

Final decision:

Indication of a minor additional benefit

› Aflibercept

Subject:

Active Substance: Aflibercept
Name: Eylea^®
Therapeutic area: Neovascular age-related macular degeneration (AMD)
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 15.12.2012
Final decision by G-BA: 06.06.2013

Final decision:

No additional benefit proved

› Aflibercept (new indication: macular oedema following central retinal vein occlusion)

Subject:

Active Substance: Aflibercept (new indication)
Name: Eylea^®
Therapeutic area: Visual impairment due to macular oedema following central retinal vein occlusion (RVO)
Company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.10.2013
Final decision by G-BA: 20.03.2014

Final decision:

No additional benefit proved

› Aflibercept (new indication: diabetic macular oedema)

Subject:

Active Substance: Aflibercept
Name: Eylea^®
Therapeutic area: Visual impairment due to diabetic macular oedema (DMO)
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 15.09.2014
Final decision by G-BA: 05.03.2015

Final decision:

No additional benefit proved

› Aflibercept (new indication: macular oedema following branch retinal vein occlusion)

Subject:

Active Substance: Aflibercept
Name: Eylea^®
Therapeutic area: Visual impairment due to macular oedema following branch retinal vein occlusion (RVO)
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 15.03.2015
Final decision by G-BA: 03.09.2015

Final decision:

No additional benefit proved

› Aflibercept (new indication: myopic choroidal neovascularisation)

Subject:

Active Substance: Aflibercept
Name: Eylea^®
Therapeutic area: Visual impairment due to myopic choroidal neovascularisation (CNV)
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.12.2015
Final decision by G-BA: 19.05.2016

Final decision:

No additional benefit proved

› Albiglutide

Subject:

Active Substance: Albiglutide
Name: Eperzan^®
Therapeutic area: Type 2 diabetes mellitus
Pharmaceutical company: GlaxoSmithKline GmbH & Co.KG

Time table:

Start: 01.10.2014
Final decision by G-BA: 19.03.2015

Final decision:

In combination with metformin: Indication for a minor additional benefit
For the other slices: No additional benefit proved

› Albutrepenonacog alfa

Subject:

Active Substance: Albutrepenonacog alfa
Name: Idelvion^®
Therapeutic area: Hemophilia B
Pharmaceutical company: CSL Behring GmbH

Time table:

Start: 01.06.2016
Final decision by G-BA: 01.12.2016

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Alecitinib

Subject:

Active Substance: Active Substance: Alecitinib
Name: Alecensa^©
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Roche Pharma GmbH

Time table:

Start: 01.05.2017
Final decision by G-BA: 16.10.2017

Final decision:

Patients for whom therapy with docetaxel or pemetrexed or ceritinib is appropriate: hint for a minor additional benefit
Patients for whom therapy with docetaxel or pemetrexed or ceritinib is not appropriate: no additional benefit proved

› Alecitinib (new indication: first-line treatment NSCLC)

Subject:

Active Substance: Alecitinib
Name: Alecensa^©
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Roche Pharma GmbH

Time table:

Start: 01.01.2018
Final decision by G-BA: 21.06.2018

Final decision:

Hint for a non-quantifiable additional benefit

› Alipogene tiparvovec

Subject:

Active Substance: Alipogene tiparvovec
Name: Glybera^®
Therapeutic area: Hyperlipoproteinemia Type I
Pharmaceutical company: Chiesi GmbH

Time table:

Start: 01.11.2014
Final decision by G-BA: 21.05.2015
The decision remains valid until: 31.12.2017

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Alirocumab

Subject:

Active Substance: Alirocumab
Name: Praluent^®
Therapeutic area: Dyslipidaemia
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.11.2015
Final decision by G-BA: 04.05.2016

Final decision:

No additional benefit proved

› Alirocumab (re-assessment according to §14)

Subject:

Active Substance: Alirocumab
Name: Praluent^®
Therapeutic area: Hypercholesterolemia
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.11.2018
Final decision by G-BA: 02.05.2019

Final decision:

a) patients who are eligible for statins

a1) without known CV disease: No additional benefit proved.
a2) with known CV disease: No additional benefit proved.

b) patients who are intolerant or contraindicated for statins: No additional benefit proved.

b1) without known CV disease: No additional benefit proved.
b2) with known CV disease: No additional benefit proved.

› Aliskiren/ amlodipine

Subject:

Active Substance: Aliskiren/ amlodipine
Name: Rasilamlo^®
Therapeutic area: Essential hypertension
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.05.2011
Final decision by G-BA: 03.05.2012

Final decision:

No additional benefit proved

› Allogeneic, genetically modified T cells

Subject:

Active Substance: Allogeneic, genetically modified T cells
Name: Zalmoxis^©
Therapeutic area: Haematopoietic stem cell transplantation (HSCT), graft-versus-host disease (GvHD)
Pharmaceutical company: Dompé farmaceutici S.p.A.

Time table:

Start: 15.01.2018
Final decision by G-BA: 05.07.2018
The decision remains valid until: 01.04.2021

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Alpelisib (breast cancer, PIK3CA-mutation, pre-treated patients, combination with fulvestrant)

Subject:

Active Substance: Alpelisib
Name: Piqray^®
Therapeutic area: Breast cancer
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

A1) Postmenopausal women with progress after (neo)adjuvant endocrine monotherapy without lung or liver metastasis: Indication for less benefit
A2) Postmenopausal women with progress after (neo)adjuvant endocrine monotherapy without lung or liver metastasis: No additional benefit proved
A2) Men with progress after (neo)adjuvant endocrine monotherapy: No additional benefit proved
B1) Postmenopausal women with progress after endocrine monotherapy in locally advanced setting or metastasized stage: Indication for less benefit
B2) Men with progress after endocrine monotherapy in locally advanced setting or metastasized stage: No additional benefit proved

› Amikacin sulfate (liposomal) (lung infection caused by Mycobacterium avium Complex (MAC))

Subject:

Active Substance: Amikacin sulfate
Name: Arikayce liposomal^®
Therapeutic area: MAC lung infection
Pharmaceutical company: Insmed Germany GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Andexanet alfa

Subject:

Active Substance: Andexanet alfa
Name: Ondexxya^®
Therapeutic area: Stopping of bleeding due to anticoagulants
Pharmaceutical company: Portola Deutschland GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020
This decision remains valid until: 01.11.2023

Final decision:

No additional benefit proved

› Apalutamide [repealed]

Subject:

Active Substance: Apalutamide
Name: Erleada^®
Therapeutic area: Prostatic Neoplasms
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.02.2019
Final decision by G-BA: 01.08.2019
The decision remains valid until: 01.04.2020

Final decision:

Hint for minor additional benefit

› Apalutamide (new indication: hormone-sensitive prostate cancer (mHSPC), combination with androgen deprivation therapy)

Subject:

Active Substance: Apalutamide
Name: Erleada^®
Therapeutic area: Prostatic Neoplasms (mHSPC)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.03.2020
Final decision by G-BA: 20.08.2020

Final decision:

No additional benefit proven

› Apalutamide (re-assessment: prostate cancer, non-metastatic, high risk of developing metastatic disease)

Subject:

Active Substance: Apalutamide
Name: Erleada^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.04.2020
Final decision by G-BA: 01.10.2020

Final decision:

Indication for a minor additional benefit

› Apixaban

Subject:

Active Substance: Apixaban
Name: Eliquis^®
Therapeutic area: Prophylaxis of thromboembolic events after total hip or knee replacement surgery
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.06.2011
Final decision by G-BA: 07.06.2012

Final decision:

Patients who have undergone elective knee replacement surgery: No additional benefit proved
Patients who have undergone elective hip replacement surgery: Hint for minor additional benefit

› Apixaban (new indication: prevention of stroke and systemic embolism)

Subject:

Active Substance: Apixaban
Name: Eliquis^®
Therapeutic area: Prevention of stroke and systemic embolism
Company: Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH

Time table:

Start: 01.01.2013
Final decision by G-BA: 20.06.2013

Final decision:

Prevention of stroke and systemic embolism

› Apixaban

Subject:

Active Substance: Apixaban
Name: Eliquis^®
Therapeutic area: Treatment and prevention of recurrent vein thrombosis and pulmonary embolism
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA / Pfizer Deutschland GmbH

Time table:

Start: 01.09.2014
Final decision by G-BA: 19.02.2015

Final decision:

Treatment: Indication of a minor additional benefit
Prophylaxis: No additional benefit proved

› Apremilast

Subject:

Active Substance: Apremilast
Name: Otezla^®
Therapeutic area: Psoriatic arthritis and psoriasis
Pharmaceutical company: Celgene GmbH

Time table:

Start: 15.02.2015
Final decision by G-BA: 06.08.2015

Final decision:

Psoriatic arthritis: No additional benefit proved
Psoriasis: No additional benefit proved

› Apremilast (new indication: Behçet’s disease)

Subject:

Active Substance: Apremilast
Name: Otezla^®
Therapeutic area: Behçet’s disease
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision:

No additional benefit proved

› Asfotase alfa (hypophospatasia)[repealed]

Subject:

Active Substance: Asfotase alfa
Name: Strensiq^®
Therapeutic area: Hypophosphatasia
Pharmaceutical company: Alexion Europe SAS

Time table:

Start: 01.10.2015
Final decision by G-BA: 17.03.2016

Final decision:

Patients aged ≤ 5 years: Non-quantifiable additional benefit proved (because of orphan drug status)
Patients aged > 5 years: Non-quantifiable additional benefit proved (because of orphan drug status)

› Asfotase alfa (re-assessment, 50 M € limit exceeded: long-term enzyme replacement therapy for hypophosphatasia)

Subject:

Active Substance: Asfotase alfa
Name: Strensiq^®
Therapeutic area: Hypophosphatasia
Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

Start: 15.10.2019
Final decision by G-BA: 02.04.2020

Final decision:

Infants (younger than 5 years) with perinatal or infantile hypophosphatasia (onset of disease until 6 months of age): hint for a non-quantifiable additional benefit
Infants (younger than 5 years) with juvenile hypophosphatasia (onset of disease after 6 months of age): no additional benefit proved
Children (older than 5 years), adolescents, or adults with perinatal, infantile or juvenile hypophosphatasia (onset of disease until 18 years of age): no additional benefit proved

› Ataluren [repealed]

Subject:

Active Substance: Ataluren
Name: TranslarnaTM
Therapeutic area: Muscular Dystrophy, Duchenne
Pharmaceutical company: PTC Therapeutics International Limited

Time table:

Start: 01.12.2014
Final decision by G-BA: 21.05.2015
Muscular dystrophy, Duchenne

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Ataluren (re-assessment)

Subject:

Active Substance: Ataluren (re-assessment)
Name: TranslarnaTM
Therapeutic area: Muscular dystrophy, Duchenne
Pharmaceutical company: PTC Therapeutics International Limited

Time table:

Start: 01.06.2016
Final decision by G-BA: 01.12.2016

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Atezolizumab (indication: urothelial carcinoma)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^©
Therapeutic area: Urothelial carcinoma (UC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.10.2017
Final decision by G-BA: 16.03.2018

Final decision:

Patients for whom a cisplatin-based chemotherapy is inappropriate (first-line): no additional benefit proved
Patients with prior platin-based therapy: hint for a minor additional benefit

› Atezolizumab (indication: non-small cell lung carcinoma)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^©
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.10.2017
Final decision by G-BA: 16.03.2018

Final decision:

Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is indicated: indication for a considerable additional benefit
Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is not indicated: no additional benefit proved

› Atezolizumab (re-assessment accord. to §13: urothelial cancer (PD-L1 expression ≥ 5%, 1^st line))

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Urothelial cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.01.2019
Final decision by G-BA: 20.06.2019

Final decision:

No additional benefit proved.

› Atezolizumab (new indication: ES-SCLC, 1st line in combination with carboplatin and etoposide, maintenance treatment)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Small cell lung cancer (SCLC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.10.2019
Final decision by G-BA: 02.04.2020

Final decision:

Hint for a minor additional benefit

› Atezolizumab (new indication: non-squamous NSCLC, 1^st line in combination with nab-paclitaxel and carboplatin)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.10.2019
Final decision by G-BA: 02.04.2020

Final decision:

Patients with tumor proportion score (TPS ≥ 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors: no additional benefit proved
Patients with TPS < 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors: no additional benefit proved

› Atezolizumab (new indication: non-squamous NSCLC, 1^st line in combination with bevacizumab, paclitaxel and carboplatin)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.10.2019
Final decision by G-BA: 02.04.2020

Final decision:

Patients with tumor proportion score (TPS ≥ 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors (first-line therapy): no additional benefit proved
Patients with TPS < 50% (PD-L1 expression)(first-line therapy) or EGFR mutant or ALK-positive tumors after prior mutation-directed therapy: no additional benefit proved

› Atezolizumab (new indication: triple-negative breast cancer, PD-L1 ≥ 1 %)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.10.2019
Final decision by G-BA: 02.04.2020

Final decision:

Hint for non-quantifiable additional benefit

› Atezolizumab (new indication: hepatocellular carcinoma, in combination with bevacizumab)

Subject:

Active Substance: Atezolizumab
Name: Tecentriq^®
Therapeutic area: Hepatocellular carcinoma (HCC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

a) Patients with HCC with Child-Pugh A or no liver cirrhosis without prior systemic therapy: indication for a considerable additional benefit
b) Patients with HCC with Child-Pugh B without prior systemic therapy: no additional benefit proved

› Avelumab (Merkel cell carcinoma) [repealed]

Subject:

Active Substance: Avelumab
Name: Bavencio^©
Therapeutic area: Merkel cell carcinoma (MCC)
Pharmaceutical company: Merck Serono GmbH/ Pfizer Pharma GmbH

Time table:

Start: 01.10.2017
Final decision by G-BA: 16.03.2018

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Avelumab (new indication: renal cell carcinoma, 1^st line, combination with axitinib)

Subject:

Active Substance: Avelumab
Name: Bavencio^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Merck Serono GmbH / Pfizer Pharma GmbH

Time table:

Start: 01.12.2019
Final decision by G-BA: 14.05.2020

Final decision:

Patients with treatment-naive, advanced renal cell carcinoma with favourable or intermediate risk profile (IMDC score 0–2): No additional benefit proved
Patients with treatment-naive, advanced renal cell carcinoma with unfavourable risk profile (IMDC score ≥3): Hint for a considerable additional benefit

› Avelumab (assessment due to loss of orphan drug status: Merkel cell carcinoma (MCC))

Subject:

Active Substance: Avelumab
Name: Bavencio^®
Therapeutic area: Merkel cell carcinoma
Pharmaceutical company: Merck Serono GmbH

Time table:

Start: 01.04.2020
Final decision by G-BA: 01.10.2020

Final decision:

No additional benefit proved

› Avelumab (new indication: urothelial carcinoma, 1^st line)

Subject:

Active Substance: Avelumab
Name: Bavencio^®
Therapeutic area: Urothelial carcinoma
Pharmaceutical company: Merck Serono GmbH and Pfizer Pharma GmbH

Time table:

Start: 01.03.2021
Final decision by G-BA: 19.08.2021

Final decision:

Hint for a considerable additional benefit

› Avapritinib (gastrointestinal stromal tumors (GIST))

Subject:

Active Substance: Avapritinib
Name: Ayvakyt^®
Therapeutic area: Gastrointestinal stromal tumors (GIST)
Pharmaceutical company: Blueprint Medicines (Germany) GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Avatrombopag (thrombocytopenia with chronic liver disease)

Subject:

Active Substance: Avatrombopag
Name: Doptelet^®
Therapeutic area: Thrombocytopenia with chronic liver disease
Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

No additional benefit proved

› Avatrombopag (immune thrombocytopenia (ITP))

Subject:

Active Substance: Avatrombopag
Name: Doptelet^®
Therapeutic area: Immune thrombocytopenia
Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

No additional benefit proved

› Axitinib [repealed]

Subject:

Active Substance: Axitinib
Name: Inlyta^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Pfizer GmbH

Time table:

Start: 01.10.2012
Final decision by G-BA: 21.03.2013
The decision remains valid until: 21.03.2017

Final decision:

Patients pre-treated with cytokines: Hint for a minor additional benefit
Patients pre-treated with sunitinib: No additional benefit proved

› Axitinib (re-assessment)

Subject:

Active Substance: Axitinib
Name: Inlyta^©
Therapeutic area: Renal cell carcinoma (RCC)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.04.2017
Final decision by G-BA: 21.09.2017

Final decision:

After first-line therapy with sunitinib: additional benefit not proved
After first-line therapy with a cytokine: hint for a minor additional benefit

› Axicabtagen-Ciloleucel (DLBCL)

Subject:

Active Substance: Axicabtagene ciloleucel
Name: YESCARTA^®
Therapeutic area: Lymphoma
Pharmaceutical company: Kite, a Gilead Company

Time table:

Start: 01.11.2018
Final decision by G-BA: 02.05.2019
This decision remains valid until: 15.05.2022

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Axicabtagen-Ciloleucel (PMBCL)

Subject:

Active Substance: Axicabtagene ciloleucel
Name: YESCARTA^®
Therapeutic area: Lymphoma
Pharmaceutical company: Kite, a Gilead Company

Time table:

Start: 01.11.2018
Final decision by G-BA: 02.05.2019
This decision remains valid until: 15.05.2022

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Azilsartan medoxomil (as a calcium salt)

Subject:

Active Substance: Azilsartan medoxomil (as a calcium salt)
Name: Edarbi^®
Therapeutic area: Hypertension
Pharmaceutical company: Takeda Pharma GmbH

Time table:

Start: 15.01.2012
Final decision by G-BA: 15.03.2012

Final decision:

No additional benefit proved
Takeda Pharma GmbH submitted no dossier
Edarbi^® is allocated to the reference price group for angiotensin II receptor antagonists

B

› Baloxavir marboxil (influenza, post-exposure prophylaxis, ≥ 12 years of age)

Subject:

Active Substance: Baloxavir marboxil
Name: Xofluza^®
Therapeutic area: Influenza
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.02.2021
Final decision by G-BA: 05.08.2021

Final decision:

Without risk for complications due to influenza: Indication for a considerable additional benefit
With risk for complications due to influenza: No additional benefit proved

› Baloxavir marboxil (influenza, ≥ 12 years of age)

Subject:

Active Substance: Baloxavir marboxil
Name: Xofluza^®
Therapeutic area: Influenza
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.02.2021
Final decision by G-BA: 05.08.2021

Final decision:

Without risk for complications due to influenza: No additional benefit proved
With risk for complications due to influenza: No additional benefit proved

› Baricitinib

Subject:

Active Substance: Active Substance: Baricitinib
Name: Olumiant^©
Therapeutic area: Rheumatoid arthritis
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.04.2017
Final decision by G-BA: 21.09.2017

Final decision:

Patients without unfavourable prognostic factors who have responded insufficiently to prior treatment with one DMARD (incl. MTX): no additional benefit proved
bDMARD-naive patients for whom a bDMARD therapy is indicated: no additional benefit proved
Patients who have responded insufficiently to or who have not tolerated prior bDMARD therapy: additional benefit not proved

› Baricitinib (new indication: atopic dermatitis)

Subject:

Active Substance: Baricitinib
Name: Olumiant^®
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.11.2020
Final decision by G-BA: 06.05.2021

Final decision:

No additional benefit proved

› Beclometasone / formoterol / glycopyrronium bromide (obligation for benefit assessment for the first time: asthma)

Subject:

Active Substance: Beclometasone / formoterol / glycopyrronium bromide
Name: Trimbow^®
Therapeutic area: Asthma
Pharmaceutical company: Chiesi GmbH

Time table:

Start: 15.02.2021
Final decision by G-BA: 05.08.2021

Final decision:

Patients who are insufficiently treated with a medium-dosed ICS / LABA therapy: No additional benefit proved
Patients who are insufficiently treated with a high-dosed ICS / LABA therapy: No additional benefit proved

› Bedaquiline (§ 15 VerfO: 1 Mio. € limit exceeded)

Subject:

Active Substance: Bedaquilin
Name: Sirturo^®
Therapeutic area: Tuberculosis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019
This decision remains valid until: 30.06.2021

Final decision:

Considerable additional benefit (proved because of orphan drug designation)

› Bedaquiline (new indication: pulmonary multidrug-resistant tuberculosis (MDR-TB), 12 – <18 years)

Subject:

Active Substance: Bedaquiline
Name: Sirturo^®
Therapeutic area: Pulmonary multi-drug resistant tuberculosis (MDR-TB)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.02.2020
Final decision by G-BA: 20.08.2020

Final decision:

Hint for a non-quantifiable additional benefit due to limited scientific evidence (and orphan drug status)

› Bedaquiline (new indication: multidrug-resistant pulmonary tuberculosis (MDR-TB), patients aged 5-11 years)

Subject:

Active Substance: Bedaquiline
Name: Sirturo^®
Therapeutic area: Tuberculosis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Belantamab mafodotin (multiple myeloma, at least 4 prior therapies, monotherapy)

Subject:

Active Substance: Belantamap mafodotin
Name: Blenrep^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.09.2020
Final decision by G-BA: 17.11.2022
This decision remains valid until: 01.04.2023

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Belatacept [repealed]

Subject:

Active Substance: Belatacept
Name: Nulojix^®
Therapeutic area: Kidney transplatation
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.07.2011
Final decision by G-BA: 05.07.2012
The decision remains valid until: 05.07.2015

Final decision:

Indication for a minor additional benefit

› Belatacept (re-assessment)

Subject:

Active Substance: Belatacept
Name: Nulojix^®
Therapeutic area: Kidney transplantation, graft rejection
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.07.2015
Final decision by G-BA: 07.01.2016

Final decision:

Indication for a considerable additional benefit.

› Belimumab

Subject:

Active Substance: Belimumab
Name: Benlysta ^®
Therapeutic area: Systemic lupus erythematosus (SLE)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 27.07.2011
Final decision by G-BA: 02.08.2012

Final decision:

Indication for a considerable additional benefit

› Belimumab (new indication: systemic lupus erythematosus 5 - < 18 years)

Subject:

Active Substance: Belimumab
Name: Benlysta^®
Therapeutic area: Systemic lupus erythematosus (SLE)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.11.2019
Final decision by G-BA: 14.05.2020

Final decision:

Hint for a non-quantifiable additional benefit

› Bempedoic acid / ezetimibe (primary hypercholersterolaemia and mixed dyslipidaemia)

Subject:

Active Substance: Bempedoic acid / ezetimibe
Name: Nustendi^®
Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
Pharmaceutical company: Daiichi Sankyo Deutschland GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
no additional benefit proved

› Bempedoic acid (primary hypercholersterolaemia and mixed dyslipidaemia)

Subject:

Active Substance: Bempedoic acid
Name: Nilemdo^®
Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
Pharmaceutical company: Daiichi Sankyo Deutschland GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
no additional benefit proved

› Benralizumab

Subject:

Active Substance: Benralizumab
Name: Fasenra^©
Therapeutic area: Asthma
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.02.2018
Final decision by G-BA: 02.08.2018

Final decision:

a) Pre-treated patients who have not exhausted further therapy options: No additional benefit proved
b) Pre-treated patients who have exhausted all therapy options: Hint for a minor additional benefit

› Betibeglogene autotemcel (CD34+ haematopoetic stem cells) (β-thalassaemia)

Subject:

Active Substance: Betibeglogene autotemcel (CD34+ haematopoetic stem cells)
Name: Zynteglo^TM
Therapeutic area: β-thalassaemia
Pharmaceutical company: bluebird bio (Germany) GmbH

Time table:

Start: 15.11.2019
Final decision by G-BA: 14.05.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Bezlotoxumab

Subject:

Active Substance: Bezlotoxumab
Name: Zinplava^©
Therapeutic area: Clostridium difficile infection
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.04.2018
Final decision by G-BA: 20.09.2018

Final decision:

Indication for a minor additional benefit

› Bictegravir/ emtricitabine/ tenofovir alafenamide

Subject:

Active Substance: Bictegravir/ emtricitabine/ tenofovir alafenamide
Name: Biktarvy^©
Therapeutic area: HIV infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.07.2018
Final decision by G-BA: 10.12.2018

Final decision:

Therapy-naive patients: no additional benefit proved.
Pre-treated patients: no additional benefit proved.

› Binimetinib

Subject:

Active Substance: Binimetinib
Name: Mektovi^®
Therapeutic area: Melanoma
Pharmaceutical company: Pierre Fabre Pharma GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Treatment-naïve patients: No additional benefit proved.
Pre-treated patients: No additional benefit proved.

› Blinatumomab [repealed]

Subject:

Active Substance: Blinatumomab
Name: Blincyto^®
Therapeutic area: Acute lymphatic leucaemia (ALL)
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.12.2015
Final decision by G-BA: 02.06.2016

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Blinatumumab (re-assessment)

Subject:

Active Substance: Blinatumumab
Name: Blincyto^©
Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.06.2017
Final decision by G-BA: 07.12.2017

Final decision:

Considerable additional benefit proven (because of orphan drug status)

› Blinatumomab (new indication: ALL, MRD-positive patients)

Subject:

Active Substance: Blinatumomab (new indication: ALL, MRD-positive patients)
Name: Blincyto^®
Therapeutic area: Acute lymphoblastic leukaemia (ALL)
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.02.2019
Final decision by G-BA: 15.08.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Blinatumomab (new indication: ALL, pediatric patients)

Subject:

Active Substance: Blinatumomab (new indication: ALL, pediatric patients)
Name: Blincyto^®
Therapeutic area: Acute lymphoblastic leukaemia (ALL)
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.02.2019
Final decision by G-BA: 15.08.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Blinatumomab (B-precursor acute lymphoblastic leukaemia (ALL), relapsed or refractory, Ph+ CD19+)

Subject:

Active Substance: Blinatumomab
Name: Blincyto^®
Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
Pharmaceutical company: Amgen GmbH

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Boceprevir

Subject:

Active Substance: Boceprevir
Name: Victrelis^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 01.09.2011
Final decision by G-BA: 01.03.2012

Final decision:

Indication for a non-quantifiable additional benefit

› Bosutinib [repealed]

Subject:

Active Substance: Bosutinib
Name: Bosulif^®
Therapeutic area: Chronic myelogenous leukaemia
Company: Pfizer Pharma GmbH

Time table:

Start: 01.05.2013
Final decision by G-BA: 17.10.2013
The decision remains valid until: 15.10.2018

Final decision:

Non-quantifiable additional benefit

› Bosutinib (new indication: newly diagnosed chronic myeloid leukemia)

Subject:

Active Substance: Bosutinib
Name: Bosulif^®
Therapeutic area: Chronic myeloid leukemia (CML)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.06.2018
Final decision by G-BA: 22.11.2018

Final decision:

No additional benefit proved

› Bosutinib (repeal of orphan drug designation)

Subject:

Active Substance: Bosutinib
Name: Bosulif^®
Therapeutic area: Chronic myeloid leukemia (CML)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.09.2018
Final decision by G-BA: 21.02.2019

Final decision:

Patients in chronic disease phase: no additional benefit proved
Patients in accelerated disease phase and in blast crisis: no additional benefit proved

› Brentuximab vedotin

Subject:

Active Substance: Brentuximab vedotin
Name: Adcetris^®
Therapeutic area: Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (sALCL)
Pharmaceutical company: Takeda Pharma Vertrieb GmbH & Co. KG

Time table:

Start: 01.12.2012
Final decision by G-BA: 16.05.2013

Final decision:

Non-quantifiable additional benefit

› Brentuximab vedotin (new indication: patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following ASCT)

Subject:

Active Substance: Brentuximab vedotin
Name: Adcetris^®
Therapeutic area: Hodgkin lymphoma (HL)
Pharmaceutical company: Takeda GmbH

Time table:

Start: 01.08.2016
Final decision by G-BA: 19.01.2017

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Brentuximab vedotin (new indication: CD30+ CTCL)

Subject:

Active Substance: Brentuximab vedotin
Name: Adcetris^©
Therapeutic area: Non-Hodgkin lymphoma, CD30+ cutaneous T-cell lymphoma (CTCL)
Pharmaceutical company: Takeda GmbH

Time table:

Start: 15.01.2018
Final decision by G-BA: 05.07.2018

Final decision:

Minor additional benefit (proven because of orphan drug designation)

› Brentuximab vedotin (new indication: Hodgkin’s lymphoma, 1^st line)

Subject:

Active Substance: Brentuximab vedotin
Name: Adcetris^®
Therapeutic area: Hodgkin’s lymphoma
Pharmaceutical company: Takeda GmbH & Co. KG

Time table:

Start: 15.03.2019
Final decision by G-BA: 05.09.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Brentuximab vedotin (new indication: systemic anaplastic large cell lymphoma (sALCL); 1^st line; combination with cyclophosphamide, doxorubicin and prednisone

Subject:

Active Substance: Brentuximab vedotin
Name: Adcetris^®
Therapeutic area: Non-Hodgkin lymphoma
Pharmaceutical company: Takeda GmbH

Time table:

Start: 15.06.2020
Final decision by G-BA: 03.12.2020
This decision remaims valid until: 01.07.2021

Final decision:

Hint for a minor additional benefit

› Brigatinib

Subject:

Active Substance: Brigatinib
Name: Alunbrig^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Takeda GmbH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019

Final decision:

No additional benefit proved

› Brigatinib (new indication: non-small cell lung cancer (NSCLC), ALK+, 1^st line)

Subject:

Active Substance: Brigatinib
Name: Alunbrig^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Takeda GmbH

Time table:

Start: 01.05.2020
Final decision by G-BA: 15.10.2020

Final decision:

a. Patients with brain metastasis: Hint for a considerable additional benefit
b. Patients without brain metastasis: Hint for minor additional benefit

› Brivaracetam

Subject:

Active Substance: Brivaracetam
Name: Briviact^®
Therapeutic area: Epilepsy
Pharmaceutical company: UCB Pharma GmbH

Time table:

Start: 15.02.2016
Final decision by G-BA: 04.08.2016

Final decision:

No additional benefit proved.

› Brivaracetam (new indication: epilepsy, patients 4 years and older)

Subject:

Active Substance: Brivaracetam
Name: Briviact^®
Therapeutic area: Epilepsy
Pharmaceutical company: UCB Pharma GmbH

Time table:

Start: 01.08.2018
Final decision by G-BA: 17.01.2019

Final decision:

No additional benefit proved

› Brodalumab

Subject:

Active Substance: Brodalumab
Name: Kyntheum^©
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Leo Pharma GmbH

Time table:

Start: 01.09.2017
Final decision by G-BA: 01.03.2018

Final decision:

Patients who are candidates for systemic therapy: additional benefit not proven
Patients whose response to other systemic therapies, including ciclosporin, methotrexate or PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: indication for a non-quantifiable additional benefit

› Brolucizumab (neovascular age-related macular degeneration (AMD))

Subject:

Active Substance: Brolucizumab
Name: Beovu^®
Therapeutic area: Neovascular age-dependent macular degeneration
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 03.09.2020
This decision remains valid until: 01.11.2023

Final decision:

No additional benefit proved

› Bromfenac

Subject:

Active Substance: Bromfenac
Name: Yellox^®
Therapeutic area: Postoperative ocular inflammation following cataract extraction
Pharmaceutical company: Bausch & Lomb/Dr. Mann Pharma

Time table:

Start: 01.08.2011
Final decision by G-BA: 19.01.2012

Final decision:

No additional benefit proved
Bausch & Lomb/Dr. Mann Pharma submitted no dossier or an incomplete dossier

› Bulevirtide (chronic hepatitis delta virus (HDV) infection, HDV-RNA-positive)

Subject:

Active Substance: Bulevirtide
Name: Hepcludex^®
Therapeutic area: Chronic hepatitis D
Pharmaceutical company: MYR GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021
The decision remains valid until: 01.06.2025

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Burosumab (X-chromosomal hypophosphataemia; patients aged ≥ 1 - ≤ 18 years) [repealed]

Subject:

Active Substance: Burosumab
Name: Crysvita^©
Therapeutic area: Hypophosphataemia
Pharmaceutical company: Kyowa Kirin GmbH

Time table:

Start: 15.04.2018
Final decision by G-BA: 04.10.2018
The decision remains valid until: 01.10.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Burosumab (re-assessment: x-linked hypophosphataemia in patients aged ≥ 1 - ≤ 18 years)

Subject:

Active Substance: Burosumab
Name: Crysvita^®
Therapeutic area: Hypophosphataemia
Pharmaceutical company: Kyowa Kirin GmbH

Time table:

Start: 01.10.2019
Final decision by G-BA: 02.04.2020

Final decision:

Hint for a non-quantifiable additional benefit (proven because of orphan drug designation). The evidence is not sufficient for a quantification of the additional benefit.

› Burosumab (new indication: X-linked hypophosphataemia, ≥ 18 years of age)

Subject:

Active Substance: Burosumab
Name: Crysvita^®
Therapeutic area: Hypophosphataemia
Pharmaceutical company: Kyowa Kirin GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a minor additional benefit (orphan drug designation)

C

› Cabazitaxel

Subject:

Active Substance: Cabazitaxel
Name: Jevtana^®
Therapeutic area: Prostate carcinoma
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.04.2011
Final decision by G-BA: 29.03.2012

Final decision:

Patients that have been previously treated with a docetaxel-containing regimen and for whom an additional treatment with docetaxel is not suitable: indication for a minor additional benefit
Patients that have been previously treated with a docetaxel-containing regimen and for whom an additional treatment with a docetaxel-containing regimen is suitable: no additional benefit proved

› Cabotegravir (HIV-1 infection, in combination with rilpivirine, for patients on a stable antiretroviral therapy)

Subject:

Active Substance: Cabotegravir
Name: Vocabria^®
Therapeutic area: HIV-1 infection
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.05.2021
Final decision by G-BA: 21.10.2021

Final decision:

No additional benefit proved

› Cabozantinib

Subject:

Active Substance: Cabozantinib
Name: Cometriq^®
Therapeutic area: Thyroid neoplasms
Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

Start: 01.08.2014
Final decision by G-BA: 22.01.2015
The decision remains valid until: 01.07.2021

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Cabozantinib (new indication: renal cell carcinoma) [repealed]

Subject:

Active Substance: Cabozantinib
Name: Cabometyx^®
Therapeutic area: Renal cell carcinoma (RCC)
Pharmaceutical company: Ipsen Pharma GmbH

Time table:

Start: 01.11.2016
Final decision by G-BA: 20.04.2017
The decision remains valid until: 15.10.2017

Final decision:

Hint for a non-quantifiable additional benefit

› Cabozantinib (new indication: 1^st line treatment)

Subject:

Active Substance: Cabozantinib (new indication: 1st line treatment)
Name: Cabometyx^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Ipsen Pharma GmbH

Time table:

Start: 15.06.2018
Final decision by G-BA: 06.12.2018
This decision remains valid until: 06.06.2019

Final decision:

No additional benefit proved

› Cabozantinib (re-assessment)

Subject:

Active Substance: Cabozantinib
Name: Cabometyx^©
Therapeutic area: Renal cell carcinoma (RCC)
Pharmaceutical company: Ipsen Pharma GmbH

Time table:

Start: 15.10.2017
Final decision by G-BA: 05.04.2018

Final decision:

Indication for a minor additional benefit

› Cabozantinib (new indication: HCC)

Subject:

Active Substance: Cabozantinib
Name: Cabometyx^®
Therapeutic area: Hepatocellular carcinoma (HCC)
Pharmaceutical company: Ipsen Pharma GmbH

Time table:

Start: 15.12.2018
Final decision by G-BA: 06.06.2019

Final decision:

Hint for a minor additional benefit

› Cabozantinib (new indication: renal cell carcinoma, in combination with nivolumab, 1^st line)

Subject:

Active Substance: Cabozantinib
Name: Cabometyx^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Ipsen Pharma GmbH

Time table:

Start: 01.05.2021
Final decision by G-BA: 21.10.2021

Final decision:

a) Patients with a favorable risk profile (IMDC-Score 0): No additional benefit proved
b) Treatment-naïve patients with advanced renal cell carcinoma with an intermediate (IMDC-Score 1–2) or unfavorable risk profile (IMDC-Score ≥ 3): No additional benefit proved

› Canagliflozin

Subject:

Active Substance: Canagliflozin
Name: Invokana^®
Therapeutic area: Type 2 diabetes mellitus
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.03.2014
Final decision by G-BA: 04.09.2014

Final decision:

No additional benefit proved

› Canagliflozin/Metformin

Subject:

Active Substance: Canagliflozin/Metformin
Name: Vokanamet^®
Therapeutic area: Type 2 diabetes mellitus
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.08.2014
Final decision by G-BA: 05.02.2015

Final decision:

No additional benefit proved.

› Cannabidiol (Dravet syndrome, patients ≥ 2 years of age, in conjunction with clobazam)

Subject:

Active Substance: Cannabidiol
Name: Epidyolex^®
Therapeutic area: Dravet syndrome
Pharmaceutical company: GW Pharmaceuticals plc

Time table:

Start: 15.10.2019
Final decision by G-BA: 02.04.2020
The decision remains valid until: 15.10.2020

Final decision:

Hint for a non-qunantifiable additional benefit (proven because of orphan drug designation). The evidence is not sufficient for a quantification of the additional benefit.

› Cannabidiol (Lennox-Gastaut syndrome, patients ≥ 2 years of age, in conjunction with clobazam)

Subject:

Active Substance: Cannabidiol
Name: Epidyolex^®
Therapeutic area: Lennox-Gastaut syndrome
Pharmaceutical company: GW Pharmaceuticals plc

Time table:

Start: 15.10.2019
Final decision by G-BA: 02.04.2020
The decision remains valid until: 15.10.2020

Final decision:

Hint for a non-qunantifiable additional benefit (proven because of orphan drug designation). The evidence is not sufficient for a quantification of the additional benefit.

› Cannabidiol (reassessment: Dravet syndrome, patients ≥ 2 years of age, in combination with clobazam)

Subject:

Active Substance: Cannabidiol
Name: Epidyolex^®
Therapeutic area: Dravet syndrome
Pharmaceutical company: GW Pharmaceuticals plc

Time table:

Start: 15.10.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a considerable additional benefit (orphan drug designation)

› Cannabidiol (reassessment: Lennox-Gastaut syndrome, patients ≥ 2 years of age, in combination with clobazam)

Subject:

Active Substance: Cannabidiol
Name: Epidyolex^®
Therapeutic area: Lennox-Gastaut syndrome
Pharmaceutical company: GW Pharmaceuticals plc

Time table:

Start: 15.10.2020
Final decision by G-BA: 15.04.2021

Final decision:

Hint for a considerable additional benefit (orphan drug designation)

› Caplacizumab

Subject:

Active Substance: Caplacizumab
Name: Cablivi^®
Therapeutic area: Acquired thrombotic thrombocytopenic purpura (aTTP)
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Caplacizumab (new indication: thrombotic thrombocytopenic purpura (aTTP), 12 to < 18 years)

Subject:

Active Substance: Caplacizumab
Name: Cablivi^®
Therapeutic area: Acquired thrombotic thrombocytopenic purpura (aTTP)
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.07.2020
Final decision by G-BA: 07.01.2021

Final decision:

Hint for a non-quantifiable additional benefit because the scientific data basis does not permit quantification (orphan drug)

› Carfilzomib [repealed]

Subject:

Active Substance: Carfilzomib
Name: Kyprolis^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.12.2015
Final decision by G-BA: 02.06.2016
The decision remains valid until: 31.12.2017

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Carfilzomib (new indication: multiple myeloma in combination with dexamethasone) [repealed]

Subject:

Active Substance: Carfilzomib
Name: Kyprolis^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Amgen GmbH

Time table:

Start: 01.08.2016
Final decision by G-BA: 19.01.2017

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Carfilzomib (re-assessment)

Subject:

Active Substance: Carfilzomib
Name: Kyprolis^©
Therapeutic area: Multiple myeloma
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.08.2017
Final decision by G-BA: 15.02.2018

Final decision:

In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit
In combination with dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit

› Carfilzomib (new indication: multiple myeloma; at least 1 prior treatment; combination with daratumumab and dexamethasone)

Subject:

Active Substance: Carfilzomib
Name: Kyprolis^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.01.2021
Final decision by G-BA: 15.07.2021

Final decision:

No additional benefit proved

› Cariprazine

Subject:

Active Substance: Cariprazine
Name: Reagila^©
Therapeutic area: Schizophrenia
Pharmaceutical company: Recordati Pharma GmbH

Time table:

Start: 15.04.2018
Final decision by G-BA: 04.10.2018

Final decision:

Acute treatment of schizophrenia: No additional benefit proved
Schizophrenia with predominantly negative symptoms in long term treatment: Hint for a minor additional benefit
Schizophrenia without predominantly negative symptoms in long term treatment: No additional benefit proved

› Autologous anti-CD19-transduced CD3+ cells (mantle cell lymphoma (MCL), pre-treated patients)

Subject:

Active Substance: Autologous anti-CD19-transduced CD3+ cells
Name: Tecartus^®
Therapeutic area: Mantle cell lymphoma (MCL)
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.02.2021
Final decision by G-BA: 05.08.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Ceftaroline fosamil

Subject:

Active Substance: Ceftaroline fosamil
Name: Zinforo^®
Therapeutic area: Other beta-lactam antibiotics
Company: AstraZeneca GmbH

Time table:

Start: Start: 14.05.2012
Final decision by G-BA: 03.05.2012

Final decision:

AstraZeneca GmbH is exempted from submitting a dossier as expected sales are below the legally defined threshold

› Ceftolozane / tazobactam (acute pyelonephritis) [repealed]

Subject:

Active Substance: Ceftolozane / tazobactam
Name: Zerbaxa^®
Therapeutic area: Acute pyelonephritis
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 17.09.2020

Final decision:

Aassessment repealed

› Ceftolozane / tazobactam (complicated urinary tract infections) [repealed]

Subject:

Active Substance: Ceftolozane / tazobactam
Name: Zerbaxa^®
Therapeutic area: Complicated urinary tract infections
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 17.09.2020

Final decision:

Assessment repealed

› Ceftolozane / tazobactam (complicated intra-abdominal infections) [repealed]

Subject:

Active Substance: Ceftolozane / tazobactam
Name: Zerbaxa^®
Therapeutic area: Complicated intra-abdominal infections
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 17.09.2020

Final decision:

Assessment repealed

› Ceftolozane / tazobactam (new indication: hospital-acquired pneumonia (HAP), incl. ventilator-associated pneumonia (VAP)) [repealed]

Subject:

Active Substance: Ceftolozane / tazobactam
Name: Zerbaxa^®
Therapeutic area: Nosocomial pneumonia
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 17.09.2020

Final decision:

Assessment repealed

› Cemiplimab

Subject:

Active Substance: Cemiplimab
Name: Libtayo^®
Therapeutic area: Cutaneous squamous cell carcinoma
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.08.2019
Final decision by G-BA: 06.02.2020

Final decision:

Patients who have not been treated with medicinal products yet: No additional benefit proved
Patients whose carcinoma has progressed after treatment with medicinal products: No additional benefit proved

› Cenegermin

Subject:

Active Substance: Cenegermin
Name: Oxervate^©
Therapeutic area: Keratitis
Pharmaceutical company: Dompé farmaceutici S.p.A.

Time table:

Start: 15.11.2017
Final decision by G-BA: 02.05.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Ceritinib [repealed]

Subject:

Active Substance: Ceritinib
Name: Zykadia^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.07.2015
Final decision by G-BA: 17.12.2015
The decision remains valid until: 01.10.2016

Final decision:

No additional benefit proved.

› Ceritinib (re-assessment)

Subject:

Active Substance: Ceritinib
Name: Zykadia^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Novartis Pharma Gm

Time table:

Start: 01.10.2016
Final decision by G-BA: 16.03.2017

Final decision:

Patients eligible for a therapy with docetaxel or pemetrexed: hint for a considerable additional benefit
Patients not eligible for a therapy with docetaxel or pemetrexed: no additional benefit proved

› Ceritinib (new indication: first-line)

Subject:

Active Substance: Certinib
Name: Zykadia^©
Therapeutic area: Non-small-cell lung carcinoma (NSCLC)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.08.2017
Final decision by G-BA: 01.02.2018

Final decision:

Additional benefit not proven

› Cerliponase alfa (neuronal ceroid lipofuscinosis type 2 (CLN2 disease)

Subject:

Active Substance: Cerliponase alfa
Name: Brineura^©
Therapeutic area: Neuronal ceroid lipofuscinosis type 2 (CLN2 disease)
Pharmaceutical company: BioMarin Deutschland GmbH

Time table:

Start: 01.07.2017
Final decision by G-BA: 21.12.2017
The decision remains valid until: 01.07.2022

Final decision:

Non-quantifiable additional benefit proven (because of orphan drug designation)

› Cholsäure

Subject:

Active Substance: Cholic acid
Name: Orphacol^®
Therapeutic area: Inborn errors in primary bile acid synthesis
Pharmaceutical company: Laboratoires CTRS

Time table:

Start: 15.05.2014
Final decision by G-BA: 06.11.2014

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Cladribine

Subject:

Active Substance: Cladribine
Name: Mavenclad^©
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Merck Serono GmbH

Time table:

Start: 01.12.2017
Final decision by G-BA: 17.05.2018

Final decision:

Patients who have not had a disease-modifying therapy yet: additional benefit not proved
Patients with highly active disease despite a disease-modifying therapy: additional benefit not proved

› Cobicistat

Subject:

Active Substance: Cobicistat
Name: Tybost^®
Therapeutic area: HIV infection
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.04.2014
Final decision by G-BA: 18.09.2014

Final decision:

No additional benefit proved because of the submission of an incomplete dossier

› Cobicistat (new indication: HIV infection, combination with atazanavir or darunavir, 12 - < 18 years)

Subject:

Active Substance: Cobicistat
Name: Tybost^®
Therapeutic area: HIV infection
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.04.2020
Final decision by G-BA: 01.10.2020

Final decision:

No additional benefit proved

› Cobimetinib

Subject:

Active Substance: Cobimetinib
Name: Cotellic^®
Therapeutic area: Melanoma
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.12.2015
Final decision by G-BA: 02.06.2016

Final decision:

Indication for a considerable additional benefit.

› Crizanlizumab (prevention of recurrent vaso-occlusive crises in sickle cell disease, patients aged ≥ 16 years)

Subject:

Active Substance: Crizanlizumab
Name: Adakevo^®
Therapeutic area: Sickle cell disease
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021
This decision remains valid until: 01.12.2025

Final decision:

Hint for a minor additional benefit

› Crizotinib [repealed]

Subject:

Active Substance: Crizotinib
Name: Xalkori^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 15.11.2012
Final decision by G-BA: 02.05.2013
The decision remains valid until: 01.07.2016

Final decision:

Patients for whom chemotherapy is indicated: hint for a considerable additional benefit
Patients for whom chemotherapy is not indicated: no additional benefit proved

› Crizotinib (new indication: non-small cell lung carcinoma (NSCLC)

Subject:

Active Substance: Crizotinib (new indication)
Name: Xalkori^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.01.2016
Final decision by G-BA: 16.06.2016

Final decision:

No additional benefit proved

› Crizotinib (re-assessment)

Subject:

Active Substance: Crizotinib (re-assessment)
Name: Xalkori^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 15.06.2016
Final decision by G-BA: 15.12.2016

Final decision:

Patients for whom chemotherapy is indicated: hint for a considerable additional benefit
Patients for whom chemotherapy is not indicated: no additional benefit proved

› Crizotinib (new indication: non-small cell lung carcinoma, ROS1 positive)

Subject:

Active Substance: Crizotinib
Name: Xalkori^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 16.03.2017

Final decision:

Therapy-naive patients with ROS1 positive advanced NSCLC: no additional benefit proved
Pre-treated patients with ROS1 positive advanced NSCLC: no additional benefit proved

D

› Dabrafenib

Subject:

Active Substance: Dabrafenib
Name: Tafinlar^®
Therapeutic area: Melanoma
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.10.2013
Final decision by G-BA: 03.04.2014
The decision remains valid until: 01.10.2017

Final decision:

No additional benefit proved

› Dabrafenib (new indication: melanoma in combination with trametinib)

Subject:

Active Substance: Dabrafenib
Name: Tafinlar^®
Therapeutic area: Melanoma
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 17.03.2016

Final decision:

Indication for a considerable additional benefit

› Dabrafenib (new indication: non-small cell lung carcinoma)

Subject:

Active Substance: Dabrafenib
Name: Tafinlar^©
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.05.2017
Final decision by G-BA: 16.10.2017

Final decision:

No additional benefit proved

› Dabrafenib (new indication: melanoma, in combination with trametinib, BRAF-V600 mutation, adjuvant therapy)

Subject:

Active Substance: Dabrafenib
Name: Tafinlar^®
Therapeutic area: Melanoma
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Indication for a considerable additional benefit

› Daclatasvir

Subject:

Active Substance: Daclatasvir
Name: Daklinza^®
Therapeutic area: Chronic hepatitis C virus (HCV) infection
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.09.2014
Final decision by G-BA: 19.02.2015

Final decision:

Therapy-naive patients without cirrhosis (genotype 1): hint for a minor additional benefit
Therapy-naive patients with compensated cirrhosis (genotype 1): no additional benefit proved
Pre-treated patients (genotype 1): no additional benefit proved
Genotype 3: no additional benefit proved
Genotype 4 in combination with sofosbuvir: no additional benefit proved
Genotype 4 in combination with peginterferon alfa and ribavirin (therapy-naive): hint for a considerable additional benefit
Genotype 4 in combination with peginterferon alfa and ribavirin (pre-treated): no additional benefit proved

› Dacomitinib

Subject:

Active Substance: Dacomitinib
Name: Vizimpro^®
Therapeutic area: Non-small cell lung cancer
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.05.2019
Final decision by G-BA: 17.10.2019

Final decision:

a) Adult patients with the activating EGFR mutations K858R or del19: No additional benefit proven
b) Adult patients with lother activating EGFR mutations than K858R or del19: No additional benefit proven

› Damoctocog alfa pegol

Subject:

Active Substance: Damoctocog alfa pegol
Name: Jivi^®
Therapeutic area: Hemophilia A
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.01.2019
Final decision by G-BA: 20.06.2019

Final decision by G-BA:

No additional benefit proved.

› Dapagliflozin [repealed]

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH

Time table:

Start: 15.12.2012
Final decision by G-BA: 06.06.2013

Final decision:

No additional benefit proved in four examined subgroups

› Dapagliflozin/ metformin (diabetes mellitus, type 2) [repealed]

Subject:

Active Substance: Dapagliflozin/ metformin
Name: Xigduo^®
Therapeutic area: Diabetes mellitus, type 2
Company: Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH

Time table:

Start: 15.02.2014
Final decision: 07.08.2014

Final decision:

No additional benefit proved

› Dapagliflozin (re-assessment accord. to § 14) [repealed]

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^©
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.01.2018
Final decision by G-BA: 21.06.2018

Final decision:

No additional benefit proved

› Dapagliflozin/ metformin (re-assessment accord. to § 14: diabetes mellitus, type 2) [repealed]

Subject:

Active Substance: Dapagliflozin/ metformin
Name: Xigduo^©
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.01.2018
Final decision by G-BA: 21.06.2018

Final decision:

No additional benefit proved

› Dapagliflozin (new indication: diabetes mellitus type 1)

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^®
Therapeutic area: Diabetes mellitus type 1
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.05.2019
Final decision by G-BA: 17.10.2019

Final decision:

Hint for a minor additional benefit

› Dapagliflozin (re-assessment accord. to § 14)

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.07.2019
Final decision by G-BA: 19.12.2019

Final decision:

Patients whose blood sugar is not sufficiently controlled by diet and exercise and who are not indicated for metformin due to intolerance:
a1) Patients with high CV risk: No additional benefit proved
a2) Patients without high CV risk: No additional benefit proved
Patients whose blood sugar is not sufficiently controlled by one other antidiabetic treatment (except insulin, here: metformin)
b1) Patients with high CV risk: Hint for a minor additional benefit
b2) Patients without high CV risk: No additional benefit proved
Patients whose blood sugar is not sufficiently controlled by at least two antidiabetic treatments (amongst metformin, except insulin)
c1) Patients with high CV risk: Hint for a minor additional benefit
c2) Patients without high CV risk: No additional benefit proved
Patients whose blood sugar is not sufficiently controlled by insulin (with another antidiabetic treatment, here: metformin)
d1) Patients with high CV risk: Hint for a minor additional benefit
d2) Patients without high CV risk: No additional benefit proved

› Dapagliflozin/metformin (re-assessment accord. to § 14)

Subject:

Active Substance: Dapagliflozin/metformin
Name: Xigduo^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.07.2019
Final decision by G-BA: 19.12.2019

Final decision:

Patients whose blood sugar is not sufficiently controlled by one other antidiabetic treatment (except insulin, here: metformin)
a1) Patients with high CV risk: Hint for a minor additional benefit
a2) Patients without high CV risk: No additional benefit proved
b) Patients whose blood sugar is not sufficiently controlled by at least two antidiabetic treatments (amongst metformin, except insulin)
b1) Patients with high CV risk: Hint for a minor additional benefit
b2) Patients without high CV risk: No additional benefit proved
c) Patients whose blood sugar is not sufficiently controlled by insulin (with another antidiabetic treatment, here: metformin)
c1) Patients with high CV risk: Hint for a minor additional benefit
c2) Patients without high risk: No additional benefit proved

› Dapagliflozin (new indication: chronic heart failure)

Subject:

Active Substance: Dapagliflozin
Name: Forxiga^®
Therapeutic area: Heart failure
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a considerable additional benefit

› Daratumumab [repealed]

Subject:

Active Substance: Daratumumab
Name: Darzalex^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.06.2016
Final decision by G-BA: 01.12.2016

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Daratumumab (re-assessment, 50 Mio. € limit exceeded: multiple myeloma, monotherapy; new indication: multiple myeloma, ≥ prior therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone)

Subject:

Active Substance: Daratumumab
Name: Darzalex^©
Therapeutic area: Multiple myeloma
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.08.2017
Final decision by G-BA: 15.02.2018
The decision remains valid until: 01.04.2022

Final decision:

In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who have received at least one prior therapy: hint for a considerable additional benefit
As monotherapy for patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy: additional benefit not proven

› Daratumumab (new indication: newly diagnosed multiple myeloma)

Subject:

Active Substance: Daratumumab
Name: Darzalex^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019
This decision remains valid until: 01.03.2022

Final decision:

Hint for a considerable additional benefit (orphan drug, €50 million sales already exceeded)

› Daratumumab (new indication: multiple myeloma, newly diagnosed, patients suitable for autologous stem cell transplant, combination with bortezomib, thalidomide, and dexamethasone)

Subject:

Active Substance: Daratumumab
Name: Darzalex^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.02.2020
Final decision by G-BA: 20.08.2020

Final decision:

Hint for a non-quantifiable additional benefit

› Daratumumab (new indication: multiple myeloma, newly diagnosed, patients not suitable for autologous stem cell transplant, combination with lenalidomide and dexamethasone)

Subject:

Active Substance: Daratumumab
Name: Darzalex^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.02.2020
Final decision by G-BA: 20.08.2020

Final decision:

Hint for a minor additional benefit

› Darolutamide (prostate cancer, non-metastatic, high risk for metastasis)

Subject:

Active Substance: Darolutamide
Name: Nubeqa^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.05.2020
Final decision by G-BA: 15.10.2020

Final decision:

Indication for a considerable additional benefit

› Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide

Subject:

Active Substance: Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Name: Symtuza^©
Therapeutic area: HIV infections
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2017
Final decision by G-BA: 16.03.2018

Final decision:

No additional benefit proved

› Darvadstrocel

Subject:

Active Substance: Darvadstrocel
Name: Alofisel^®
Therapeutic area: Rectal fistulas in adults with Morbus Crohn’s disease
Pharmaceutical company: Takeda Pharma Vertrieb GmbH & Co. KG

Time table:

Start: 01.06.2018
Final decision by G-BA: 22.11.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Dasabuvir

Subject:

Active Substance: Dasabuvir
Name: Exviera^®
Therapeutic area: Chronic hepatitis C virus (HCV) infection
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.02.2015
Final decision by G-BA: 16.07.2015

Final decision:

Therapy-naive patients without cirrhosis (genotype 1): indication for a considerable additional benefit
Therapy-naive patients with cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Pre-treated patients without cirrhosis (genotype 1a/1b): hint for a considerable additional benefit
Pre-treated patients with cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Therapy-naive and pre-treated patients with HIV coinfection (genotype 1a/1b): hint for a minor additional benefit

› Daunorubicin/ cytarabine

Subject:

Active Substance: Daunorubicin/ cytarabine
Name: Vyxeos^®
Therapeutic area: Acute myeloid leukaemia (AML)
Pharmaceutical company: Jazz Pharmaceuticals

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Considerable additional benefit (proved because of orphan drug designation)

› Decitabine

Subject:

Active Substance: Decitabine
Name: Dacogen^®
Therapeutic area: Myeloid leukaemia
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.11.2012
Final decision by G-BA: 02.05.2013

Final decision:

Minor additional benefit

› Dexmedetomidine hydrochloride

Subject:

Active Substance: Dexmedetomidine hydrochloride
Name: Dexdor^®
Therapeutic area: Conscious sedation
Pharmaceutical company: Orion Corporation

Time table:

Start: 13.07.2011
Final decision by G-BA: 18.08.2011

Final decision:

Orion Corporation is exempted from submitting a dossier as expected sales are below the legally defined threshold

› Dimethyl fumarate

Subject:

Active Substance: Dimethyl fumarate
Name: Tecfidera^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Biogen Idec GmbH

Time table:

Start: 01.05.2014
Final decision by G-BA: 16.10.2014

Final decision:

No additional benefit proved, because of inadequate statistical analysis

› Dimethyl fumarate (new indication: psoriasis)

Subject:

Active Substance: Dimethyl fumarate
Name: Skilarence^©
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2017
Final decision by G-BA: 16.03.2018

Final decision:

No additional benefit proved

› Dolutegravir

Subject:

Active Substance: Dolutegravir
Name: Tivicay^®
Therapeutic area: HIV infection
Company: ViiV Healthcare GmbH

Time table:

Start: 15.02.2014
Final decision: 07.08.2014

Final decision:

Therapy-naive adult patients: proof of a considerable additional benefit
Pre-treated patients: indication for a minor additional benefit
Adolescent patients: no additional benefit proved

› Dolutegravir (new indication: HIV, age 6 and older)

Subject:

Active Substance: Dolutegravir
Name: Tivicay^©
Therapeutic area: HIV infections
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.04.2017
Final decision by G-BA: 21.09.2017

Final decision:

Treatment-naive patients, from 6 to 12 years: no additional benefit proved
Pre-treated patients, from 6 to 12 years: no additional benefit proved

› Dolutegravir/ abacavir/ lamivudine

Subject:

Active Substance: Dolutegravir/ abacavir/ lamivudine
Name: Triumeq^®
Therapeutic area: HIV infections
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.10.2014
Final decision by G-BA: 19.03.2015

Final decision:

Pre-treated patients: no additional benefit proved
Therapy-naive adult patients: indication for a considerable additional benefit

› Dolutegravir/ rilpivirin

Subject:

Active Substance: Dolutegravir/ rilpivirin
Name: Juluca^®
Therapeutic area: HIV infection
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 15.06.2018
Final decision by G-BA: 06.12.2018

Final decision:

No additional benefit proved

› Dolutegravir / lamivudine

Subject:

Active Substance: Dolutegravir / lamivudine
Name: Dovato^®
Therapeutic area: HIV infection
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.08.2019
Final decision by G-BA: 06.02.2020

Final decision:

Therapy-naïve adults: No additional benefit proved
Pre-treated patients adults: No additional benefit proved
Therapy-naïve adolescents at the age of ≥ 12 years: No additional benefit proved
Pre-treated adolescent patients at the age of ≥ 12 years: No additional benefit proved

› Dolutegravir (new indication: HIV infection, children at the age of ≥ 4 weeks up to < 6 years)

Subject:

Active Substance: Dolutegravir
Name: Tivicay^®
Therapeutic area: HIV-1 infection
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021
This decision is limited until: 01.01.2023

Final decision:

Therapy-naïve children: No additional benefit proved
Pre-treated children: No additional benefit proved

› Doravirine

Subject:

Active Substance: Doravirine
Name: Pifeltro^®
Therapeutic area: HIV infection
Pharmaceutical company: MSD SHARH & DOHME GMBH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019

Final decision:

Therapy-naïve patients: no additional benefit proved
Pre-treated patients: no additional benefit proved

› Doravirine/ lamivudine/ tenofovir disoproxil

Subject:

Active Substance: Doravirine/ lamivudine/ tenofovir disproxil
Name: Delstrigo^®
Therapeutic area: HIV infection
Pharmaceutical company: MSD SHARH & DOHME GMBH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019

Final decision:

Therapy-naïve patients: no additional benefit proved
Pre-treated patients: no additional benefit proved

› Dulaglutide (diabetes mellitus, type 2) [repealed]

Subject:

Active Substance: Dulaglutid
Name: Trulicity^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.02.2015
Final decision by G-BA: 16.07.2015

Final decision:

Monotherapy: no additional benefit proved
Dual therapy (+ oral antidiabetic drug): no additional benefit proved
Triple therapy (+ 2 oral antidiabetic drugs): no additional benefit proved
Combination with Insulin (with or without oral antidiabetic drug): hint for a minor additional benefit

› Dulaglutide (re-assessment accord. to § 13: type 2 diabetes mellitus)

Subject:

Active Substance: Dulaglutide
Name: Trulicity^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.02.2020
Final decision by G-BA: 16.07.2020

Final decision:

Monotherapy
a) monotherapy: No additional benefit proved
Combination therapy
b) in combination with another antidiabetic (except for insulin, here: metformin): No additional benefit proved
c) in combination with two other antidiabetics (except for insulin): No additional benefit proved
d) in combination with insulin (with or w/o another antidiabetic):
d₁) patients without renal insufficiency: Hint for a minor additional benefit
d₂) patients with moderate or severe renal insufficiency (CKD 3 and 4): Hint for a minor additional benefit

› Dupilumab

Subject:

Active Substance: Dupilumab
Name: Dupixent^©
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.12.2017
Final decision by G-BA: 17.05.2018

Final decision:

Indication for a considerable additional benefit

› Dupilumab (new indication: asthma)

Subject:

Active Substance: Dupilumab
Name: Dupixent^®
Therapeutic area: Asthma
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Pre-treated adolescents (12–17 years): No additional benefit proved
Pre-treated adults: No additional benefit proved

› Dupilumab (new indication: atopic dermatitis, adolescents 12 years and older)

Subject:

Active Substance: Dupilumab
Name: Dupixent^®
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Hint for a non-quantifiable additional benefit

› Dupilumab (new indication: chronic rhinosinusitis with nasal polyposis (CRSwNP))

Subject:

Active Substance: Dupilumab
Name: Dupixent^®
Therapeutic area: Chronic rhinosinusitis with nasal polyposis (CRSwNP)
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.12.2019
Final decision by G-BA: 14.05.2020

Final decision:

Indication for a considerable additional benefit

› Dupilumab (new indication: atopic dermatitis, children aged 6-11 years)

Subject:

Active Substance: Dupilumab
Name: Dupixent^®
Therapeutic area: Atopic dermatitis
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.01.2021
Final decision by G-BA: 01.07.2021

Final decision:

Hint for a non-quantifiable additional benefit

› Durvalumab

Subject:

Active Substance: Durvalumab
Name: Imfinzi^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.10.2018
Final decision by G-BA: 04.04.2019

Final decision:

Hint for a considerable additional benefit

› Durvalumab (new indication: small-cell lung cancer (SCLC), 1^st line, combination with etoposide and either carboplatin or cisplatin

Subject:

Active Substance: Durvalumab
Name: Imfinzi^®
Therapeutic area: Small-cell lung cancer (SCLC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.10.2020
Final decision by G-BA: 01.04.2021

Final decision:

Hint for a minor additional benefit

E

› Edoxaban

Subject:

Active Substance: Edoxaban
Name: Lixiana^®
Therapeutic area: Prophylaxis of stroke and treatment and prophylaxis of venous thrombosis and pulmonary embolism
Pharmaceutical company: Daiichi Sankyo Deutschland GmbH

Time table:

Start: 01.08.2015
Final decision by G-BA: 21.01.2016

Final decision:

Prophylaxis of stroke and systemic embolism of adult patients with non-valvular atrial fibrillation (NVAF) and one or more risk factors: indication for a minor additional benefit
Treatment of deep venous thrombosis (TVT) and pulmonary embolism (LE) as well as prophylaxis of recurrent TVT and LE: no additional benefit proved

› Efmoroctocog alfa

Subject:

Active Substance: Efmoroctocog alfa
Name: Elocta^®
Therapeutic area: Hemophilia A
Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

Start: 01.01.2016
Final decision by G-BA: 16.06.2016

Final decision:

No additional benefit proved

› Eftrenonacog alfa

Subject:

Active Substance: Eftrenonacog alfa
Name: Alprolix^®
Therapeutic area: Hemophilia B
Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

Start: 15.06.2016
Final decision by G-BA: 15.12.2016

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Elbasvir/ grazoprevir

Subject:

Active Substance: Elbasvir/ grazoprevir
Name: Zepatier^®
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.12.2016
Final decision by G-BA: 15.06.2014

Final decision:

Genotype 1, Patients without cirrhosis or with compensated cirrhosis: no additional benefit proved
Genotype 4, Patients without cirrhosis or with compensated cirrhosis: no additional benefit proved

› Eliglustat

Subject:

Active Substance: Eliglustat
Name: Cerdelga^®
Therapeutic area: Gaucher disaese type 1 (GD1)
Pharmaceutical company: Genzyme GmbH

Time table:

Start: 01.04.2015
Final decision by G-BA: 01.10.2015

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Elosulfase alfa [repealed]

Subject:

Active Substance: Elosulfase alfa
Name: Vimizim^®
Therapeutic area: Mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA)
Pharmaceutical company: BioMarin Deutschland

Time table:

Start: 01.06.2014
Final decision by G-BA: 20.11.2014

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Elosulfase alfa (re-assessment)

Subject:

Active Substance: Elosulfase alfa (re-assessment)
Name: Vimizim^©
Therapeutic area: Mucopolysaccharidosis type IVA (Morquio A syndrome, MPS IVA)
Pharmaceutical company: BioMarin Deutschland GmbH

Time table:

Start: 15.09.2017
Final decision by G-BA: 16.03.2018

Final decision:

Minor additional benefit proven (because of orphan drug status)

› Elotuzumab

Subject:

Active Substance: Elotuzumab
Name: Empliciti^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Bristol-Meyers Squibb GmbH & Co. KGaA

Time table:

Start: 01.06.2016
Final decision by G-BA: 01.12.2016

Final decision:

Hint for a minor additional benefit

› Elotuzumab (new indication: multiple myeloma, in combination with pomalidomide and dexamethasone)

Subject:

Active Substance: Elotuzumab
Name: Empliciti^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.10.2019
Final decision by G-BA: 02.04.2020
The decision remains valid until: 01.07.2021

Final decision:

Hint for a considerable additional benefit

› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide

Subject:

Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Name: Genvoya^®
Therapeutic area: HIV infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.01.2016
Final decision by G-BA: 16.06.2016

Final decision:

Therapy-naïve adults: no additional benefit proved
Therapy-naïve patients older than 12 years: no additional benefit proved
Pre-treated adults: no additional benefit proved
Pre-treated patients older than 12 years: no additional benefit proved

› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide (new indication: patients of 6 years and older)

Subject:

Active Substance: Elvitegravir/ cobicistate/ emtricitabine/ tenofovir alafenamide
Name: Genvoya^©
Therapeutic area: HIV infection
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.01.2018
Final decision by G-BA: 05.07.2018

Final decision:

Treatment-naïve patients (age ≥ 6 years < 12 years): No additional benefit proved
Pre-treated patients (age ≥ 6 years < 12 years): No additional benefit proved

› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil

Subject:

Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil
Name: Stribild^©
Therapeutic area: HIV infection
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.11.2017
Final decision by G-BA: 02.05.2018

Final decision:

Additional benefit not proved

› Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate

Subject:

Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate
Name: Stribild^®
Therapeutic area: HIV infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.06.2013
Final decision by G-BA: 05.12.2013

Final decision:

No additional benefit proved

› Emicizumab

Subject:

Active Substance: Emicizumab
Name: Hemlibra^©
Therapeutic area: Hemophilia A
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.04.2018
Final decision by G-BA: 20.09.2018

Final decision:

Patients for whom exclusive on-demand treatment with bypassing products equals a patient-individual therapy: hint for a non-quantifiable additional benefit
Patients for whom another therapy equals a patient-individual therapy: no additional benefit proved.

› Emicizumab (new indication: hemophilia A without factor VIII inhibitors)

Subject:

Active Substance: Emicizumab
Name: Hemlibra^®
Therapeutic area: Hemophilia A
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.03.2019
Final decision by G-BA: 05.09.2019

Final decision:

No additional benefit proved

› Empagliflozin [repealed]

Subject:

Active Substance: Empagliflozin
Name: Jardiance^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.08.2014
Final decision by G-BA: 05.02.2015

Final decision:

No additional benefit proved

› Empagliflozin (re-assessment)

Subject:

Active Substance: Empagliflozin
Name: Jardiance^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 01.03.2016
Final decision by G-BA: 01.06.2016

Final decision:

Monotherapy (without cardiovascular disease): no additional benefit proved
Monotherapy (with cardiovascular disease): no additional benefit proved

Combination with metformin (without cardiovascular disease): hint for a minor additional benefit
Combination with metformin (with cardiovascular disease): hint for a considerable additional benefit

Combination with 1 other anti-diabetic medicinal product (except of metformin and insulin) (without cardiovascular disease): no additional benefit proved
Combination with 1 other anti-diabetic medicinal product (except of metformin and insulin) (with cardiovascular disease): hint for a considerable additional benefit

Combination with at least 2 other anti-diabetic medicinal products (without cardiovascular disease): no additional benefit proved
Combination with at least 2 other anti-diabetic medicinal products (with cardiovascular disease): hint for a considerable additional benefit

Combination with insulin (with or without oral anti-diabetic drug) (without cardiovascular disease): no additional benefit proved
Combination with insulin (with or without oral anti-diabetic drug) (with cardiovascular disease): hint for a considerable additional benefit

› Empagliflozin/ metformin

Subject:

Active Substance: Empagliflozin/ metformin
Name: Synjardy^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 01.03.2016
Final decision by G-BA: 01.06.2016

Final decision:

Monotherapy empagliflozin/metformin (with or without cardiovascular disease): no additional benefit proved
Combination with other anti-diabetic medicinal products (except of insulin) (with or without cardiovascular disease): no additional benefit proved
Combination with insulin (with or without cardiovascular disease): no additional benefit proved

› Empagliflozin / linagliptin

Subject:

Active Substance: Empagliflozin/linagliptin
Name: Glyxambi^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 01.06.2019
Final decision by G-BA: 22.11.2019

Final decision: No additional benefit proved

› Emtricitabine/ rilpivirine hydrochloride/ tenofovir disoproxil fumarate

Subject:

Active Substance: Emtricitabine/ rilpivirine hydrochloride/ tenofovir disoproxil fumarate
Name: Eviplera^®
Therapeutic area: HIV infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.01.2012
Final decision by G-BA: 05.07.2012

Final decision:

Proof of a minor additional benefit

› Emtricitabine/ rilpivirine hydrochloride/ tenofovir disoproxil fumarate (new indication: pre-treated patients infected with HIV-1 without mutations associated with resistance)

Subject:

Active Substance: Emtricitabine/ rilpivirine hydrochloride/ tenofovir disoproxil fumarate
Name: Eviplera^®
Therapeutic area: HIV-1 infection with viral load ≤ 100,000 HIV-1 RNA copies/mL without mutations associated with resistance
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.01.2014
Final decision by G-BA: 19.06.2014

Final decision:

No additional benefit proved

› Emtricitabine/ rilpivirine/ tenofovir alafenamide

Subject:

Active Substance: Emtricitabine/ rilpivirine/ tenofovir alafenamide
Name: Odefsey^®
Therapeutic area: HIV infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.07.2016
Final decision by G-BA: 05.01.2017

Final decision:

Therapy-naïve adults: no additional benefit proved
Therapy-naive patients, 12 years or older: no additional benefit proved
Pre-treated adults: no additional benefit proved
Pre-treated patients, 12 years or older: no additional benefit proved

› Emtricitabine / tenofovir alafenamide

Subject:

Active Substance: Emtricitabine / tenofovir alafenamide
Name: Descovy^®
Therapeutic area: HIV infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.05.2016
Final decision by G-BA: 03.11.2016

Final decision:

Therapy-naïve adults: no additional benefit proved.
Therapy-naïve teenagers (12 – 18 years): no additional benefit proved.
Pre-treated patients (≥ 12 years): no additional benefit proved.

› Encorafenib

Subject:

Active Substance: Encorafenib
Name: Braftovi^®
Therapeutic area: Melanoma
Pharmaceutical company: Pierre Fabre Pharma GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Treatment-naïve patients: No additional benefit proved.
Pre-treated patients: No additional benefit proved.

› Encorafenib (new indication: metastasized colorectal carcinoma (CRC) with BRAF-V600E mutation and previous systemic therapy)

Subject:

Active Substance: Encorafenib
Name: Braftovi^®
Therapeutic area: Colorectal carcinoma (CRC)
Pharmaceutical company: Pierre Fabre Pharma GmbH

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

Hint for a considerable additional benefit

› Entrectinib (NSCLC, ROS1-positive, advanced, 1^st line)

Subject:

Active Substance: Entrectinib
Name: Rozlytrek^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021
This decision remains valid until: 31.12.2027

Final decision:

No additional benefit proved

› Entrectinib (solid tumors, neurotrophin tyrosine receptor kinase (NTRK) gene fusion, histology-independent)

Subject:

Active Substance: Entrectinib
Name: Rozlytrek^®
Therapeutic area: Tumors with neurotrophin tyrosine receptor kinase (NTRK) gene fusion
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

No additional benefit proved

› Enzalutamide

Subject:

Active Substance: Enzalutamide
Name: Xtandi^®
Therapeutic area: Prostate cancer
Company: Astellas Pharma GmbH

Time table:

Start: 01.09.2013
Final decision by G-BA: 20.02.2014

Final decision:

Indication for a considerable additional benefit

› Enzalutamide (new indication: prostate cancer after failure of androgen deprivation therapy and prior to chemotherapy)

Subject:

Active Substance: Enzalutamide
Name: XtandiTM
Therapeutic area: Prostate cancer
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: 01.01.2015
Final decision by G-BA: 18.06.2015

Final decision:

Indication for a considerable additional benefit

› Enzalutamide (new indication: non-metastatic castration-resistant prostate cancer) [repealed]

Subject:

Active Substance: Enzalutamide
Name: Xtandi^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: : 01.12.2018
Final decision by G-BA: 16.05.2019
This decision remains valid until: 15.05.2020

Final decision:

Additional benefit not proved

› Enzalutamide (re-assessment: prostate cancer, non-metastatic, high risk)

Subject:

Active Substance: Enzalutamide
Name: Xtandi^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision:

Indication for a minor additional benefit

› Erenumab

Subject:

Active Substance: Erenumab
Name: Aimovig^®
Therapeutic area: Migraine
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.11.2018
Final decision by G-BA: 02.05.2019

Final decision:

a) Treatment-naïve patients and patients who failed treatment with at least one medication: No additional benefit proved.
b) Patients who are not eligible for the following therapies/substance classes (metoprolol or propranolol or flunarizine or topiramate or amitriptyline): No additional benefit proved.
c) Patients who are not eligible for any of the following therapies/substance classes (metoprolol or propranolol or flunarizine or topiramate or amitriptyline or valproic acid or clostridium botulinum toxin type A): Hint for considerable additional benefit.

› Erenumab (new scientific evidence (§ 14): migraine prophylaxis)

Subject:

Active Substance: Erenumab
Name: Aimovig^®
Therapeutic area: Migraine prophylaxis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.05.2021
Final decision by G-BA: 21.10.2021

Final decision:

Hint for a considerable additional benefit

› Eribulin [repealed]

Subject:

Active Substance: Eribulin
Name: Halaven^®
Therapeutic area: Breast cancer
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.05.2011
Final decision by G-BA: 19.04.2012
The decision remains valid until: 19.04.2014

Final decision:

Patients for whom retreatment with taxanes or anthracyclines is not indicated: hint for a minor additional benefit
Patients for whom retreatment with taxanes or anthracyclines is indicated: hint for a less benefit than the comparative therapy

› Eribulin (re-assessment and new indication: breast cancer progression after chemotherapy)

Subject:

Active Substance: Eribulin
Name: Halaven^®
Therapeutic area: Breast cancer
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.08.2014
Final decision by G-BA: 22.01.2015

Final decision:

Patients for whom retreatment with taxanes or anthracyclines is not indicated: hint for a considerable additional benefit
Patients for whom retreatment with taxanes or anthracyclines is indicated: no additional benefit proved
Patients with HER2-positive breast cancer for whom an anti-HER2-therapy is indicated: no additional benefit proved

› Eribulin (new indication: liposarcoma)

Subject:

Active Substance: Eribulin
Name: Halaven^®
Therapeutic area: Liposarcoma
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.06.2016
Final decision by G-BA: 01.12.2016

Final decision:

Patients for whom dacarbazine is an appropriate option: hint for a considerable additional benefit
Patients for whom dacarbazine is not an appropriate option: no additional benefit proved

› Ertugliflozin/ sitagliptin

Subject:

Active Substance: Ertugliflozin/ sitagliptin
Name: Steglujan^®
Therapeutic area: Diabetes mellitus type 2
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.05.2018
Final decision by G-BA: 01.11.2018

Final decision:

No additional benefit proved

› Esketamine (depression, acute short-term treatment, combination therapy)

Subject:

Active Substance: Esketamine
Name: Spravato^®
Therapeutic area: Depression
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.03.2021
Final decision by G-BA: 19.08.2021

Final decision:

Hint for a minor additional benefit

› Esketamine (depression, treatment resistant, in combination with SSRI or SNRI)

Subject:

Active Substance: Esketamine
Name: Spravato^®
Therapeutic area: Depression
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.03.2021
Final decision by G-BA: 17.11.2022
The decision is limited until: 15.03.2023

Final decision:

No additional benefit proved

› Eszopiclone (insomnia)

Subject:

Active Substance: Eszopiclone
Name: Lunivia^®
Therapeutic area: Insomnia
Pharmaceutical company: Henning Arzneimittel GmbH & Co. KG

Time table:

Start: 15.02.2021
Final decision by G-BA: 06.05.2021

Final decision:

No additional benefit proved since there has not been submitted any dossier. The drug is subject to reference pricing.

› Etelcalcetid

Subject:

Active Substance: Etelcalcetid
Name: Parsabiv^©
Therapeutic area: Secondary hyperparathyroidism
Pharmaceutical company: Amgen GmbH

Time table:

Start: 01.06.2017
Final decision by G-BA: 17.11.2017

Final decision:

No additional benefit proved

› Evolocumab

Subject:

Active Substance: Evolocumab
Name: Repatha^®
Therapeutic area: Hypercholesterolemia
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.09.2015
Final decision by G-BA: 09.03.2016

Final decision:

No additional benefit proved for any patient population

› Evolocumab (re-assessment accord. to § 14)

Subject:

Active Substance: Evolocumab (re-assessment accord. to § 14)
Name: Repatha^®
Therapeutic area: Hypercholesterolemia
Pharmaceutical company: Amgen GmbH

Time table:

Start: 01.03.2018
Final decision by G-BA: 06.09.2018

Final decision:

Evolocumab in combination with a statin or a statin and other lipid lowering therapies:

Patients without known atherosclerotic cardiovascular disease: no additional benefit proved
Patients with known atherosclerotic cardiovascular disease: no additional benefit proved

Patients whose medicinal and dietetic therapy options to lower lipids have been exhausted: no additional benefit proved

› Extract from Cannabis sativa [repealed]

Subject:

Active Substance: Extract from Cannabis sativa
Name: Sativex^®
Therapeutic area: Spasticity related to multiple sclerosis
Pharmaceutical company: Almirall Hermal GmbH

Time table:

Start: 01.07.2011
Final decision by G-BA: 21.06.2012
The decision remains valid until: 21.06.2015

Final decision:

Hint for a minor additional benefit

› Extract of Cannabis sativa (re-assessment)

Subject:

Active Substance: Extract of Cannabis sativa
Name: Sativex^®
Therapeutic area: Spasticity related to multiple sclerosis
Pharmaceutical company: Almirall Hermal GmbH

Time table:

Start: 01.05.2018
Final decision by G-BA: 01.11.2018

Final decision:

Indication for a minor additional benefit

F

› Fedratinib (myelofibrosis)

Subject:

Active Substance: Fedratinib
Name: Inrebic^®
Therapeutic area: Chronic myeloproliferative diseases
Pharmaceutical company: Celgene GmbH

Time table:

Start: 15.03.2021
Final decision by G-BA: 02.09.2021
The resolution remains valid until: 01.03.2025

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Fenfluramine (Dravet syndrome; age ≥ 2 years)

Subject:

Active Substance: Fenfluramine
Name: Fintepla^®
Therapeutic area: Dravet syndrome
Pharmaceutical company: Zogenix GmbH

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

Hint for a considerable additional benefit (orphan drug designation)

› Fidaxomicin (new indication: Clostridioides difficile infections (CDI), children and adolescents)

Subject:

Active Substance: Fidaxomicin
Name: Dificlir^®
Therapeutic area: Clostridioides difficile infections
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 03.09.2020

Final decision:

a) Patients with mild C. difficile-associated diarrhea (CDAD) that requires treatment: no additional benefit proved
b) Patients with severe and / or recurrent CDAD: hint for a considerable additional benefit

› Filgotinib (rheumatoid arthritis)

Subject:

Active Substance: Filgotinib
Name: Jyseleca^®
Therapeutic area: Rheumatoid arthritis
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.10.2020
Final decision by G-BA: 15.04.2021

Final decision:

a1) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. methotrexate (MTX)): no additional benefit proved
a2) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. MTX); filgotinib as in combination with MTX: no additional benefit proved
b1) Patients for whom treatment with biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is indicated for the first time; filgotinib as monotherapy: no additional benefit proved
b2) Patients for whom treatment with bDMARDs or tsDMARDs is indicated for the first time; filgotinib in combination with MTX: hint for a minor additional benefit
c1) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib as monotherapy: no additional benefit proved
c2) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib in combination with MTX: no additional benefit proved

› Fingolimod [repealed]

Subject:

Active Substance: Fingolimod
Name: Gilenya^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.04.2011
Final decision by G-BA: 29.03.2012
The decision remains valid until: 20.03.2015

Final decision:

Patients with highly active RRMS: hint for a minor additional benefit
Patients that have not been treated sufficiently with INF-β: no additional benefit proved
Patients with rapidly evolving severe RRMS: hint for a minor additional benefit

› Fingolimod (new indication: multiple sclerosis after prior therapy) [repealed]

Subject:

Active Substance: Fingolimod
Name: Gilenya^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.07.2014
Final decision by G-BA: 18.12.2014

Final decision:

No additional benefit proved

› Fingolimod (new indication: multiple sclerosis, modified prerequisites for pre-treatment)

Subject:

Active Substance: Fingolimod
Name: Gilenya^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.12.2015
Final decision by G-BA: 19.05.2016

Final decision:

No additional benefit proved

› Fingolimod (re-assessment)

Subject:

Active Substance: Fingolimod
Name: Gilenya^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.04.2015
Final decision by G-BA: 01.10.2015

Final decision:

Patients with highly active relapsing-remitting multiple sclerosis (RRMS), completely pre-treated (≥ 1 year) with IFN-β: no additional benefit proved
Patients with highly active RRMS, not completely pre-treated with IFN-β: indication for a considerable additional benefit
Patients with rapidly progressing severe RRMS: indication for a minor additional benefit

› Fingolimod (new indication: pediatric patients with MS)

Subject:

Active Substance: Fingolimod
Name: Gilenya^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.01.2019
Final decision by G-BA: 20.06.2019

Final decision:

a1) children and adolescents (≥ 10 and < 18 years) with highly active, relapsing-remitting multiple sclerosis (RRMS) despite a full and adequate course of treatment with at least one disease-modifying therapy (DMT) who are eligible for a therapy escalation: No additional benefit proved
a2) children and adolescents (≥ 10 and < 18 years) with highly active RRMS despite a full and adequate course of treatment with at least one DMT for whom a change within the basic therapeutics is indicated: Hint for a non-quantifiable additional benefit
b1) children and adolescents (≥ 10 and < 18 years) with rapidly evolving severe RRMS defined by 2 or more disabling relapses within one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI, who have not had a DMT: Hint for a non-quantifiable additional benefit
b2) children and adolescents (≥ 10 and < 18 years) with rapidly evolving severe RRMS defined by 2 or more disabling relapses within one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI despite DMT: No additional benefit proved

› Fluticasone/ vilanterol

Subject:

Active Substance: Fluticasone/ vilanterol
Name: Relvar^® Ellipta^®
Therapeutic area: Asthma, COPD
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.01.2014
Final decision by G-BA: 20.03.2014

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Fluticasone furoate/ vilanterol (re-assessment accord. to § 14)

Subject:

Active Substance: Fluticasone furoate/ vilanterol
Name: Relvar^® Ellipta^®
Therapeutic area: Asthma, bronchial
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.02.2018
Final decision by G-BA: 02.08.2018

Final decision:

Proof for therapeutic improvements not provided (no comparative therapy as Relvar Ellipta^® is part of the reference price group “combination of glucocorticoids and long-acting beta2-agonists”)

› Fluticasone furoate/ umeclidinium bromide/ vilanterol

Subject:

Active Substance: Fluticasone furoate/ umeclidinium bromide/ vilanterol
Name: Trelegy Ellipta^©
Therapeutic area: Chronic obstructive pulmonary disease (COPD)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.03.2018
Final decision by G-BA: 16.08.2018

Final decision:

No additional benefit proved

› Fluticasone furoate/ umeclidinium/ vilanterol fluticasone (new indication: COPD, not adequately treated with LAMA and LABA combination)

Subject:

Active Substance: Fluticasone furoate/ umeclidinium/ vilanterol fluticasone (new indication: COPD, not adequately treated with LAMA and LABA combination)
Name: Trelegy Ellipta®/ Elebrato Ellipta^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.11.2018
Final decision by G-BA: 02.05.2019

Final decision:

No additional benefit proved.

› Fostamatinib (chronic immune thrombocytopenia (ITP))

Subject:

Active Substance: Fostamatinib
Name: Tavlesse^®
Therapeutic area: Chronic immune thrombocytopenia (ITP)
Pharmaceutical company: Grifols Deutschland GmbH

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

No additional benefit proved

› Fostemsavir (multidrug-resistant HIV infection)

Subject:

Active Substance: Fostemsavir
Name: Rukobia^®
Therapeutic area: HIV infection
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

No additional benefit proved

› Frampridine

Subject:

Active Substance: Frampridine
Name: Fampyra^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Biogen Idec GmbH

Time table:

Start: 29.07.2011
Final decision by G-BA: 02.08.2012

Final decision:

No additional benefit proved

› Fremanezumab

Subject:

Active Substance: Fremanezumab
Name: Ajovy^®
Therapeutic area: Migraine prophylaxis
Pharmaceutical company: Teva GmbH

Time table:

Start: 15.05.2019
Final decision by G-BA: 07.11.2019

Final decision:

Treatment-naïve adult patients with inadequate response or who are intolerant or contraindicated to at least one prophylactic therapy: No additional benefit proved
Adult patients who show no response or are intolerant or contraindicated to the medicinal products/substance classes metoprolol, propranolol, flunarizine, topiramate, amitriptyline: No additional benefit proved
Adult patients who show now response or are intolerant or contraindicated to any of the above-mentioned substance classes: Hint for a considerable additional benefit

G

› Galcanezumab

Subject:

Active Substance: Galcanezumab
Name: Emgality^®
Therapeutic area: Prophylaxis of migraine
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.04.2019
Final decision by G-BA: 19.09.2019

Final decision:

Treatment-naïve patients and patients that have responded insufficiently, have not tolerated, or are not suitable for at least one prophylactic medication: no additional benefit proved
Patients ineligible, intolerant or irresponsive to any of the above drug classes: no additional benefit proved
Patients ineligible, intolerant or irresponsive to any of the above drug classes: hint for a considerable additional benefit

› Gaxilose

Subject:

Active Substance: Gaxilose
Name: LacTest^TM
Therapeutic area: Diagnosis of hypolactasia
Pharmaceutical company: VENTER PHARMA S.L.

Time table:

Start: 15.08.2015
Final decision by G-BA: 04.02.2016

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Gemtuzumab ozogamicin

Subject:

Active Substance: Gemtuzumab ozogamicin
Name: Mylotarg^®
Therapeutic area: Acute myeloid leukemia (AML)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.09.2018
Final decision by G-BA: 21.02.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Givosiran (acute hepatic porphyria, patients aged ≥ 12 years)

Subject:

Active Substance: Givosiran
Name: Givlaari^®
Therapeutic area: Acute hepatic porphyria
Pharmaceutical company: Alnylam Germany GmbH

Time table:

Start: 15.04.2020
Final decision by G-BA: 15.10.2020

Final decision:

Indication for a considerable additional benefit (orphan drug)

› Glecaprevir/ pibrentasvir

Subject:

Active Substance: Glecaprevir/ pibrentasvir
Name: Maviret^©
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.08.2017
Final decision by G-BA: 01.02.2018

Final decision:

Additional benefit not proven for any patient population:
Patients without cirrhosis or with compensated cirrhosis genotype 1
Patients without cirrhosis genotype 2
Patients with compensated cirrhosis genotype 2
Patients without cirrhosis or with compensated cirrhosis genotype 3
Patients without cirrhosis or with compensated cirrhosis genotype 4
Patients without or with compensated cirrhosis with genotypes 5, 6
Patients pre-treated with sofosbuvir + ribavirin

› Glecaprevir / pibrentasvir (new indication: chronic hepatitis C, adolescent patients at the age of 12 to < 18 years)

Subject:

Active Substance: Glecaprevir/pibrentasvir
Name: Maviret^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 15.04.2019
Final decision by G-BA: 17.10.2019

Final decision:

Patients with genotype 1, 4, 5, or 6: No additional benefit proven
Patients with genotype 2 or 3: No additional benefit proven

› Gilteritinib (acute myeloid leukaemia (AML), FLT3 mutation)

Subject:

Active Substance: Gilteritinib
Name: XOSPATA^®
Therapeutic area: Acute myeloid leukaemia (AML)
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: 01.12.2019
Final decision by G-BA: 14.05.2020

Final decision:

Hint for a considerable additional benefit (orphan drug)

› Glycerol phenylbutyrate

Subject:

Active Substance: Glycerol phenylbutyrate
Name: Ravicti^©
Therapeutic area: Urea cycle disorders (UCD)
Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

Start: 01.03.2018
Final decision by G-BA: 16.08.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Glycerol phenylbutyrate (new indication: urea cycle disorders, infants age 0 up to < 2 months)

Subject:

Active Substance: Glycerol phenylbutyrate
Name: Ravicti^®
Therapeutic area: Urea cycle disorders
Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Glycopyrroniumbromid

Subject:

Active Substance: Glycopyrroniumbromid
Name: Sialanar^©
Therapeutic area: Sialorrhea
Pharmaceutical company: Proveca Limited

Time table:

Start: 01.04.2018
Final decision by G-BA: 20.09.2018

Final decision:

Hint for a non-quantifiable additional benefit

› Guselkumab

Subject:

Active Substance: Guselkumab
Name: Tremfya^©
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.12.2017
Final decision by G-BA: 17.05.2018

Final decision:

Patients for whom systemic therapy is appropriate: indication for a considerable additional benefit
Patients whose response to other systemic therapies, including ciclosporin, methotrexate or oral PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: proof for a considerable additional benefit

› Guselkumab (new indication: psoriatic arthritis)

Subject:

Active Substance: Guselkumab
Name: Tremfya^®
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Patients who have responded insufficiently to or have not tolerated prior disease-modifying antirheumatic drug (DMARD) therapy: no additional benefit proved
Patients who have responded insufficiently to or have not tolerated prior biological DMARD (bDMARD) therapy: no additional benefit proved

H

› Hydrocortisone

Subject:

Active Substance: Hydrocortisone
Name: Alkindi^®
Therapeutic area: Adrenal insufficiency of patients › 18 years
Pharmaceutical company: Diurnal Ltd.

Time table:

Start: 15.05.2018
Final decision by G-BA: 01.11.2018

Final decision:

No additional benefit proved

I

› Ibalizumab (multi-resistant HIV infection)

Subject:

Active Substance: Ibalizumab
Name: Trogarzo^®
Therapeutic area: HIV infection
Pharmaceutical company: Theratechnologies Europe limited

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

No additional benefit proved

› Ibrutinib [repealed]

Subject:

Active Substance: Ibrutinib
Name: Imbruvica^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.11.2014
Final decision by G-BA: 16.04.2015

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Ibrutinib (new indication: chronic lymphocytic leukaemia, first-line)

Subject:

Active Substance: Ibrutinib
Name: Imbruvica^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.07.2016
Final decision by G-BA: 15.12.2016

Comparative therapy:

Patients with previously untreated CLL who are eligible for a FCR therapy: no additional benefit proved
Patients with previously untreated CLL who are not eligible for FCR therapy: no additional benefit proved
Patients with previously untreated CLL without a 17p deletion or TP53 mutation who are not eligible for chemoimmunotherapy: no additional benefit proved

› Ibrutinib (re-assessment)

Subject:

Active Substance: Ibrutinib
Name: IMBRUVICA^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL), Waldenström‘s macroglobulinaemia (WM)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.02.2016
Final decision by G-BA: 21.07.2016

Final decision:

Patient population A: CLL
- Patients with recurrent or refractory CLL for whom chemotherapy is indicated: no additional benefit proved
- Patients with recurrent or refractory CLL for whom chemotherapy is not indicated: hint for a non-quantifiable additional benefit
- Patients with 17p deletion or TP53 mutation who are not eligible for chemoimmunotherapy (first-line): hint for a non-quantifiable additional benefit
Patient population B: recurrent or refractory MCL
- Patients for whom temsirolimus is the appropriate therapy: indication for a considerable additional benefit
- Patients for whom temsirolimus is not the appropriate therapy: no additional benefit proved
Patient population C: WM
No additional benefit proved

› Ibrutinib (chronic lymphocytic leukaemia, in combination with bendamustine and rituximab)

Subject:

Active Substance: Ibrutinib
Name: Imbruvica^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 16.03.2017

Final decision:

Patients with at least 2 prior therapies for whom Bendamustin in combination with Rituximab is the patient individual optimized therapy: hint for a considerable additional benefit
Patients with a prior treatment for whom Bendamustin in combination with Rituximab is not the patient individual optimized therapy: no additional benefit proved

› Ibrutinib (new indication: CLL, 1st line, combination with obinutuzumab)

Subject:

Active Substance: Ibrutinib
Name: Imbruvica^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Patients for whom a therapy with fludarabine in combination with cyclophosphamide and rituximab (FCR) is indicated: No additional benefit proved
Patients for whom a therapy with FCR is not indicated: Hint for a minor additional benefit
Patients with 17p depletion and/or TP53 mutation or who are not indicated for a chemo-immunotherapy due to other reasons: No additional benefit proved

› Ibrutinib (new indication: Waldenström’s macroglobulinaemia, combination with rituximab)

Subject:

Active Substance: Ibrutinib
Name: Imbruvica^®
Therapeutic area: Waldenström’s macroglobulinaemia
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

No additional benefit proved

› Ibrutinib (new indication: chronic lymphatic leukemia (CLL), 1^st line, combination with rituximab)

Subject:

Active Substance: Ibrutinib
Name: Imbruvica^®
Therapeutic area: Chronic lymphatic leukemia (CLL)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.10.2020
Final decision by G-BA: 01.04.2021
This decision remains valid until: 01.04.2024

Final decision:

a) Patients who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): hint for a considerable additional benefit
b) Patients who cannot be treated with FCR: no additional benefit proved
c) Patients with 17p-deletion and/or T53-mutation or for whom a chemoimmunotherapy is not indicated due to other reasons: no additional benefit proved

› Idebenone

Subject:

Active Substance: Idebenone
Name: Raxone^®
Therapeutic area: Leber‘s Hereditary Optic Neuropathy (LHON)
Pharmaceutical company: Santhera Pharmaceuticals

Time table:

Start: 01.10.2016
Final decision by G-BA: 17.03.2016
The decision remains valid until: 01.04.2022

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Idelalisib

Subject:

Active Substance: Idelalisib
Name: Zydelig^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL), follicular lymphoma (FL)
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.10.2014
Final decision by G-BA: 19.03.2015
The decision remains valid until: 01.04.2016

Final decision:

Patients with recurrent CLL for whom chemotherapy is indicated: no additional benefit proved
Patients with recurrent CLL for whom chemotherapy is not indicated: hint for a non-quantifiable additional benefit
Patients with refractory CLL for whom chemotherapy or ofatumumab therapy is indicated: no additional benefit proved
Patients with refractory CLL for whom chemotherapy or ofatumumab therapy is not indicated: no additional benefit proved
Patients with 17p deletion or TP53 mutation who are not eligible for any other therapies (first-line treatment): hint for a non-quantifiable additional benefit

› Idelalisib (re-assessment)

Subject:

Active Substance: Idelalisib
Name: Zydelig^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.04.2016
Final decision by G-BA: 15.09.2016

Final decicion:

Patients with recurrent or refractory CLL for whom chemotherapy is indicated: no additional benefit proved
Patients with recurrent or refractory CLL for whom chemotherapy is not indicated: hint for a non-quantifiable additional benefit
Patients with 17p deletion or TP53 mutation who are not eligible for chemoimmunotherapy and where idelalisib treatment has already been initiated: no additional benefit proved

› Idelalisib (new indication: chronic lymphocytic leukaemia in combination with ofatumumab or rituximab)

Subject:

Active Substance: Idelalisib
Name: Zydelig^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 16.03.2017

Final decision:

In combination with rituximab:
- Treatment-naive patients with 17p deletion or TP53 mutation for whom no other therapy is appropriate: hint for a non-quantifiable additional benefit
In combination with ofatumumab:
- Pre-treated patients with relapsing or refractory CLL: no additional benefit proved
- Treatment-naive patients with 17p deletion or TP53 mutation for whom no other therapy is appropriate: no additional benefit proved

› Imlifidase (desensitization treatment of kidney transplant patients)

Subject:

Active Substance: Imlifidase
Name: Idefirix^®
Therapeutic area: Desensitization of kidney transplant
Pharmaceutical company: Hansa Biopharma AB

Time table:

Start: 15.03.2021
Final decision by G-BA: 02.09.2021
The resolution remains valid until: 01.04.2026

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Inclisiran (primary hypercholesterolaemia or mixed dyslipidaemia)

Subject:

Active Substance: Inclisiran
Name: Leqvio^®
Therapeutic area: Primary hypercholesterolaemia or mixed dyslipidaemia
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

Patients who have not already exhausted all available dietary and medicinal lipid-lowering options: No additional benefit proved
Patients who have already exhausted all available dietary and medicinal lipid-lowering options (except for evolocumab or alirocumab): No additional benefit proved

› Indacaterol/ glycopyrronium bromide

Subject:

Active Substance: Indacaterol/ glycopyrronium bromide
Name: Ultibro^® Breezhaler^®, Xoterna^® Breezhaler^®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.11.2013
Final decision by G-BA: 08.05.2014

Final decision:

Patients with COPD stage II: hint for a minor additional benefit
Patients with COPD stage III and ≤ 1 exacerbation/year: indication for a minor additional benefit
Patients with COPD stage IV and ≤ 1 exacerbation/year: no additional benefit proved
Patients with COPD stage III and IV and ≥ 2 exacerbations/year: no additional benefit proved

› Indacaterol acetate / glycopyrronium bromide / mometasone furoate (asthma bronchiale)

Subject:

Active Substance: Indacaterol acetate
Name: Enerzair Breezhaler^®
Therapeutic area: Asthma bronchiale
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

No additional benefit proved

› Ingenol mebutate

Subject:

Active Substance: Ingenol mebutate
Name: Picato^®
Therapeutic area: Actinic keratosis
Pharmaceutical company: LEO Pharma GmbH

Time table:

Start: 15.01.2013
Final decision by G-BA: 04.07.2013

Final decision:

No additional benefit proved

› Ingenol mebutate [repealed] (re-assessment according to § 14)

Subject:

Active Substance: Ingenol mebutate
Name: Picato^®
Therapeutic area: Actinic keratosis (AK)
Pharmaceutical company: Leo Pharma GmbH

Time table:

Start: 01.09.2018
Final decision by G-BA: 21.02.2019
Assessment repealed as of: 20.08.2020

Final decision:

Adult patients with actinic keratosis on the face and scalp: hint for a non-quantifiable additional benefit
Adult patients with actinic keratosis on the trunk and extremities: no additional benefit proved

› Inotersen

Subject:

Active Substance: Inotersen
Name: Tegsedi^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Akcea Therapeutics Germany GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Inotuzumab Ozogamicin

Subject:

Active Substance: Inotuzumab ozogamicin
Name: Besponsa^©
Therapeutic area: B cell precursor acute lymphoblastic leukaemia (ALL)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 15.07.2017
Final decision by G-BA: 18.01.2018

Final decision:

Minor additional benefit proven (because of orphan drug designation)

› Insulin degludec

Subject:

Active Substance: Insulin degludec
Name: Tresiba^®
Therapeutic area: Diabetes mellitus
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.05.2014
Final decision by G-BA: 16.10.2014

Final decision:

No additional benefit proved because of missing access to relevant data concerning study methodology and results

› Insulin degludec (new indication: diabetes mellitus, type 2, in combination with GLP-1 receptor agonists) [repealed]

Subject:

Active Substance: Insulin degludec
Name: Tresiba^®
Therapeutic area: Diabetes mellitus
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 15.06.2014
Final decision by G-BA: 04.12.2014

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Insulin degludec (new indication: diabetes mellitus, children from the age of 1 year)

Subject:

Active Substance: Insulin degludec
Name: Tresiba^®
Therapeutic area: Diabetes mellitus
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.03.2015
Final decision by G-BA: 20.08.2015

Final decision:

Diabetes mellitus type 1: no additional benefit proved
Diabetes mellitus type 2: no additional benefit proved

› Insulin degludec (re-assessment according to §13)

Subject:

Active Substance: : Insulin degludec
Name: Tresiba^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.12.2018
Final decision by G-BA: 16.05.2019

Final decision:

a) patients who are not sufficiently controlled by treatment with at least two antidiabetics (except insulin):

insulin + metformin or
insulin + empagliflozin (empagliflozin in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or
insulin + liraglutide (liraglutide in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or
insulin, if metformin and empagliflozin and liraglutide are according to the SmPC not appropriate due to intolerance or contraindication

b) patients who are not sufficiently controlled by treatment with insulin (with or w/o another antidiabetic):

a) patients who are not sufficiently controlled by treatment with ≥ 2 antidiabetics (except insulin): additional benefit not proved
b) patients who are not sufficiently controlled by treatment with insulin (with or w/o another antidiabetic): additional benefit not proved

› Insulin degludec/ liraglutide

Subject:

Active Substance: Insulin degludec/ liraglutide
Name: Xultophy^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Novo Nordisk GmbH

Time table:

Start: 01.05.2015
Final decision by G-BA: 15.10.2015

Final decision:

No additional benefit proved for each of the three slices

› Insulin degludec/ liraglutide (new indication: diabetes mellitus, type 2, in combination with oral antidiabetic medicinal products)

Subject:

Active Substance: Insulin degludec/ liraglutide
Name: Xultophy^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 15.08.2015
Final decision by G-BA: 04.02.2016

Final decision:

No additional benefit proved

› Insulin glargine/ lixisenatide

Subject:

Active Substance: Insulin glargine/ lixisenatide
Name: Suliqua^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 01.03.2018
Final decision by G-BA: 16.08.2018

Final decision:

Patients for whom the treatment with at least two blood glucose lowering medicines (only oral drugs including metformin) is inadequate: no additional benefit proved
Patients who are inadequately treated by insulin (in combination with another blood glucose lowering medicine, here metformin): no additional benefit proved

› Insulin glargine / lixisenatide (new indication: type 2 diabetes mellitus, in combination with metformin and SGLT2-inhibitors)

Subject:

Active Substance: Insulin glargine / lixisenatide
Name: Suliqua^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.04.2020
Final decision by G-BA: 15.10.2020

Final decision:

a. Patients who are not sufficiently treated with 2 antidiabetics (except of insulin): No additional benefit proved
b. Patients who are not sufficiently treated with insulin: No additional benefit proved

› Ipilimumab

Subject:

Active Substance: Ipilimumab
Name: Yervoy^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.08.2011
Final decision by G-BA: 02.08.2012

Final decision:

Indication for a considerable additional benefit

› Ipilimumab (new indication: melanoma, first-line)

Subject:

Active Substance: Ipilimumab
Name: Yervoy^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.12.2013
Final decision by G-BA: 05.06.2014

Final decision:

No additional benefit proved

› Ipilimumab (new indication: melanoma patients from 12 years and older)

Subject:

Active Substance: Ipilimumab
Name: Yervoy^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.02.2018
Final decision by G-BA: 02.08.2018

Final decision:

No additional benefit proved

› Ipilimumab (new indication: melanoma; in combination with nivolumab)

Subject:

Active Substance: Ipilimumab
Name: Yervoy^©
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.07.2018
Final decision by G-BA: 10.12.2018

Final decision:

Treatment-naive BRAFwt patients: indication for less benefit
Treatment-naive BRAFmut patients: no additional benefit proved
Pre-treated patients: no additional benefit proved

› Ipilimumab (new indication: renal cell carcinoma, in combination with nivolumab, 1st line)

Subject:

Active Substance: Ipilimumab (new indication: renal cell carcinoma, in combination with nivolumab, 1st line)
Name: Yervoy^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.02.2019
Final decision by G-BA: 15.08.2019

Final decision:

Patients with intermediate risk profile (IMDS score 1-2): Indication for a considerable additional benefit
Patients with unfavourable risk profile (IMDS score ≥ 3): Indication for a considerable additional benefit

› Ipilimumab (new indication: non-small cell lung cancer (NSCLC), combination with nivolumab and platinum-based chemotherapy, 1^st line)

Subject:

Active Substance: Ipilimumab
Name: Yervoy^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit proved

› Isavuconazole

Subject:

Active Substance: Isavuconazole
Name: Cresemba^®
Therapeutic area: Aspergillosis and mucormycosis
Pharmaceutical company: Basilea Pharmaceutica International Ltd.

Time table:

Start: 15.11.2015
Final decision by G-BA: 04.05.2016

Final decision:

Non quantifiable additional benefit proved (because of orphan drug status)

› Ivacaftor (cystic fibrosis in patients aged ≤ 6 years who have a G551D mutation) [repealed]

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals GmbH

Time table:

Start: 15.08.2012
Final decision by G-BA: 07.02.2013

Final decision:

Children aged 6-11 years: minor additional benefit
Adolescents and adults aged 12 years and older: considerable additional benefit

› Ivacaftor (new indication: cystic fibrosis in patients aged 2-5 years and in patients aged 18 years and older who have an R117H mutation in the CFTR gene) [repealed]

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

Start: 15.12.2015
Final decision by G-BA: 02.06.2016

Final decision:

Children aged 2-5 years with a gating mutation class III in the CFTR gene: non-quantifiable additional benefit proved (because of orphan drug status)
Patients aged 18 years and older who have an R117H mutation in the CFTR gene: minor additional benefit proved (because of orphan drug status)

› Ivacaftor (new indication: cystic fibrosis, extension to various gating mutations) [repealed]

Subject:

Active Substance: Ivacaftor
Name: Kalydeco™
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals Limited

Time table:

Start: 01.09.2014
Final decision by G-BA: 19.02.2015

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Ivacaftor (new indication: cystic fibrosis, combination therapy in patients > 12 years) [assessment stopped]

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.12.2018
Final decision by G-BA: [assessment stopped]

Final decision:

assessment stopped

› Ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients 6 years and older with G551D mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Patients aged 6 – 11 years: hint for a non-quantifiable additional benefit
Patients aged 12 years and older: hint for a considerable additional benefit

› Ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, combination with tezacaftor / ivacaftor for patients 12 years and older (homozygous regarding F508del)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

No additional benefit proved

› Ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, combination with tezacaftor/ ivacaftor for patients 12 years and older (heterozygous regarding F508del)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision by G-BA: 20.02.2020:

No additional benefit proved

› Ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients 6 years and older, various gating mutations)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Hint for a non-quantifiable additional benefit

› Ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients aged 2 – 5 years)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Hint for a non-quantifiable additional benefit

› Ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients 18 years and older with R117H mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Hint for a non-quantifiable additional benefit

› Ivacaftor (new indication: cystic fibrosis, patients aged 12–24 months)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Hint for a non-quantifiable additional benefit

› Ivacaftor (new indication: cystic fibrosis, patients aged 6-12 months)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 15.12.2019
Final decision by G-BA: 04.06.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Ivacaftor (new indication: cystic fibrosis, patients aged ≥ 6 months - < 18 years (R117H))

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

Patients aged 6 months up to < 6 years: Hint for a non-quantifiable additional benefit
Patients aged 6 years up to < 18 years: Hint for a non-quantifiable additional benefit

› Ivacaftor / tezacaftor / elexacaftor (cystic fibrosis, combination with ivacaftor for patients aged ≥ 12 years (heterozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor / tezacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Hint for a major additional benefit

› Ivacaftor / tezacaftor / elexacaftor (cystic fibrosis, combination with ivacaftor for patients aged ≥ 12 years (homozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor / tezacaftor / elexacaftor
Name: Kaftrio^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Indication for a major additional benefit

› Ivacaftor (cystic fibrosis, combination with ivacaftor / tezacaftor / elexacaftor for patients aged ≥ 12 years (heterozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Hint for a major additional benefit

› Ivacaftor (cystic fibrosis, combination with ivacaftor / tezacaftor / elexacaftor for patients aged ≥ 12 years (homozygous for F508del and MF mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Indication for a major additional benefit

› Ivacaftor (new indication: cystic fibrosis, in combination with tezacaftor/ ivacaftor, patients aged 6 to < 12 years (heterozygous for F508del and RF mutation))

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› Ivacaftor (new indication: cystic fibrosis, in combination with tezacaftor/ ivacaftor, patients aged 6 to < 12 years (homozygous for F508del and RF mutation))

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› Ivacaftor (new indication: cystic fibrosis, patients aged 4 to < 6 months, R117H mutation)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a non-quantifiable additional benefit

› Ivacaftor (new indication: cystic fibrosis, patients aged 4 to < 6 months, gating mutations)

Subject:

Active Substance: Ivacaftor
Name: Kalydeco^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Hint for a non-quantifiable additional benefit

› Ivermectin

Subject:

Active Substance: Ivermectin
Name: Soolantra^®
Therapeutic area: Rosacea
Pharmaceutical company: Galderma Laboratorium GmbH

Time table:

Start: 01.06.2015
Final decision by G-BA: 27.11.2015

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Ixazomib (multiple myeloma, at least 1 previous therapy, combination with lenalidomide and dexamethasone)

Subject:

Active Substance: Ixazomib
Name: Ninlaro^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Takeda GmbH

Time table:

Start: 15.01.2017
Final decision by G-BA: 06.07.2014
The decision remains valid until: 01.11.2021

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Ixekizumab

Subject:

Active Substance: Ixekizumab
Name: Taltz^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.03.2017
Final decision by G-BA: 17.08.2017

Final decision:

Patients for whom systemic therapy is appropriate: hint for a considerable additional benefit
Patients whose response to other systemic therapies, including ciclosporin, methotrexate or PUVA (psoralen and ultraviolet A-light) has been inadequate or who have contraindication or intolerance for these therapies: hint for a minor additional benefit

› Ixekizumab (new indication: psoriatic arthritis)

Subject:

Active Substance: Ixekizumab
Name: Taltz^©
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.03.2018
Final decision by G-BA: 16.08.2018

Final decision:

Patients for whom another classical disease-modifying anti-rheumatic drug (DMARD) therapy except MTX is indicated: no additional benefit proved
bDMARD-naïve patients for whom a therapy with bDMARDs is indicated for the first time: hint for a minor additional benefit
Patients who have responded inadequately or who are intolerant to one prior therapy with bDMARDs: no additional benefit proved

› Ixekizumab (new indication: plaque psoriasis in children and adolescents aged ≥ 6 to < 18 years, with body weight ≥ 25 kg)

Subject:

Active Substance: Ixekizumab
Name: Taltz^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

No additional benefit proved

› Ixekizumab (new indication: axial spondyloarthritis)

Subject:

Active Substance: Ixekizumab
Name: Taltz^®
Therapeutic area: Axial spondyloarthritis (AS)
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

a1) Patients who did not sufficiently respond to or who are intolerant to conventional therapy: no additional benefit proved
a2) Patients who did not sufficiently respond to a previous therapy with biological antirheumatic drugs (bDMARD) or who are intolerant to these: no additional benefit proved
b) Patients with severe disease without radiographic verification of a AS but with objective signs of inflammation who did not sufficiently respond to a previous therapy with non-steroidal antirheumatic drugs (NSAR) or who are intolerant to NSAR: no additional benefit proved

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› Lanadelumab

Subject:

Active Substance: Lanadelumab
Name: Takhzyro^®
Therapeutic area: Hereditary Angioedemas
Pharmaceutical company: Shire Deutschland GmbH, part of the Takeda Group

Time table:

Start: 01.02.2019
Final decision by G-BA: 01.08.2019

Final decision:

Considerable additional benefit (proved because of orphan drug designation)

› Larotrectinib (solid tumors, NTRK gene fusion, independent of histology)

Subject:

Active Substance: Larotrectinib
Name: Vitrakvi^®
Therapeutic area: Solid tumors
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 15.10.2019
Final decision by G-BA: 02.04.2020

Final decision

No additional benefit proved

› Larvae of Lucilia sericata

Subject:

Active Substance: Larvae of Lucilia sericata
Name: BioBag^®/ BioMonde^®
Therapeutic area: Wound debridement
Pharmaceutical company: BioMonde GmbH

Time table:

Start: 01.06.2014
Final decision by G-BA: 20.11.2014

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Ledipasvir/ sofosbuvir

Subject:

Active Substance: Ledipasvir/ sofosbuvir
Name: Harvoni^®
Therapeutic area: Chronic hepatitis C virus (HCV) infection
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.12.2014
Final decision by G-BA: 21.05.2015

Final decision:

Therapy-naive patients without cirrhosis (genotype 1): hint for a considerable additional benefit
Therapy-naive patients with compensated cirrhosis (genotype 1): hint for a considerable additional benefit
Pre-treated patients without cirrhosis or with compensated cirrhosis (genotype 1): hint for a considerable additional benefit
Therapy-naive patients with compensated cirrhosis and pre-treated patients (genotype 3): no additional benefit proved
Therapy-naive patients and pre-treated patients (genotype 4): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients with a HIV coinfection (genotype 1): hint for a non-quantifiable additional benefit
Patients with decompensated cirrhosis (genotype 1): hint for a non-quantifiable additional benefit

› Ledipasvir/ sofosbuvir (new indication: juvenile patients (12-17 years))

Subject:

Active Substance: Ledipasvir/ sofosbuvir
Name: Harvoni^©
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.08.2017
Final decision by G-BA: 15.02.2018

Final decision:

Treatment-naïve patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
Treatment-naïve patients with compensated cirrhosis, genotype 3: additional benefit not proven
Pretreated patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
Pretreated patients, genotype 3: additional benefit not proven

› Ledipasvir / sofosbuvir (new indication: chronic hepatitis C, patients aged 3 to < 12 years)

Subject:

Active Substance: Ledipasvir / sofosbuvir
Name: Harvoni^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: Gilead Sciences Ireland UC

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

Genotype 1, 4, 5, or 6: hint for a non-quantifiable additional benefit
Genotype 3 (pre-treated patients or patients with cirrhosis): no additional benefit proved

› Lenvatinib [repealed]

Subject:

Active Substance: Lenvatinib
Name: Lenvima^®
Therapeutic area: Thyroid neoplasms
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.07.2015
Final decision by G-BA: 17.12.2015

Final decision by G-BA:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Lenvatinib (new indication: renal cell carcinoma) [repealed]

Subject:

Active Substance: Lenvatinib
Name: Kisplyx^®
Therapeutic area: Renal cell carcinoma (RCC)
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 16.03.2017
The decision remains valid until: 31.12.2020

Final decision:

Hint for a minor additional benefit

› Lenvatinib (new indication: HCC)

Subject:

Active Substance: Lenvatinib
Name: Lenvima^®
Therapeutic area: Hepatocellular carcinoma (HCC)
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Patients with Child-Pugh A or without cirrhosis of the liver: No additional benefit proved.
Patients with Child-Pugh B: No additional benefit proved.

› Lenvatinib (repeal of orphan drug designation)

Subject:

Active Substance: Lenvatinib (repeal of orphan drug designation)
Name: Lenvima^®
Therapeutic area: Thyroid carcinoma
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.02.2019
Final decision by G-BA: 15.08.2019

Final decision:

Additional benefit not proved

› Lenvatinib (re-assessment: renal cell carcinoma)

Subject:

Active Substance: Lenvatinib
Name: Kisplyx^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.01.2021
Final decision by G-BA: 01.07.2021

Final decision:

No additional benefit proved

› Letermovir

Subject:

Active Substance: Letermovir
Name: Prevymis^©
Therapeutic area: Cytomegalovirus infections
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.02.2018
Final decision by G-BA: 02.08.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Levofloxacin / dexamethasone (infections and inflammation associated with cataract surgery)

Subject:

Active Substance: Levofloxacin / dexamethasone
Name: Ducressa^®
Therapeutic area: Infections and inflammation associated with cataract surgery
Pharmaceutical company: Santen GmbH

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

No additional benefit proved

› Linaclotide

Subject:

Active Substance: Linaclotide
Name: Constella^®
Therapeutic area: Irritable bowel syndrome (IBS) with constipation
Pharmaceutical company: Almirall Hermal GmbH

Time table:

Start: 01.05.2013
Final decision by G-BA: 17.10.2013

Final decision:

No additional benefit proved

› Linagliptin [repealed]

Subject:

Active Substance: Linagliptin
Name: Trajenta^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Boehringer Ingelheim International GmbH

Time table:

Start: 01.10.2011
Final decision by G-BA: 29.03.2012

Final decision:

No additional benefit proved

› Linagliptin (new indication: diabetes mellitus, type 2, in combination with insulin with or without metformin)

Subject:

Active Substance: Linagliptin
Name: Trajenta^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Boehringer Ingelheim International GmbH

Time table:

Start: 01.12.2012
Final decision by G-BA: 16.05.2013

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Linagliptin (re-assessment)

Subject:

Active Substance: Linagliptin
Name: Trajenta^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Boehringer Ingelheim International GmbH

Time table:

Start: 01.09.2012
Final decision by G-BA: 21.02.2013

Final decision:

No additional benefit proved

› Lisdexamfetamine

Subject:

Active Substance: Lisdexamfetamine
Name: Elvanse^®
Therapeutic area: Attention deficit hyperactivity disorder (ADHD)
Pharmaceutical company: Shire Deutschland GmbH

Time table:

Start: 01.06.2013
Final decision by G-BA: 14.11.2013

Final decision:

No additional benefit proved

› Lisdexamfetamine dimesilate (new indication: ADHD, adult patients)

Subject:

Active Substance: Lisdexamfetamine dimesilate
Name: Elvanse Adult^®
Therapeutic area: Adults with Attention Deficit Hyperactivity Disorder (ADHD)
Pharmaceutical company: Shire Deutschland GmbH, now part of Takeda Group

Time table:

Start: 01.05.2019
Final decision by G-BA: 17.10.2019

Final decision:

a) Adults with ADHD since childhood with at least moderate severity and pre-treatment with one medicinal therapy: No additional benefit proven
b) Adults with ADHD since childhood with at least moderate severity who have not received a medicinal therapy yet: No additional benefit proven

› Lixisenatide

Subject:

Active Substance: Lixisenatide
Name: Lyxumia^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.03.2013
Final decision by G-BA: 05.09.2013

Final decision:

No additional benefit proved

› Lomitapide [repealed]

Subject:

Active Substance: Lomitapide
Name: Lojuxta^®
Therapeutic area: Hypercholesterolaemia
Company: Aegerion Pharmaceuticals GmbH

Time table:

Start: 15.12.2013
Final decision by G-BA: 05.06.2014
The decision remains valid until: 15.06.2015

Final decision:

No additional benefit proved

› Lomitapide (re-assessment)

Subject:

Active Substance: Lomitapide
Name: Lojuxta^®
Therapeutic area: Homozygous hypercholesterolemia
Pharmaceutical company: Aegerion Pharmaceuticals

Time table:

Start: 15.06.2015
Final decision by G-BA: 27.11.2015

Final decision:

Patients whose lipid lowering therapy is exhausted (with LDL apheresis): no additional benefit proved
Patients whose lipid lowering therapy is exhausted (without LDL apheresis): no additional benefit proved
Patients whose lipid lowering therapy is not exhausted: no additional benefit proved

› Lonoctocog alfa

Subject:

Active Substance: Lonoctocog alfa
Name: Afstyla^®
Therapeutic area: Hemophilia A
Pharmaceutical company: CSL Behring GmbH

Time table:

Start: 01.02.2017
Final decision by G-BA: 20.07.2017

Final decision:

No additional benefit benefit proved

› Lorlatinib

Subject:

Active Substance: Lorlatinib
Name: Lorviqua^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.06.2019
Final decision by G-BA: 22.11.2019

Final decision:

a) Patients eligible for another antineoplastic systemic therapy: No additional benefit proved
b) Patients not eligible for another antineoplastic systemic therapy: No additional benefit proved

› Lumacaftor/ ivacaftor

Subject:

Active Substance: Lumacaftor/ ivacaftor
Name: Orkambi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

Start: 15.12.2015
Final decision by G-BA: 02.06.2016

Final decision:

Indication for a considerable additional benefit

› Lumacaftor/ ivacaftor (new indication: patients at the age of 2 to 5 years)

Subject:

Active Substance: Lumacaftor/ ivacaftor (new indication: patients at the age of 2 to 5 years)
Name: Orkambi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

Start: 15.02.2019
Final decision by G-BA: 15.08.2019
Decision remains valid until: 01.10.2021

Final decision:

Hint for a non-quantifiable additional benefit

› Lumacaftor/ ivacaftor (new indication: patients of 6 years and older)

Subject:

Active Substance: Lumacaftor/ ivacaftor
Name: Orkambi^©
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

Start: 01.02.2018
Final decision by G-BA: 02.08.2018

Final decision:

Hint for a non-quantifiable additional benefit

› Lumasiran (hyperoxaluria)

Subject:

Active Substance: Lumasiran
Name: Oxlumo^®
Therapeutic area: Hyperoxaluria
Pharmaceutical company: Alnylam Germany GmbH

Time table:

Start: 01.01.2021
Final decision by G-BA: 01.07.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Lurasidone

Subject:

Active Substance: Lurasidon
Name: Latuda^®
Therapeutic area: Schizophrenia
Pharmaceutical company: Takeda GmbH

Time table:

Start: 01.11.2014
Final decision by G-BA: 16.04.2015

Final decision:

Acute therapy: no additional benefit proved
Relapse prophylaxis: no additional benefit proved

› Luspatercept (anaemia due to myelodysplastic syndromes (MDS))

Subject:

Active Substance: Luspatercept
Name: Reblozyl^®
Therapeutic area: Anaemia due to myelodysplastic syndromes (MDS)
Pharmaceutical company: Celgene GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Luspatercept (beta thalassaemia)

Subject:

Active Substance: Luspatercept
Name: Reblozyl^®
Therapeutic area: Beta thalassaemia
Pharmaceutical company: Celgene GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

M

› Macitentan [repealed]

Subject:

Active Substance: Macitentan
Name: Opsumit^®
Therapeutic area: Pulmonary arterial hypertension (PAH)
Pharmaceutical company: Actelion Pharmaceuticals Deutschland GmbH

Time table:

Start: 01.02.2014
Final decision by G-BA: 17.07.2014

Final decision:

Minor additional benefit

› Macitentan (re-assessment, 50 Mio. € limit exceeded)

Subject:

Active Substance: Macitentan
Name: Opsumit^®
Therapeutic area: Pulmonary arterial hypertension (PAH)
Pharmaceutical company: Actelion Pharmaceuticals Deutschland GmbH

Time table:

Start: 15.10.2016
Final decision by G-BA: 06.04.2017

Final decision:

No additional benefit proved

› Melatonin

Subject:

Active Substance: Melatonin
Name: Slenyto^®
Therapeutic area: Insomnia
Pharmaceutical company: InfectoPharm Arzneimittel und Consilium GmbH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019

Final decision:

Hint for a minor additional benefit

› Mepolizumab

Subject:

Active Substance: Mepolizumab
Name: Nucala^®
Therapeutic area: Refractory eosinophilic asthma
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.02.2016
Final decision by G-BA: 21.07.2016

Final decision:

Patients who are not (or only during acute exacerbations) treated with oral corticosteroids: no additional benefit proved
Patients who are treated with oral corticosteroids on a regular basis: hint for a minor additional benefit

› Mepolizumab (new indication: patients 6 years and older)

Subject:

Active Substance: Mepolizumab
Name: Nucala^®
Therapeutic area: Asthma
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

No additional benefit proved.

› Metreleptin

Subject:

Active Substance: Metreleptin
Name: Myalepta^®
Therapeutic area: Lipodystrophy
Pharmaceutical company: Aegerion Pharmaceuticals GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Mexiletine

Subject:

Active Substance: Mexiletine
Name: Namuscla^®
Therapeutic area: Myotonic Disorders
Pharmaceutical company: Lupin Europe GmbH

Time table:

Start: 01.02.2019
Final decision by G-BA: 01.08.2019

Final decision:

Non-quantifiable benefit (proved because of orphan drug designation)

› Microbial collagenase from Clostridium histolyticum

Subject:

Active Substance: Active Substance: Microbial collagenase from Clostridium histolyticum
Name: Xiapex^®
Therapeutic area: Dupuytren's contracture
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.05.2011
Final decision by G-BA: 19.04.2012

Final decision:

No additional benefit proved

› Midostaurin (Acute myeloid leukaemia (AML))

Subject:

Active Substance: Midostaurin
Name: Rydapt^©
Therapeutic area: Acute myeloid leukaemia (AML)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.10.2017
Final decision by G-BA: 05.04.2018

Final decision:

Considerable additional benefit (proved because of orphan drug status)

› Midostaurin (Advanced systemic mastocytosis (advSM))

Subject:

Active Substance: Midostaurin
Name: Rydapt^©
Therapeutic area: Advanced systemic mastocytosis (advSM)
Pharmaceutical company: : Novartis Pharma GmbH

Time table:

Start: 15.10.2017
Final decision by G-BA: 05.04.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug status)

› Migalastat

Subject:

Active Substance: Migalastat
Name: Galafold^TM
Therapeutic area: Fabry Disease
Pharmaceutical company: Amicus Therapeutics GmbH

Time table:

Start: 01.06.2016
Final decision by G-BA: 01.12.2016

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Mirabegron

Subject:

Active Substance: Mirabegron
Name: Betmiga™
Therapeutic area: Overactive bladder syndrome
Pharmaceutical company: Astellas Pharma GmbH

Time table:

Start: 01.06.2014
Final decision by G-BA: 20.11.2014

Final decision:

No additional benefit proved

› Mogamulizumab (Mycosis fungoides; Sézary syndrome)

Subject:

Active Substance: Mogamulizumab
Name: Poteligeo^®
Therapeutic area: Mycosis fungoides; Sézary syndrome
Pharmaceutical company: Kyowa Kirin GmbH

Time table:

Start: 15.06.2020
Final decision by G-BA: 03.12.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

N

› Naldemedin (opioid-induced constipation)

Subject:

Active Substance: Naldemedin
Name: Rizmoic^®
Therapeutic area: Opioid-induced constipation
Pharmaceutical company: Hexal AG

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision by G-BA:

Patients pretreated with a laxative: No additional benefit proved
Patients not eligible anymore for a laxative not subject to prescription or for a reimbursable medicinal product for the treatment of constipation: No additional benefit proved

› Nalmefene

Subject:

Active Substance: Nalmefene
Name: Selincro^®
Therapeutic area: Reduction of alcohol consumption in patients with alcohol dependence
Pharmaceutical company: Lundbeck GmbH

Time table:

Start: 01.09.2014
Final decision by G-BA: 19.02.2015

Final decision:

No additional benefit proved

› Necitumumab

Subject:

Active Substance: Necitumumab
Name: Portrazza^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.04.2016
Final decision by G-BA: 15.09.2016

Final decicion:

No additional benefit proved

› Nepafenac

Subject:

Active Substance: Nepafenac
Name: Nevanac^®
Therapeutic area: Postoperative pain after cataract surgery
Pharmaceutical company: Alcon Pharma GmbH

Time table:

Start: 01.07.2013
Final decision by G-BA: 19.12.2013

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Neratinib (breast cancer, HR+, HER2+, adjuvant therapy)

Subject:

Active Substance: Neratinib
Name: Nerlynx^®
Therapeutic area: Breast cancer
Pharmaceutical company: Pierre Fabre Pharma

Time table:

Start: 01.12.2019
Final decision by G-BA: 14.05.2020

Final decision:

Hint for a minor additional benefit

› Netupitant/ palonosetron

Subject:

Active Substance: Netupitant/ palonosetron
Name: Akynzeo^®
Therapeutic area: Nausea and vomiting during chemotherapy due to cancer
Pharmaceutical company: RIEMSER Pharma GmbH

Time table:

Start: 15.08.2015
Final decision by G-BA: 04.02.2016

Final decision:

Moderately emetogenic chemotherapy: no additional benefit proved
Highly emetogenic chemotherapy: no additional benefit proved

› Nintedanib

Subject:

Active Substance: Nintedanib
Name: Vargatef^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 01.01.2015
Final decision by G-BA: 18.06.2015

Final decision:

Indication for a minor additional benefit

› Nintedanib (new indication: Idiopathic Pulmonary Fibrosis)[repealed]

Subject:

Active Substance: Nintedanib
Name: Ofev^®
Therapeutic area: Idiopathic Pulmonary Fibrosis (IPF)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.03.2015
Final decision by G-BA: 03.09.2015

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Nintedanib (reassessment:, 50 Mio. € limit exceeded)

Subject:

Active Substance: Nintedanib
Name: Ofev^®
Therapeutic area: Idiopathic pulmonary fibrosis (IPF)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.04.2019
Final decision by G-BA: 17.10.2019

Final decision:

Hint for a considerable additional benefit

› Nintedanib (new indication: systemic sclerosis associated interstitial lung disease (SSc-ILD))

Subject:

Active Substance: Nintedanib
Name: Ofev^®
Therapeutic area: Systemic sclerosis associated interstitial lung disease (SSc-ILD)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

No additional benefit proved (orphan drug, 50 M € sales exceeded)

› Nintedanib (new indication: chronic fibrosing interstitial lung disease (ILD) with progressive phenotype)

Subject:

Active Substance: Nintedanib
Name: Ofev^®
Therapeutic area: Chronic fibrosing interstitial lung disease (ILD) with progressive phenotype
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

Hint for a minor additional benefit (orphan drug, 50 M € sales exceeded)

› Niraparib [repealed]

Subject:

Active Substance: Niraparib [repealed]
Name: Zejula^©
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: TESARO Bio Germany GmbH

Time table:

Start: 15.12.2017
Final decision by G-BA: 07.06.2018
The decision remains valid until: 01.10.2020

The decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Niraparib (re-assessment, 50 M € limit exceeded: ovarian, fallopian tube, or peritoneal cancer, maintenance treatment after platinum-based chemotherapy)

Subject:

Active Substance: Niraparib
Name: Zejula^®
Therapeutic area: Ovarian, fallopian tube, or peritoneal cancer
Pharmaceutical company: TESARO Bio Germany GmbH

Time table:

Start: 15.10.2019
Final decision by G-BA: 02.04.2020
The decision remains valid until: 01.02.2021

Final decision:

No additional benefit proved

› Niraparib (new indication: ovarian, fallopian tube, or primary peritoneal cancer, FIGO stage III and IV, maintenance therapy)

Subject:

Active Substance: Niraparib
Name: Zejula^®
Therapeutic area: Ovarian, fallopian tube, or peritoneal cancer
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› Niraparib (re-assessment: ovarian, fallopian tube, or primary peritoneal cancer)

Subject:

Active Substance: Niraparib
Name: Zejula^®
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

No additional benefit proved (orphan drug)

› Nivolumab

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.07.2015
Final decision by G-BA: 07.01.2016

Final decision:

Therapy-naive patients with BRAF-V600-mutated tumor: no additional benefit proved
Therapy-naive patients with BRAF-V600-wildtype tumor: indication for a considerable additional benefit
Pre-treated patients: no additional benefit proved

› Nivolumab (new indication: non-small cell lung carcinoma)

Subject:

Active Substance: Nivolumab
Name: Nivolumab BMS
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 15.08.2015
Final decision by G-BA: 04.02.2016

Final decision:

Patients for whom docetaxel is indicated: indication for a considerable additional benefit
Patients for whom docetaxel is not indicated: no additional benefit proved

› Nivolumab (new indication: non-small cell lung carcinoma, after prior chemotherapy)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.05.2016
Final decision by G-BA: 20.10.2016

Final decision:

Patients for whom a therapy with docetaxel, pemetrexed, gefitinib, erlotinib or crizotinib is appropriate: hint for considerable additional benefit
Patients for whom such a therapy is not appropriate: no additional benefit proved

› Nivolumab (new indication: renal cell carcinoma)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Renal cell carcinoma (RCC)
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.05.2016
Final decision by G-BA: 20.10.2016

Final decision:

Patients who are pretreated with everolimus: indication for a considerable additional benefit.
Patients who are pretreated with temsirolimus: no additional benefit proved.

› Nivolumab (new indication: melanoma, in combination with ipilimumab)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA

Time table:

Start: 15.06.2016
Final decision by G-BA: 15.12.2016

Final decision:

Therapy-naive patients with BRAF-V600 mutation: no additional benefit proved.
Therapy-naive patients with BRAF-V600 wildtype tumor: no additional benefit proved.
Pre-treated patients: Patient-individual therapy: no additional benefit proved

› Nivolumab (new indication: Hodgkin lymphoma)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Hodgkin lymphoma (HL)
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.01.2017
Final decision by G-BA: 15.06.2014

Final decision:

No additional benefit proved

› Nivolumab (new indication: squamous cell cancer of the head and neck)

Subject:

Active Substance: Nivolumab
Name: Opdivo^©
Therapeutic area: Squamous cell cancer of the head and neck (SCCHN)
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.06.2017
Final decision by G-BA: 17.11.2017

Final decision:

Patients with early progression during or after a platin-based therapy: hint for a considerable additional benefit
Patients with late progression after a platin-based therapy and for whom another platin-based therapy is appropriate: no additional benefit proved

› Nivolumab (re-assessment: melanoma, in combination with ipilimumab) [repealed]

Subject:

Active Substance: Nivolumab
Name: Opdivo^©
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA

Time table:

Start: 15.06.2017
Final decision by G-BA: 07.12.2017
The decision remains valid until: 15.06.2018

Final decision:

Additional benefit not proved

› Nivolumab (new indication: urothelial carcinoma)

Subject:

Active Substance: Nivolumab
Name: Opdivo^©
Therapeutic area: Urothel carcinoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.07.2017
Final decision by G-BA: 21.12.2017

Final decision:

No additional benefit proved

› Nivolumab (re-assessment: melanoma; in combination with ipilimumab)

Subject:

Active Substance: Nivolumab (combi with Ipilimumab, melanoma, re-assessment)
Name: Opdivo^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA

Time table:

Start: 15.06.2018
Final decision by G-BA: 20.12.2018

Final decision:

Indication for less benefit (treatment-naive BRAFwt patients)

› Nivolumab (new indication: melanoma, adjuvant treatment) [repealed]

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.09.2018
Final decision by G-BA: 21.02.2019
This decision remains valid until: 01.04.2021

Final decision:

Hint for a non-quantifiable additional benefit

› Nivolumab (new indication: renal cell carcinoma, in combination with ipilimumab, 1st line)

Subject:

Active Substance: Nivolumab (new indication: renal cell carcinoma, in combination with ipilimumab, 1st line)
Name: Opdivo^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start:15.02.2019
Final decision by G-BA: 15.08.2019

Final decision:

Patients with intermediate risk profile (IMDS score 1-2): Indication for a considerable additional benefit
Patients with unfavourable risk profile (IMDS score ≥ 3): Indication for a considerable additional benefit

› Nivolumab (new indication: non-small cell lung cancer (NSCLC), combination with ipilimumab and platinum-based chemotherapy, 1^st line)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit

› Nivolumab (new indication: squamous oesophageal cancer; pre-treated patients)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Squamous oesophageal cancer
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.01.2021
Final decision by G-BA: 01.07.2021

Final decision:

Patients for whom chemotherapy is an option: Hint for a minor additional benefit
Patients for whom chemotherapy is not an option: No additional benefit proved

› Nivolumab (re-assessment: melanoma, adjuvant therapy)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Melanoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

Hint for a considerable additional benefit

› Nivolumab (new indication: renal cell carcinoma in combination with cabozantinib, 1^st line)

Subject:

Active Substance: Nivolumab
Name: Opdivo^®
Therapeutic area: Renal cell carcinoma
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KG

Time table:

Start: 01.05.2021
Final decision by G-BA: 21.10.2021

Final decision:

a) Patients with a favorable risk profile (IMDC-Score 0): No additional benefit proved
b) Treatment-naïve patients with advanced renal cell carcinoma with an intermediate (IMDC-Score 1–2) or unfavorable risk profile (IMDC-Score ≥ 3): No additional benefit proved

› Nonacog beta pegol

Subject:

Active Substance: Nonacog beta pegol
Name: Refixia^©
Therapeutic area: Haemophilia B
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.11.2017
Final decision by G-BA: 19.04.2018

Final decision:

Additional benefit not proved

› Nusinersen [repealed]

Subject:

Active Substance: Nusinersen
Name: Spinraza^©
Therapeutic area: Spinal muscular atrophy (5q-SMA)
Pharmaceutical company: Biogen GmbH

Time table:

Start: 01.07.2017
Final decision by G-BA: 21.12.2017
The decision remains valid until: 01.07.2024

Final decision:

Type 1: major additional benefit proven (because of orphan drug designation)
Type 2: considerable additional benefit proven (because of orphan drug designation)
Type 3: Non-quantifiable additional benefit proven (because of orphan drug designation)
Type 4: Non-quantifiable additional benefit proven (because of orphan drug designation)

› Nusinersen (re-assessment, 50 Mio. € limit exceeded: spinal muscular atrophy)

Subject:

Active Substance: Nusinersen
Name: Spinraza^®
Therapeutic area: Spinal muscular atrophy (SMA)
Pharmaceutical company: Biogen GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

a) Type 1: indication for a major additional benefit
b) Type 2: hint for a considerable additional benefit
c) Type 3/4: no additional benefit proved
d1) Pre-symptomatic and 2 SMN2 gene copies: hint for a major addiitional benefit
d2) Pre-symptomatic and 3 SMN2 gene copies: hint for a non-quantifiable addiitional benefit
d3) Pre-symptomatic and more than 3 SMN2 gene copies: no additional benefit proved

O

› Obeticholic acid

Subject:

Active Substance: Obeticholic acid
Name: Ocaliva^®
Therapeutic area: Biliary liver cirrhosis
Pharmaceutical company: Intercept Pharma Deutschland GmbH

Time table:

Start: 15.01.2017
Final decision by G-BA: 06.07.2014
The decision remains valid until: 31.10.2023

The decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Obinutuzumab

Subject:

Active Substance: Obinutuzumab
Name: Gazyvaro™
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.08.2014
Final decision by G-BA: 05.02.2015

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Obinutuzumab (new indication: follicular lymphoma)

Subject:

Active Substance: Obinutuzumab
Name: Gazyvaro^®
Therapeutic area: Follicular lymphoma (FL)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.07.2016
Final decision by G-BA: 15.12.2016

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Obinutuzumab (new indication: follicular lymphoma, 1st line)

Subject:

Active Substance: Obinutuzumab
Name: Gazyvaro^©
Therapeutic area: Follicular lymphoma (FL)
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.10.2017
Final decision by G-BA: 05.04.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug status)

› Ocrelizumab

Subject:

Active Substance: Ocrelizumab
Name: Ocrevus^©
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.02.2018
Final decision by G-BA: 02.08.2018

Final decision:

Patients with RMS and active disease who either have not been pretreated with a disease-modifying therapy or have been pretreated but do not have highly active disease: Proof for a minor additional benefit
Patients with RMS and highly active disease despite treatment with a disease-modifying therapy: No additional benefit proved
Patients with primary progredient MS (PPMS): Hint for a minor additional benefit

› Ocriplasmin [repealed]

Subject:

Active Substance: Ocriplasmin
Name: Jetrea^®
Therapeutic area: Vitreomacular traction syndrome
Pharmaceutical company: ThromboGenics NV / Alcon Pharma GmbH

Time table:

Start: 01.05.2013
Final decision by G-BA: 17.10.2013
The decision remains valid until: 15.10.2018

Final decision:

Patients with mild symptoms: hint for a considerable additional benefit
Patients with severe symptoms: no additional benefit proved

› Ocriplasmin (re-assessment)

Subject:

Active Substance: Ocriplasmin
Name: Jetrea^®
Therapeutic area: Vitreomacular traction (VMT)
Pharmaceutical company: Oxurion NV

Time table:

Start: 15.10.2018
Final decision by G-BA: 04.04.2019

Final decision:

a) for patients with light symptoms (e.g. minor worsening of visual acuity, slightly impaired vision, no progression of symptoms): hint for a minor additional benefit
b) for patients with severe symptoms (e.g. progressive worsening of visual acuity, progressive retinal disorder, progressive impaired vision): no additional benefit proved

› Olaparib

Subject:

Active Substance: Olaparib
Name: Lynparza^TM
Therapeutic area: Ovarial neoplasms
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.06.2015
Final decision by G-BA: 27.11.2015

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Olaparib (new indication: high-grade cancer of the ovary, fallopian tube or peritoneum, including re-assessment after revocation of orphan drug designation)

Subject:

Active Substance: Olaparib (new indication: high-grade cancer of the ovary, fallopian tube or peritoneum)
Name: Lynparza^®
Therapeutic area: Ovarian neoplasms
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.06.2018
Final decision by G-BA: 06.12.2018

Final decision:

Hint for a minor additional benefit

› Olaparib (new indication: breast cancer, locally advanced or metastatic)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.07.2019
Final decision by G-BA: 16.01.2020

Final decision:

Hint for a minor additional benefit

› Olaparib (new indication: high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, BRCA-mutated, maintenance treatment)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.07.2019
Final decision by G-BA: 16.01.2020
The decision remains valid until: 01.04.2024

Final decision:

No additional benefit proved.

› Olaparib (new indication: ovarian, fallopian tube, or primary peritoneal cancer, FIGO stages III + IV, HRD-positive, maintenance therapy, combination with bevacizumab)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Ovarian cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021
This decision remains valid until: 01.12.2022

Final decision:

No additional benefit proved

› Olaparib (new indication: prostate cancer, BRCA 1/2 mutations, progress after hormonal treatment)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Prostate cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Hint for a considerable additional benefit

› Olaparib (new indication: pancreatic cancer, BRCA 1/2 mutations, maintenance therapy)

Subject:

Active Substance: Olaparib
Name: Lynparza^®
Therapeutic area: Pancreatic cancer
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

› Olaratumab

Subject:

Active Substance: Olaratumab
Name: Lartruvo^TM
Therapeutic area: Sarcoma
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.12.2016
Final decision by G-BA: 18.05.2017
Benefit assessment stopped because of withdrawal of marketing authorization by EMA (16.01.2020)

Final decision:

› Ombitasvir/ paritaprevir/ ritonavir

Subject:

Active Substance: Ombitasvir/ paritaprevir/ ritonavir
Name: Viekirax^®
Therapeutic area: Chronic hepatitis C virus (HCV) infection
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.02.2015
Final decision by G-BA: 16.07.2015

Final decision:

Therapy-naive patients without cirrhosis (genotype 1a/1b): indication for a considerable additional benefit
Therapy-naive patients with compensated cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Pre-treated patients without cirrhosis (genotype 1a/1b): hint for a considerable additional benefit
Pre-treated patients with compensated cirrhosis (genotype 1a/1b): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients (genotype 4): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients without cirrhosis (genotype 4): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients with a HIV coinfection (genotype 1a/1b): hint for a minor additional benefit

› Onasemnogene abeparvovec (5q-associated spinal muscle atrophy)

Subject:

Active Substance: Onasemnogene abeparvovec
Name: Zolgensma^®
Therapeutic area: Spinal muscle atrophy
Pharmaceutical company: AveXis

Time table:

Start: 01.07.2020
Final decision by G-BA: 03.12.2020

Final decision:

Assessment is suspended due to expected full assessment after exceedance of 50 M € annual sales

› Opicapone

Subject:

Active Substance: Opicapone
Name: Ongentys^®
Therapeutic area: Parkinson’s disease
Pharmaceutical company: Bial Portela

Time table:

Start: 01.10.2016
Final decision by G-BA: 16.03.2017

Final decision:

No additional benefit proved

› Osilodrostat (endogenous Cushing's syndrome)

Subject:

Active Substance: Osilodrostat
Name: Isturisa^®
Therapeutic area: Endogenous Cushing's syndrome
Pharmaceutical company: Recordati Rare Diseases Germany GmbH

Time table:

Start: 15.07.2020
Final decision by G-BA: 07.01.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Osimertinib [repealed]

Subject:

Active Substance: Osimertinib
Name: TAGRISSO^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.03.2016
Final decision by G-BA: 15.09.2016
The decision remains valid until: 30.04.2017

Final decision:

Patients with prior treatment with an EGFR tyrosine kinase inhibitor: no additional benefit proved
Therapy-naive patients with de novo positive T790M mutation: no additional benefit proved
Patients with prior platin-based chemotherapy and de novo positive T790M mutation: no additional benefit proved

› Osimertinib (re-assessment)

Subject:

Active Substance: Osimertinib
Name: Tagrisso^©
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.05.2017
Final decision by G-BA: 16.10.2017

Final decision:

With EGFR tyrosine kinase inhibitor pre-treated patients: hint for a major additional benefit

› Osimertinib (new indication: 1^st line treatment)

Subject:

Active Substance: Osimertinib
Name: Tagrisso^©
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.07.2018
Final decision by G-BA: 17.01.2019

Final decision:

Patients with activating EGFR mutations L858 or del 19: hint for a considerable additional benefit
Patients with activating EGFR mutations other than L858 or del 19 (except for de novo T790M): no additional benefit prove

› Ospemifen

Subject:

Active Substance: Ospemifen
Name: Senshio^®
Therapeutic area: Vulvar and vaginal atrophy (VVA) in post-menopausal women
Pharmaceutical company: Shionogi GmbH

Time table:

Start: 01.05.2016
Final decision by G-BA: 20.10.2016

Final decision:

No additional benefit proved

› Ozanimod (relapsing remitting multiple sclerosis (RRMS))

Subject:

Active Substance: Ozanimod
Name: Zeposia^®
Therapeutic area: Multiple sclerosis (MS)
Pharmaceutical company: Celgene GmbH

Time table:

Start: 15.07.2020
Final decision by G-BA: 07.01.2021

Final decision:

a. Adult patients who have not yet received a disease-modifying treatment or whose disease is not highly active with a disease-modifying treatment: Indication for a minor additional benefit
b. Adult patients with highly active disease despite treatment with a disease-modifying therapy: No additional benefit proved

P

› Palbociclib

Subject:

Active Substance: Palbociclib
Name: Ibrance^®
Therapeutic area: Breast cancer
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.12.2016
Final decision by G-BA: 18.05.2017
The decision remains valid until: 01.07.2022 (first-line) / 01.10.2018 (second-line)

Final decision:

Treatment-naive patients: no additional benefit proved
Pre-treated patients: no additional benefit proved

› Palbociclib (re-assessment, patient population b1 and b2)

Subject:

Active Substance: Palbociclib
Name: Ibrance^®
Therapeutic area: Breast cancer
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

b1) postmenopausal women with progress after endocrine therapy: No additional benefit proved.
b2) pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

› Panobinostat

Subject:

Active Substance: Panobinostat
Name: Farydak^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 17.03.2016

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Pasireotide

Subject:

Active Substance: Pasireotide
Name: Signifor^®
Therapeutic area: Hypophysis dysfunction
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.06.2012
Final decision by G-BA: 06.12.2012

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Pasireotide (new indication: acromegaly)

Subject:

Active Substance: Pasireotide
Name: Signifor^®
Therapeutic area: Acromegaly
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.01.2015
Final decision by G-BA: 18.06.2015

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Patiromer

Subject:

Active Substance: Patiromer
Name: Veltassa^©
Therapeutic area: Hyperkalemia
Pharmaceutical company: Fresenius Medical Care Nephrologica Deutschland GmbH

Time table:

Start: 01.04.2018
Final decision by G-BA: 20.09.2018

Final decision:

No additional benefit proved.

› Patisiran

Subject:

Active Substance: Patisiran
Name: Onpattro^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Alnylam Germany GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Considerable additional benefit (proved because of orphan drug designation)

› Pegvaliase

Subject:

Active Substance: Pegvaliase
Name: Palynziq^™
Therapeutic area: Phenylketonuria
Pharmaceutical company: BioMarin International Limited

Time table:

Start: 01.07.2019
Final decision by G-BA: 19.12.2019

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Pembrolizumab

Subject:

Active Substance: Pembrolizumab
Name: KEYTRUDA^®
Therapeutic area: Melanoma
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.08.2015
Final decision by G-BA: 04.02.2016

Final decision:

Therapy-naive patients with BRAF-V600 mutation: No additional benefit proved
Therapy-naive patients without BRAF-V600 mutation: hint for a considerable additional benefit
Pre-treated patients: indication for a considerable additional benefit

› Pembrolizumab (new indication: non-small cell lung carcinoma after prior chemotherapy)

Subject:

Active Substance: Pembrolizumab
Name: KEYTRUDA^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.08.2016
Final decision by G-BA: 02.02.2017

Final decision:

Patients for whom a therapy with docetaxel, pemetrexed or nivolumab is appropriate: indication for a considerable additional benefit
Patients for whom the above therapy is not appropriate: no additional benefit proved

› Pembrolizumab (new indication: non-small cell lung carcinoma, first-line)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 15.02.2017
Final decision by G-BA: 03.08.2017

Final decision:

Indication for a considerable additional benefit

› Pembrolizumab (new indication: Hodgkin lymphoma)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^©
Therapeutic area: Hodgkin lymphoma (HL)
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.06.2017
Final decision by G-BA: 17.11.2017

Final decision:

No additional benefit proved

› Pembrolizumab (new indication: urothelial carcinoma)

Subject:

Active Substance: Pembrolizumab (new indication: urothelial carcinoma)
Name: Keytruda^©
Therapeutic area: Urothelial carcinoma
Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

Start: 15.09.2017
Final decision by G-BA: 16.03.2018

Final decision:

Patients for whom cisplatin-based chemotherapy based is inappropriate: no additional benefit proved
Patients who are pretreated with cisplatin-based chemotherapy: indication for a considerable additional benefit

› Pembrolizumab (new indication: head and neck squamous cell carcinoma (HNSCC))

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

Start: 15.10.2018
Final decision by G-BA: 04.04.2019
This decision remains valid until: 01.10.2019

Final decision:

No additional benefit proved

› Pembrolizumab (re-assessment accord. to §13: urothelial cancer (1^st line))

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Urothelial cancer
Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

Start: 01.01.2019
Final decision by G-BA: 20.06.2019
The decision remains valid until: 01.04.2021

Final decision:

No additional benefit proved.

› Pembrolizumab (new indication: NSCLC, 1^st line, combination with carboplatin and (nab-) paclitaxel)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: NSCLC
Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

Start: 01.04.2019
Final decision by G-BA: 19.09.2019

Final decision:

Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS): no additional benefit proved
Patients with PD-L1 expression < 50 % (TPS): hint for a considerable additional benefit

› Pembrolizumab (new indication: NSCLC, 1^st line, combination with pemetrexed and platinum chemotherapy)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: NSCLC
Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

Start: 01.04.2019
Final decision by G-BA: 19.09.2019

Final decision:

Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS): hint for a non-quantifiable additional benefit
Patients with PD-L1 expression < 50 % (TPS): hint for a non-quantifiable additional benefit

› Pembrolizumab (new indication: Melanoma, adjuvant treatment)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Melanoma
Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

Start: 01.04.2019
Final decision by G-BA: 19.09.2019

Final decision:

Indication for a non-quantifiable additional benefit

› Pembrolizumab (new indication: renal cell carcinoma, 1^st line, in combination with axitinib)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.12.2019
Final decision by G-BA: 14.05.2020

Final decision:

a) Patients with treatment-naive, advanced renal cell carcinoma with favourable or intermediate risk profile (IMDC score 0-2): Hint for a considerable additional benefit
b) Patients with treatment-naive advanced renal cell carcinoma with unfavourable risk profile (IMDC score ≥3): Indication for a considerable additional benefit

› Pembrolizumab (new indication: head and neck squamous cell carcinoma (HNSCC), 1^st line, PD-L1 expression ≥1%, monotherapy)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.12.2019
Final decision by G-BA: 14.05.2020

Final decision:

Hint for considerable additional benefit

› Pembrolizumab (new indication: head and neck squamous cell carcinoma (HNSCC), 1^st line, PD-L1 expression ≥1%, combination with platin and 5-FU chemo)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.12.2019
Final decision by G-BA: 14.05.2020

Final decision:

Indication for a minor additional benefit

› Pembrolizumab (new indication: colorectal cancer, MSI-H or dMMR, 1^st line)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Colorectal cancer
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

Patients for whom an intensive therapy is indicated: Hint for a minor additional benefit
Patients for whom an intensive therapy is not indicated: No additional benefit proved

› Pembrolizumab (new indication: urothelial cancer, CPS ≥ 10, 1^st line)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Urothelial cancer
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

No additional benefit proved

› Pembrolizumab (new indication: Hodgkin lymphoma, pre-treated patients, aged ≥ 3 years)

Subject:

Active Substance: Pembrolizumab
Name: Keytruda^®
Therapeutic area: Hodgkin lymphoma
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

Adults:

Brentuximab vedotin is the appropriate therapy: Hint for a considerable additional benefit
Brentuximab vedotin is not the appropriate therapy: No additional benefit proved

Children and adolescents aged 3 years and older: No additional benefit proved

› Pemigatinib (cholangiocarcinoma with FGFR2 fusion or rearrangement, at least one prior therapy)

Subject:

Active Substance: Pemigatinib
Name: Pemazyre^®
Therapeutic area: Cholangiocarcinoma
Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

Start: 15.04.2021
Final decision by G-BA: 07.10.2021

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug designation)

› Perampanel (re-assessement)

Subject:

Active Substance: Perampanel
Name: Fycompa^®
Therapeutic area: Partial epilepsies
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.05.2014
Final decision by G-BA: 06.11.2014

Final decision:

Re-assessment was applied by pharmaceutical company
No additional benefit proved

› Perampanel [repealed]

Subject:

Active Substance: Perampanel
Name: Fycompa^®
Therapeutic area: Partial epilepsy
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.09.2012
Final decision by G-BA: 07.03.2013

Final decision:

No additional benefit proved

› Perampanel (new indication: adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age)

Subject:

Active Substance: Perampanel
Therapeutic area: Epilepsy
Pharmaceutical company: Eisai GmbH

Time table:

Start: 01.12.2017
Final decision by G-BA: 17.05.2018

Final decision:

Additional benefit not proved

› Perampanel (new indication: epilepsy, primary generalised seizures, patients aged 7 – < 12 years)

Subject:

Active Substance: Perampanel
Name: Fycompa^®
Therapeutic area: Epilepsy
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

› Perampanel (new indication: epilepsy, partial seizures, patients aged 4 – < 12 years)

Subject:

Active Substance: Perampanel
Name: Fycompa^®
Therapeutic area: Epilepsy
Pharmaceutical company: Eisai GmbH

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

› Pertuzumab

Subject:

Active Substance: Pertuzumab
Name: Perjeta^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.04.2013
Final decision by G-BA: 01.10.2013

Final decision:

Patients with HER2-positive metastatic breast cancer with visceral metastases: hint for a considerable additional benefit
Patients with HER2-positive metastatic breast cancer with non-visceral metastases: no additional benefit proved
Patients with HER2-positive locally recurrent, not resectable breast cancer: no additional benefit proved

› Pertuzumab (new indication)

Subject:

Active Substance: Pertuzumab
Name: Perjeta^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.09.2015
Final decision by G-BA: 18.02.2016

Final decision:

No additional benefit proved

› Pertuzumab (new indication: breast cancer; adjuvant treatment)

Subject:

Active Substance: Pertuzumab
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.07.2018
Final decision by G-BA: 10.12.2018
This decision remains valid until: 02.01.2022

Final decision:

Hint for a minor additional benefit

› Pertuzumab / trastuzumab (breast cancer, HER2+, early with high risk of recurrence, adjuvant)

Subject:

Active Substance: Pertuzumab / trastuzumab
Name: Phesgo^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021
The decision remains valid until: 01.10.2022

Final decision:

Hint for a minor additional benefit

› Pertuzumab / trastuzumab (breast cancer, HER2+, locally advanced or inflammatory or early with high risk of recurrence, neo-adjuvant)

Subject:

Active Substance: Pertuzumab / trastuzumab
Name: Phesgo^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

No additional benefit proved

› Pertuzumab / trastuzumab (breast cancer, HER2+, metastasized or with local recurrence (inoperable), 1st line, combination with docetaxel)

Subject:

Active Substance: Pertuzumab / trastuzumab
Name: Phesgo^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

No additional benefit proved

› Piperaquine tetraphosphate/ dihydroartemisinin

Subject:

Active Substance: Piperaquine tetraphosphate/ dihydroartemisinin
Name: Eurartesim^®
Therapeutic area: Malaria
Pharmaceutical company: Sigma-tau Arzneimittel GmbH

Time table:

Start: 21.03.2012
Final decision by G-BA: 03.05.2012

Final decision:

Sigma-tau Arzneimittel GmbH is exempted from submitting a dossier as expected sales are below the legally defined threshold

› Pirfenidone

Subject:

Active Substance: Pirfenidone
Name: Esbriet^®
Therapeutic area: Idiopathic Pulmonary Fibrosis (IPF)
Pharmaceutical company: InterMune Deutschland GmbH

Time table:

Start: 15.09.2011
Final decision by G-BA: 15.03.2012

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Pitavastatin

Subject:

Active Substance: Pitavastatin
Name: Livazo^®
Therapeutic area: Primary hypercholesterolaemia and combined (mixed) dyslipidaemia
Pharmaceutical company: Merckle Recordati GmbH

Time table:

Start: 01.06.2011
Final decision by G-BA: 18.08.2011

Final decision:

No additional benefit proved
Pharmaceutical company submitted no dossier

› Pitolisant

Subject:

Active Substance: Pitolisant
Name: Wakix^®
Therapeutic area: Narcolepsy
Pharmaceutical company: Bioprojet Pharma SARL

Time table:

Start: 01.08.2016
Final decision by G-BA: 19.01.2017

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Pixantrone

Subject:

Active Substance: Pixantrone
Name: Pixuvri^®
Therapeutic area: Non-Hodgkin B-cell lymphoma (NHL)
Pharmaceutical company: CTI Life Sciences Ltd.

Time table:

Start: 01.12.2012
Final decision by G-BA: 16.05.2013

Final decision:

No additional benefit proved

› Polatuzumab vedotin (diffuse large B-cell lymphoma (DLBCL), combination with bendamustine and rituximab)

Subject:

Active Substance: Polatuzumab vedotin
Name: Polivy^®
Therapeutic area: Diffuse large B-cell lymphoma (DLBCL)
Pharmaceutical company: Roche Pharma GmbH

Time table:

Start: 15.02.2020
Final decision by G-BA: 20.08.2020

Final decision:

Hint for a non-quantifiable additional benefit due to limited scientific evidence (and orphan drug status)

› Pomalidomide [repealed]

Subject:

Active Substance: Pomalidomide
Name: Imnovid^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Celgene GmbH

Time table:

Start: 01.09.2013
Final decision by G-BA: 20.02.2014

Final decision:

Considerable additional benefit

› Pomalidomide (re-assessment, 50 Mio. € limit exceeded)

Subject:

Active Substance: Pomalidomide
Name: Imnovid^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Celgene GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 17.03.2016

Final decision:

High dose dexamethasone as patient-individual target-oriented therapy is appropriate: hint for a considerable additional benefit
High dose dexamethasone is not appropriate as patient-individual target-oriented therapy: no additional benefit proved

› Pomalidomide

Subject:

Active Substance: Pomalidomide
Name: Imnovid^®
Therapeutic area: Multiple myeloma
Pharmaceutical company: Celgene GmbH

Time table:

Start: 15.06.2019
Final decision by G-BA: 05.12.2019

Final decision:

No additional benefit proved

› Ponatinib

Subject:

Active Substance: Ponatinib
Name: Iclusig^®
Therapeutic area: Lymphoblastic or myeloid leukaemia
Pharmaceutical company: ARIAD Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.08.2013
Final decision by G-BA: 23.01.2014
The decision remains valid until: 01.06.2020

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Ponatinib (re-assessment: acute lymphatic leukemia)

Subject:

Active Substance: Ponatinib
Name: Iclusig^®
Therapeutic area: Acute lymphatic leukemia (ALL)
Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

Start: 01.06.2020
Final decision by G-BA: 20.11.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Ponatinib (re-assessment: chronic myeloid leukemia)

Subject:

Active Substance: Ponatinib
Name: Iclusig^®
Therapeutic area: Chronic myeloid leukemia (CML)
Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

Start: 01.06.2020
Final decision by G-BA: 20.11.2020

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Prasterone

Subject:

Active Substance: Prasterone
Name: Intrarosa^®
Therapeutic area: Post menopause
Pharmaceutical company: Endoceutics, Inc.

Time table:

Start: 01.05.2019
Final decision by G-BA: 17.10.2019

Final decision:

The assessment has been stopped because the launched package is not reimbursable by SHI

› Propranolol

Subject:

Active Substance: Propranolol
Name: Hemangiol^®
Therapeutic area: Hemangioma
Pharmaceutical company: Pierre Fabre Dermatologie

Time table:

Start: 01.09.2014
Final decision by G-BA: 19.02.2015

Final decision:

Life-threatening or ulcerative hemangioma: hint for a non-quantifiable additional benefit
Hemangioma with risk of permanent scars: indication for a major additional benefit

Q

Kein Eintrag.

R

› Radium-223 dichloride [repealed]

Subject:

Active Substance: Radium-223 dichloride
Name: Xofigo^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.01.2014
Final decision by G-BA: 19.06.2014

Final decision:

Indication for a considerable additional benefit

› Radium-223 dichloride (re-assessment accord. to §13)

Subject:

Active Substance: Radium-223 dichloride
Name: Xofigo^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 15.04.2019
Final decision by G-BA: 17.10.2019

Final decision:

Patients with progression of disease after treatment with at least two prior systemic therapy lines: No additional benefit proven
Patients for whom no other systemic mCRPC treatment is appropriate: No additional benefit proven

› Ramucirumab [repealed]

Subject:

Active Substance: Ramucirumab
Name: Cyramza^®
Therapeutic area: Gastric cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.02.2015
Final decision by G-BA: 16.07.2015

Final decision:

Monotherapy: minor additional benefit proved (because of orphan drug status)
In combination with paclitaxel: minor additional benefit proved (because of orphan drug status)

› Ramucirumab (new indication: colorectal cancer)

Subject:

Active Substance: Ramucirumab
Name: Cyramza^®
Therapeutic area: Colorectal cancer (CRC
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.03.2016
Final decision by G-BA: 01.06.2016

Final decision:

No additional benefit proved

› Ramucirumab (new indication: non-small cell lung carcinoma)

Subject:

Active Substance: Ramucirumab
Name: Cyramza^®
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.03.2016
Final decision by G-BA: 01.06.2016

Final decision:

No additional benefit proved

› Ramucirumab (withdrawal of orphan drug status)

Subject:

Active Substance: Ramucirumab
Name: Cyramza^®
Therapeutic area: Gastric cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.05.2016
Final decision by G-BA: 20.10.2016

Final decision:

In combination with paclitaxel: hint for a minor additional benefit
Monotherapy: no additional benefit proved

› Ramucirumab (new indication: hepatocellular carcinoma)

Subject:

Active Substance: Ramucirumab
Name: Cyramza^®
Therapeutic area: Hepatocellular carcinoma (HCC)
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 01.09.2019
Final decision by G-BA: 20.02.2020

Final decision:

Proof for a minor additional benefit

› Ramucirumab (new indication: NSCLC, EGFR mutation, 1^st line)

Subject:

Active Substance: Ramucirumab
Name: Cyramza^®
Therapeutic area: Non-small cell lung cancer (NSCLC)
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.02.2020
Final decision by G-BA: 20.08.2020

Final decision:

Patients with activating EGFR mutations L858R (exon 21 substitution mutation) or del 19 (exon 19 deletion): no additional benefit proved
Patients with other activating EGFR mutations than L858R or del 19 (exon 19 deletion): no additional benefit proved

› Ravulizumab

Subject:

Active Substance: Ravulizumab
Name: Ultomiris^®
Therapeutic area: Paroxysmal nocturnal haemoglobinuria (PNH)
Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

Start: 01.08.2019
Final decision by G-BA: 06.02.2020

Final decision:

Patients with high disease activity: No additional benefit proved
Patients receiving eculizumab for ≥ 6 months and who are clinically stable:: No additional benefit proved

› Ravulizumab (new indication: atypical haemolytic uremic syndrome (aHUS))

Subject:

Active Substance: Ravulizumab
Name: Ultomiris^®
Therapeutic area: Atypical haemolytic uremic syndrome (aHUS)
Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

No additional benefit proved

› Regadenoson

Subject:

Active Substance: Regadenoson
Name: Rapiscan^®
Therapeutic area: Myocardial perfusion imaging
Pharmaceutical company: Rapidscan Pharma Solutions EU Ltd.

Time table:

Start: 15.04.2011
Final decision by G-BA: 29.03.2012

Final decision:

No additional benefit proved
Rapidscan Pharma Solutions EU Ltd. submitted an incomplete dossier
The pharmaceutical company is given the opportunity to resubmit the benefit dossier in one year

› Regadenoson (new indication: measurement of fractional flow reserve (FFR) of stenosis)

Subject:

Active Substance: Regadenoson
Name: Rapiscan^®
Therapeutic area: Measurement of fractional flow reserve (FFR) of stenosis
Pharmaceutical company: GE Healthcare Buchler GmbH & Co. KG

Time table:

Start: 01.03.2019
Final decision by G-BA: 15.08.2019

Final decision:

Additional benefit not proved (no dossier submitted)

› Regorafenib [repealed]

Subject:

Active Substance: Regorafenib
Name: Stivarga^®
Therapeutic area: Colorectal cancer (CRC)
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.10.2013
Final decision by G-BA: 20.03.2014
The decision remains valid until: 01.10.2015

Final decision:

Hint for a minor additional benefit

› Regorafenib (new indication)

Subject:

Active Substance: Regorafenib
Name: Stivarga^®
Therapeutic area: Gastrointestinal stromal tumours (GIST)
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.09.2014
Final decision by G-BA: 19.02.2015

Final decision:

No additional benefit proved
Bayer Vital GmbH submitted an incomplete dossier

› Regorafenib (re-assessment)

Subject:

Active Substance: Regorafenib
Name: Stivarga^®
Therapeutic area: Colorectal cancer (CRC)
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 17.03.2016

Final decision:

No additional benefit proved

› Remdesivir (COVID-19, patients aged ≥ 12 years, requirement of supplemental oxygen)

Subject:

Active Substance: Remdesivir
Name: Veklury^®
Therapeutic area: Coronavirus disease 2019 (COVID-19)
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

Adults:

Receiving low-flow oxygen at the beginning of the therapy: Hint for a minor additional benefit
Receiving high-flow oxygen at the beginning of the therapy: No additional benefit proved

Adolescents aged 12 years and older: No additional benefit proved

› Reslizumab

Subject:

Active Substance: Reslizumab
Name: Cinqaero^®
Therapeutic area: Asthma
Pharmaceutical company: Teva GmbH

Time table:

Start: 15.01.2017
Final decision by G-BA: 06.07.2014
The decision remains valid until: 31.07.2020

Final decision:

Patients who are treated with inhaled corticosteroids in case of exacerbations: no additional benefit proved
Patients who are regularly treated with inhaled corticosteroids: minor additional benefit

› Retigabine [repealed]

Subject:

Active Substance: Retigabine
Name: Trobalt^®
Therapeutic area: Epilepsy
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.05.2011
Final decision by G-BA: 03.05.2012

Final decision:

No additional benefit proved
GlaxoSmithKline did not chose the comparative therapy, which was decided at the advisory meeting with the G-BA
GlaxoSmithKline is given the opportunity to resubmit the benefit dossier in one year

› Retigabine (re-assessment)

Subject:

Active Substance: Retigabine
Name: Trobalt^®
Therapeutic area: Epilepsy
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.01.2014
Final decision by G-BA: 03.07.2014

Final decision:

No additional benefit proved

› Ribociclib

Subject:

Active Substance: Ribociclib
Therapeutic area: Breast cancer
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.09.2017
Final decision by G-BA: 16.03.2018
The decision remains valid until: 01.03.2020

Final decision:

No additional benefit proved

› Ribociclib (new indication: breast cancer, in combination with an aromatase inhibitor / pre-, peri-menopausal women)

Subject:

Active Substance: Ribociclib
Name: Kisqali^®
Therapeutic area: Breast cancer
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019
This decision remains valid until: 01.03.2022

Final decision:

A) For women who are not pre-treated with an endocrine therapy:
A2) pre- and peri-menopausal women: no additional benefit proved
B) For women who are pre-treated with an endocrine therapy:
B2) pre- and peri-menopausal women with progress after endocrine therapy: no additional benefit proved

› Ribociclib (new indication: breast cancer, in combination with fulvestrant / pre-, peri-menopausal women)

Subject:

Active Substance: Ribociclib
Name: Kisqali^®
Therapeutic area: Breast cancer
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.01.2019
Final decision by G-BA: 04.07.2019
This decision remains valid until: 01.03.2022

Final decision:

A) For women who are not pre-treated with an endocrine therapy:
A1) post-menopausal women: no additional benefit proved
A2) pre- and peri-menopausal women: no additional benefit proved
B) For women who are pre-treated with an endocrine therapy:
B1) post-menopausal women with progress after endocrine therapy: no additional benefit proved
B2) pre- and peri-menopausal women with progress after endocrine therapy: no additional benefit proved

› Ribociclib (re-assessment: breast cancer, HR+, HER2-, combination with fulvestrant)

Subject:

Active Substance: Ribociclib
Name: Kisqali^®
Therapeutic area: Breast cancer
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.03.2020
Final decision by G-BA: 20.08.2020

Final decision:

Post-menopausal women who are not pre-treated with an endocrine therapy: indication for a minor additional benefit
Post-menopausal women who are pre-treated with an endocrine therapy: hint for a minor additional benefit

› Ribociclib (re-assessment: breast cancer, HR+, HER2-, combination with aromatase inhibitor)

Subject:

Active Substance: Ribociclib
Name: Kisqali^®
Therapeutic area: Breast cancer
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.03.2020
Final decision by G-BA: 20.08.2020

Final decision:

Hint for a minor additional benefit

› Rilpivirine

Subject:

Active Substance: Rilpivirine
Name: Edurant^®
Therapeutic area: HIV infections
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.01.2012
Final decision by G-BA: 05.07.2012

Final decision:

Proof of a minor additional benefit

› Rilpivirine (new indication: HIV infections, patients aged 12-17 years)

Subject:

Active Substance: Rilpivirine
Name: Edurant^®
Therapeutic area: HIV infections
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.01.2016
Final decision by G-BA: 16.06.2016

Final decision:

No additional benefit proved

› Rilpivirine (HIV-1 infection, in combination with cabotegravir, for patients on a stable antiretroviral therapy)

Subject:

Active Substance: Rilpivirine
Name: Rekambys^®
Therapeutic area: HIV-1 infection
Pharmaceutical company: ViiV Healthcare GmbH

Time table:

Start: 01.05.2021
Final decision by G-BA: 21.10.2021

Final decision:

No additional benefit proved

› Riociguat

Subject:

Active Substance: Riociguat
Name: Adempas^®
Therapeutic area: Pulmonary hypertension
Pharmaceutical company: Bayer Vital GmbH

Time table:

Start: 01.05.2014
Final decision by G-BA: 16.10.2014

Final decision:

Adult patients with chronic thromboembolic pulmonary hypertension (CTEPH): minor additional benefit proved (because of orphan drug status)
Adult patients with pulmonary arterial hypertension (PAH): minor additional benefit proved (because of orphan drug status)

› Riociguat (re-assessment, 50 Mio. € limit exceeded: chronic thromboembolic pulmonary hypertension (CTEPH))

Subject:

Active Substance: Riociguat
Name: Adempas^®
Therapeutic area: Pulmonary Hypertension
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 03.09.2020

Final decision:

No additional benefit proved

› Riociguat (re-assessment, 50 Mio. € limit exceeded: pulmonary arterial hypertension (PAH))

Subject:

Active Substance: Riociguat
Name: Adempas^®
Therapeutic area: Pulmonary Hypertension
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 03.09.2020

Final decision:

No additional benefit proved

› Risankizumab

Subject:

Active Substance: Risankizumab
Name: Skyrizi^TM
Therapeutic area: Plaque psoriasis
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.06.2019
Final decision by G-BA: 22.11.2019

Final decision:

Patients that are not eligible for a conventional therapy as part of the first systemic treatment: No additional benefit proved
Patients that have responded insufficiently to or are intolerant to a systemic treatment: Proof for a considerable additional benefit

› Risdiplam (5q-associated spinal muscular atrophy (SMA))

Subject:

Active Substance: Risdiplam
Name: Evrysdi^®
Therapeutic area: Spinal muscular atrophy
Pharmaceutical company: Roche Pharma GmbH

Time table:

Start: 01.05.2021
Final decision by G-BA: 21.10.2021

Final decision:

a) Patients with a 5q-associated SMA type I: Hint for a non-quantifiable additional benefit
b) Patients with a 5q-associated SMA type II: No additional benefit proved
c1) Patients with a 5q-associated SMA type III, intrathecal administration of nusinersen possible: No additional benefit proved
c2) Patients with a 5q-associated SMA type III, intrathecal administration of nusinersen not possible: Hint for a non-quantifiable additional benefit
d1) Presymptomatic patients with a 5q-associated SMA and ≤ 3 copies of the SMN2 gene: No additional benefit proved
d2) Presymptomatic patients with a 5q-associated SMA and 4 copies of the SMN2 gene: No additional benefit proved

› Rolapitant

Subject:

Active Substance: Rolapitant
Name: Varuby^©
Therapeutic area: Nausea and vomiting due to chemotherapy
Pharmaceutical company: TESARO Bio Germany GmbH

Time table:

Start: 01.06.2017
Final decision by G-BA: 17.11.2017

Final decision:

Patients with highly emetogenic chemotherapy: no additional benefit proved
Patients with moderately emetogenic chemotherapy: no additional benefit proved

› Romosozumab (osteoporosis, post-menopausal women)

Subject:

Active Substance: Romosozumab
Name: Evenity^®
Therapeutic area: Osteoporosis
Pharmaceutical company: UCB Pharma GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 03.09.2020

Final decision:

Indication for a minor additional benefit

› Ropeginterferon alfa-2b (polycythaemia vera)

Subject:

Active Substance: Ropeginterferon alfa-2b
Name: Besremi^®
Therapeutic area: Polycythaemia vera
Pharmaceutical company: AOP Orphan Pharmaceuticals AG

Time table:

Start: 15.09.2019
Final decision by G-BA: 05.03.2020

Final decision:

Treatment-naïve patients or patients pretreated with hydroxycarbamide without resistance or intolerance against hydroxycarbamide: additional benefit not proved
Patients pretreated with hydroxycarbamide who are resistant or intolerant against hydroxycarbamide: additional benefit not proved
Patients pretreated with hydroxycarbamide who are resistant or intolerant against hydroxycarbamide: Ruxolitinib

› Rucaparib (maintenance therapy)

Subject:

Active Substance: Rucaparib
Name: Rubraca^®
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

Start: 01.03.2019
Final decision by G-BA: 15.08.2019
The decision remains valid until: 01.04.2023

Final decision:

Additional benefit not proved

› Rucaparib (after ≥ 2 prior therapies, with BRCA mutation)

Subject:

Active Substance: Rucaparib
Name: Rubraca^®
Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

Start: 01.03.2019
Final decision by G-BA: 15.08.2019

Final decision:

Additional benefit not proved

› Rurioctocog alfa pegol)

Subject:

Active Substance: Rurioctocog alfa pegol
Name: Adynovi^®
Therapeutic area: Hemophilia A
Pharmaceutical company: Shire Deutschland GmbH

Time table:

Start: 15.05.2018
Final decision by G-BA: 01.11.2018

Final decision:

No additional benefit proved

› Ruxolitinib [repealed]

Subject:

Active Substance: Ruxolitinib
Name: Jakavi^®
Therapeutic area: Chronic myeloproliferative disorders
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.09.2012
Final decision by G-BA: 07.03.2013

Final decision:

Minor additional benefit proved proved (because of orphan drug status)

› Ruxolitinib (re-assessment, 50 Mio. € limit exceeded)

Subject:

Active Substance: Ruxolitinib
Name: Jakavi^®
Therapeutic area: Chronic myeloproliferative disorders
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.05.2014
Final decision by G-BA: 06.11.2014

Final decision:

Hint for a considerable additional benefit

› Ruxolitinib (new indication: polycythaemia vera)

Subject:

Active Substance: Ruxolitinib
Name: Jakavi^®
Therapeutic area: Polycythaemia vera
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.04.2015
Final decision by G-BA: 15.10.2015

Final decision:

Hint for a considerable additional benefit

S

› Sacubitril/ valsartan

Subject:

Active Substance: Sacubitril/ valsartan
Name: Entresto^®
Therapeutic area: Chronic heart failure with reduced ejection fraction
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.01.2016
Final decision by G-BA: 16.06.2016

Final decision:

Patients who suffer from diabetes mellitus: hint for a minor additional benefit
Patients who do not suffer from diabetes mellitus: hint for a considerable additional benefit

› Safinamide

Subject:

Active Substance: Safinamide
Name: Xadago^®
Therapeutic area: Parkinson‘s disease (PD)
Pharmaceutical company: Zambon S.p.A.

Time table:

Start: 15.05.2015
Final decision by G-BA: 05.11.2015

Final decision:

No additional benefit proved
The indirect comparison was accepted for benefit assessment

› Sarilumab

Subject:

Active Substance: Sarilumab
Therapeutic area: Rheumatoid arthritis
Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

Start: 15.08.2017
Final decision by G-BA: 15.02.2018

Final decision:

As monotherapy or in combination with methotrexate (MTX) for patients who have responded inadequately to, or who are intolerant to one disease modifying anti rheumatic drug (DMARD), and who do not have unfavourable prognostic factors: additional benefit not proven
As monotherapy for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time and who are intolerant to MTX or for whom MTX treatment is inappropriate: hint for a considerable additional benefit
In combination with MTX for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time: additional benefit not proven
As monotherapy or in combination with MTX for patients who have responded inadequately to, or who are intolerant to one or more bDMARDs: additional benefit not proven

› Saxagliptin [repealed]

Subject:

Active Substance: Saxagliptin
Name: Onglyza^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH

Time table:

Start: 01.04.2013
Final decision by G-BA: 01.10.2013
The decision remains valid until: 01.10.2015

Final decision:

Hint for a minor additional benefit

› Saxagliptin (new indication: diabetes mellitus, type 2, monotherapy)

Subject:

Active Substance: Saxagliptin
Name: Onglyza^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Bristol-Myers Squibb GmbH &Co. KGaA and AstraZeneca Gmb

Time table:

Start: 01.09.2013

Final decision:

Process stopped due to withdrawal of „Bestandsmarkt“ (benefit assessment of selected pharmaceuticals in market)

› Saxagliptin (re-assessment)

Subject:

Active Substance: Saxagliptin
Name: Onglyza^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.07.2016
Final decision by G-BA: 15.12.2016

Final decision:

Monotherapy: no additional benefit proved
Combination with metformin: no additional benefit proved
Combination with sulfonylurea: no additional benefit proved
Combination with metformin + sulfonylurea: no additional benefit proved
Combination with insulin (± metformin): no additional benefit proved

› Saxagliptin/ metformin [repealed]

Subject:

Active Substance: Saxagliptin/ metformin
Name: Komboglyze^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Astra Zeneca GmbH & Bristol-Myers Squibb GmbH & Co. KG

Time table:

Start: 15.11.2012
Final decision by G-BA: 02.05.2013
The decision remains valid until: 01.10.2015

Final decision:

Dual combination therapy saxagliptin + metformin: hint for a minor additional benefit
Triple combination therapy saxagliptin + metformin + insulin: no additional benefit proved

› Saxagliptin/ metformin (new indication: diabetes mellitus, type 2, in combination with sulfonylurea)

Subject:

Active Substance: Saxagliptin/ metformin
Name: Komboglyze^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH

Time table:

Start: 01.04.2013
Final decision by G-BA: 01.10.2013

Final decision:

No additional benefit proved

› Saxagliptin/ metformin (new indication: combination with other antidiabetic drugs)

Subject:

Active Substance: Saxagliptin/ metformin
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.08.2017
Final decision by G-BA: 01.02.2018

Final decision:

Additional benefit not proven

› Saxagliptin/ metformin (re-assessment)

Subject:

Active Substance: Saxagliptin/ metformin
Name: Komboglyze^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.07.2016
Final decision by G-BA: 15.12.2016

Final decision:

Dual combination therapy saxagliptin + metformin: no additional benefit proved
Triple combination therapy saxagliptin + metformin + insulin: no additional benefit proved

› Sebelipase alfa (lyosomal acid deficiency) [repealed]

Subject:

Active Substance: Sebelipase alfa
Name: Kanuma^®
Therapeutic area: Lysosomal acid lipase (LAL) deficiency
Pharmaceutical company: Synageva BioPharma Limited

Time table:

Start: 01.10.2016
Final decision by G-BA: 17.03.2016
The decision remains valid until: 01.12.2020

Final decision:

Infants (< 6 months) with rapidly progressive LAL deficiency: non-quantifiable additional benefit proved (because of orphan drug status)
Patients with LAL deficiency: non-quantifiable additional benefit proved (because of orphan drug status)

› Sebelipase alfa (re-assessment: lysosomal acid lipase deficiency)

Subject:

Active Substance: Sebelipase alfa
Name: Kanuma^®
Therapeutic area: Lysosomal acid lipase (LAL) deficiency
Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

Patients with rapidly progressing LAL deficiency during infancy (≥ 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)
Patients with LAL deficiency not already rapidly progressing during infancy (< 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)

› Secukinumab [repealed]

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Psoriasis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.06.2015
Final decision by G-BA: 27.11.2015

Final decision:

Adult patients with moderate to severe psoriasis that are suitable for a systemic and/or phototherapy: no additional benefit proved
Adult patients with moderate to severe psoriasis if other systemic therapies (incl. ciclosporin, methotrexate or phototherapy) were not sufficiently effective or if there are contraindications or intolerances (previous therapy with biologica): indication for a considerable additional benefit.
Adult patients with moderate to severe psoriasis if other systemic therapies (incl. ciclosporin, methotrexate or phototherapy) were not sufficiently effective or if there are contraindications or intolerances (no previous therapy with biologica): indication for a minor additional benefit.

› Secukinumab (new indication: psoriatric arthritis, ankylosing spondylitis)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Psoriatic arthritis and ankylosing spondylitis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.12.2015
Final decision by G-BA: 02.06.2016

Final decision:

Psoriasis arthritis: no additional benefit proved
Ankylosing spondylitis: no additional benefit proved

› Secukinumab (re-assessment)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.03.2017
Final decision by G-BA: 17.08.2017

Final decision:

Patients for whom systemic therapy is appropriate: Hint for a considerable additional benefit

› Secukinumab (new scientific evidence (§14): psoriatic arthritis)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

A1) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy with concurrent moderate to severe plaque psoriasis: Indication for a minor additional benefit
A2) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy without concurrent moderate to severe plaque psoriasis: No additional benefit proved
B) Patients who did not benefit sufficiently from or who did not tolerate a previous bDMARD therapy: No additional benefit proved

› Secukinumab (new indication: Plaque psoriasis, patients aged > 6 years)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

Hint for a minor additional benefit

› Secukinumab (new indication: axial spondyloarthritis)

Subject:

Active Substance: Secukinumab
Name: Cosentyx^®
Therapeutic area: Axial spondyloarthritis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.09.2020
Final decision by G-BA: 18.02.2021

Final decision:

No additional benefit proved

› Selexipag

Subject:

Active Substance: Selexipag
Name: Uptravi^®
Therapeutic area: Pulmonary arterial hypertension (PAH)
Pharmaceutical company: Actelion Pharmaceuticals Deutschland GmbH

Time table:

Start: 15.06.2016
Final decision by G-BA: 15.12.2016

Final decision:

No additional benefit proved

› Selpercatinib (thyroid cancer, RET fusion+, prior treatment with sorafenib and/or lenvatinib)

Subject:

Active Substance: Selpercatinib
Name: Retsevmo^®
Therapeutic area: Thyroid cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.03.2021
Final decision by G-BA: 02.09.2021

Final decision:

Patients with an advanced, differentiated thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): No additional benefit proved
Patients with an advanced, anaplastic thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): No additional benefit proved

› Selpercatinib (medullary thyroid cancer, RET-mutated, prior treatment with cabozantinib and/or vandetanib, patients aged ≥ 12 years)

Subject:

Active Substance: Selpercatinib
Name: Retsevmo^®
Therapeutic area: Thyroid cancer
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.03.2021
Final decision by G-BA: 02.09.2021

Final decision:

No additional benefit proved

› Selpercatinib (NSCLC, RET fusion+, prior treatment with platinum-based chemo- and/or immunotherapy)

Subject:

Active Substance: Selpercatinib
Name: Retsevmo^®
Therapeutic area: NSCLC
Pharmaceutical company: Lilly Deutschland GmbH

Time table:

Start: 15.03.2021
Final decision by G-BA: 02.09.2021

Final decision:

a) After first-line therapy with a PD-1/PD-L1 antibody as monotherapy: No additional benefit proved
b) After first-line therapy with a cytotoxic chemotherapy: No additional benefit proved
c) After first-line therapy with a PD-1/PD-L1 antibody in combination with a platin-based chemotherapy or after sequential therapy with a PD-1/PD-l1 antibody and a platin-based chemotherapy:No additional benefit proved

› Semaglutide [repealed]

Subject:

Active Substance: Semaglutide
Name: Ozempic^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.11.2018
Final decision by G-BA: 02.05.2019

Final decision:

a) monotherapy: No additional benefit proved.
b) in combination with another antidiabetic (except for insulin, here: metformin):

b1) patients with high CV risk: Hint for a minor additional benefit.
b2) patients without high CV risk: No additional benefit proved.

c) in combination with two other antidiabetics (except for insulin):

c1) patients with high CV risk: Hint for a minor additional benefit.
c2) patients without high CV risk: No additional benefit proved.

d) in combination with insulin (with or w/o another antidiabetic):

d1) patients with high CV risk: Hint for a minor additional benefit.
d2) patients without high CV risk: No additional benefit proved.

› Semaglutide (new scientific evidence (§13): diabetes mellitus type 2)

Subject:

Active Substance: Semaglutide
Name: Rybelsus^® / Ozempic^®
Therapeutic area: Diabetes mellitus type 2
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.11.2020
Final decision by G-BA: 15.04.2021

Final decision:

a) monotherapy:
- a1) patients with high CV risk: no additional benefit proved)
- a2) patients without high CV risk: no additional benefit proved
b) in combination with another antidiabetic (except for insulin, here: metformin):
- b1) patients with high CV risk: no additional benefit proved
- b2) patients without high CV risk: no additional benefit proved
c) in combination with two other antidiabetics (except for insulin):
- c1) patients with high cardiovascular risk: no additional benefit proved
- c2) patients without high CV risk: no additional benefit proved
d) in combination with insulin (with or w/o metformin or empagliflozin* or liraglutide*, if appropriate):
- d1) patients with high CV risk: no additional benefit proved
- d2) patients without high CV risk: no additional benefit proved

› Siltuximab

Subject:

Active Substance: Siltuximab
Name: Sylvant^®
Therapeutic area: Multicentric Castleman‘s disease (MCD)
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 15.06.2014
Final decision by G-BA: 04.12.2014

Final decision:

Non quantifiable additional benefit proved (because of orphan drug status)

› Simeprevir

Subject:

Active Substance: Simeprevir
Name: Olysio^®
Therapeutic area: Chronic hepatitis C virus (HCV) infection
Pharmaceutical company: Janssen-Cilag GmbH

Time table:

Start: 01.06.2014
Final decision by G-BA: 20.11.2014

Final decision:

Therapy-naive patients with and without cirrhosis (genotype 1): indication for a considerable additional benefit
Pre-treated patients (genotype 1): indication for a considerable additional benefit
Pre-treated patients who were non-responders (genotype 1): indication for a considerable additional benefit
Therapy-naive patients and pre-treated patients (genotype 4): hint for a minor additional benefit
Pre-treated patients who were non-responders (genotype 4): no additional benefit proved
Therapy-naive patients and pre-treated patients without cirrhosis and a HIV coinfection (genotype 1, 4): hint for a minor additional benefit
Therapy-naive patients with cirrhosis and pre-treated patients who were non-responders with/without cirrhosis and a HIV coinfection: no additional benefit proved

› Simoctocog alfa

Subject:

Active Substance: Simoctocog alfa
Name: Nuwiq^®
Therapeutic area: Hemophilia A
Pharmaceutical company: Octapharma GmbH

Time table:

Start: Start: 15.11.2014
Final decision by G-BA: 07.05.2015

Final decision:

No additional benefit proved

› Siponimod (secondary progressive multiple sclerosis (SPMS))

Subject:

Active Substance: Siponimod
Name: Mayzen^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.02.2020
Final decision by G-BA: 20.08.2020

Final decision:

Patients with SPMS with relapses: no additional benefit proved
Patients with SPMS without relapses: no additional benefit proved

› Sipuleucel-T

Subject:

Active Substance: Sipuleucel-T
Name: Provenge^®
Therapeutic area: Prostate cancer
Pharmaceutical company: Dendreon UK Limited

Time table:

Start: 01.10.2014
Final decision by G-BA: 19.03.2015

Final decision:

Hint for a non-quantifiable additional benefit

› Sitagliptin [repealed]

Subject:

Active Substance: Sitagliptin
Name: Januvia^®, Xelevia^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 01.04.2013
Final decision by G-BA: 01.10.2013
The decision remains valid until: 01.10.2015

Final decision:

Hint for a minor additional benefit

› Sitagliptin/ metformin [repealed]

Subject:

Active Substance: Sitagliptin/ metformin
Name: Janumet^®, Velmetia^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

Start: 01.04.2013
Final decision by G-BA: 01.10.2013
The decision remains valid until: 01.10.2015

Final decision:

Hint for a minor additional benefit

› Sitagliptin/ metformin (re-assessment)

Subject:

Active Substance: Sitagliptin/ metformin
Name: Janumet^®, Velmetia^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.07.2016
Final decision by G-BA: 15.12.2016

Final decision:

Monotherapy sitagliptin/metformin: no additional benefit proved
Combination with sulfonylurea: no additional benefit proved
Combination with insulin (± metformin): no additional benefit proved

› Sitagliptin (re-assessment)

Subject:

Active Substance: Sitagliptin (re-assessment)
Name: Januvia^®, Xelevia^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

Start: 01.07.2016
Final decision by G-BA: 15.12.2016
The decision remains valid until: 15.06.2018

Final decision:

Monotherapy: no additional benefit proved
Combination with metformin: hint for a minor additional benefit
Combination with sulfonylurea: no additional benefit proved
Combination with metformin + sulfonylurea: no additional benefit proved
Combination with insulin (± metformin): no additional benefit proved

› Sitagliptin (re-assessment, in combination with metformin)

Subject:

Active Substance: Sitagliptin
Name: Januvia®, Xelevia^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Hint for a minor additional benefit

› Sodium zirconium cyclosilicate (hyperkalaemia)

Subject:

Active Substance: Sodium zirkonium cyclosilicate
Name: Lokelma^®
Therapeutic area: Hyperkalaemia
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.04.2021
Final decision by G-BA: 16.09.2021

Final decision:

No additional benefit proved

› Sofosbuvir

Subject:

Active Substance: Sofosbuvir
Name: Sovaldi^®
Therapeutic area: Chronic hepatitis C virus (HCV) infection
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.02.2014
Final decision by G-BA: 17.07.2014

Final decision:

Therapy-naive patients without cirrhosis (genotype 1): hint for a minor additional benefit
Therapy-naive patients with cirrhosis (genotype 1): hint for a minor additional benefit
Pre-treated patients (genotype 1): no additional benefit proved
Therapy-naive patients (genotype 2): indication for a considerable additional benefit
Pre-treated patients (genotype 2): hint for a minor additional benefit
Therapy-naive patients and pre-treated patients in combination with ribavirin (genotype 3): hint for a minor additional benefit
Therapy-naive and pre-treated patients in combination with ribavirin and peginterferon alfa (genotype 3): no additional benefit proved
Therapy-naive patients and pre-treated patients (genotype 4, 5, 6): no additional benefit proved
Therapy-naive patients and pre-treated patients in combination with ribavirin and peginterferon alfa: hint for a minor additional benefit

› Sofosbuvir (new indication: chronic hepatitis C in juvenile patients (12-18 years))

Subject:

Active Substance: Sofosbuvir
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.10.2017
Final decision by G-BA: 05.04.2018

Final decision:

Treatment-naïve patients: hint for a non-quantifiable additional benefit
Pre-treated patients: hint for a non-quantifiable additional benefit

› Sofosbuvir/ velpatasvir

Subject:

Active Substance: Sofosbuvir/ velpatasvir
Name: Epclusa^®
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.07.2016
Final decision by G-BA: 05.01.2017

Final decision:

Patients without cirrhosis, genotype 1: no additional benefit proved
Patients with compensated cirrhosis, genotype 1: no additional benefit proved
Patients without cirrhosis or with compensated cirrhosis, genotype 2: hint for a minor additional benefit
Patients without cirrhosis or with compensated cirrhosis, genotype 3: hint for a considerable additional benefit
Patients without cirrhosis, genotype 4: no additional benefit proved
Patients with compensated cirrhosis, genotype 4: no additional benefit proved
Patients without cirrhosis or with compensated cirrhosis, genotype 5 or 6: no additional benefit proved
Patients with decompensated cirrhosis, genotype 1: no additional benefit proved
Patients with decompensated cirrhosis, genotype 2, 3, 4, 5 or 6: hint for a non-quantifiable additional benefit

› Sofosbuvir/ velpatasvir/ voxilaprevir

Subject:

Active Substance: Sofosbuvir/ velpatasvir/ voxilarprevir
Name: Vosevi^©
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 15.08.2017
Final decision by G-BA: 15.02.2018

Final decision:

DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 1: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 2: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 3: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 4: additional benefit not proven
DAA naïve patients without cirrhosis or with compensated cirrhosis, genotypes 5 or 6: additional benefit not proven
DAA experienced patients without cirrhosis or with compensated cirrhosis: additional benefit not proven

› Sofosbuvir (new indication: chronic hepatitis C, patients aged 3 to < 12 years)

Subject:

Active Substance: Sofosbuvir
Name: Sovaldi^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: Gilead Sciences Ireland UC

Time table:

Start: 01.08.2020
Final decision by G-BA: 21.01.2021

Final decision:

Hint for non-quantifiable additional benefit

› Sofosbuvir / velpatasvir (new indication: chronic hepatitis C, patients aged ≥ 6 and < 18 years)

Subject:

Active Substance: Sofosbuvir / velpatasvir
Name: Epclusa^®
Therapeutic area: Chronic hepatitis C
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.10.2020
Final decision by G-BA: 01.04.2021

Final decision:

a) Patients aged 6 up to < 12 years (genotype 1, 4, 5, or 6): no additional benefit proved
b) Patients aged 6 up to < 12 years (genotype 2 or 3): no additional benefit proved
c) Patients aged 12 up to < 18 years (genotype 1, 4, 5, or 6): no additional benefit proved
d) Patients aged 12 up to < 18 years (genotype 2 or 3): no additional benefit proved

› Solriamfetol (narcolepsy)

Subject:

Active Substance: Solriamfetol
Name: Sunosi^®
Therapeutic area: Narcolepsy
Pharmaceutical company: Jazz Pharmaceuticals

Time table:

Start: 15.05.2020
Final decision by G-BA: 05.11.2020

Final decision:

Narcolepsy without cataplexy: No additional benefit proved
Narcolepsy with cataplexy: No additional benefit proved

› Sonidegib

Subject:

Active Substance: Sonidegib
Name: Odomzo^©
Therapeutic area: Basal cell carcinoma
Pharmaceutical company: Sun Pharmaceuticals Germany GmbH

Time table:

Start: 15.02.2018
Final decision by G-BA: 02.08.2018

Final decision:

No additional benefit proved

› Sucroferric oxyhydroxide

Subject:

Active Substance: Sucroferric oxyhydroxide
Name: Velphoro^®
Therapeutic area: Hyperphosphatemia, renal dialysis
Pharmaceutical company: Fresenius Medical Care Deutschland GmbH

Time table:

Start: 01.10.2014
Final decision by G-BA: 19.03.2015

Final decision:

No additional benefit proved

› Sucroferric oxyhydroxide (new indication: control of blood-phosphate levels in patients with chronic kidney disease, aged ≥ 2 – 18 years)

Subject:

Active Substance: Sucroferric oxyhydroxide
Name: Velphoro^®
Therapeutic area: To control blood-phosphate levels in patients with chronic kidney disease
Pharmaceutical company: Fresenius Medical Care Deutschland GmbH

Time table:

Start: 15.12.2020
Final decision by G-BA: 03.06.2021

Final decision:

No additional benefit proved

T

› Tafamidis meglumine

Subject:

Active Substance: Tafamidis meglumine
Name: Vyndaqel^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 15.12.2011
Final decision by G-BA: 07.06.2012

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Tafamidis (new indication: amyloid cardiomyopathy)

Subject:

Active Substance: Tafamidis
Name: Vyndaqel^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.03.2020
Final decision by G-BA: middle of August 2020

Final decision:

Hint for a considerable additional benefit

› Tafamidis (re-assessment, 50 Mio. € limit exceeded: amyloidosis with cardiomyopathy)

Subject:

Active Substance: Tafamidis
Name: Vyndaqel^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

Indication for a considerable additional benefit

› Tafamidis (re-assessment, 50 Mio. € limit exceeded: amyloidosis with polyneuropathy)

Subject:

Active Substance: Tafamidis
Name: Vyndaqel^®
Therapeutic area: Amyloidosis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› Tafluprost/ timolol

Subject:

Active Substance: Tafluprost/ timolol
Name: Taptiqom^®
Therapeutic area: Open-angle glaucoma, ocular hypertension
Pharmaceutical company: Santen GmbH

Time table:

Start: 01.01.2015
Final decision by G-BA: 18.06.2015

Final decision:

No additional benefit proved

› Talazoparib (breast cancer, BRCA1/2 mutation, HER2-)

Subject:

Active Substance: Talazoparib
Name: Talzenna^®
Therapeutic area: Breast cancer
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.06.2020
Final decision by G-BA: 20.11.2020

Final decision:

Hint for a considerable additional benefit

› Talimogen laherparepvec

Subject:

Active Substance: Talimogen laherparepvec
Name: Imlygic^®
Therapeutic area: Melanoma
Pharmaceutical company: Amgen GmbH

Time table:

Start: 15.06.2016
Final decision by G-BA: 15.12.2016

Final decision:

Therapy-naive patients with BRAF-V600 mutation: no additional benefit proved
Therapy-naive patients with BRAF-V600 wildtype tumor: no additional benefit proved
Pre-treated patients: no additional benefit proved

› Tasimelteon

Subject:

Active Substance: Tasimelteon
Name: Hetlioz^®
Therapeutic area: Non-24-Hour Sleep-Wake Disorder (Non-24)
Pharmaceutical company: Vanda Pharmaceuticals Inc.

Time table:

Start: 01.08.2016
Final decision by G-BA: 19.01.2017

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Teduglutide

Subject:

Active Substance: Teduglutide
Name: Revestive^®
Therapeutic area: Short Bowel Syndrome (SBS)
Pharmaceutical company: NPS Pharma Germany GmbH

Time table:

Start: 01.09.2014
Final decision by G-BA: 19.02.2015

Final decision:

Minor additional benefit proved (because of orphan drug status)

› Teduglutide (new indication: Short Bowel Syndrome in patients aged 1 year and above)

Subject:

Active Substance: Teduglutide (new indication)
Name: Revestive^®
Therapeutic area: Short Bowel Syndrome in patients aged 1 year and above
Pharmaceutical company: Shire Deutschland GmbH

Time table:

Start: 01.08.2016
Final decision by G-BA: 19.01.2017

Final decision:

Non-quantifiable additional benefit proved (because of orphan drug status)

› Tegafur/ gimeracil/ oteracil

Subject:

Active Substance: Tegafur/ gimeracil/ oteracil
Name: Teysuno^®
Therapeutic area: Gastric cancer (GC)
Pharmaceutical company: Nordic Pharma GmbH

Time table:

Start: 01.07.2012
Final decision by G-BA: 20.12.2012

Final decision:

No additional benefit proved
Nordic Pharma GmbH submitted an incomplete dossier (only module 3)

› Telaprevir

Subject:

Active Substance: Telaprevir
Name: Incivo^®
Therapeutic area: Chronic hepatitis C virus (HCV) infections
Pharmaceutical company: Janssen Cilag GmbH

Time table:

Start: 15.10.2011
Final decision by G-BA: 29.03.2012

Final decision:

Indication for a non-quantifiable additional benefit

› Telotristat ethyl

Subject:

Active Substance: Telotristat ethyl
Therapeutic area: Carcinoid syndrome diarrhoea
Pharmaceutical company: Ipsen Pharma GmbH

Time table:

Start: 15.10.2017
Final decision by G-BA: 05.04.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug status)

› Tenofovir alafenamide [repealed]

Subject:

Active Substance: Tenofovir alafenamide
Therapeutic area: Chronic hepatitis B virus (HBV) infections
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.04.2017
Final decision by G-BA: 21.09.2017
The decision remains valid until: 01.10.2018

Final decision:

Treatment-naive adult patients: additional benefit not proved
Pre-treated adult patients: additional benefit not proved
Treatment-naive adolescent patients (≥ 12 years): additional benefit not proved
Pre-treated adolescent patients (≥ 12 years): additional benefit not proved

› Tenofovir alafenamide (re-assessment)

Subject:

Active Substance: : Tenofovir alafenamide
Name: Vemlidy^®
Therapeutic area: Chronic hepatitis B
Pharmaceutical company: Gilead Sciences GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Therapy-naïve adult patients: No additional benefit proved.
Pre-treated adult patients: No additional benefit proved.
Therapy-naïve adolescent (12 years and older) patients: No additional benefit proved.
Pre-treated adolescent (12 years and older) patients: No additional benefit proved.

› Teriflunomide

Subject:

Active Substance: Teriflunomide
Name: Aubagio^®
Therapeutic area: Multiple sclerosis
Pharmaceutical company: Sanofi-aventis groupe/Genzyme GmbH

Time table:

Start: 01.10.2013
Final decision by G-BA: 20.03.2014

Final decision:

No additional benefit proved

› Tezacaftor / ivacaftor

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

Start: 01.12.2018
Final decision by G-BA: 16.05.2019

Final decision:

a) Patients with homozygous F508del mutation: considerable additional benefit (proved because of orphan drug designation)
b) Patients with heterozygous F508del mutation: minor additional benefit (proved because of orphan drug designation)

› Tezacaftor / ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients aged ≥ 12 years (homozygous for F508del))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

No additional benefit proved

› Tezacaftor / ivacaftor (re-assessment, 50 Mio. € limit exceeded: cystic fibrosis, patients aged ≥ 12 years (heterozygous for F508del))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals

Time table:

Start: 01.07.2020
Final decision by G-BA: 17.12.2020

Final decision:

No additional benefit proved

› Tezacaftor / ivacaftor (new indication: cystic fibrosis, in combination with ivacaftor, patients aged 6 to < 12 years (heterozygous for F508del and CF mutation))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› Tezacaftor / ivacaftor (new indication: cystic fibrosis, in combination with ivacaftor, patients aged 6 to < 12 years (homozygous for F508del and CF mutation))

Subject:

Active Substance: Tezacaftor / ivacaftor
Name: Symkevi^®
Therapeutic area: Cystic fibrosis
Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

Start: 01.12.2020
Final decision by G-BA: 20.05.2021

Final decision:

No additional benefit proved

› Ticagrelor

Subject:

Active Substance: Ticagrelor
Name: Brilique^®
Therapeutic area: Acute coronary syndromes (ACS)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.01.20111
Final decision by G-BA: 15.12.2011

Final decision:

Instable angina pectoris (IA)/non-ST-segment elevation myocardial infarction (NSTEMI): proof of a considerable additional benefit
ST-segment elevation myocardial infarction (STEMI), pharmaceutically treated: no additional benefit proved
ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI): no additional benefit proved (except for patients ≥ 75 years for whom treatment with prasugrel is not appropriate and patients with a history of transient ischemic attack or ischemic stroke: hint for a non-quantifiable additonal benefit)
ST-segment elevation myocardial infarction (STEMI), coronary artery bypass surgery: no additional benefit proved

› Ticagrelor (new indication: prevention of artherothrombotic events in patients with a history of myocardial infarction and a high risk of developing an atherothrombotic event)

Subject:

Active Substance: Ticagrelor (new indication: prevention of artherothrombotic events in patients with a history of myocardial infarction and a hig risk of developing an atherothrombotic event)
Name: Brilique^®
Therapeutic area: Prevention of artherothrombotic events in patients with a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 01.04.2016
Final decision by G-BA: 15.09.2016

Final decision:

Hint for a minor additional benefit

› Tildrakizumab

Subject:

Active Substance: Tildrakizumab
Name: Ilumetri^®
Therapeutic area: Plaque psoriasis
Pharmaceutical company: Almirall Hermal GmbH

Time table:

Start: 15.11.2018
Final decision by G-BA: 02.05.2019

Final decision:

a) Patients for whom a systemic therapy for the first time is indicated: No additional benefit proved.
b) Patients who were insufficiently treated with a systemic therapy: No additional benefit proved.

› Tiotropium/ olodaterol

Subject:

Active Substance: Tiotropium/ olodaterol
Name: Spiolto^® Respimat^®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co.KG

Time table:

Start: 15.08.2015
Final decision by G-BA: 04.02.2016

Final decision:

COPD stage II and higher: indication for a minor additional benefit
COPD stage II/IV or respiratory insufficiency and 2 or more exacerbations per year: hint for less benefit than the comparative therapy

› Tisagenlecleucel (B-cell acute lymphoblastic leukemia (ALL))

Subject:

Active Substance: Tisagenlecleucel
Name: Kymriah^®
Therapeutic area: B-cell acute lymphoblastic leukemia (ALL)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.09.2018
Final decision by G-BA: 07.03.2019
This decision remains valid until: 15.03.2020

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Tisagenlecleucel (diffuse large B-cell lymphoma (DLBCL))

Subject:

Active Substance: Tisagenlecleucel
Name: Kymriah^®
Therapeutic area: Diffuse large B-cell lymphoma (DLBCL)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.09.2018
Final decision by G-BA: 07.03.2019
This decision remains valid until: 15.03.2020

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Tisagenlecleucel (re-assessment: B-cell acute lymphoblastic leukaemia (ALL))

Subject:

Active Substance: Tisagenlecleucel
Name: Kymriah^®
Therapeutic area: B-cell acute lymphoblastic leukaemia (ALL)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 17.09.2020
This decision remains valid until: 01.09.2023

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Tisagenlecleucel (re-assessment: diffuse large B-cell lymphoma (DLBCL))

Subject:

Active Substance: Tisagenlecleucel
Name: Kymriah^®
Therapeutic area: Diffuse large B-cell lymphoma
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.03.2020
Final decision by G-BA: 17.09.2020
This decision remains valid until: 01.09.2023

Final decision:

Hint for a non-quantifiable additional benefit (orphan drug)

› Tivozanib

Subject:

Active Substance: Tivozanib
Therapeutic area: Renal cell carcinoma (RCC)
Pharmaceutical company: EUSA Pharma GmbH

Time table:

Start: 01.11.2017
Final decision by G-BA: 19.04.2018

Final decision:

First line therapy:
1. with favorable or intermediate prognosis (MSKCC score 0-2): additional benefit not proved
2. with non-favorable prognosis (MSKCC score ≥ 3): additional benefit not proved
With progression following cytokine therapy but only if treatment-naïve regarding VEGFR or TOR pathway inhibitors: additional benefit not proved

› Tofacitinib

Subject:

Active Substance: Tofacitinib
Therapeutic area: Rheumatoid arthritis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.05.2017
Final decision by G-BA: 19.10.2017

Final decision:

No additional benefit proved

› Tofacitinib (re-assessment of patient population b2)

Subject:

Active Substance: Tofacitinib
Name: Xeljanz^®
Therapeutic area: Rheumatoid Arthritis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.05.2018
Final decision by G-BA: 01.11.2018

Final decision:

b2) insufficiently pre-treated patients who are bDMARD-naïve: no additional benefit proved

› Tofacitinib (new indication: colitis ulcerosa)

Subject:

Active Substance: Tofacitinib
Name: Xeljanz^®
Therapeutic area: Colitis ulcerosa
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.09.2018
Final decision by G-BA: 21.02.2019

Final decision:

Patients who have not responded sufficiently, do not respond any more or have a contraindication or intolerance to a conventional treatment: no additional benefit proved
Patients who have responded insufficiently to a biological such as TNF-alfa antagonist or integrin inhibitor or do not respond any more or have an intolerance against such treatments: no additional benefit proved

› Tofacitinib (new indication: psoriasis arthritis)

Subject:

Active Substance: Tofacitinib
Name: Xeljanz^®
Therapeutic area: Psoriasis arthritis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Start: 01.09.2018
Final decision by G-BA: 21.02.2019

Final decision:

Patients who have not responded sufficiently or tolerated a previous antirheumatic (DMARD-) therapy: hint for a minor additional benefit
Patients who have not responded sufficiently or tolerated a previous therapy with bDMARD: no additional benefit proved

› Trametinib

Subject:

Active Substance: Trametinib
Name: Mekinist^®
Therapeutic area: Melanoma
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.10.2016
Final decision by G-BA: 17.03.2016

Final decision:

In combination with dabrafenib: indication for a considerable additional benefit
Monotherapy: no additional benefit proved

› Trametinib (new indication: non-small cell lung carcinoma)

Subject:

Active Substance: Trametinib
Therapeutic area: Non-small cell lung carcinoma (NSCLC)
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.05.2017
Final decision by G-BA: 16.10.2017

Final decision:

No additional benefit proved

› Trametinib (new indication: melanoma, in combination with dabrafenib, BRAF-V600 mutation, adjuvant therapy)

Subject:

Active Substance: Trametinib
Name: Mekinist^®
Therapeutic area: Melanoma
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Indication for a considerable additional benefit

› Trastuzumab emtansine

Subject:

Active Substance: Trastuzumab emtansine
Name: Kadcyla^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 01.01.2014
Final decision by G-BA: 19.06.2014

Final decision:

Patients with HER2 positive, locally advanced, unresectable breast cancer: no additional benefit proved
Patients with HER2 positive, metastatic breast cancer after prior therapy containing anthracyclines, taxanes, trastuzumab: indication for a considerable additional benefit
Patients with HER2 positive, metastatic breast cancer after prior therapy containing taxanes and trastuzumab: no additional benefit proved

› Trastuzumab emtansine (new indication: breast cancer, HER2+, adjuvant treatment)

Subject:

Active Substance: Trastuzumab emtansine
Name: Kadcyla^®
Therapeutic area: Breast cancer
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.01.2020
Final decision by G-BA: 02.07.2020

Final decision:

Indication for a minor additional benefit

› Trifarotene (acne vulgaris, ≥ 12 years of age)

Subject:

Active Substance: Trifarotene
Name: Selgamis^®
Therapeutic area: Acne vulgaris
Pharmaceutical company: Galderma Laboratorium GmbH

Time table:

Start: 15.08.2020
Final decision by G-BA: 04.02.2021

Final decision:

No additional benefit proved

› Trifluridine/ tipiracil

Subject:

Active Substance: Trifluridine/ tipiracil
Name: Lonsurf^®
Therapeutic area: Colorectal cancer
Pharmaceutical company: Servier Deutschland GmbH

Time table:

Start: 15.08.2016
Final decision by G-BA: 02.02.2017
The decision remains valid until: 01.04.2020

Final decision:

Hint for a minor additional benefit

› Trifluridine / tipiracil (new indication: metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, pre-treated patients)

Subject:

Active Substance: Trifluridine / tipiracil
Name: Lonsurf^®
Therapeutic area: Gastric cancer, adenocarcinoma
Pharmaceutical company: Servier Deutschland GmbH

Time table:

Start: 15.10.2019
Final decision by G-BA: 02.04.2020

Final decision:

Indication for a minor additional benefit

› Trifluridine / tipiracil (re-assessment: colorectal cancer (CRC), pretreated patients)

Subject:

Active Substance: Trifluridine / tipiracil
Name: Lonsurf^®
Therapeutic area: Colorectal cancer
Pharmaceutical company: Servier Deutschland GmbH

Time table:

Start: 01.04.2020
Final decision by G-BA: 01.10.2020

Final decision:

Hint for a minor additional benefit

› Tucatinib (breast cancer, HER2+, ≥ 2 prior therapies, combination with trastuzumab and capecitabine)

Subject:

Active Substance: Tucatinib
Name: Tukysa^®
Therapeutic area: Breast cancer
Pharmaceutical company: Seagen Germany GmbH

Time table:

Start: 15.03.2021
Final decision by G-BA: 02.09.2021

Final decision:

Hint for a considerable additional benefit

› Turoctocog alfa

Subject:

Active Substance: Turoctocog alfa
Name: NovoEight^®
Therapeutic area: Haemophilia A
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 15.01.2014
Final decision by G-BA: 03.07.2014

Final decision:

No additional benefit proved

› Turoctocog alfa pegol

Subject:

Active Substance: Turoctocog alfa pegol
Name: Esperoct^®
Therapeutic area: Hemophilia A
Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

Start: 01.08.2019
Final decision by G-BA: 06.02.2020

Final decision:

No additional benefit proved

U

› Umeclidinium

Subject:

Active Substance: Umeclidinium
Name: Incruse^®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 01.02.2016
Final decision by G-BA: 21.07.2016

Final decision:

Patients with stage II: no additional benefit proved
Patients with higher stages: no additional benefit proved

› Umeclidinium/ vilanterol

Subject:

Active Substance: Umeclidinium/ vilanterol
Name: Anoro^®, Laventair^®
Therapeutic area: Pulmonary disease, chronic obstructive (COPD)
Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

Start: 15.07.2014
Final decision by G-BA: 08.01.2015

Final decision:

No additional benefit proved

› Upadacitinib (rheumatoid arthritis)

Subject:

Active Substance: Upadacitinib
Name: Rinvoq^®
Therapeutic area: Rheumatoid arthritis
Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

Start: 01.02.2020
Final decision by G-BA: 16.07.2020

Final decision:

a₁) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib as monotherapy: No additional benefit proved
a₂) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib in combination with MTX: No additional benefit proved
b₁) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib as monotherapy: No additional benefit proved
b₂) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib in combination with MTX: Hint for a considerable additional benefit
c₁) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib as monotherapy: No additional benefit proved
c_2A) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients with high disease activity [DAS28 CRP > 5.1]: Hint for a minor additional benefit
c_2B) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients without high disease activity [DAS28 CRP ≤ 5.1]: No additional benefit proved

› Upadacitinib (new indication: ankylosing spondylitis)

Subject:

Active Substance: Upadacitinib
Name: Rinvoq^®
Therapeutic area: Ankylosing spondylitis
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

a1) Patients who have responded inadequately to conventional therapy: No additional benefit proved
a2) Patients who have responded inadequately or who are intolerant to biological disease-modifying antirheumatic drugs (bDMARDs): No additional benefit proved

› Upadacitinib (new indication: psoriatic arthritis)

Subject:

Active Substance: Upadacitinib
Name: Rinvoq^®
Therapeutic area: Psoriatic arthritis
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 01.02.2021
Final decision by G-BA: 15.07.2021

Final decision:

a1) Patients who have responded inadequately to or did not tolerate conventional disease-modifying antirheumatic drugs (DMARDs): Hint for a considerable additional benefit
a2) Patients who have responded inadequately to or did not tolerate biological disease-modifying antirheumatic drugs (bDMARDs):: No additional benefit proved

V

› Vandetanib [repealed]

Subject:

Active Substance: Vandetanib
Name: Caprelsa^®
Therapeutic area: Medullary thyroid carcinoma (MTC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.03.2012
Final decision by G-BA: 06.09.2012

Final decision:

No additional benefit proved
AstraZeneca GmbH submitted an incomplete dossier
The pharmaceutical company is given the opportunity to resubmit the benefit dossier in one year

› Vandetanib (re-assessment)

Subject:

Active Substance: Vandetanib
Name: Caprelsa^®
Therapeutic area: Medullary thryoid cancer (MTC)
Pharmaceutical company: AstraZeneca GmbH

Time table:

Start: 15.03.2013
Final decision by G-BA: 05.09.2013
The decision remains valid until: 01.10.2021

Final decision:

Hint for a minor additional benefit

› Vandetanib (new indication: thyroid neoplasms, age 5 and older)

Subject:

Active Substance: Vandetanib
Name: Caprelsa^®
Therapeutic area: Thyroid neoplasms (age 5 and older)
Pharmaceutical company: Genzyme GmbH

Time table:

Start: 15.01.2017
Final decision by G-BA: 06.07.2014

Final decision:

Non-quantifiable additional benefit (because of evidence transfer to pediatric population)

› Vedolizumab

Subject:

Active Substance: Vedolizumab
Name: Entyvio^®
Therapeutic area: Crohn‘s disease, ulcerative colitis
Pharmaceutical company: Takeda Pharma A/S

Time table:

Start: 15.07.2014
Final decision by G-BA: 08.01.2015

Final decision:

No additional benefit proved

› Velmanase alfa

Subject:

Active Substance: Velmanase alfa
Therapeutic area: Alpha-mannosidosis
Pharmaceutical company: Chiesi GmbH

Time table:

Start: 01.07.2018
Final decision by G-BA: 20.12.2018

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Vemurafenib [repealed]

Subject:

Active Substance: Vemurafenib
Name: Zelboraf^®
Therapeutic area: Melanoma
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.03.2012
Final decision by G-BA: 06.09.2012
The decision remains valid until: 06.09.2013

Final decision:

Indication for a considerable additional benefit

› Vemurafenib (re-assessment)

Subject:

Active Substance: Vemurafenib
Name: Zelboraf^®
Therapeutic area: Melanoma
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.09.2012
Final decision by G-BA: 06.03.2014

Final decision:

Indication for a considerable additional benefit

› Venetoclax

Subject:

Active Substance: Venetoclax
Name: Venclyxto^®
Therapeutic area: Chronic lymphocytic leukaemia (CLL)
Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

Start: 01.01.2017
Final decision by G-BA: 15.06.2014
The decision remains valid until: 15.06.2022

Final decision:

Adult patients with CLL with 17p depletion or TP53 mutation who are not suited for treatment with a B cell pathway inhibitor or whose therapy failed: non-quantifiable additional benefit proved (because of orphan drug status)
Adult patients with CLL without 17p depletion or TP53 mutation who failed chemoimmunotherapy as well as treatment with a B cell pathway inhibitor: non-quantifiable additional benefit proved (because of orphan drug status)

› Venetoclax (repeal of orphan drug designation)

Subject:

Active Substance: Venetoclax
Name: Venclyxto^®
Therapeutic area: Chronic lymphatic leukemia (CLL)
Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

Start: 01.12.2018
Final decision by G-BA: 16.05.2019

Final decision:

a) patients with 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor: additional benefit not proved
b) patients without 17p deletion or TP53 mutation who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor: additional benefit not proved

› Venetoclax (new indication: CLL in combination with rituximab)

Subject:

Active Substance: Venetoclax
Name: Venclyxto^®
Therapeutic area: Chronic lymphatic leukemia (CLL)
Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

Start: 01.12.2018
Final decision by G-BA: 16.05.2019

Final decision:

a) patients without 17p deletion and/or TP53 mutation who are suitable for chemoimmunotherapy

a1) for whom the combination therapy of bendamustine and rituximab is the patient-individual therapy: indication for a minor additional benefit
a2) for whom other therapies than bendamustine plus rituximab is the patient-individual therapy: additional benefit not proved

b) patients with 17p deletion and/or TP53 mutation or for whom a chemoimmunotherapy is not suitable: additional benefit not proved

› Venetoclax (new indication: CLL, 1st line, in combination with obinutuzumab)

Subject:

Active Substance: Venetoclax
Name: Venclyxto^®
Therapeutic area: Chronic lymphatic leukaemia (CLL)
Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

Start: 15.04.2020
Final decision by G-BA: 15.10.2020

Final decision:

a. Patients who are suited for a treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR): No additional benefit proved
b. Patients who are not suited for a treatment with FCR: No additional benefit proved
c. Patients with 17p deletion or TP53 mutation, or who are not suited for chemoimmunotherapy due to other reasons: No additional benefit proved

› Vestronidase alfa

Subject:

Active Substance: Vestronidase alfa
Name: Mepsevii^®
Therapeutic area: Mucopolysaccharidosis
Pharmaceutical company: Ultragenyx Germany GmbH

Time table:

Start: 01.10.2018
Final decision by G-BA: 22.03.2019

Final decision:

Non-quantifiable additional benefit (proved because of orphan drug designation)

› Vigabatrine (epilepsy)

Subject:

Active Substance: Vigabatrine
Name: Kigabeq^®
Therapeutic area: Epilepsy
Pharmaceutical company: Desitin Arzneimittel GmbH

Time table:

Start: 01.07.2019
Final decision by G-BA: 19.12.2019

Final decision:

No additional benefit proved (no dossier submitted)

› Vigabatrine (West syndrome)

Subject:

Active Substance: Vigabatrine
Name: Kigabeq^®
Therapeutic area: West syndrome
Pharmaceutical company: Desitin Arzneimittel GmbH

Time table:

Start: 01.07.2019
Final decision by G-BA: 19.12.2019

Final decision:

No additional benefit proved (no dossier submitted)

› Vildagliptin [repealed]

Subject:

Active Substance: Vildagliptin
Name: Galvus^®, Jalra^®, Xiliarx^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.04.2013
Final decision by G-BA: 01.10.2013

Final decision:

No additional benefit proved

› Vildagliptin (re-assessment)

Subject:

Active Substance: Vildagliptin
Name: Galvus^®, Jalra^®, Xiliarx^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.12.2014
Final decision by G-BA: 21.05.2015

Comparative therapy:

No additional benefit proved

› Vildagliptin/ metformin

Subject:

Active Substance: Vildagliptin/ metformin
Name: Eucreas^®, Icandra^®, Zomarist^®
Therapeutic area: Diabetes mellitus, type 2
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 01.04.2013
Final decision by G-BA: 01.10.2013

Final decision:

No additional benefit proved

› Vismodegib [repealed]

Subject:

Active Substance: Vismodegib
Name: Erivedge^®
Therapeutic area: Basal cell carcinoma
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.08.2013
Final decision by G-BA: 06.02.2014
The decision remains valid until: 15.02.2016

Final decision:

Patients with symptomatic metastatic basal cell carcinoma: no additional benefit proved
Patients with lokally advanced basal cell carcinoma inappropriate for surgery or radiotherapy: hint for a minor additional benefit

› Vismodegib (re-assessment)

Subject:

Active Substance: Vismodegib (re-assessment)
Name: Erivedge^®
Therapeutic area: Basal cell carcinoma
Pharmaceutical company: Roche Pharma AG

Time table:

Start: 15.02.2016
Final decision by G-BA: 04.08.2016

Final decision:

Patients with symptomatic metastatic basal cell carcinoma: no additional benefit proved
Patients with lokally advanced basal cell carcinoma inappropriate for surgery or radiotherapy: hint for a minor additional benefit

› Volanesorsen

Subject:

Active Substance: Volanesorsen
Name: Waylivra^®
Therapeutic area: Familial chylomicronaemia syndrome (FCS)
Pharmaceutical company: Akcea Therapeutics Germany GmbH

Time table:

Start: 15.08.2019
Final decision by G-BA: 20.02.2020

Final decision:

Hint for a non-quantifiable additional benefit (because of orphan drug indication)

› Voretigene neparvovec

Subject:

Active Substance: Voretigene neparvovec
Name: Luxturna^®
Therapeutic area: Retinal dystrophy
Pharmaceutical company: Novartis Pharma GmbH

Time table:

Start: 15.04.2019
Final decision by G-BA: 17.10.2019
The decision is limited until: 01.04.2022

Final decision:

Hint for a considerable additional benefit (orphan drug designation)

› Vortioxetine

Subject:

Active Substance: Vortioxetin
Name: Brintellix^®
Therapeutic area: Major depression
Pharmaceutical company: Lundbeck GmbH

Time table:

Start: 01.05.2015
Final decision by G-BA: 15.10.2015

Final decision:

No additional benefit proved

W

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Y

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