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

 

A

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

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

Subject:

  • Active Substance: Aclidinium bromidee
  • 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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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)

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

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)

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

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

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

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

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

Subject:

  • Active Substance: Apixaban
  • Name: Eliquis®
  • Therapeutic area: Treatment and prevention of recurrent vein thrombosis and pulmonary embolism
  • Pharmaceutical company: Bristol-Meyers 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

Subject:

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

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 17.03.2016
  • The decision remains valid until: 01.12.2018

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)

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)

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)

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

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

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

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

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

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.

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

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)

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)

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

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

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

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)

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.

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

 

 

C

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

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: 01.01.2020

Final decision:

  • Minor additional benefit proved (because of orphan drug status)

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

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

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.

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)

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)

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

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.

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

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: 01.06.2021

Final decision:

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

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)

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

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.

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

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

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

 

 

E

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

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

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)

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

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)

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)

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

Subject:

  • Active Substance: Extract from Canabis 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

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

 

 

F

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

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

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

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

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

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

 

 

G

Subject:

  • Active Substance: Gaxilose
  • Name: LacTestTM
  • 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

 

 

H

Kein Eintrag.

 

 

I

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)

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

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

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

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: 01.09.2020

Final decision:

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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)

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)

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

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: 01.07.2020

Final decision:

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

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

 

 

J

Kein Eintrag.

 

 

K

Kein Eintrag.

 

 

L

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

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

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)

Subject:

  • Active Substance: Lenvatinib
  • Name: Kisplyx®
  • Therapeutic area: Renal cell carcinoma (RCC)
  • Pharmaceutical company: Eisei 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

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

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

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

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

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

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

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

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

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

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

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

 

 

M

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

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

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

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

Subject:

  • Active Substance: Migalastat
  • Name: GalafoldTM
  • 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)

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

 

 

N

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

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

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

Comparative therapy:

  • No additional benefit proved
  • Pharmaceutical company submitted no dossier

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

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

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)

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

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

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

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.

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

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

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

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

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

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: 01.01.2020

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)

 

 

O

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)

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)

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)

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

Subject:

  • Active Substance: Olaparib
  • Name: LynparzaTM
  • 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)

Subject:

  • Active Substance: Olaratumab
  • Name: LartruvoTM
  • Therapeutic area: Sarcoma
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.12.2016
  • Final decision by G-BA: 18.05.2017
  • The decision remains valid until: 01.05.2020

Final decision:

  • Considerable additional benefit proved (because of orphan drug status)

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

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

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

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

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

 

 

P

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: 01.03.2019 (first-line)/ 01.10.2018 (second-line)

Final decision:

  • Treatment-naive patients: no additional benefit proved
  • Pre-treated patients: no additional benefit proved

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)

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)

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)

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

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

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

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

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

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

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

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

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

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)

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

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)

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

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

Subject:

  • Active Substance: Pomalidomid
  • 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

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: 01.12.2019

Final decision:

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

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

Subject:

  • Active Substance: Radium 223
  • 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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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)

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

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

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

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

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

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)

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

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

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

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

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

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)

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 notsufficiently effective or if there are contraindications or intolerances (no previous therapy with biologica): indication for a minor additional benefit.

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

 

 

T

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)

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

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

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)

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)

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)

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)

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

Subject:

  • Active Substance: Tenofovir alafenamide
  • Name: Vemlidy©
  • 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

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

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

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 hig 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

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

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz©
  • 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

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

Subject:

  • Active Substance: Trametinib
  • Name: Mekinist©
  • 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

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

Subject:

  • Active Substance: Trifludine/ 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: 31.01.2019

Final decision:

  • Hint for a minor additional benefit

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

 

 

U

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

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

 

 

V

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

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: 01.10.2020

Final decision:

  • Hint for a minor additional benefit

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)

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

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

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

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)

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

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

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

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

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

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

 

 

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Ansprechpartner

 
 
 
 
Dr. Thomas Ecker
Tel. +49 (40) 41 33 081-10
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