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Subject:

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

Time table:

• Start: 15.01.2019
• Publication of assessment: 15.04.2019
• End of public hearing: 06.05.2019
• Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

• No comparative therapy because of orphan drug status

Subject:

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

Time table:

• Start: 15.01.2019
• Publication of assessment: 15.04.2019
• End of public hearing: 06.05.2019
• Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

• Ceritinib

Subject:

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

Time table:

• Start: 15.01.2019
• Publication of assessment: 15.04.2019
• End of public hearing: 06.05.2019
• Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

• No comparative therapy because of orphan drug status

Subject:

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

Time table:

• Start: 15.01.2019
• Publication of assessment: 15.04.2019
• End of public hearing: 06.05.2019
• Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

• Best supportive care

Subject:

• Active Substance: Ribociclib
• Name: Kisqali^®
• Therapeutic area: Breast cancer
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 15.01.2019
• Publication of assessment: 15.04.2019
• End of public hearing: 06.05.2019
• Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

• A) For women who are not pre-treated with an endocrine therapy:
• A1) post-menopausal women: anastrozole OR letrozole OR fulvestrant or (if appropriate) tamoxifen only if aromatase inhibitors are not indicated
• A2) pre- and peri-menopausal women: tamoxifen in combination with depletion of ovarian function
• B) For women who are pre-treated with an endocrine therapy:
• B1) post-menopausal women with progress after endocrine therapy: another endocrine therapy with respect to pre-treatment with: tamoxifen OR anastrozole OR fulvestrant (only for patients with recurrence or progress after anti-estrogen treatment) OR letrozole (only for patients with recurrence or progress after anti-estrogen treatment) OR exemestane (only for patients with progress after anti-estrogen treatment) OR everolimus in combination with exemestane (only for patients without symptomatic visceral metastasis after progress with a non-steroidal aromatase inhibitor)
• B2) pre- and peri-menopausal women with progress after endocrine therapy: endocrine therapy at the physician’s discretion and under consideration of the respective marketing authorization

Subject:

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

Time table:

• Start: 15.01.2019
• Publication of assessment: 15.04.2019
• End of public hearing: 06.05.2019
• Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

• Therapy-naïve patients: rilpivirine OR dolutegravir, each in combination with 2 nucleoside-/ nucleotide analogs (tenofovir disoproxil/ alafenamide plus emtricitabine or abacavir plus lamivudine)
• Pre-treated patients: individual anti-retroviral therapy under consideration of pre-treatment(s) and the reason for change of therapy, especially treatment failure due to loss of virologic response and accompanied formation of resistance or due to adverse events

Subject:

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

Time table:

• Start: 15.01.2019
• Publication of assessment: 15.04.2019
• End of public hearing: 06.05.2019
• Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

• Therapy-naïve patients: rilpivirine OR dolutegravir, each in combination with 2 nucleoside-/ nucleotide analogs (tenofovir disoproxil/ alafenamide plus emtricitabine or abacavir plus lamivudine)
• Pre-treated patients: individual anti-retroviral therapy under consideration of pre-treatment(s) and the reason for change of therapy, especially treatment failure due to loss of virologic response and accompanied formation of resistance or due to adverse events

Subject:

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

Time table:

• Start: 01.02.2019
• ublication of assessment: 02.05.2019
• End of public hearing: 23.05.2019
• Final decision by G-BA: expected for the beginning of August 2019

Comparative therapy:

• Watchful waiting with continuation of existing conventional androgen deprivation

Subject:

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

Time table:

• Start: 01.02.2019
• Publication of assessment: 02.05.2019
• End of public hearing: 23.05.2019
• Final decision by G-BA: expected for the beginning of August 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

• Active Substance: Mexiletine
• Name: Namuscla^®
• Therapeutic area: Myotonic Disorders
• Pharmaceutical company: Lupin Europe GmbH

Time table:

• Start: 01.02.2019
• Publication of assessment: 02.05.2019
• End of public hearing: 23.05.2019
• Final decision by G-BA: expected for the beginning of August 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

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

Time table:

• Start: 15.02.2019
• Publication of assessment: 15.05.2019
• End of public hearing: 05.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• Best supportive care

Subject:

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

Time table:

• Start: 15.02.2019
• Publication of assessment: 15.05.2019
• End of public hearing: 05.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• No comparative therapy because of orphan drug indication

Subject:

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

Time table:

• Start: 15.02.2019
• Publication of assessment: 15.05.2019
• End of public hearing: 05.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• No comparative therapy because of orphan drug indication

Subject:

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

Time table:

• Start: 15.02.2019
• Publication of assessment: 15.05.2019
• End of public hearing: 05.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• Patients with intermediate risk profile (IMDS score 1-2): bevacizumab in combination with interferon alfa-2a OR monotherapy with pazopanip OR sunitinib
• Patients with unfavourable risk profile (IMDS score ≥ 3): temsirolimus OR sunitinib

Subject:

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

Time table:

• Start:15.02.2019
• Publication of assessment: 15.05.2019
• End of public hearing: 05.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• Patients with intermediate risk profile (IMDS score 1-2): bevacizumab in combination with interferon alfa-2a OR monotherapy with pazopanib OR sunitinib
• Patients with unfavourable risk profile (IMDS score ≥ 3): temsirolimus OR sunitinib

Subject:

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

Time table:

• Start: 15.02.2019
• Publication of assessment: 15.05.2019
• End of public hearing: 05.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• Sorafenib

Subject:

• Active Substance: Regadenoson
• Name: Rapiscan^®
• Therapeutic area: Measurement of fractional flow reserve (FFR) of stenosis
• Pharmaceutical company: GE Healthcare Buchler GmbH & Co. KG

Time table:

• Start: 01.03.2019
• Publication of assessment: 03.06.2019
• End of public hearing: 24.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• Therapy at the physician’s discretion

Subject:

• Active Substance: Rucaparib
• Name: Rubraca^®
• Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
• Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

• Start: 01.03.2019
• Publication of assessment: 03.06.2019
• End of public hearing: 24.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• Watchful waiting

Subject:

• Active Substance: Rucaparib
• Name: Rubraca^®
• Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
• Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

• Start: 01.03.2019
• Publication of assessment: 03.06.2019
• End of public hearing: 24.06.2019
• Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

• Monotherapy with topotecan or monotherapy with pegylated liposomal doxorubicin

Subject:

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

Time table:

• Start: 15.03.2019
• Publication of assessment: 17.06.2019
• End of public hearing: 08.07.2019
• Final decision by G-BA: expected for the beginning of September 2019

Comparative therapy:

• Recombinant or human plasma-derived blood coagulation factor VIII products (prophylaxis treatment)

Subject:

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

Time table:

• Start: 15.03.2019
• Publication of assessment: 17.06.2019
• End of public hearing: 08.07.2019
• Final decision by G-BA: expected for the beginning of September 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

• Active Substance: Pembrolizumab
• Name: Keytruda^®
• Therapeutic area: Urothelial cancer
• Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

• Start: 01.01.2019
• Final decision by G-BA: 20.06.2019
• The decision remains valid until: 01.07.2020

Final decision:

• No additional benefit proved.

Subject:

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

Time table:

• Start: 01.01.2019
• Publication of assessment: 01.04.2019
• Final decision by G-BA: 20.06.2019
• The decision remains valid until: 01.10.2021

Final decision:

• No additional benefit proved.

Subject:

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

Time table:

• Start: 01.01.2019
• Final decision by G-BA: 20.06.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.01.2019
• Final decision by G-BA: 20.06.2019

Final decision by G-BA:

• No additional benefit proved.

Subject:

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

Time table:

• Start: 15.12.2018
• Final decision by G-BA: 06.06.2019

Final decision:

• Hint for a minor additional benefit

Subject:

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

Time table:

• Start: 01.12.2018
• Final decision by G-BA: 16.05.2019

Final decision:

• a) patients who are not sufficiently controlled by treatment with at least two antidiabetics (except insulin):
• insulin + metformin or
• insulin + empagliflozin (empagliflozin in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or
• insulin + liraglutide (liraglutide in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or
• insulin, if metformin and empagliflozin and liraglutide are according to the SmPC not appropriate due to intolerance or contraindication
• b) patients who are not sufficiently controlled by treatment with insulin (with or w/o another antidiabetic):
• a) patients who are not sufficiently controlled by treatment with ≥ 2 antidiabetics (except insulin): additional benefit not proved
• b) patients who are not sufficiently controlled by treatment with insulin (with or w/o another antidiabetic): additional benefit not proved

Subject:

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

Time table:

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

Final decision:

• assessment stopped

Subject:

• Active Substance: Venetoclax
• Name: Venclyxto^®
• Therapeutic area: Chronic lymphatic leukemia (CLL)
• Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

• Start: 01.12.2018
• Final decision by G-BA: 16.05.2019

Final decision:

• a) patients with 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor: additional benefit not proved
• b) patients without 17p deletion or TP53 mutation who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor: additional benefit not proved

Subject:

• Active Substance: Venetoclax
• Name: Venclyxto^®
• Therapeutic area: Chronic lymphatic leukemia (CLL)
• Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

• Start: 01.12.2018
• Final decision by G-BA: 16.05.2019

Final decision:

• a) patients without 17p deletion and/or TP53 mutation who are suitable for chemoimmunotherapy
• a1) for whom the combination therapy of bendamustine and rituximab is the patient-individual therapy: indication for a minor additional benefit
• a2) for whom other therapies than bendamustine plus rituximab is the patient-individual therapy: additional benefit not proved
• b) patients with 17p deletion and/or TP53 mutation or for whom a chemoimmunotherapy is not suitable: additional benefit not proved

Subject:

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

Time table:

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

Final decision:

• Additional benefit not proved

Subject:

• Active Substance: Tezacaftor / ivacaftor
• Name: Symkevi^®
• Therapeutic area: Cystic fibrosis
• Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

• Start: 01.12.2018
• Final decision by G-BA: 16.05.2019

Final decision:

• a) Patients with homozygous F508del mutation: considerable additional benefit (proved because of orphan drug designation)
• b) Patients with heterozygous F508del mutation: minor additional benefit (proved because of orphan drug designation)

Subject:

• Active Substance: Semaglutide
• Name: Ozempic^®
• Therapeutic area: Diabetes mellitus, type 2
• Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

• Start: 01.11.2018
• Final decision by G-BA: 02.05.2019

Final decision:

• a) monotherapy: No additional benefit proved.
• b) in combination with another antidiabetic (except for insulin, here: metformin):
• b1) patients with high CV risk: Hint for a minor additional benefit.
• b2) patients without high CV risk: No additional benefit proved.
• c) in combination with two other antidiabetics (except for insulin):
• c1) patients with high CV risk: Hint for a minor additional benefit.
• c2) patients without high CV risk: No additional benefit proved.
• d) in combination with insulin (with or w/o another antidiabetic):
• d1) patients with high CV risk: Hint for a minor additional benefit.
• d2) patients without high CV risk: No additional benefit proved.

Subject:

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

Time table:

• Start: 01.11.2018
• Final decision by G-BA: 02.05.2019

Final decision:

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

Subject:

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

Time table:

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

Final decision:

• a) as initial endocrine therapy
• a1) for postmenopausal women: No additional benefit proved.
• a2) for pre- and perimenopausal women: No additional benefit proved.
• b) with endocrine therapy pre-treated
• b1) for postmenopausal women with progress after endocrine therapy: No additional benefit proved.
• b2) for pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

Subject:

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

Time table:

• Start: 01.11.2018
• Final decision by G-BA: 02.05.2019
• This decision remains valid until: 31.12.2020

Final decision:

• a) as initial endocrine therapy
• a1) for postmenopausal women: No additional benefit proved.
• a2) for pre- and perimenopausal women: No additional benefit proved.
• b) with endocrine therapy pre-treated
• b1) for postmenopausal women with progress after endocrine therapy: No additional benefit proved.
• b2) for pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

Subject:

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

Time table:

• Start: 01.11.2018
• Final decision by G-BA: 02.05.2019

Final decision:

• a) patients who are eligible for statins
• a1) without known CV disease: No additional benefit proved.
• a2) with known CV disease: No additional benefit proved.
• b) patients who are intolerant or contraindicated for statins: No additional benefit proved.
• b1) without known CV disease: No additional benefit proved.
• b2) with known CV disease: No additional benefit proved.

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

• Active Substance: Tildrakizumab
• Name: Ilumetri^®
• Therapeutic area: Plaque psoriasis
• Pharmaceutical company: Almirall Hermal GmbH

Time table:

• Start: 15.11.2018
• Final decision by G-BA: 02.05.2019

Final decision:

• a) Patients for whom a systemic therapy for the first time is indicated: No additional benefit proved.
• b) Patients who were insufficiently treated with a systemic therapy: No additional benefit proved.

Subject:

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

Time table:

• Start: 15.11.2018
• Final decision by G-BA: 02.05.2019

Final decision:

• No additional benefit proved.

Subject:

• Active Substance: Pembrolizumab
• Name: Keytruda^®
• Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
• Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

• Start: 15.10.2018
• Final decision by G-BA: 04.04.2019
• This decision remains valid until: 01.10.2019

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 15.10.2018
• Final decision by G-BA: 04.04.2019

Final decision:

• Hint for a considerable additional benefit

Subject:

• Active Substance: Ocriplasmin
• Name: Jetrea^®
• Therapeutic area: Vitreomacular traction (VMT)
• Pharmaceutical company: Oxurion NV

Time table:

• Start: 15.10.2018
• Final decision by G-BA: 04.04.2019

Final decision:

• a) for patients with light symptoms (e.g. minor worsening of visual acuity, slightly impaired vision, no progression of symptoms): hint for a minor additional benefit
• b) for patients with severe symptoms (e.g. progressive worsening of visual acuity, progressive retinal disorder, progressive impaired vision): no additional benefit proved

Subject:

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

Time table:

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

Final decision:

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

Subject:

• Active Substance: Vestronidase alfa
• Name: Mepsevii^®
• Therapeutic area: Mucopolysaccharidosis
• Pharmaceutical company: Ultragenyx Germany GmbH

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

• Active Substance: : Tenofovir alafenamide
• Name: Vemlidy^®
• Therapeutic area: Chronic hepatitis B
• Pharmaceutical company: Gilead Sciences GmbH

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

• Therapy-naïve adult patients: No additional benefit proved.
• Pre-treated adult patients: No additional benefit proved.
• Therapy-naïve adolescent (12 years and older) patients: No additional benefit proved.
• Pre-treated adolescent (12 years and older) patients: No additional benefit proved.

Subject:

• Active Substance: Sitagliptin
• Name: Januvia®, Xelevia^®
• Therapeutic area: Diabetes mellitus, type 2
• Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

• Hint for a minor additional benefit

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

• No additional benefit proved.

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

• Active Substance: Palbociclib
• Name: Ibrance^®
• Therapeutic area: Breast cancer
• Pharmaceutical company: Pfizer Pharma GmbH

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

• Active Substance: Patisiran
• Name: Onpattro^®
• Therapeutic area: Amyloidosis
• Pharmaceutical company: Alnylam Germany GmbH

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019
• This decision remains valid until: 01.04.2024

Final decision:

• Indication for a considerable additional benefit

Subject:

• Active Substance: Trametinib
• Name: Mekinist^®
• Therapeutic area: Melanoma
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 01.10.2018
• Final decision by G-BA: 22.03.2019
• This decision remains valid until: 01.04.2024

Final decision:

• Indication for a considerable additional benefit

Subject:

• Active Substance: Tisagenlecleucel
• Name: Kymriah^®
• Therapeutic area: B-cell acute lymphoblastic leukemia (ALL)
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 15.09.2018
• Final decision by G-BA: 07.03.2019
• This decision remains valid until: 15.03.2020

Final decision:

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

Subject:

• Active Substance: Tisagenlecleucel
• Name: Kymriah^®
• Therapeutic area: Diffuse large B-cell lymphoma (DLBCL)
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 15.09.2018
• Final decision by G-BA: 07.03.2019
• This decision remains valid until: 15.03.2020

Final decision:

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

Subject:

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

Time table:

• Start: 01.09.2018
• Final decision by G-BA: 21.02.2019
• This decision remains valid until: 28.02.2022

Final decision:

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

Subject:

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

Time table:

• Start: 01.09.2018
• Final decision by G-BA: 21.02.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.09.2018
• Final decision by G-BA: 21.02.2019

Final decision:

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

Subject:

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

Time table:

• Start: 01.09.2018
• Final decision by G-BA: 21.02.2019
• This decision remains valid until: 01.04.2021

Final decision:

• Hint for a non-quantifiable additional benefit

Subject:

• Active Substance: Tofacitinib
• Name: Xeljanz^®
• Therapeutic area: Colitis ulcerosa
• Pharmaceutical company: Pfizer Pharma GmbH

Time table:

• Start: 01.09.2018
• Final decision by G-BA: 21.02.2019

Final decision:

• Patients who have not responded sufficiently, do not respond any more or have a contraindication or intolerance to a conventional treatment: no additional benefit proved
• Patients who have responded insufficiently to a biological such as TNF-alfa antagonist or integrin inhibitor or do not respond any more or have an intolerance against such treatments: no additional benefit proved

Subject:

• Active Substance: Tofacitinib
• Name: Xeljanz^®
• Therapeutic area: Psoriasis arthritis
• Pharmaceutical company: Pfizer Pharma GmbH

Time table:

• Start: 01.09.2018
• Final decision by G-BA: 21.02.2019

Final decision:

• Patients who have not responded sufficiently or tolerated a previous antirheumatic (DMARD-) therapy: hint for a minor additional benefit
• Patients who have not responded sufficiently or tolerated a previous therapy with bDMARD: no additional benefit proved

Subject:

• Active Substance: Osimertinib
• Name: Tagrisso^©
• Therapeutic area: Non-small cell lung cancer (NSCLC)
• Pharmaceutical company: AstraZeneca GmbH

Time table:

• Start: 15.07.2018
• Final decision by G-BA: 17.01.2019

Final decision:

• Patients with activating EGFR mutations L858 or del 19: hint for a considerable additional benefit
• Patients with activating EGFR mutations other than L858 or del 19 (except for de novo T790M): no additional benefit prove

Subject:

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

Time table:

• Start: 01.08.2018
• Final decision by G-BA: 17.01.2019

Final decision:

• No additional benefit proved