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Subject:

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

Time table:

• Start: 15.09.2020
• Publication of assessment: 15.12.2020
• End of public hearing: 05.01.2021
• Final decision by G-BA: beginning of March 2021

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

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

Time table:

• Start: 01.10.2020
• Publication of assessment: 04.01.2021
• End of public hearing: 25.01.2021
• Final decision by G-BA: beginning of April 2021

Comparative therapy:

• 1. Patients who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): FCR
• 2. Patients who cannot be treated with FCR: bendamustine in combination with rituximab OR chlorambucil in combination wiht rituximab or obinutuzumab
• 3. Patients with 17p-deletion and/or T53-mutation or for whom a chemoimmunotherapy is not indicated due to other reasons: ibrutinib

Subject:

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

Time table:

• Start: 01.10.2020
• Publication of assessment: 04.01.2021
• End of public hearing: 25.01.2021
• Final decision by G-BA: beginning of April 2021

Comparative therapy:

• Cisplatin in combination with etoposide OR
• Carboplatin in combination with etoposide

Subject:

• Active Substance: Sofosbuvir / velpatasvir
• Name: Epclusa^®
• Therapeutic area: Chronic hepatitis C
• Pharmaceutical company: Gilead Sciences GmbH

Time table:

• Start: 01.10.2020
• Publication of assessment: 04.01.2021
• End of public hearing: 25.01.2021
• Final decision by G-BA: beginning of April 2021

Comparative therapy:

• Patients aged up to < 12 years: watchful waiting
• Patients aged 12 up to < 18 years (genotype 1, 4, 5, or 6): Ledipasvir / sofosbuvir OR glecaprevir / pibrentasvir
• Patients aged 12 up to < 18 years (genotype 2 or 3): Sofosbuvir + ribavirin OR glecaprevir / pibrentasvir

Subject:

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

Time table:

• Start: 15.10.2020
• Publication of assessment: 15.01.2021
• End of public hearing: 05.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• 1. Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. methotrexate (MTX)): alternative classical DMARDs, if appropriate (e.g. MTX, leflunomide) as monotherapy or combination therapy
• 2. Patients for whom treatment with biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is indicated for the first time: bDMARDs or tsDMARDs (abatacept OR adalimumab OR baricitinib OR certolizumab pegol OR etanercept OR golimumab OR infliximab OR sarilumab OR tocilizumab OR tofacitinib, in combination with MTX; possibly as monotherapy but only under consideration of the respective authorization status in case of intolerance or no suitability for MTX)
• 3. Patients who have responded insufficiently or did not tolerate prior treatment wiht one or several bDMARDs and/or tsDMARDs: switch of bDMARD or tsDMARD therapy (abatacept OR adalimumab OR baricitinib OR certolizumab pegol OR etanercept OR golimumab OR infliximab OR sarilumab OR tocilizumab OR tofacitinib, in combination with MTX; possibly as monotherapy but only under consideration of the respective authorization status in case of intolerance or no suitability for MTX); or for patients with severe rheumatoid arthritis; rituximab considering the authorization) under consideration of prior treatment

Subject:

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

Time table:

• Start: 15.10.2020
• Publication of assessment: 15.01.2021
• End of public hearing: 05.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

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

Time table:

• Start: 15.10.2020
• Publication of assessment: 15.01.2021
• End of public hearing: 05.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

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

Time table:

• Start: 01.11.2020
• Publication of assessment: 01.02.2021
• End of public hearing: 22.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• a) monotherapy: sulfonyl urea (glibenclamide or glimepiride)
• b) in combination with another antidiabetic (except for insulin, here: metformin):
  metformin + sulfonyl urea (glibenclamide or glimepiride) or metformin + emplagliflozin or metformin + liraglutide*
  (*liraglutide in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or human insulin, if metformin is not appropriate due to intolerance or contraindication according to the SMPC)
• c) in combination with two other antidiabetics (except for insulin):
Human insulin + metformin or human insulin + empagliflozin* or human insulin + liraglutide*
(*liraglutide and empagliflozin only in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or human insulin, if the respective combination partners are not appropriate due to intolerance or contraindication according to the SMPC or if their efficacy is insufficient to an advanced diabetes mellitus
• d) in combination with insulin (with or w/o metformin or empagliflozin* or liraglutide*, if appropriate):
  optimization of human insulin regimen (*liraglutide and empagliflozin in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)

Subject:

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

Time table:

• Start: 01.11.2020
• Publication of assessment: 01.02.2021
• End of public hearing: 22.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: maximum tolerated medicinal therapy at the discretion of the physician under consideration of statins, cholesterol absorption inhibitors, and bile acid sequestrants
• b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
  evolocumab* or LDL apheresis (as "ultima ratio" for refractory disease), if appropriate in combination with adjacent medicinal lipid-lowering therapy) (*specification regarding exclusion of prescription according to AM-RL appendix III is to be followed)

Subject:

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

Time table:

• Start: 01.11.2020
• Publication of assessment: 01.02.2021
• End of public hearing: 22.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: maximum tolerated medicinal therapy at the discretion of the physician under consideration of statins, cholesterol absorption inhibitors, and bile acid sequestrants
• b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
  evolocumab* or LDL apheresis (as "ultima ratio" for refractory disease), if appropriate in combination with adjacent medicinal lipid-lowering therapy) (*specification regarding exclusion of prescription according to AM-RL appendix III is to be followed)

Subject:

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

Time table:

• Start: 01.11.2020
• Publication of assessment: 01.02.2021
• End of public hearing: 22.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• No comparative therapy due to orphan drug status

Subject:

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

Time table:

• Start: 01.11.2020
• Publication of assessment: 01.02.2021
• End of public hearing: 22.02.2021
• Final decision by G-BA: middle of April 2021

Comparative therapy:

• No comparative therapy due to orphan drug status

Subject:

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

Time table:

• Start: 15.11.2020
• Publication of assessment: 15.02.2021
• End of public hearing: 09.03.2021
• Final decision by G-BA: middle of May 2021

Comparative therapy:

• For patients who are not indicated for a long-term/ continuous systemic therapy: A patient-individual optimized treatment regimen with topical and systemic therapy, depending on characteristics of the disease and under consideration of prior therapy, choosing from the following treatments:
  - topical glucocorticoids classes 2-4
  - tacrolimus (topical)
  - UV therapy (UVA/ NB-UVB/ balneotherapy
  - systemic glucocorticoids (short-term treatment only during therapy of relapse)
  - ciclosporin
• For patients who are indicated for a long-term/ continuous systemic therapy: Dupilumab (if appropriate, in combination with TCS and/or TCI)

Subject:

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

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• Hint for a major additional benefit

Subject:

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

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• Indication for a major additional benefit

Subject:

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

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• Hint for a major additional benefit

Subject:

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

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• Indication for a major additional benefit

Subject:

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

Time table:

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

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Secukinumab
• Name: Cosentyx^®
• Therapeutic area: Psoriatic arthritis
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• A1) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy with concurrent moderate to severe plaque psoriasis: Indication for a minor additional benefit
• A2) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy without concurrent moderate to severe plaque psoriasis: No additional benefit proved
• B) Patients who did not benefit sufficiently from or who did not tolerate a previous bDMARD therapy: No additional benefit proved

Subject:

• Active Substance: Secukinumab
• Name: Cosentyx^®
• Therapeutic area: Plaque psoriasis
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• Hint for a minor additional benefit

Subject:

• Active Substance: Secukinumab
• Name: Cosentyx^®
• Therapeutic area: Axial spondyloarthritis
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 01.09.2020
• Final decision by G-BA: 18.02.2021

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Nintedanib
• Name: Ofev^®
• Therapeutic area: Systemic sclerosis associated interstitial lung disease (SSc-ILD)
• Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

• Start: 15.08.2020
• Final decision by G-BA: 04.02.2021

Final decision:

• No additional benefit proved (orphan drug, 50 M € sales exceeded)

Subject:

• Active Substance: Nintedanib
• Name: Ofev^®
• Therapeutic area: Chronic fibrosing interstitial lung disease (ILD) with progressive phenotype
• Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

• Start: 15.08.2020
• Final decision by G-BA: 04.02.2021

Final decision:

• Hint for a minor additional benefit (orphan drug, 50 M € sales exceeded)

Subject:

• Active Substance: Trifarotene
• Name: Selgamis^®
• Therapeutic area: Acne vulgaris
• Pharmaceutical company: Galderma Laboratorium GmbH

Time table:

• Start: 15.08.2020
• Final decision by G-BA: 04.02.2021

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 15.08.2020
• Final decision by G-BA: 04.02.2021

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 01.08.2020
• Final decision by G-BA: 21.01.2021

Final decision:

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

Subject:

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

Time table:

• Start: 01.08.2020
• Final decision by G-BA: 21.01.2021

Final decision:

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

Subject:

• Active Substance: Sofosbuvir
• Name: Sovaldi^®
• Therapeutic area: Chronic hepatitis C
• Pharmaceutical company: Gilead Sciences Ireland UC

Time table:

• Start: 01.08.2020
• Final decision by G-BA: 21.01.2021

Final decision:

• HInt for non-quantifiable additional benefit

Subject:

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

Time table:

• Start: 01.08.2020
• Final decision by G-BA: 21.01.2021

Final decision:

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

Subject:

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

Time table:

• Start: 01.08.2020
• Final decision by G-BA: 21.01.2021

Final decision:

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

Subject:

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

Time table:

• Start: 01.08.2020
• Final decision by G-BA: 21.01.2021

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Ravulizumab
• Name: Ultomiris^®
• Therapeutic area: Atypical haemolytic uremic syndrome (aHUS)
• Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

• Start: 01.08.2020
• Final decision by G-BA: 21.01.2021

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Osilodrostat
• Name: Isturisa^®
• Therapeutic area: Endogenous Cushing's syndrome
• Pharmaceutical company: Recordati Rare Diseases Germany GmbH

Time table:

• Start: 15.07.2020
• Final decision by G-BA: 07.01.2021

Final decision:

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

Subject:

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

Time table:

• Start: 15.07.2020
• Final decision by G-BA: 07.01.2021

Final decision:

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

Subject:

• Active Substance: Ozanimod
• Name: Zeposia^®
• Therapeutic area: Multiple sclerosis (MS)
• Pharmaceutical company: Celgene GmbH

Time table:

• Start: 15.07.2020
• Final decision by G-BA: 07.01.2021

Final decision:

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

Subject:

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

Time table:

• Start: 01.07.2020
• Final decision by G-BA: 17.12.2020

Final decision:

• Hint for a considerable additional benefit

Subject:

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

Time table:

• Start: 01.07.2020
• Final decision by G-BA: 17.12.2020

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 01.07.2020
• Final decision by G-BA: 17.12.2020

Final decision:

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

Subject:

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

Time table:

• Start: 01.07.2020
• Final decision by G-BA: 17.12.2020

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 01.07.2020
• Final decision by G-BA: 17.12.2020

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 15.06.2020
• Final decision by G-BA: 03.12.2020
• This decision remaims valid until: 01.07.2020

Final decision:

• Hint for a minor additional benefit

Subject:

• Active Substance: Mogamulizumab
• Name: Poteligeo^®
• Therapeutic area: Mycosis fungoides; Sézary syndrome
• Pharmaceutical company: Kyowa Kirin GmbH

Time table:

• Start: 15.06.2020
• Final decision by G-BA: 03.12.2020

Final decision:

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

Subject:

• Active Substance: Onasemnogene abeparvovec
• Name: Zolgensma^®
• Therapeutic area: Spinal muscle atrophy
• Pharmaceutical company: AveXis

Time table:

• Start: 01.07.2020
• Final decision by G-BA: 03.12.2020

Final decision:

• Assessment is suspended due to expected full assessment after exceedance of 50 M € annual sales

Subject:

• Active Substance: Ponatinib
• Name: Iclusig^®
• Therapeutic area: Acute lymphatic leukemia (ALL)
• Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

• Start: 01.06.2020
• Final decision by G-BA: 20.11.2020

Final decision:

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

Subject:

• Active Substance: Ponatinib
• Name: Iclusig^®
• Therapeutic area: Chronic myeloid leukemia (CML)
• Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

• Start: 01.06.2020
• Final decision by G-BA: 20.11.2020

Final decision:

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

Subject:

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

Time table:

• Start: 01.06.2020
• Final decision by G-BA: 20.11.2020

Final decision:

• Hint for a considerable additional benefit

Subject:

• Active Substance: Solriamfetol
• Name: Sunosi^®
• Therapeutic area: Narcolepsy
• Pharmaceutical company: Jazz Pharmaceuticals

Time table:

• Start: 15.05.2020
• Final decision by G-BA: 05.11.2020

Final decision:

1. Narcolepsy without cataplexy: No additional benefit proved
2. Narcolepsy with cataplexy: No additional benefit proved

Subject:

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

Time table:

• Start: 15.05.2020
• Final decision by G-BA: 05.11.2020

Final decision:

• Indication for a minor additional benefit

Subject:

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

Time table:

• Start: 15.05.2020
• Final decision by G-BA: 05.11.2020

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Naldemedin
• Name: Rizmoic^®
• Therapeutic area: Opioid-induced constipation
• Pharmaceutical company: Hexal AG

Time table:

• Start: 15.05.2020
• Final decision by G-BA: 05.11.2020

Final decision by G-BA:

1. Patients pretreated with a laxative: No additional benefit proved
2. Patients not eligible anymore for a laxative not subject to prescription or for a reimbursable medicinal product for the treatment of constipation: No additional benefit proved

Subject:

• Active Substance: Venetoclax
• Name: Venclyxto^®
• Therapeutic area: Chronic lymphatic leukaemia (CLL)
• Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

• Start: 15.04.2020
• Final decision by G-BA: 15.10.2020

Final decision:

• a. Patients who are suited for a treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR): No additional benefit proved
• b. Patients who are not suited for a treatment with FCR: No additional benefit proved
• c. Patients with 17p deletion or TP53 mutation, or who are not suited for chemoimmunotherapy due to other reasons: No additional benefit proved

Subject:

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

Time table:

• Start: 15.04.2020
• Final decision by G-BA: 15.10.2020

Final decision:

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

Subject:

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

Time table:

• Start: 15.04.2020
• Final decision by G-BA: 15.10.2020

Final decision:

• Indication for a considerable additional benefit (orphan drug)

Subject:

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

Time table:

• Start: 01.05.2020
• Final decision by G-BA: 15.10.2020

Final decision:

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

Subject:

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

Time table:

• Start: 01.05.2020
• Final decision by G-BA: 15.10.2020

Final decision:

• Indication for a considerable additional benefit

Subject:

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

Time table:

• Start: 01.04.2020
• Final decision by G-BA: 01.10.2020

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 01.04.2020
• Final decision by G-BA: 01.10.2020

Final decision:

• Indication for a minor additional benefit

Subject:

• Active Substance: Trifluridine / tipiracil
• Name: Lonsurf^®
• Therapeutic area: Colorectal cancer
• Pharmaceutical company: Servier Deutschland GmbH

Time table:

• Start: 01.04.2020
• Final decision by G-BA: 01.10.2020

Final decision:

• Hint for a minor additional benefit

Subject:

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

Time table:

• Start: 01.04.2020
• Final decision by G-BA: 01.10.2020

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 17.09.2020
• This decision remains valid until: 01.09.2023

Final decision:

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

Subject:

• Active Substance: Tisagene lecleucel
• Name: Kymriah^®
• Therapeutic area: Diffuse large B-cell lymphoma
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 17.09.2020
• This decision remains valid until: 01.09.2023

Final decision:

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

Subject:

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

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 17.09.2020

Final decision:

• Aassessment repealed

Subject:

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

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 17.09.2020

Final decision:

• Assessment repealed

Subject:

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

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 17.09.2020

Final decision:

• Assessment repealed

Subject:

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

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 17.09.2020

Final decision:

• Assessment repealed

Subject:

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

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 03.09.2020
• This decision remains valid until:: 01.06.2021

Final decision:

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

Subject:

• Active Substance: Riociguat
• Name: Adempas^®
• Therapeutic area: Pulmonary Hypertension
• Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 03.09.2020

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Riociguat
• Name: Adempas^®
• Therapeutic area: Pulmonary Hypertension
• Pharmaceutical company: MSD SHARP & DOHME GmbH

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 03.09.2020

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 03.09.2020

Final decision:

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

Subject:

• Active Substance: Romosozumab
• Name: Evenity^®
• Therapeutic area: Osteoporosis
• Pharmaceutical company: UCB Pharma GmbH

Time table:

• Start: 15.03.2020
• Final decision by G-BA: 03.09.2020

Final decision:

• Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Ramucirumab
• Name: Cyramza^®
• Therapeutic area: Non-small cell lung cancer (NSCLC)
• Pharmaceutical company: Lilly Deutschland GmbH

Time table:

• Start: 15.02.2020
• Final decision by G-BA: 20.08.2020

Final decision:

• Patients with activating EGFR mutations L858R (exon 21 substitution mutation) or del 19 (exon 19 deletion): no additional benefit proved
• Patients with other activating EGFR mutations than L858R or del 19 (exon 19 deletion): no additional benefit proved

Subject:

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

Time table:

• Start: 15.02.2020
• Final decision by G-BA: 20.08.2020

Final decision:

• Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

• Start: 15.02.2020
• Final decision by G-BA: 20.08.2020

Final decision:

• Hint for a minor additional benefit

Subject:

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

Time table:

• Start: 15.02.2020
• Final decision by G-BA: 20.08.2020

Final decision:

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

Subject:

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

Time table:

• Start: 15.02.2020
• Final decision by G-BA: 20.08.2020

Final decision:

• Patients with SPMS with relapses: no additional benefit proved
• Patients with SPMS without relapses: no additional benefit proved

Subject:

• Active Substance: Polatuzumab vedotin
• Name: Polivy^®
• Therapeutic area: Diffuse large B-cell lymphoma (DLBCL)
• Pharmaceutical company: Roche Pharma GmbH

Time table:

• Start: 15.02.2020
• Final decision by G-BA: 20.08.2020

Final decision:

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

Subject:

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

Time table:

• Start: 01.03.2020
• Final decision by G-BA: 20.08.2020

Final decision:

• Post-menopausal women who are not pre-treated with an endocrine therapy: indication for a minor additional benefit
• Post-menopausal women who are pre-treated with an endocrine therapy: hint for a minor additional benefit

Subject:

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

Time table:

• Start: 01.03.2020
• Final decision by G-BA: 20.08.2020

Final decision:

• Hint for a minor additional benefit

Subject:

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

Time table:

• Start: 01.03.2020
• Final decision by G-BA: 20.08.2020

Final decision:

• No additional benefit proven

Subject:

• Active Substance: Tafamidis
• Name: Vyndaqel^®
• Therapeutic area: Amyloidosis
• Pharmaceutical company: Pfizer Pharma GmbH

Time table:

• Start: 01.03.2020
• Final decision by G-BA: middle of August 2020

Final decision:

• Hint for a considerable additional benefit

Subject:

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

Time table:

• Start: 01.02.2020
• Final decision by G-BA: 16.07.2020

Final decision:

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

Subject:

• Active Substance: Upadacitinib
• Name: Rinvoq^®
• Therapeutic area: Rheumatoid arthritis
• Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

• Start: 01.02.2020
• Final decision by G-BA: 16.07.2020

Final decision:

• a₁) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib as monotherapy: No additional benefit proved
• a₂) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib in combination with MTX: No additional benefit proved
• b₁) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib as monotherapy: No additional benefit proved
• b₂) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib in combination with MTX: Hint for a considerable additional benefit
• c₁) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib as monotherapy: No additional benefit proved
• c_2A) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients with high disease activity [DAS28 CRP > 5.1]: Hint for a minor additional benefit
• c_2B) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients without high disease activity [DAS28 CRP ≤ 5.1]: No additional benefit proved

Subject:

• Active Substance: Trastuzumab emtansine
• Name: Kadcyla^®
• Therapeutic area: Breast cancer
• Pharmaceutical company: Roche Pharma AG

Time table:

• Start: 15.01.2020
• Final decision by G-BA: 02.07.2020
• The decision remains valid until: 30.09.2024

Final decision:

• Indication for a minor additional benefit

Subject:

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

Time table:

• Start: 15.12.2019
• Final decision by G-BA: 04.06.2020

Final decision:

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