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Ongoing (preliminary decision published)
Subject:
- Active Substance: Pemigatinib
- Name: Pemazyre®
- Therapeutic area: Cholangiocarcinoma
- Pharmaceutical company: Incyte Biosciences Germany GmbH
Time table:
- Start: 15.04.2021
- Publication of assessment: 15.07.2021
- End of public hearing: 05.08.2021
- Final decision by G-BA: beginning of October 2021
Comparative therapy:
- No comparative therapy because of orphan drug designation
Subject:
- Active Substance: Cabogratevir
- Name: Vocabria®
- Therapeutic area: HIV-1 infection
- Pharmaceutical company: ViiV Healthcare GmbH
Time table:
- Start: 01.05.2021
- Publication of assessment: 02.08.2021
- End of public hearing: 23.08.2021
- Final decision by G-BA: end of October 2021
Comparative therapy:
- A patient-individual antiretroviral therapy choosing from approved medicines, taking into account the previous therap(ies) and, if indicated, adverse events
Subject:
- Active Substance: Rilpirivine
- Name: Rekambys®
- Therapeutic area: HIV-1 infection
- Pharmaceutical company: ViiV Healthcare GmbH
Time table:
- Start: 01.05.2021
- Publication of assessment: 02.08.2021
- End of public hearing: 23.08.2021
- Final decision by G-BA: end of October 2021
Comparative therapy:
- A patient-individual antiretroviral therapy choosing from approved medicines, taking into account the previous therap(ies) and, if indicated, adverse events
Subject:
- Active Substance: Erenumab
- Name: Aimovig®
- Therapeutic area: Migraine prophylaxis
- Pharmaceutical company: Novartis Pharma GmbH
Time table:
- Start: 01.05.2021
- Publication of assessment: 02.08.2021
- End of public hearing: 23.08.2021
- Final decision by G-BA: end of October 2021
Comparative therapy:
- Metoprolol or propranolol or flunarizine or topiramate or amitriptyline or Clostridium botulinum toxin type A taking into account the approval and previous therapy
Subject:
- Active Substance: Risdiplam
- Name: Evrysdi®
- Therapeutic area: Spinal muscular atrophy
- Pharmaceutical company: Roche Pharma GmbH
Time table:
- Start: 01.05.2021
- Publication of assessment: 02.08.2021
- End of public hearing: 23.08.2021
- Final decision by G-BA: end of October 2021
Comparative therapy:
- a) Presymptomatic patients aged 2 months and older with a 5q-associated SMA and 1–3 copies of the SMN2 gene / symptomatic patients aged 2 months and older with a clinically diagnosed SMA type I or type II: Nusinersen
- b) Presymptomatic patients aged 2 months and older with a 5q-associated SMA and 4 copies of the SMN2 gene / symptomatic patients with a clinically diagnosed SMA type III: a therapy at the physician’s discretion choosing from nusinersen or best supportive care
Subject:
- Active Substance: Cabozantinib
- Name: Cabometyx®
- Therapeutic area: Renal cell carcinoma
- Pharmaceutical company: Ipsen Pharma GmbH
Time table:
- Start: 01.05.2021
- Publication of assessment: 02.08.2021
- End of public hearing: 23.08.2021
- Final decision by G-BA: end of October 2021
Comparative therapy:
- a) Patients with a favorable risk profile (IMDC-Score 0): Pembrolizumab
- b) Treatment-naïve patients with advanced renal cell carcinoma with an intermediate (IMDC-Score 1–2) or unfavorable risk profile (IMDC-Score ≥ 3):
- Avelumab in combination with axitinib (only for patients with an unfavorable risk profile) OR
- nivolumab in combination with ipilimumab OR
- pembrolizumab in combination with axitinib
Subject:
- Active Substance: Nivolumab
- Name: Opdivo®
- Therapeutic area: Renal cell carcinoma
- Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KG
Time table:
- Start: 01.05.2021
- Publication of assessment: 02.08.2021
- End of public hearing: 23.08.2021
- Final decision by G-BA: end of October 2021
Comparative therapy:
- a) Patients with a favorable risk profile (IMDC-Score 0): Pembrolizumab in combination with axitinib
- b) Treatment-naïve patients with advanced renal cell carcinoma with an intermediate (IMDC-Score 1–2) or unfavorable risk profile (IMDC-Score ≥ 3):
- Avelumab in combination with axitinib (only for patients with an unfavorable risk profile) OR
- nivolumab in combination with ipilimumab OR
- pembrolizumab in combination with axitinib
Subject:
- Active Substance: Atidarsagene autotemcel OTL-200
- Name: Libmeldy®
- Therapeutic area: Metachromatic leukodystrophy
- Pharmaceutical company: Orchard Therapeutics GmbH
Time table:
- Start: 01.05.2021
- Publication of assessment: 02.08.2021
- End of public hearing: 23.08.2021
- Final decision by G-BA: end of October 2021
Comparative therapy:
- No comparative therapy because of orphan drug indication
Subject:
- Active Substance: Cannabidiol
- Name: Epidyolex®
- Therapeutic area: Seizures associated with tuberous sclerosis complex (TSC)
- Pharmaceutical company: GW Pharmaceuticals plc
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- No comparative therapy because of orphan drug indication
Subject:
- Active Substance: Obinutuzumab
- Name: Gazyvaro®
- Therapeutic area: Follicular lymphoma
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- Patient-individual therapy choosing from chemotherapies, [90Y]-radiolabeled iritumomab tiuxetan and best supportive care, under consideration of the previous therapy, the course of disease and the general health status
Subject:
- Active Substance: Obinutuzumab
- Name: Gazyvaro®
- Therapeutic area: Chronic lymphocytic leukemia (CLL)
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- Bendamustine in combination with rituximab or
- Chlorambucil in combination with rituximab
Subject:
- Active Substance: Obinutuzumab
- Name: Gazyvaro®
- Therapeutic area: Follicular lymphoma (FL)
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- Rituximab in combination with a chemotherapy (preferably in combination with cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) or cyclophosphamide, vincristine and prednisolone (CVP) or bendamustine), followed by a maintenance therapy with rituximab for patients who responded to the induction therapy
Subject:
- Active Substance: Onasemnogene abeparvovec
- Name: Zolgensma®
- Therapeutic area: Spinal muscular atrophy (SMA)
- Pharmaceutical company: Novartis Gene Therapies EU Limited
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- a. Pre-symptomatic patients with a 5q-associated SMA as well as symptomatic patients with 5q-associated SMA type I and II (both with a biallelic mutation of SMN1 gene and up to 3 opies of SMN2 gene): Nusinersen
- b. Symtomatic patients with 5q-associated SMA type III (with a biallelic mutation of SMN1 gene and up to 3 copies of SMN2 gene): therapy at the discretion of the physician choosing from nusinersen or best supportive care
Subject:
- Active Substance: Lanadelumab
- Name: Tykhzyro®
- Therapeutic area: Hereditary angioedema
- Pharmaceutical company: Takeda GmbH
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- A routine prophylaxis with a C1 esterase inhibitor
Subject:
- Active Substance: Isatuximab
- Name: Sarclisa®
- Therapeutic area: Multiple myeloma
- Pharmaceutical company: Sanofi-Aventis Deutschland GmbH
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- Bortezomib in combination with pegylated liposomal doxorubicin or
- Bortezomib in combination with dexamethasone or
- Lenalidomide in combination with dexamethasone or
- Pomalidomide in combination with dexamethasone or
- Elotuzumab in combination with lenalidomide and dexamethasone or
- Elotuzumab in combination with pomalidomide and dexamethasone or
- Carfilzomib in combination with lenalidomide and dexamethasone or
- Carfilzomib in combination with pomalidomide and dexamethasone or
- Daratumumab in combination with lenalidomide and dexamethasone or
- Daratumumab in combination with bortezomib and dexamethasone
Subject:
- Active Substance: Isatuximab
- Name: Sarclisa®
- Therapeutic area: Hereditary angioedema
- Pharmaceutical company: Takeda GmbH
Time table:
- Start: 15.05.2021
- Publication of assessment: 16.08.2021
- End of public hearing: 06.09.2021
- Final decision by G-BA: beginning of November 2021
Comparative therapy:
- Bortezomib in combination with pegylated liposomal doxorubicin or
- Bortezomib in combination with dexamethasone or
- Lenalidomide in combination with dexamethasone or
- Elotuzumab in combination with lenalidomide and dexamethasone or
- Carfilzomib in combination with lenalidomide and dexamethasone or
- Carfilzomib in combination with dexamethasone or
- Daratumumab in combination with lenalidomide and dexamethasone or
- Daratumumab in combination with bortezomib and dexamethasone
Subject:
- Active Substance: Bosutinib
- Name: Bosulif®
- Therapeutic area: Chronic myelogenous leukemia (CML)
- Pharmaceutical company: Pfizer Pharma GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Imatinib OR
- Nilotinib OR
- Dasatinib
Subject:
- Active Substance: Ivacaftor / tezacaftor / elexacaftor
- Name: Kaftrio®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Best supportive care
Subject:
- Active Substance: Ivacaftor / tezacaftor / elexacaftor
- Name: Kaftrio®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Tezacaftor / ivacaftor in combination with ivacaftor
Subject:
- Active Substance: Ivacaftor / tezacaftor / elexacaftor
- Name: Kaftrio®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Ivacaftor
Subject:
- Active Substance: Ivacaftor
- Name: Kalydeco®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Best supportive care
Subject:
- Active Substance: Ivacaftor
- Name: Kalydeco®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Tezacaftor / ivacaftor in combination with ivacaftor
Subject:
- Active Substance: Ivacaftor
- Name: Kalydeco®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Ivacaftor
Subject:
- Active Substance: Enzalutamide
- Name: Xtandi®
- Therapeutic area: Prostate cancer
- Pharmaceutical company: Astellas Pharma GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Conventional androgen deprivation therapy in combination with docetaxel with or without prednisone or prednisolone (only for patients with remote metastases (M1-Stage) and good general health (according to ECOG / WHO 0 – 1 or Karnofsky index ≥ 70 %) OR
- Conventional androgen deprivation therapy in combination with abiraterone acetate and prednisone or prednisolone (only for patients with newly diagnosed high-risk-metastasized, hormone-sensitive prostate cancer
Subject:
- Active Substance: Cenobamate
- Name: Ontozry®
- Therapeutic area: Epilepsy
- Pharmaceutical company: Angelini Pharma Deutschland GmbH
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Patient-individual anti-epileptic adjunctive therapy, insofar medically indicated and if no pharmacoresistance (in line with an insufficient response), intolerance or contraindication are known with the choice of:
Brivaracetam OR eslicarbazepine OR gabapentin OR lacosamide OR lamotrigine OR levetiracetam OR oxcarbazepine OR perampanel OR pregabalin OR topiramate OR valproic acid OR zonisamide - Considering the basic therapy and prior therapy(ies), the reason for switch of therapy and accompanying side effects
Subject:
- Active Substance: Atezolizumab
- Name: Tecentriq®
- Therapeutic area: Lung cancer, non-small cell
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 01.06.2021
- Publication of assessment: 01.09.2021
- End of public hearing: 22.09.2021
- Final decision by G-BA: middle of November 2021
Comparative therapy:
- Monotherapy with pembrolizumab
Subject:
- Active Substance: Dostarlimab
- Name: Jemperli®
- Therapeutic area: endometrial cancer (EC)
- Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG
Time table:
- Start: 15.06.2021
- Publication of assessment: 15.09.2021
- End of public hearing: 06.10.2021
- Final decision by G-BA: beginning of December 2021
Comparative therapy:
- Therapy at the physician’s discretion, i.e.:
- Endocrine therapy (medroxyprogesterone acetate, megestrol acetate);
- Systemic chemotherapy which can be platin-based re-therapy (cisplatin (monotherapy or in combination with doxorubicin), doxorubicin (monotherapy or in combination with cisplatin), carboplatin in combination with paclitaxel);
- best supportive care alone
Subject:
- Active Substance: Tagraxofusp
- Name: Elzonris®
- Therapeutic area: blastic plasmacytoid dendritic cell neoplasm (BPDCN)
- Pharmaceutical company: Stemline Therapeutics B.V.
Time table:
- Start: 15.06.2021
- Publication of assessment: 15.09.2021
- End of public hearing: 06.10.2021
- Final decision by G-BA: beginning of December 2021
Comparative therapy:
- No comparative therapy because of orphan drug indication
Subject:
- Active Substance: Ponesimod
- Name: Ponvory®
- Therapeutic area: multiple sclerosis
- Pharmaceutical company: Janssen-Cilag GmbH
Time table:
- Start: 15.06.2021
- Publication of assessment: 15.09.2021
- End of public hearing: 06.10.2021
- Final decision by G-BA: beginning of December 2021
Comparative therapy:
- patients who did not yet receive disease modifying therapeutics or who did receive disease modifying therapeutics but have not a highly active disease:
- Interferon beta-1a OR
- Interferon beat-1b OR
- Glatiramer acetate OR
- Ocrelizumab - patients who received disease modifying therapeutics but still have a highly active disease:
- Alemtuzumab OR
- Fingolimod OR
- Natalizumab
Subject:
- Active Substance: Berotralstat
- Name: Orladeyo®
- Therapeutic area: hereditary angioedema (HAE)
- Pharmaceutical company: BioCryst Pharma Deutschland GmbH
Time table:
- Start: 15.06.2021
- Publication of assessment: 15.09.2021
- End of public hearing: 06.10.2021
- Final decision by G-BA: beginning of December 2021
Comparative therapy:
- Prophylactic treatment with C1-esterase-inhibitor
Subject:
- Active Substance: Venetoclax
- Name: Venclyxto®
- Therapeutic area: Acute myeloid leukaemia (AML)
- Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG
Time table:
- Start: 15.06.2021
- Publication of assessment: 15.09.2021
- End of public hearing: 06.10.2021
- Final decision by G-BA: beginning of December 2021
Comparative therapy:
- Azacitidine OR
- Decitabine OR
- Glasdegib in combination with low dose cytarabine
Completed (final decision published)
Subject:
- Active Substance: Bedaquiline
- Name: Sirturo®
- Therapeutic area: Tuberculosis
- Pharmaceutical company: Janssen-Cilag GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Pembrolizumab
- Name: Keytruda®
- Therapeutic area: Colorectal cancer
- Pharmaceutical company: MSD Sharp & Dohme GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- Patients for whom an intensive therapy is indicated: Hint for a minor additional benefit
- Patients for whom an intensive therapy is not indicated: No additional benefit proved
Subject:
- Active Substance: Pembrolizumab
- Name: Keytruda®
- Therapeutic area: Urothelial cancer
- Pharmaceutical company: MSD Sharp & Dohme GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- No additional benefit proved
› 16.09.2021: Pembrolizumab (new indication: Hodgkin lymphoma, pre-treated patients, aged ≥ 3 years)
Subject:
- Active Substance: Pembrolizumab
- Name: Keytruda®
- Therapeutic area: Hodgkin lymphoma
- Pharmaceutical company: MSD Sharp & Dohme GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- Adults:
- Brentuximab vedotin is the appropriate therapy: Hint for a considerable additonal benefit
- Brentuximab vedotin is not the appropriate therapy: No additional benefit proved
- Children and adolescents aged 3 years and older: No additional benefit proved
Subject:
- Active Substance: Fostemsavir
- Name: Rukobia®
- Therapeutic area: HIV infection
- Pharmaceutical company: ViiV Healthcare GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Avatrombopag
- Name: Doptelet®
- Therapeutic area: Thrombocytopenia with chronic liver disease
- Pharmaceutical company: Swedish Orphan Biovitrum GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Avatrombopag
- Name: Doptelet®
- Therapeutic area: Immune thrombocytopenia
- Pharmaceutical company: Swedish Orphan Biovitrum GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Remdesivir
- Name: Veklury®
- Therapeutic area: Coronavirus disease 2019 (COVID-19)
- Pharmaceutical company: Gilead Sciences GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- Adults:
- Recieving low-flow oxygen at the beginning of the therapy: Hint for a minor additional benefit
- Recieving high-flow oxygen at the beginning of the therapy: No additional benefit proved
- Adolescents aged 12 years and older: No additional benefit proved
Subject:
- Active Substance: Sodium zirkonium cyclosilicate
- Name: Lokelma®
- Therapeutic area: Hyperkalaemia
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Nivolumab
- Name: Opdivo®
- Therapeutic area: Melanoma
- Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA
Time table:
- Start: 01.04.2021
- Final decision by G-BA: 16.09.2021
Final decision:
- Hint for a considerable additional benefit
Subject:
- Active Substance: Selpercatinib
- Name: Retsevmo®
- Therapeutic area: Thyroid cancer
- Pharmaceutical company: Lilly Deutschland GmbH
Time table:
- Start: 15.03.2021
- Final decision by G-BA: 02.09.2021
Final decision:
- Patients with an advanced, differentiated thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): No additional benefit proved
- Patients with an advanced, anaplastic thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): No additional benefit proved
Subject:
- Active Substance: Selpercatinib
- Name: Retsevmo®
- Therapeutic area: Thyroid cancer
- Pharmaceutical company: Lilly Deutschland GmbH
Time table:
- Start: 15.03.2021
- Final decision by G-BA: 02.09.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Selpercatinib
- Name: Retsevmo®
- Therapeutic area: NSCLC
- Pharmaceutical company: Lilly Deutschland GmbH
Time table:
- Start: 15.03.2021
- Final decision by G-BA: 02.09.2021
Final decision:
- a) After first-line therapy with a PD-1/PD-L1 antibody as monotherapy: No additional benefit proved
- b) After first-line therapy with a cytotoxic chemotherapy: No additional benefit proved
- c) After first-line therapy with a PD-1/PD-L1 antibody in combination with a platin-based chemotherapy or after sequential therapy with a PD-1/PD-l1 antibody and a platin-based chemotherapy:No additional benefit proved
Subject:
- Active Substance: Tucatinib
- Name: Tukysa®
- Therapeutic area: Breast cancer
- Pharmaceutical company: Seagen Germany GmbH
Time table:
- Start: 15.03.2021
- Final decision by G-BA: 02.09.2021
Final decision:
- Hint for a considerable additional benefit
Subject:
- Active Substance: Fedratinib
- Name: Inrebic®
- Therapeutic area: Chronic myeloproliferative diseases
- Pharmaceutical company: Celgene GmbH
Time table:
- Start: 15.03.2021
- Final decision by G-BA: 02.09.2021
- The resolution remains valid until: 01.03.2025
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Imlifidase
- Name: Idefirix®
- Therapeutic area: Desensitization of kidney transplant
- Pharmaceutical company: Hansa Biopharma AB
Time table:
- Start: 15.03.2021
- Final decision by G-BA: 02.09.2021
- The resolution remains valid until: 01.04.2026
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Esketamine
- Name: Spravato®
- Therapeutic area: Depression
- Pharmaceutical company: Janssen-Cilag GmbH
Time table:
- Start: 01.03.2021
- Final decision by G-BA: 19.08.2021
Final decision:
- Hint for a minor additional benefit
Subject:
- Active Substance: Esketamine
- Name: Spravato®
- Therapeutic area: Depression
- Pharmaceutical company: Janssen-Cilag GmbH
Time table:
- Start: 01.03.2021
- Final decision by G-BA: 19.08.2021
- The decision is limited until: 15.06.2023
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Avelumab
- Name: Bavencio®
- Therapeutic area: Urothelial carcinoma
- Pharmaceutical company: Merck Serono GmbH and Pfizer Pharma GmbH
Time table:
- Start: 01.03.2021
- Final decision by G-BA: 19.08.2021
Final decision:
- Hint for a considerable additional benefit
Subject:
- Active Substance: Acalabrutinib
- Name: Calquence®
- Therapeutic area: Chronic lymphocytic leukaemia (CLL)
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 05.08.2021
Final decision:
- a1) Patients with neither 17p deletion nor TP53 mutation and who can be treated with a chemo-immunotherapy and for whom the patient-individual therapy is rituximab in combination bendamustine (BR): No additional benefit proved
- a2) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with chemo-immunotherapy and for whom the patient-individual therapy is not rituximab in combination with BR: No additional benefit proved
- b) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemo-immunotherapy due to other reasons: Hint for a considerable additional benefit
- c1) Patients with at least 2 prior therapies and for whom the patient-individual therapy is idelalisib in combination with rituximab or rituximab or rituximab in combination with BR: Hint for a minor additional benefit
- c2) Patients with at least 2 prior therapies and for whom the patient-individual therapy is not idelalisib in combination with rituximab or rituximab or rituximab in combination with BR: No additional benefit proved
Subject:
- Active Substance: Autologous anti-CD19-transduced CD3+ cells
- Name: Tecartus®
- Therapeutic area: Mantle cell lymphoma (MCL)
- Pharmaceutical company: Gilead Sciences GmbH
Time table:
- Start: 15.02.2021
- Final decision by G-BA: 05.08.2021
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Baloxavir marboxil
- Name: Xofluza®
- Therapeutic area: Influenza
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 15.02.2021
- Final decision by G-BA: 05.08.2021
Final decision:
- Without risk for complications due to influenza: Indication for a considerable additional benefit
- With risk for complications due to influenza: No additional benefit proved
Subject:
- Active Substance: Baloxavir marboxil
- Name: Xofluza®
- Therapeutic area: Influenza
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 15.02.2021
- Final decision by G-BA: 05.08.2021
Final decision:
- Without risk for complications due to influenza: No additional benefit proved
- With risk for complications due to influenza: No additional benefit proved
Subject:
- Active Substance: Beclometasone / formoterol / glycopyrronium bromide
- Name: Trimbow®
- Therapeutic area: Asthma
- Pharmaceutical company: Chiesi GmbH
Time table:
- Start: 15.02.2021
- Final decision by G-BA: 05.08.2021
Final decision:
- Patients who are insufficiently treated with a medium-dosed ICS / LABA therapy: No additional benefit proved
- Patients who are insufficiently treated with a high-dosed ICS / LABA therapy: No additional benefit proved
Subject:
- Active Substance: Carfilzomib
- Name: Kyprolis®
- Therapeutic area: Multiple myeloma
- Pharmaceutical company: Amgen GmbH
Time table:
- Start: 15.01.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Upadacitinib
- Name: Rinvoq®
- Therapeutic area: Ankylosing spondylitis
- Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- a1) Patients who have responded inadequately to conventional therapy: No additional benefit proved
- a2) Patients who have responded inadequately or who are intolerant to biological disease-modifying antirheumatic drugs (bDMARDs): No additional benefit proved
Subject:
- Active Substance: Upadacitinib
- Name: Rinvoq®
- Therapeutic area: Psoriatic arthritis
- Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- a1) Patients who have responded inadequately to or did not tolerate conventional disease-modifying antirheumatic drugs (DMARDs): Hint for a considerable additional benefit
- a2) Patients who have responded inadequately to or did not tolerate biological disease-modifying antirheumatic drugs (bDMARDs):: No additional benefit proved
Subject:
- Active Substance: Inclisiran
- Name: Leqvio®
- Therapeutic area: Primary hypercholesterolaemia or mixed dyslipidaemia
- Pharmaceutical company: Novartis Pharma GmbH
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- Patients who have not already exhausted all available dietary and medicinal lipid-lowering options: No additional benefit proved
- Patients who have already exhausted all available dietary and medicinal lipid-lowering options (except for evolocumab or alirocumab): No additional benefit proved
Subject:
- Active Substance: Fenfluramine
- Name: Fintepla®
- Therapeutic area: Dravet syndrome
- Pharmaceutical company: Zogenix GmbH
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- Hint for a considerable additional benefit (orphan drug designation)
Subject:
- Active Substance: Niraparib
- Name: Zejula®
- Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
- Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- No additional benefit proved (orphan drug)
Subject:
- Active Substance: Dolutegravir
- Name: Tivicay®
- Therapeutic area: HIV-1 infection
- Pharmaceutical company: ViiV Healthcare GmbH
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- Therapy-naïve children: No additional benefit proved
- Pre-treated children: No additional benefit proved
Subject:
- Active Substance: Levofloxacin / dexamethasone
- Name: Ducressa®
- Therapeutic area: Infections and inflammation associated with cataract surgery
- Pharmaceutical company: Santen GmbH
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Pertuzumab / trastuzumab
- Name: Phesgo®
- Therapeutic area: Breast cancer
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
- The decision remains valid until: 01.10.2022
Final decision:
- Hint for a minor additional benefit
Subject:
- Active Substance: Pertuzumab / trastuzumab
- Name: Phesgo®
- Therapeutic area: Breast cancer
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Pertuzumab / trastuzumab
- Name: Phesgo®
- Therapeutic area: Breast cancer
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Blinatumomab
- Name: Blincyto®
- Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
- Pharmaceutical company: Amgen GmbH
Time table:
- Start: 01.02.2021
- Final decision by G-BA: 15.07.2021
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Lumasiran
- Name: Oxlumo®
- Therapeutic area: Hyperoxaluria
- Pharmaceutical company: Alnylam Germany GmbH
Time table:
- Start: 01.01.2021
- Final decision by G-BA: 01.07.2021
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug)
Subject:
- Active Substance: Lenvatinib
- Name: Kisplyx®
- Therapeutic area: Renal cell carcinoma
- Pharmaceutical company: Eisai GmbH
Time table:
- Start: 01.01.2021
- Final decision by G-BA: 01.07.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Dupilumab
- Name: Dupixent®
- Therapeutic area: Atopic dermatitis
- Pharmaceutical company: Sanofi-Aventis Deutschland GmbH
Time table:
- Start: 01.01.2021
- Final decision by G-BA: 01.07.2021
Final decision:
- Hint for a non-quantifiable additional benefit
Subject:
- Active Substance: Afamelanotide
- Name: Scenesse®
- Therapeutic area: Erythropoietic protoporphyria (EPP)
- Pharmaceutical company: Clinuvel UK Limited
Time table:
- Start: 01.01.2021
- Final decision by G-BA: 01.07.2021
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug)
Subject:
- Active Substance: Nivolumab
- Name: Opdivo®
- Therapeutic area: Squamous oesophageal cancer
- Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA
Time table:
- Start: 01.01.2021
- Final decision by G-BA: 01.07.2021
Final decision:
- Patients for whom chemotherapy is an option: Hint for a minor additional benefit
- Patients for whom chemotherapy is not an option: No additional benefit proved
Subject:
- Active Substance: Olaparib
- Name: Lynparza®
- Therapeutic area: Ovarian cancer
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 03.06.2021
- This decision remains valid until: 01.10.2022
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Olaparib
- Name: Lynparza®
- Therapeutic area: Prostate cancer
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- Hint for a considerable additional benefit
Subject:
- Active Substance: Olaparib
- Name: Lynparza®
- Therapeutic area: Pancreatic cancer
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Acalabrutinib
- Name: Calquence®
- Therapeutic area: Chronic lymphocytic leukaemia (CLL)
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
- b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
- c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved
Subject:
- Active Substance: Acalabrutinib
- Name: Calquence®
- Therapeutic area: Chronic lymphocytic leukaemia (CLL)
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
- b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
- c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved
Subject:
- Active Substance: Sucroferric oxyhydroxide
- Name: Velphoro®
- Therapeutic area: To control blood-phosphate levels in patients with chronic kidney disease
- Pharmaceutical company: Fresenius Medical Care Deutschland GmbH
Time table:
- Start: 15.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Perampanel
- Name: Fycompa®
- Therapeutic area: Epilepsy
- Pharmaceutical company: Eisai GmbH
Time table:
- Start: 15.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Perampanel
- Name: Fycompa®
- Therapeutic area: Epilepsy
- Pharmaceutical company: Eisai GmbH
Time table:
- Start: 15.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Nivolumab
- Name: Opdivo®
- Therapeutic area: Non-small cell lung cancer (NSCLC)
- Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG
Time table:
- Start: 15.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
- Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit
Subject:
- Active Substance: Ipilimumab
- Name: Yervoy®
- Therapeutic area: Non-small cell lung cancer (NSCLC)
- Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG
Time table:
- Start: 15.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
- Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit proved
Subject:
- Active Substance: Sebelipase alfa
- Name: Kanuma®
- Therapeutic area: Lysosomal acid lipase (LAL) deficiency
- Pharmaceutical company: Alexion Pharma Germany GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 03.06.2021
Final decision:
- Patients with rapidly progressing LAL deficiency during infancy (≥ 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)
- Patients with LAL deficiency not already rapidly progressing during infancy (< 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Guselkumab
- Name: Tremfya®
- Therapeutic area: Psoriatic arthritis
- Pharmaceutical company: Janssen-Cilag GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- Patients who have responded insufficiently to or have not tolerated prior disease-modifying antirheumatic drug (DMARD) therapy: no additional benefit proved
- Patients who have responded insufficiently to or have not tolerated prior biological DMARD (bDMARD) therapy: no additional benefit proved
Subject:
- Active Substance: Nusinersen
- Name: Spinraza®
- Therapeutic area: Spinal muscular atrophy (SMA)
- Pharmaceutical company: Biogen GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- a) Type 1: indication for a major additional benefit
- b) Type 2: hint for a considerable additional benefit
- c) Type 3/4: no additional benefit proved
- d1) Pre-symptomatic and 2 SMN2 gene copies: hint for a major addiitional benefit
- d2) Pre-symptomatic and 3 SMN2 gene copies: hint for a non-quantifiable addiitional benefit
- d3) Pre-symptomatic and more than 3 SMN2 gene copies: no additional benefit proved
Subject:
- Active Substance: Tezacaftor / ivacaftor
- Name: Symkevi®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Tezacaftor / ivacaftor
- Name: Symkevi®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Tafamidis
- Name: Vyndaqel®
- Therapeutic area: Amyloidosis
- Pharmaceutical company: Pfizer Pharma GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- Indication for a considerable additional benefit
Subject:
- Active Substance: Tafamidis
- Name: Vyndaqel®
- Therapeutic area: Amyloidosis
- Pharmaceutical company: Pfizer Pharma GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Niraparib
- Name: Zejula®
- Therapeutic area: Ovarian, fallopian tube, or peritoneal cancer
- Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Ivacaftor
- Name: Kalydeco®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Ivacaftor
- Name: Kalydeco®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Ivacaftor
- Name: Kalydeco®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- Hint for a non-quantifiable additional benefit
Subject:
- Active Substance: Ivacaftor
- Name: Kalydeco®
- Therapeutic area: Cystic fibrosis
- Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- Hint for a non-quantifiable additional benefit
Subject:
- Active Substance: Dapagliflozin
- Name: Forxiga®
- Therapeutic area: Heart failure
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- Hint for a considerable additional benefit
Subject:
- Active Substance: Crizanlizumab
- Name: Adakevo®
- Therapeutic area: Sickle cell disease
- Pharmaceutical company: Novartis Pharma GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
- This decision remains valid until: 01.12.2025
Final decision:
- Hint for a minor additional benefit
Subject:
- Active Substance: Atezolizumab
- Name: Tecentriq®
- Therapeutic area: Hepatocellular carcinoma (HCC)
- Pharmaceutical company: Roche Pharma AG
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- a) Patients with HCC with Child-Pugh A or no liver cirrhosis without prior systemic therapy: indication for a considerable additional benefit
- b) Patients with HCC with Child-Pugh B without prior systemic therapy: no additional benefit proved
Subject:
- Active Substance: Amikacin sulfate
- Name: Arikayce liposomal®
- Therapeutic area: MAC lung infection
- Pharmaceutical company: Insmed Germany GmbH
Time table:
- Start: 01.12.2020
- Final decision by G-BA: 20.05.2021
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Eszopiclone
- Name: Lunivia®
- Therapeutic area: Insomnia
- Pharmaceutical company: Henning Arzneimittel GmbH & Co. KG
Time table:
- Start: 15.02.2021
- Final decision by G-BA: beginning of August 2021
Final decision:
- No additional benefit proved since there has not been submitted any dossier. The drug is subject to reference pricing.
Subject:
- Active Substance: Baricitinib
- Name: Olumiant®
- Therapeutic area: Atopic dermatitis
- Pharmaceutical company: Lilly Deutschland GmbH
Time table:
- Start: 15.11.2020
- Final decision by G-BA: 06.05.2021
Final decision:
- No additional benefit proved
Subject:
- Active Substance: Filgotinib
- Name: Jyseleca®
- Therapeutic area: Rheumatoid arthritis
- Pharmaceutical company: Gilead Sciences GmbH
Time table:
- Start: 15.10.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- a1) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. methotrexate (MTX)): no additional benefit proved
- a2) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. MTX); filgotinib as in combination with MTX: no additional benefit proved
- b1) Patients for whom treatment with biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is indicated for the first time; filgotinib as monotherapy: no additional benefit proved
- b2) Patients for whom treatment with bDMARDs or tsDMARDs is indicated for the first time; filgotinib in combination with MTX: hint for a minor additional benefit
- c1) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib as monotherapy: no additional benefit proved
- c2) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib in combination with MTX: no additional benefit proved
Subject:
- Active Substance: Cannabidiol
- Name: Epidyolex®
- Therapeutic area: Dravet syndrome
- Pharmaceutical company: GW Pharmaceuticals plc
Time table:
- Start: 15.10.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- Hint for a considerable additional benefit (orphan drug designation)
Subject:
- Active Substance: Cannabidiol
- Name: Epidyolex®
- Therapeutic area: Lennox-Gastaut syndrome
- Pharmaceutical company: GW Pharmaceuticals plc
Time table:
- Start: 15.10.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- Hint for a considerable additional benefit (orphan drug designation)
Subject:
- Active Substance: Semaglutide
- Name: Rybelsus® / Ozempic®
- Therapeutic area: Diabetes mellitus type 2
- Pharmaceutical company: Novo Nordisk Pharma GmbH
Time table:
- Start: 01.11.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- a) monotherapy:
- a1) patients with high CV risk: no additional benefit proved)
- a2) patients without high CV risk: no additional benefit proved - b) in combination with another antidiabetic (except for insulin, here: metformin):
- b1) patients with high CV risk: no additional benefit proved
- b2) patients without high CV risk: no additional benefit proved - c) in combination with two other antidiabetics (except for insulin):
- c1) patients with high cardiovascular risk: no additional benefit proved
- c2) patients without high CV risk: no additional benefit proved - d) in combination with insulin (with or w/o metformin or empagliflozin* or liraglutide*, if appropriate):
- d1) patients with high CV risk: no additional benefit proved
- d2) patients without high CV risk: no additional benefit proved
Subject:
- Active Substance: Bempedoic acid / ezetimibe
- Name: Nustendi®
- Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
- Pharmaceutical company: Daiichi Sankyo Deutschland GmbH
Time table:
- Start: 01.11.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
- b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
no additional benefit proved
Subject:
- Active Substance: Bempedoic acid
- Name: Nilemdo®
- Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
- Pharmaceutical company: Daiichi Sankyo Deutschland GmbH
Time table:
- Start: 01.11.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
- b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
no additional benefit proved
Subject:
- Active Substance: Burosumab
- Name: Crysvita®
- Therapeutic area: Hypophosphataemia
- Pharmaceutical company: Kyowa Kirin GmbH
Time table:
- Start: 01.11.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- Hint for a minor additional benefit (orphan drug designation)
Subject:
- Active Substance: Avapritinib
- Name: Ayvakyt®
- Therapeutic area: Gastrointestinal stromal tumors (GIST)
- Pharmaceutical company: Blueprint Medicines (Germany) GmbH
Time table:
- Start: 01.11.2020
- Final decision by G-BA: 15.04.2021
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug designation)
Subject:
- Active Substance: Ibrutinib
- Name: Imbruvica®
- Therapeutic area: Chronic lymphatic leukemia (CLL)
- Pharmaceutical company: Janssen-Cilag GmbH
Time table:
- Start: 01.10.2020
- Final decision by G-BA: 01.04.2021
- This decision remains valid until: 01.04.2024
Final decision:
- a) Patients who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): hint for a considerable additional benefit
- b) Patients who cannot be treated with FCR: no additional benefit proved
- c) Patients with 17p-deletion and/or T53-mutation or for whom a chemoimmunotherapy is not indicated due to other reasons: no additional benefit proved
Subject:
- Active Substance: Durvalumab
- Name: Imfinzi®
- Therapeutic area: Small-cell lung cancer (SCLC)
- Pharmaceutical company: AstraZeneca GmbH
Time table:
- Start: 01.10.2020
- Final decision by G-BA: 01.04.2021
Final decision:
- Hint for a minor additional benefit
Subject:
- Active Substance: Sofosbuvir / velpatasvir
- Name: Epclusa®
- Therapeutic area: Chronic hepatitis C
- Pharmaceutical company: Gilead Sciences GmbH
Time table:
- Start: 01.10.2020
- Final decision by G-BA: 01.04.2021
Final decision:
- a) Patients aged 6 up to < 12 years (genotype 1, 4, 5, or 6): no additional benefit proved
- b) Patients aged 6 up to < 12 years (genotype 2 or 3): no additional benefit proved
- c) Patients aged 12 up to < 18 years (genotype 1, 4, 5, or 6): no additional benefit proved
- d) Patients aged 12 up to < 18 years (genotype 2 or 3): no additional benefit proved
Subject:
- Active Substance: Belantamap mafodotin
- Name: Blenrep®
- Therapeutic area: Multiple myeloma
- Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG
Time table:
- Start: 15.09.2020
- Final decision by G-BA: 04.03.2021
- This decision remains valid until: 01.09.2022
Final decision:
- Hint for a non-quantifiable additional benefit (orphan drug)
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:
- a. Adult patients who have not yet received a disease-modifying treatment or whose disease is not highly active with a disease-modifying treatment: Indication for a minor additional benefit
- b. Adult patients with highly active disease despite treatment with a disease-modifying therapy: No additional benefit proved
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