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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

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

 

Ansprechpartner

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