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Ongoing (preliminary decision published)

Subject:

  • Active Substance: Acalabrutinib
  • Name: Calquence®
  • Therapeutic area: Chronic lymphocytic leukaemia (CLL)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Publication of assessment: 15.03.2021
  • End of public hearing: 06.04.2021
  • Final decision by G-BA: beginning of June 2021

Comparative therapy:

  • a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with a chemo-immunotherapy: a patient-individual therapy choosing from fludarabine in combination with cyclophosphamide and rituximab (FCR), rituximab in combination with bendamustine (BR), venetoclax in combination with rituximab, rituximab in combination with chlorambucil (ClbR); under consideration of the molecular-cytogenic characteristics of the disease, the general health status, and success and tolerance of prior therapy
  • b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with chemo-immunotherapy for other reasons: ibrutinib OR idelalisib + rituximab OR best supportive care (only for patients for whom prior therapy with ibrutinib or idelalisib + rituximab failed)
  • c) Patients with at least 2 prior therapies: a patient-individual therapy choosing from ibrutinib, idelalisib in combination with rituximab, venetoclax in combination with rituximab, FCR, BR, ClbR, ibrutinib in combination with BR and best supportive care; under consideration of the molecular-cytogenic characteristics of the disease, the general health status, and success and tolerance of prior therapy

Subject:

  • Active Substance: Lumasiran
  • Name: Oxlumo®
  • Therapeutic area: Hyperoxaluria
  • Pharmaceutical company: Alnylam Germany GmbH

Time table:

  • Start: 01.01.2021
  • Publication of assessment: 01.04.2021
  • End of public hearing: 22.04.2021
  • Final decision by G-BA: beginning of July 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Lenvatinib
  • Name: Kisplyx®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.01.2021
  • Publication of assessment: 01.04.2021
  • End of public hearing: 22.04.2021
  • Final decision by G-BA: beginning of July 2021

Comparative therapy:

  • Nivolumab or cabozantinib

Subject:

  • Active Substance: Dupilumab
  • Name: Dupixent®
  • Therapeutic area: Atopic dermatitis
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.01.2021
  • Publication of assessment: 01.04.2021
  • End of public hearing: 22.04.2021
  • Final decision by G-BA: beginning of July 2021

Comparative therapy:

  • A patient-individual optimized treatment regimen in dependence of the severity of the disease and under consideration of prior treatment and the following therapies and their respective authorization status: topical glucocorticoids (classes 2-3), tacrolimus (topical)

Subject:

  • Active Substance: Afamelanotide
  • Name: Scenesse®
  • Therapeutic area: Erythropoietic protoporphyria (EPP)
  • Pharmaceutical company: Clinuvel UK Limited

Time table:

  • Start: 01.01.2021
  • Publication of assessment: 01.04.2021
  • End of public hearing: 22.04.2021
  • Final decision by G-BA: beginning of July 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

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
  • Publication of assessment: 01.04.2021
  • End of public hearing: 22.04.2021
  • Final decision by G-BA: beginning of July 2021

Comparative therapy:

  • Best supportive care

Subject:

  • Active Substance: Carfilzomib
  • Name: Kyprolis®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.01.2021
  • Publication of assessment: 15.04.2021
  • End of public hearing: 06.05.2021
  • Final decision by G-BA: 15.07.2021

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: Upadacitinib
  • Name: Rinvoq®
  • Therapeutic area: Ankylosing spondylitis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • a1) Patients who have responded inadequately to conventional therapy: a TNF-alpha inhibitor (etanercept or adalimumab or infliximab or golimumab or certolizumab pegol) or a IL-17 inhibitor (secukinumab)
  • a2) Patients who have responded inadequately or who are intolerant to biological disease-modifying antirheumatic drugs (bDMARDs): switch to another bDMARD, i.e. a TNF-alpha inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or a IL-17 inhibitor (secukinumab)

Subject:

  • Active Substance: Upadacitinib
  • Name: Rinvoq®
  • Therapeutic area: Psoriatic arthritis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • a1) Patients who have responded inadequately to or did not tolerate conventional disease-modifying antirheumatic drugs (DMARDs): a TNF-alpha inhibitor (adalimumab or infliximab or golimumab or certolizumab pegol or etanercept) or a IL-17 inhibitor (ixekizumab), in combination with methotrexate if indicated
  • a2) Patients who have responded inadequately to or did not tolerate biological disease-modifying antirheumatic drugs (bDMARDs): switch to another bDMARD (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab or ixekizumab or secukinumab or ustekinumab), in combination with methotrexate if indicated

Subject:

  • Active Substance: Inclisiran
  • Name: Leqvio®
  • Therapeutic area: Primary hypercholesterolaemia or mixed dyslipidaemia
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • Patients who have not already exhausted all available dietary and medicinal lipid-lowering options: maximum tolerated medicinal treatment at the physician’s discretion under consideration of statins, inhibitors of cholesterol absorption, and bile acid sequestrants
  • Patients who have already exhausted all available dietary and medicinal lipid-lowering options (except for evolocumab): evolocumab or LDL-apheresis (as “ultima ratio” in treatment refractory patients), if indicated in combination with medicinal lipid-lowering treatment

Subject:

  • Active Substance: Fenfluramine
  • Name: Fintepla®
  • Therapeutic area: Dravet syndrome
  • Pharmaceutical company: Zogenix GmbH

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • No comparative therapy due to 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
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • Olaparib or watchful waiting

Subject:

  • Active Substance: Dolutegravir
  • Name: Tivicay®
  • Therapeutic area: HIV-1 infection
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • Therapy-naïve children: abacavir plus lamivudine or abacavir plus emtricitabine, each in combination with either
    - lopinavir / ritonavir or
    - raltegravir or
    - nevirapine
  • Pre-treated children: a patient-individual antiretroviral therapy considering all approved substances; under consideration of pre-treatment(s) and reason for therapy switch, especially failure of treatment due to virological failure and accompanying resistance or adverse events

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
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • A combination of a local antibiotic therapy (cefuroxime, polymyxin-B/neomycin/gramicidin, tobramycin*, gentamicin*, neomycin*) together with an anti-inflammatory mono or combination therapy: glucocorticoid steroid, e.g. rimexolone, dexamethasone, fluorometholone, prednisolone, loteprednol etabonate and/or NSAID, e.g. diclofenac, nepafenac, indomethacin, ketorolac

* in fix-combination with dexamethasone only

Subject:

  • Active Substance: Pertuzumab / trastuzumab
  • Name: Phesgo®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • A therapy regimen consisting of trastuzumab, a taxane (paclitaxel or docetaxel) and, if appropriate, an anthracycline (doxorubicin or epirubicin)

Subject:

  • Active Substance: Pertuzumab / trastuzumab
  • Name: Phesgo®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • A therapy regimen consisting of trastuzumab, a taxane (paclitaxel or docetaxel) and, if appropriate, an anthracycline (doxorubicin or epirubicin)

Subject:

  • Active Substance: Pertuzumab / trastuzumab
  • Name: Phesgo®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • Pertuzumab in combination with trastuzumab and docetaxel

Subject:

  • Active Substance: Blinatumomab
  • Name: Blincyto®
  • Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.02.2021
  • Publication of assessment: 03.05.2021
  • End of public hearing: 25.05.2021
  • Final decision by G-BA: middle of July 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

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
  • Publication of assessment: 17.05.2021
  • End of public hearing: 07.06.2021
  • Final decision by G-BA: beginning of August 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Baloxavir marboxil
  • Name: Xofluza®
  • Therapeutic area: Influenza
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.02.2021
  • Publication of assessment: 17.05.2021
  • End of public hearing: 07.06.2021
  • Final decision by G-BA: beginning of August 2021

Comparative therapy:

  • Without risk for complications due to influenza: watchful waiting
  • With risk for complications due to influenza: an antiviral therapy (oseltamivir or zanamivir)

Subject:

  • Active Substance: Baloxavir marboxil
  • Name: Xofluza®
  • Therapeutic area: Influenza
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.02.2021
  • Publication of assessment: 17.05.2021
  • End of public hearing: 07.06.2021
  • Final decision by G-BA: beginning of August 2021

Comparative therapy:

  • Without risk for complications due to influenza: a symptomatic therapy (antipyretics, anti-inflammatory drugs, analgesics)
  • With increased risk for a severe course of the disease: an antiviral therapy (oseltamivir or zanamivir)

Subject:

  • Active Substance: Beclometasone / formoterol / glycopyrronium bromide
  • Name: Trimbow®
  • Therapeutic area: Asthma
  • Pharmaceutical company: Chiesi GmbH

Time table:

  • Start: 15.02.2021
  • Publication of assessment: 17.05.2021
  • End of public hearing: 07.06.2021
  • Final decision by G-BA: beginning of August 2021

Comparative therapy:

  • Patients who are insufficiently treated with a medium-dosed ICS / LABA therapy: a patient-individual therapy escalation under consideration of prior therapy, severity of disease and symptoms, choosing from:
    - Medium-dosed ICS and LABA and LAMA or
    - High-dosed ICS and LABA
  • Patients who are insufficiently treated with a high-dosed ICS / LABA therapy: high-dosed ICS and LABA and LAMA

Subject:

  • Active Substance: Esketamine
  • Name: Spravato®
  • Therapeutic area: Depression
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.03.2021
  • Publication of assessment: 01.06.2021
  • End of public hearing: 22.06.2021
  • Final decision by G-BA: middle of August 2021

Comparative therapy:

  • Therapy at the physician's discretion under consideration of:
    - crisis intervention / psychotherapy,
    - medicinal acute therapy of anxiety, insommnia, psychotic symptoms, agitation
    - induction of an adequate anti-depressant medication or optimization of existing therapy,
    - electroconvulsive therapy

Subject:

  • Active Substance: Esketamine
  • Name: Spravato®
  • Therapeutic area: Depression
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.03.2021
  • Publication of assessment: 01.06.2021
  • End of public hearing: 22.06.2021
  • Final decision by G-BA: middle of August 2021

Comparative therapy:

  • Augmentation with lithium (1) OR
  • augmentation with quetiapine retard (1) OR
  • combination with a second antidepressant OR
  • change of antidepressant monotherapy to another substance class
    (1) as add-on to latest antidepressant monotherapy

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
  • Publication of assessment: 01.06.2021
  • End of public hearing: 22.06.2021
  • Final decision by G-BA: middle of August 2021

Comparative therapy:

  • Best supportive care

Subject:

  • Active Substance: Selpercatinib
  • Name: Retsevmo®
  • Therapeutic area: Thyroid cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 15.03.2021
  • Publication of assessment: 15.06.2021
  • End of public hearing: 06.07.2021
  • Final decision by G-BA: beginning of September 2021

Comparative therapy:

  • a) Patients with an advanced, differentiated thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): Best supportive care
  • b) Patients with an advanced, anaplastic thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): Best supportive care

Subject:

  • Active Substance: Selpercatinib
  • Name: Retsevmo®
  • Therapeutic area: Thyroid cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 15.03.2021
  • Publication of assessment: 15.06.2021
  • End of public hearing: 06.07.2021
  • Final decision by G-BA: beginning of September 2021

Comparative therapy:

  • Best supportive care

Subject:

  • Active Substance: Selpercatinib
  • Name: Retsevmo®
  • Therapeutic area: NSCLC
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 15.03.2021
  • Publication of assessment: 15.06.2021
  • End of public hearing: 06.07.2021
  • Final decision by G-BA: beginning of September 2021

Comparative therapy:

  • a) After first-line therapy with a PD-1/PD-L1 antibody as monotherapy:
    - Cisplatin in combination with a third generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mostly squamous epithelial histology) OR
    - Carboplatin in combination with a third generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for mostly squamous epithelial histology) (see appendix VI, section K of AM-RL) OR
    - Carboplatin in combination wit nab-paclitaxel OR
    - Monotherapy with gemcitabine or vinorelbine (as alternative to platin-based combination therapy only for patients with ECOG performance status 2)
  • b) After first-line therapy with a cytotoxic chemotherapy:
    - Docetaxel (only for patients with PD-L1 negative tumors) OR
    - Pemetrexed (only for patients with PD-L1 negative tumors but except for mostly squamous epithelial histology) OR
    - Nivolumab OR
    - Pembrolizumab (only for patients with PD-L1 expressing tumors (TPS ≥ 1 %)) OR
    - Atezolizumab OR
    - Docetaxel in combination with nintedanib (only for patients with PD-L1 negative tumors and adenocarcinoma histology)
  • 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:
    Patient-individual therapy under consideration of prior therapy and histology, choosing from: afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, docetaxel in combination with nintedanib, and vinorelbine

Subject:

  • Active Substance: Tucatinib
  • Name: Tukysa®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Seagen Germany GmbH

Time table:

  • Start: 15.03.2021
  • Publication of assessment: 15.06.2021
  • End of public hearing: 06.07.2021
  • Final decision by G-BA: beginning of September 2021

Comparative therapy:

  • Lapatinib in combination with capecitabine OR
  • Lapatinib in combination with trastuzumab (only for patients with hormone receptor negative breast cancer)

Subject:

  • Active Substance: Fedratinib
  • Name: Inrebic®
  • Therapeutic area: Chronic myeloproliferative diseases
  • Pharmaceutical company: Celgene GmbH

Time table:

  • Start: 15.03.2021
  • Publication of assessment: 15.06.2021
  • End of public hearing: 06.07.2021
  • Final decision by G-BA: beginning of September 2021

Comparative therapy:

  • No comparative therapy due to 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
  • Publication of assessment: 15.06.2021
  • End of public hearing: 06.07.2021
  • Final decision by G-BA: beginning of September 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

 

Completed (final decision published)

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

Subject:

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

Time table:

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

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision by G-BA:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Indication for a considerable additional benefit (orphan drug)

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Indication for a considerable additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

 

Ansprechpartner

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