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Ongoing (preliminary decision published)

Subject:

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

Time table:

  • Start: 15.06.2020
  • Publication of assessment: 15.09.2020
  • End of public hearing: 06.10.2020
  • Final decision by G-BA: beginning of December 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.06.2020
  • Publication of assessment: 15.09.2020
  • End of public hearing: 06.10.2020
  • Final decision by G-BA: beginning of December 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.07.2020
  • Publication of assessment: 01.10.2020
  • End of public hearing: 22.10.2020
  • Final decision by G-BA: middle of December 2020

Comparative therapy:

  • A patient-individual therapy, choosing from the following and considering the general health status and type and number of previous therapies:
    - 5-fluorouracil (5-FU) + folinic acid + oxaliplatin ± bevacizumab
    - Capecitabine + oxaliplatin ± bevacizumab
    - 5-FU + folinic acid + irinotecan ± aflibercept or ramucirumab or bevacizumab
    - Irinotecan
    - Trifluridine / tipiracil
    - 5-FU ± bevacizumab
    - Capecitabine ± bevacizumab

Subject:

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

Time table:

  • Start: 01.07.2020
  • Publication of assessment: 01.10.2020
  • End of public hearing: 22.10.2020
  • Final decision by G-BA: middle of December 2020

Comparative therapy:

  • Eltotrombopag or romiplostim

Subject:

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

Time table:

  • Start: 01.07.2020
  • Publication of assessment: 01.10.2020
  • End of public hearing: 22.10.2020
  • Final decision by G-BA: middle of December 2020

Comparative therapy:

  • No comparative therapy because of orphan drug status
  • G-BA has requested the initiation of a registry according to § 35a, par. 3b, SGB V

Subject:

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

Time table:

  • Start: 01.07.2020
  • Publication of assessment: 01.10.2020
  • End of public hearing: 22.10.2020
  • Final decision by G-BA: middle of December 2020

Comparative therapy:

  • Patients aged 6 months up to < 6 years: Best supportive care
  • Patients aged 6 years up to < 18 years: Best supportive care

Subject:

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

Time table:

  • Start: 01.07.2020
  • Publication of assessment: 01.10.2020
  • End of public hearing: 22.10.2020
  • Final decision by G-BA: middle of December 2020

Comparative therapy:

  • Lumacaftor / ivacaftor

Subject:

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

Time table:

  • Start: 01.07.2020
  • Publication of assessment: 01.10.2020
  • End of public hearing: 22.10.2020
  • Final decision by G-BA: middle of December 2020

Comparative therapy:

  • Best supportive care

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
  • Publication of assessment: 15.10.2020
  • End of public hearing: 05.11.2020
  • Final decision by G-BA: beginning of January 2021

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.07.2020
  • Publication of assessment: 15.10.2020
  • End of public hearing: 05.11.2020
  • Final decision by G-BA: beginning of January 2021

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.07.2020
  • Publication of assessment: 15.10.2020
  • End of public hearing: 05.11.2020
  • Final decision by G-BA: beginning of January 2021

Comparative therapy:

  • Adult patients who have not yet received a disease-modifying treatment or whose disease is not highly active with a disease-modifying treatment: interferon beta-1a, or interferon beta-1b, or glatiramer acetate, or ocrelizumab under consideration of the authorization status
  • Adult patients with highly active disease despite treatment with a disease-modifying therapy: alemtuzumab, or fingolimod, or natalizumab, or, if indicated, a change within basic treatment options (interferon beta-1a, or interferon beta-1b, or glatiramer acetate under consideration of the authorization status)

Subject:

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

Time table:

  • Start: 01.08.2020
  • Publication of assessment: 02.11.2020
  • End of public hearing: 23.11.2020
  • Final decision by G-BA: middle of January 2021

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.08.2020
  • Publication of assessment: 02.11.2020
  • End of public hearing: 23.11.2020
  • Final decision by G-BA: middle of January 2021

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.08.2020
  • Publication of assessment: 02.11.2020
  • End of public hearing: 23.11.2020
  • Final decision by G-BA: middle of January 2021

Comparative therapy:

  • Watchful waiting

Subject:

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

Time table:

  • Start: 01.08.2020
  • Publication of assessment: 02.11.2020
  • End of public hearing: 23.11.2020
  • Final decision by G-BA: middle of January 2021

Comparative therapy:

  • Watchful waiting

Subject:

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

Time table:

  • Start: 01.08.2020
  • Publication of assessment: 02.11.2020
  • End of public hearing: 23.11.2020
  • Final decision by G-BA: end of January 2021

Comparative therapy:

  • a1) Patients who did not sufficiently respond to or who are intolerant to conventional therapy: a TNF-α inhibitor (etanercept or adalimumab or infliximab or golimumab or certolizumab pegol) or a IL-17 inhibitor (secukinumab)
  • a2) Patients who did not sufficiently respond to a previous therapy with biological antirheumatic drugs (bDMARD) or who are intolerant to these: switch to another bDMARD: a TNF-α inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or a IL-17 inhibitor (secukinumab)
  • 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: a TNF-α inhibitor (etanercept or adalimumab or golimumab or certolizumab pegol)

Subject:

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

Time table:

  • Start: 01.08.2020
  • Publication of assessment: 02.11.2020
  • End of public hearing: 23.11.2020
  • Final decision by G-BA: end of January 2021

Comparative therapy:

  • Adalimumab or etanercept or ustekinumab

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
  • Publication of assessment: 02.11.2020
  • End of public hearing: 23.11.2020
  • Final decision by G-BA: end of January 2021

Comparative therapy:

  • Eculizumab

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
  • Publication of assessment: 16.11.2020
  • End of public hearing: 07.12.2020
  • Final decision by G-BA: beginning of February 2021

Comparative therapy:

  • Best supportive care (orphan drug but 50 mio. € threshold already 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
  • Publication of assessment: 16.11.2020
  • End of public hearing: 07.12.2020
  • Final decision by G-BA: beginning of February 2021

Comparative therapy:

  • Best supportive care (orphan drug but 50 mio. € threshold already exceeded)

Subject:

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

Time table:

  • Start: 15.08.2020
  • Publication of assessment: 16.11.2020
  • End of public hearing: 07.12.2020
  • Final decision by G-BA: beginning of February 2021

Comparative therapy:

  • A topical combination therapy with adapalene + benzoyl peroxide
    OR
  • A topical combination therapy with clindamycin + benzoyl peroxide

Subject:

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

Time table:

  • Start: 15.08.2020
  • Publication of assessment: 16.11.2020
  • End of public hearing: 07.12.2020
  • Final decision by G-BA: beginning of February 2021

Comparative therapy:

  • High-dosed inhaled corticosteroid (ICS) + long-acting beta-adrenoceptor agonist (LABA) + long-acting muscarinic antagonist (LAMA)
  • A topical combination therapy with clindamycin + benzoyl peroxide

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • A1) Postmenopausal women with progress after (neo)adjuvant endocrine monotherapy: ribociclib in combination with non-steroidal aromatase inhibitor OR ribociclib in combination with fulvestrant OR anastrozole OR letrozole OR fulvestrant OR (if aromatase inhibitors are not indicated) tamoxifen
  • A2) Men with progress afer (neo)adjuvant endocrine monotherapy: Therapy at the physician`s discretion
  • B1) Postmenopausal women with progress after endocrine monotherapy in locally advanced setting or metastasized stage: and additional endocrine therapy with: abemaciclib in combination with fulvestrant OR ribociclib in combination with fulvestrant OR tamoxifen OR anastrozole OR fulvestrant as monotherapy (only for patients with recurrence or progress after antiestrogen therapy) OR exemestane (only for patients with progress after anti-estrogen therapy) OR everolimus in combination with exemestane (only for patients without symptomatic visceral metastasis, after progress with non-steroidal aromatase inhibitor treatment)
  • B2) Men with progress after endocrine monotherapy in locally advanced setting or metastasized stage: Therapy at the physician's discretion

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • Best supportive care

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • Lumacaftor / ivacaftor OR
  • Tezacaftor / ivacaftor in combination with ivacaftor

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
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • Crizotinib

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
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • Patient-individual therapy considering:
    - Best supportive care
    - Surgical resection, that will probably lead to high morbidity, and for that a patient-individual benefit is expected

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • A patient-individual antiretroviral therapy, choosing from all approved active substances, considering previous therapy(s) and reason for change of treatment, especially treatment failure due to virological failure and respective development of resistance, or due to adverse reactions

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • a) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy: a TNF-alpha antagonist (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) OR an IL-17 antibody (ixekizumab), in combination with methotrexate (if appropriate)
  • b) Patients who did not benefit sufficiently from or who did not tolerate a previous bDMARD therapy: switch to another bDMARD (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab or ixekizumab or ustekinumab), in combination with methotrexate (if appropriate)

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • Adalimumab OR etanercept OR ustekinumab

Subject:

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

Time table:

  • Start: 01.09.2020
  • Publication of assessment: 01.12.2020
  • End of public hearing: 22.12.2020
  • Final decision by G-BA: middle of February 2021

Comparative therapy:

  • A TNF-alpha inhibitor (etanercept OR adalimumab OR golimumab OR certolizumab pegol)

 

Completed (final decision published)

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision by G-BA:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Indication for a considerable additional benefit (orphan drug)

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Indication for a considerable additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Aassessment repealed

Subject:

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

Time table:

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

Final decision:

  • Assessment repealed

Subject:

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

Time table:

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

Final decision:

  • Assessment repealed

Subject:

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

Time table:

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

Final decision:

  • Assessment repealed

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

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

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • No additional benefit proven

Subject:

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

Time table:

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

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • a1) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib as monotherapy: No additional benefit proved
  • a2) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib in combination with MTX: No additional benefit proved
  • b1) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib as monotherapy: No additional benefit proved
  • b2) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib in combination with MTX: Hint for a considerable additional benefit
  • c1) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib as monotherapy: No additional benefit proved
  • c2A) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients with high disease activity [DAS28 CRP > 5.1]: Hint for a minor additional benefit
  • c2B) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients without high disease activity [DAS28 CRP ≤ 5.1]: No additional benefit proved

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

  • Active Substance: Betibeglogene autotemcel (CD34+ haematopoetic stem cells)
  • Name: ZyntegloTM
  • Therapeutic area: β-thalassaemia
  • Pharmaceutical company: bluebird bio (Germany) GmbH

Time table:

  • Start: 15.11.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

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

Subject:

  • Active Substance: Belimumab
  • Name: Benlysta®
  • Therapeutic area: Systemic lupus erythematosus (SLE)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.11.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.12.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • a) Patients with treatment-naive, advanced renal cell carcinoma with favourable or intermediate risk profile (IMDC score 0-2): Hint for a considerable additional benefit
  • b) Patients with treatment-naive advanced renal cell carcinoma with unfavourable risk profile (IMDC score ≥3): Indication for a considerable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.12.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • Hint for considerable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.12.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • Indication for a minor additional benefit

Subject:

  • Active Substance: Dupilumab
  • Name: Dupixent®
  • Therapeutic area: Chronic rhinosinusitis with nasal polyposis (CRSwNP)
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.12.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Avelumab
  • Name: Bavencio®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Merck Serono GmbH / Pfizer Pharma GmbH

Time table:

  • Start: 01.12.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • Patients with treatment-naive, advanced renal cell carcinoma with favourable or intermediate risk profile (IMDC score 0–2): No additional benefit proved
  • Patients with treatment-naive, advanced renal cell carcinoma with unfavourable risk profile (IMDC score ≥3): Hint for a considerable additional benefit

Subject:

  • Active Substance: Gilteritinib
  • Name: XOSPATA®
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: 01.12.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • Hint for a considerable additional benefit (orphan drug)

Subject:

  • Active Substance: Neratinib
  • Name: Nerlynx®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Pierre Fabre Pharma

Time table:

  • Start: 01.12.2019
  • Final decision by G-BA: 14.05.2020

Final decision:

  • Hint for a minor additional benefit

 

Ansprechpartner

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