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Ongoing (preliminary decision published)

Subject:

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

Time table:

  • Start: 15.04.2018
  • Publication of assessment: 16.07.2018
  • End of public hearing: 06.08.2018
  • Final decision by G-BA: expected for the beginning of October 2018

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

  • Active Substance: Cariprazine
  • Name: Reagila©
  • Therapeutic area: Schizophrenia
  • Pharmaceutical company: Recordati Pharma GmbH

Time table:

  • Start: 15.04.2018
  • Publication of assessment: 16.07.2018
  • End of public hearing: 06.08.2018
  • Final decision by G-BA: expected for the beginning of October 2018

Comparative therapy:

  • Amisulpride or aripiprazole or olanzapine or paliperidone or quetiapine or risperidone or ziprasidone

Subject:

  • Active Substance: Extract of Cannabis sativa
  • Name: Sativex®
  • Therapeutic area: Spasticity related to multiple sclerosis
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 01.05.2018
  • Publication of assessment: 01.08.2018
  • End of public hearing: 22.08.2018
  • Final decision by G-BA: expected for the beginning of November 2018

Comparative therapy:

  • Optimized standard therapy with baclofen (oral) or tizanidine or dantrolene according to the approved dosages. At least two prior optimized therapies with different oral spasmolytic drugs should have been tried beforehand, among them at least one medicinal product with baclofen or tizanidine.

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Rheumatoid Arthritis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.05.2018
  • Publication of assessment: 01.08.2018
  • End of public hearing: 22.08.2018
  • Final decision by G-BA: expected for the beginning of November 2018

Comparative therapy:

  • a) insufficiently pre-treated patients with one standard DMARD and without unfavorable prognostic factors: alternative classical DMARDs (such as MTX, leflunomid) as mono or combination therapy
  • b) insufficiently pre-treated patients who are bDMARD-naïve: biotechnologically produced DMARDs (bDMARD) in combination with MTX (adalimumab or etanercept or certolizumab pegol or golimumab or abatacept or tocilizumab) (as monotherapy only if appropriate)
  • c) insufficiently pre-treated patients with one or more bDMARD: change of bDMARD(s) (adalimumab or etanercept or certolizumab pegol or golimumab or abatacept or tocilizumab, all in combination with MTX (as monotherapy only if appropriate) or rituximab for patients with severe rheumatoid arthritis) in consideration of pre-treatment

Subject:

  • Active Substance: Rurioctocog alfa pegol
  • Name: Adynovi®
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: Shire Deutschland GmbH

Time table:

  • Start: 15.05.2018
  • Publication of assessment: 15.08.2018
  • End of public hearing: 05.09.2018
  • Final decision by G-BA: expected for the beginning of November 2018

Comparative therapy:

  • Recombinant or human plasma-derived blood coagulation factor VIII products

Subject:

  • Active Substance: Ertugliflozin/ sitagliptin
  • Name: Steglujan®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.05.2018
  • Publication of assessment: 15.08.2018
  • End of public hearing: 05.09.2018
  • Final decision by G-BA: expected for the beginning of November 2018

Comparative therapy:

  • Patients for whom the treatment with at least two blood glucose lowering medicines (except for insulin, here: metformin and/or sulfonyl urea and ertugliflozin and sitagliptin) is inadequate:
    - human insulin + metformin or
    - human insulin + empagliflozin* or
    - human insulin + liraglutide* or
    - human insulin, if the stated combination partners are inappropriate or contraindicated according to the summary of product characteristics or are insufficient due to a progressive diabetes mellitus type 2)
    (* empagliflozin or liraglutide only in combination with standard of care for the treatment of patients with manifest cardiovascular disease)

Subject:

  • Active Substance: Hydrocortisone
  • Name: Alkindi®
  • Therapeutic area: Adrenal insufficiency of patients › 18 years
  • Pharmaceutical company: Diurnal Ltd.

Time table:

  • Start: 15.05.2018
  • Publication of assessment: 15.08.2018
  • End of public hearing: 05.09.2018
  • Final decision by G-BA: expected for the beginning of November 2018

Comparative therapy:

  • Hydrocortisone (not Alkindi®)

Subject:

  • Active Substance: Bosutinib
  • Name: Bosulif®
  • Therapeutic area: Chronic myeloid leukemia (CML)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.06.2018
  • Publication of assessment: 03.09.2018
  • End of public hearing: 24.09.2018
  • Final decision by G-BA: expected for the end of November 2018

Comparative therapy:

  • Imatinib or Nilotinib or Dasatinib

Subject:

  • Active Substance: Darvadstrocel
  • Name: Alofisel®
  • Therapeutic area: Rectal fistulas in adults with Morbus Crohn’s disease
  • Pharmaceutical company: Takeda Pharma Vertrieb GmbH & Co. KG

Time table:

  • Start: 01.06.2018
  • Publication of assessment: 03.09.2018
  • End of public hearing: 24.09.2018
  • Final decision by G-BA: expected for the end of November 2018

Comparative therapy:

  • No comparative therapy because of orphan drug indication

Subject:

  • Active Substance: Evolocumab (re-assessment accord. to § 14)
  • Name: Repatha®
  • Therapeutic area: Hypercholesterolemia
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 06.09.2018

Final decision:

  • Evolocumab in combination with a statin or a statin and other lipid lowering therapies:
    • Patients without known atherosclerotic cardiovascular disease: no additional benefit proved
    • Patients with known atherosclerotic cardiovascular disease: no additional benefit proved
  • Patients whose medicinal and dietetic therapy options to lower lipids have been exhausted: no additional benefit proved

Subject:

  • Active Substance: Olaparib (new indication: high-grade cancer of the ovary, fallopian tube or peritoneum)
  • Name: Lynparza®
  • Therapeutic area: Ovarian neoplasms
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.06.2018
  • Publication of assessment: 17.09.2018
  • End of public hearing: 08.10.2018
  • Final decision by G-BA: expected for the beginning of December 2018

Final decision:

  • Watchful waiting

Subject:

  • Active Substance: Olaparib (revocation of orphan drug status)
  • Name: Lynparza®
  • Therapeutic area: Ovarian neoplasms
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: Start: 15.06.2018
  • Publication of assessment: 17.09.2018
  • End of public hearing: 08.10.2018
  • Final decision by G-BA: expected for the beginning of December 2018

Final decision:

  • Watchful waiting

Subject:

  • Active Substance: Dolutegravir/ rilpivirin
  • Name: Juluca®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 15.06.2018
  • Publication of assessment: 17.09.2018
  • End of public hearing: 08.10.2018
  • Final decision by G-BA: expected for the beginning of December 2018

Final decision:

  • Individual antiretroviral therapy (ART) in consideration of previous therapy and adverse events

Subject:

  • Active Substance: Cabozantinib (new indication: 1st line treatment)
  • Name: Cabometyx®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 15.06.2018
  • Publication of assessment: 17.09.2018
  • End of public hearing: 08.10.2018
  • Final decision by G-BA: expected for the beginning of December 2018

Final decision:

  • a) Patients with intermediate prognosis (IMDC score 1-2): bevacizumab in combination with interferon alfa-2a OR monotherapy with pazopanib OR sunitinib
  • b) Patients with unfavorable prognosis (IMDC score ≥ 3): temsirolimus

Subject:

  • Active Substance: Nivolumab (combi with Ipilimumab, melanoma, re-assessment)
  • Name: Opdivo®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.06.2018
  • Publication of assessment: 17.09.2018
  • End of public hearing: 08.10.2018
  • Final decision by G-BA: expected for the beginning of December 2018

Final decision:

  • Nivolumab OR pembrolizumab

 

Completed (final decision published)

Subject:

  • Active Substance: Bezlotoxumab
  • Name: Zinplava©
  • Therapeutic area: Clostridium difficile infection
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • Indication for a minor additional benefit

Subject:

  • Active Substance: Glycopyrroniumbromid
  • Name: Sialanar©
  • Therapeutic area: Sialorrhea
  • Pharmaceutical company: Proveca Limited

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Emicizumab
  • Name: Hemlibra©
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • Patients for whom exclusive on-demand treatment with bypassing products equals a patient-individual therapy: hint for a non-quantifiable additional benefit
  • Patients for whom another therapy equals a patient-individual therapy: no additional benefit proved.

Subject:

  • Active Substance: Patiromer
  • Name: Veltassa©
  • Therapeutic area: Hyperkalemia
  • Pharmaceutical company: Fresenius Medical Care Nephrologica Deutschland GmbH

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • 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: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

  • Patients for whom the treatment with at least two blood glucose lowering medicines (only oral drugs including metformin) is inadequate: no additional benefit proved
  • Patients who are inadequately treated by insulin (in combination with another blood glucose lowering medicine, here metformin): no additional benefit proved

Subject:

  • Active Substance: Fluticasone furoate/ umeclidinium bromide/ vilanterol
  • Name: Trelegy Ellipta©
  • Therapeutic area: Chronic obstructive pulmonary disease (COPD)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Glycerol phenylbutyrate
  • Name: Ravicti©
  • Therapeutic area: Urea cycle disorders (UCD)
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Ixekizumab
  • Name: Taltz©
  • Therapeutic area: Psoriatic arthritis
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

  • Patients for whom another classical disease-modifying anti-rheumatic drug (DMARD) therapy except MTX is indicated: no additional benefit proved
  • bDMARD-naïve patients for whom a therapy with bDMARDs is indicated for the first time: hint for a minor additional benefit
  • Patients who have responded inadequately or who are intolerant to one prior therapy with bDMARDs: no additional benefit proved

Subject:

  • Active Substance: Ocrelizumab
  • Name: Ocrevus©
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • Patients with RMS and active disease who either have not been pretreated with a disease-modifying therapy or have been pretreated but do not have highly active disease: Proof for a minor additional benefit
  • Patients with RMS and highly active disease despite treatment with a disease-modifying therapy: No additional benefit proved
  • Patients with primary progredient MS (PPMS): Hint for a minor additional benefit

Subject:

  • Active Substance: Lumacaftor/ ivacaftor
  • Name: Orkambi©
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

  • Start: 01.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Letermovir
  • Name: Prevymis©
  • Therapeutic area: Cytomegalovirus infections
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Benralizumab
  • Name: Fasenra©
  • Therapeutic area: Asthma
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • a) Pre-treated patients who have not exhausted further therapy options: No additional benefit proved
  • b) Pre-treated patients who have exhausted all therapy options: Hint for a minor additional benefit

Subject:

  • Active Substance: Sonidegib
  • Name: Odomzo©
  • Therapeutic area: Basal cell carcinoma
  • Pharmaceutical company: Sun Pharmaceuticals Germany GmbH

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Fluticasone furoate/ vilanterol
  • Name: Relvar® Ellipta®
  • Therapeutic area: Asthma, bronchial
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • Proof for therapeutic improvements not provided (no comparative therapy as Relvar Ellipta® is part of the reference price group “combination of glucocorticoids and long-acting beta2-agonists”)

Subject:

  • Active Substance: Ipilimumab
  • Name: Yervoy®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Brentuximab vedotin
  • Name: Adcetris©
  • Therapeutic area: Non-Hodgkin lymphoma, CD30+ cutaneous T-cell lymphoma (CTCL)
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.01.2018
  • Final decision by G-BA: 05.07.2018

Final decision:

  • Minor additional benefit (proven because of orphan drug designation)

Subject:

  • Active Substance: Elvitegravir/ cobicistate/ emtricitabine/ tenofovir alafenamide
  • Name: Genvoya©
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.01.2018
  • Final decision by G-BA: 05.07.2018

Final decision:

  • Treatment-naïve patients (age ≥ 6 years < 12 years): No additional benefit proved
  • Pre-treated patients (age ≥ 6 years < 12 years): No additional benefit proved

Subject:

  • Active Substance: Allogeneic, genetically modified T cells
  • Name: Zalmoxis©
  • Therapeutic area: Haematopoietic stem cell transplantation (HSCT), graft-versus-host disease (GvHD)
  • Pharmaceutical company: Dompé farmaceutici S.p.A.

Time table:

  • Start: 15.01.2018
  • Final decision by G-BA: 05.07.2018
  • The decision remains valid until: 01.04.2021

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga©
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.01.2018
  • Final decision by G-BA: 21.06.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Dapagliflozin/ metformin
  • Name: Xigduo©
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.01.2018
  • Final decision by G-BA: 21.06.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Alecitinib
  • Name: Alecensa©
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Roche Pharma GmbH

Time table:

  • Start: 01.01.2018
  • Final decision by G-BA: 21.06.2018

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Abiraterone acetate
  • Name: Zytiga©
  • Therapeutic area: Prostatic neoplasms
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.12.2017
  • Final decision by G-BA: 07.06.2018

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Niraparib
  • Name: Zejula©
  • Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
  • Pharmaceutical company: TESARO Bio Germany GmbH

Time table:

  • Start: 15.12.2017
  • Final decision by G-BA: 07.06.2018
  • The decision remains valid until: 01.10.2020

The decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Cladribine
  • Name: Mavenclad©
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Merck Serono GmbH

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Patients who have not had a disease-modifying therapy yet: additional benefit not proved
  • Patients with highly active disease despite a disease-modifying therapy: additional benefit not proved

Subject:

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

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Guselkumab
  • Name: Tremfya©
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Patients for whom systemic therapy is appropriate: indication for a considerable additional benefit
  • Patients whose response to other systemic therapies, including ciclosporin, methotrexate or oral PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: proof for a considerable additional benefit

Subject:

  • Active Substance: Perampanel
  • Name: Fycompa©
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil
  • Name: Stribild©
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.11.2017
  • Final decision by G-BA: 02.05.2018

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Cenegermin
  • Name: Oxervate©
  • Therapeutic area: Keratitis
  • Pharmaceutical company: Dompé farmaceutici S.p.A.

Time table:

  • Start: 15.11.2017
  • Final decision by G-BA: 02.05.2018

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Nonacog beta pegol
  • Name: Refixia©
  • Therapeutic area: Haemophilia B
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.11.2017
  • Final decision by G-BA: 19.04.2018

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Tivozanib
  • Name: Fotivda©
  • Therapeutic area: Renal cell carcinoma (RCC)
  • Pharmaceutical company: EUSA Pharma GmbH

Time table:

  • Start: 01.11.2017
  • Final decision by G-BA: 19.04.2018

Final decision:

  • First line therapy:
    1. with favorable or intermediate prognosis (MSKCC score 0-2): additional benefit not proved
    2. with non-favorable prognosis (MSKCC score ≥ 3): additional benefit not proved
  • With progression following cytokine therapy but only if treatment-naïve regarding VEGFR or TOR pathway inhibitors: additional benefit not proved

Subject:

  • Active Substance: Telotristat ethyl
  • Name: Xermelo©
  • Therapeutic area: Carcinoid syndrome diarrhoea
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug status)

Subject:

  • Active Substance: Midostaurin
  • Name: Rydapt©
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Considerable additional benefit (proved because of orphan drug status)

Subject:

  • Active Substance: Midostaurin
  • Name: Rydapt©
  • Therapeutic area: Advanced systemic mastocytosis (advSM)
  • Pharmaceutical company: : Novartis Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug status)

Subject:

  • Active Substance: Cabozantinib
  • Name: Cabometyx©
  • Therapeutic area: Renal cell carcinoma (RCC)
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Indication for a minor additional benefit

Subject:

  • Active Substance: Sofosbuvir
  • Name: Sovaldi©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Treatment-naïve patients: hint for a non-quantifiable additional benefit
  • Pre-treated patients: hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro©
  • Therapeutic area: Follicular lymphoma (FL)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Non-quantifiable additional benefit (proved because of orphan drug status)

Subject:

  • Active Substance: Elosulfase alfa (re-assessment)
  • Name: Vimizim©
  • Therapeutic area: Mucopolysaccharidosis type IVA (Morquio A syndrome, MPS IVA)
  • Pharmaceutical company: BioMarin Deutschland GmbH

Time table:

  • Start: 15.09.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Minor additional benefit proven (because of orphan drug status)

Subject:

  • Active Substance: Pembrolizumab (new indication: urothelial carcinoma)
  • Name: Keytruda©
  • Therapeutic area: Urothelial carcinoma
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Start: 15.09.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Patients for whom cisplatin-based chemotherapy based is inappropriate: no additional benefit proved
  • Patients who are pretreated with cisplatin-based chemotherapy: indication for a considerable additional benefit

Subject:

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

Time table:

  • Start: 15.09.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide
  • Name: Symtuza©
  • Therapeutic area: HIV infections
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Dimethyl fumarate
  • Name: Skilarence©
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Avelumab
  • Name: Bavencio©
  • Therapeutic area: Merkel cell carcinoma (MCC)
  • Pharmaceutical company: Merck Serono GmbH/ Pfizer Pharma GmbH

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Non-quantifiable additional benefit proved (because of orphan drug status)

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq©
  • Therapeutic area: Urothelial carcinoma (UC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Patients for whom a cisplatin-based chemotherapy is inappropriate (first-line): no additional benefit proved
  • Patients with prior platin-based therapy: hint for a minor additional benefit

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq©
  • Therapeutic area: Non-small cell lung carcinoma (NSCLC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is indicated: indication for a considerable additional benefit
  • Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is not indicated: no additional benefit proved

Subject:

  • Active Substance: Brodalumab
  • Name: Kyntheum©
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Leo Pharma GmbH

Time table:

  • Start: 01.09.2017
  • Final decision by G-BA: 01.03.2018

Final decision:

  • Patients who are candidates for systemic therapy: additional benefit not proven
  • Patients whose response to other systemic therapies, including ciclosporin, methotrexate or PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: indication for a non-quantifiable additional benefit

Subject:

  • Active Substance: Ledipasvir/ sofosbuvir
  • Name: Harvoni©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • Treatment-naïve patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
  • Treatment-naïve patients with compensated cirrhosis, genotype 3: additional benefit not proven
  • vPretreated patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
  • Pretreated patients, genotype 3: additional benefit not proven

Subject:

  • Active Substance: Sofosbuvir/ velpatasvir/ voxilarprevir
  • Name: Vosevi©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 1: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 2: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 3: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 4: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotypes 5 or 6: additional benefit not proven
  • DAA experienced patients without cirrhosis or with compensated cirrhosis: additional benefit not proven

Subject:

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

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit
  • In combination with dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who have received at least one prior therapy: hint for a considerable additional benefit
  • As monotherapy for patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy: additional benefit not proven

Subject:

  • Active Substance: Sarilumab
  • Name: Kevzara©
  • Therapeutic area: Rheumatoid arthritis
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • As monotherapy or in combination with methotrexate (MTX) for patients who have responded inadequately to, or who are intolerant to one disease modifying anti rheumatic drug (DMARD), and who do not have unfavourable prognostic factors: additional benefit not proven
  • As monotherapy for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time and who are intolerant to MTX or for whom MTX treatment is inappropriate: hint for a considerable additional benefit
  • In combination with MTX for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time: additional benefit not proven
  • As monotherapy or in combination with MTX for patients who have responded inadequately to, or who are intolerant to one or more bDMARDs: additional benefit not proven

Subject:

  • Active Substance: Certinib
  • Name: Zykadia©
  • Therapeutic area: Non-small-cell lung carcinoma (NSCLC)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.08.2017
  • Final decision by G-BA: 01.02.2018

Final decision:

  • Additional benefit not proven

Subject:

  • Active Substance: Glecaprevir/ pibrentasvir
  • Name: Maviret©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.08.2017
  • Final decision by G-BA: 01.02.2018

Final decision:

  • Additional benefit not proven for any patient population:
    Patients without cirrhosis or with compensated cirrhosis genotype 1
  • Patients without cirrhosis genotype 2
  • Patients with compensated cirrhosis genotype 2
  • Patients without cirrhosis or with compensated cirrhosis genotype 3
  • Patients without cirrhosis or with compensated cirrhosis genotype 4
  • Patients without or with compensated cirrhosis with genotypes 5, 6
  • Patients pre-treated with sofosbuvir + ribavirin

Subject:

  • Active Substance: Saxagliptin/ metformin
  • Name: Komboglyze©
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.08.2017
  • Final decision by G-BA: 01.02.2018

Final decision:

  • Additional benefit not proven

Subject:

  • Active Substance: Inotuzumab ozogamicin
  • Name: Besponsa©
  • Therapeutic area: B cell precursor acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.07.2017
  • Final decision by G-BA: 18.01.2018

Final decision:

  • Minor additional benefit proven (because of orphan drug designation)

 

Ansprechpartner

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