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Ongoing (preliminary decision published)

Subject:

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

Time table:

  • Start: 01.01.2018
  • Publication of assessment: 03.04.2018
  • End of public hearing: 24.04.2018
  • Final decision by G-BA: expected for the end of June 2018

Comparative therapy:

  • In combination with other antidiabetics (except of insulin, here: metformin):
    • metformin + sulfonyl urea (glibenclamide or glimepiride) or
    • metformin + empagliflozin or
    • metformin + liraglutide (liraglutide in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)

Subject:

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

Time table:

  • Start: 01.01.2018
  • Publication of assessment: 03.04.2018
  • End of public hearing: 24.04.2018
  • Final decision by G-BA: expected for the end of June 2018

Comparative therapy:

  • metformin + sulfonyl urea (glibenclamide or glimepiride) or
  • metformin + empagliflozin or
  • metformin + liraglutide (liraglutide in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)

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
  • Publication of assessment: 03.04.2018
  • End of public hearing: 24.04.2018
  • Final decision by G-BA: expected for the end of June 2018

Comparative therapy:

  • Crizotinib

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
  • Publication of assessment: 16.04.2018
  • End of public hearing: 07.05.2018
  • Final decision by G-BA: expected for the beginning of July 2018

Comparative therapy:

  • No comparative therapy 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
  • Publication of assessment: 16.04.2018
  • End of public hearing: 07.05.2018
  • Final decision by G-BA: expected for the beginning of July 2018

Comparative therapy:

  • treatment-naïve patients (age ≥ 6 years < 12 years): antiretroviral combination therapy of 2 NRTI (abacavir or lamivudine or emtricitabine or zidovudine) and 1 NNRTI (efavirenz or nevirapine) or 1 proteinase inhibitor (lopinavir or atazanavir or darunavir each in combination with ritonavir)
  • pre-treated patients (age ≥ 6 years < 12 years): individual antiretroviral therapy depending on previous therapies and under consideration of the reason for switching therapies, in particular treatment failure due to virological failure and possible associated resistance formation or due to side effects.

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
  • Publication of assessment: 16.04.2018
  • End of public hearing: 07.05.2018
  • Final decision by G-BA: expected for the beginning of July 2018

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.02.2018
  • Publication of assessment: 02.05.2018
  • End of public hearing: 23.05.2018
  • Final decision by G-BA: expected for the beginning of August 2018

Comparative therapy:

  • Patients who have either not been pretreated with a disease-modifying therapy or who have been pretreated but do not have highly active disease: interferon beta-1a or interferon beta-1b or glatiramer acetate
  • Patients with highly active disease despite treatment with a disease-modifying therapy: alemtuzumab or fingolimod or natalizumab or, if appropriate, a change of basis therapeutic (interferon beta-1a or interferon beta-1b or glatiramer acetate)
  • Patients with primary progredient MS (PPMS): best supportive care

Subject:

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

Time table:

  • Start: 01.02.2018
  • Publication of assessment: 02.05.2018
  • End of public hearing: 23.05.2018
  • Final decision by G-BA: expected for the beginning of August 2018

Comparative therapy:

  • Best possible symptomatic therapy (especially antibiotics for pulmonary infections, mucolytics, pancreas enzymes for pancreas insufficiency, physiotherapy) with exhaustion of any possible dietary measure

Subject:

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

Time table:

  • Start: 15.02.2018
  • Publication of assessment: 15.05.2018
  • End of public hearing: 05.06.2018
  • Final decision by G-BA: expected for the beginning of August 2018

Comparative therapy:

  • No comparative therapy because of orphan drug designationth

Subject:

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

Time table:

  • Start: 15.02.2018
  • Publication of assessment: 15.05.2018
  • End of public hearing: 05.06.2018
  • Final decision by G-BA: expected for the beginning of August 2018

Comparative therapy:

  • G-BA did not define the comparative therapy (yet)
  • According to IQWIG assessment: Patient-individual therapy escalation of
    • high dose inhaled corticosteroids (ICS) and LABA in combination with tiotropium and, if appropriate, with oral corticosteroids (OCS) or
    • omalizumab (if IgE-mediated pathogenesis is present) as an adjunct to high-dose ICS and LABA (in combination with oral corticosteroids, if appropriate) or
    • if appropriate, high-dose ICS and LABA with OCS

Subject:

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

Time table:

  • Start: 15.02.2018
  • Publication of assessment: 15.05.2018
  • End of public hearing: 05.06.2018
  • Final decision by G-BA: expected for the beginning of August 2018

Comparative therapy:

  • Vismodegib or best supportive care

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
  • Publication of assessment: 15.05.2018
  • End of public hearing: 05.06.2018
  • Final decision by G-BA: expected for the beginning of August 2018

Comparative therapy:

  • 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
  • Publication of assessment: 15.05.2018
  • End of public hearing: 05.06.2018
  • Final decision by G-BA: expected for the beginning of August 2018

Comparative therapy:

  • Therapy at the physician's discretion

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
  • Publication of assessment: 01.06.2018
  • End of public hearing: 22.06.2018
  • Final decision by G-BA: expected for the middle of August 2018

Comparative therapy:

  • Patients for whom the treatment with at least two blood glucose lowering medicines (only oral drugs including metformin) 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
  • Patients who are inadequately treated by insulin (in combination with another blood glucose lowering medicine, here metformin): optimization of human insulin regimen (possibly + metformin or empagliflozin or liraglutide)

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
  • Publication of assessment: 01.06.2018
  • End of public hearing: 22.06.2018
  • Final decision by G-BA: expected for the middle of August 2018

Comparative therapy:

  • Patients who are symptomatic (including exacerbations) despite their current treatment: patient individual therapy optimization according to the physician - under consideration of previous treatments – with LABA (long acting beta-2-sympathomimetics) and LAMA and possibly ICS (inhalative corticosteroids)

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
  • Publication of assessment: 01.06.2018
  • End of public hearing: 22.06.2018
  • Final decision by G-BA: expected for the middle of August 2018

Comparative therapy:

  • No comparative therapy 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
  • Publication of assessment: 01.06.2018
  • End of public hearing: 22.06.2018
  • Final decision by G-BA: expected for the middle of August 2018

Comparative therapy:

  • Patients without unfavourable prognostic factors and who have responded inadequately to or who are intolerant to one prior disease-modifying anti-rheumatic drug (DMARD) (including MTX): alternative classical DMARDs if appropriate (MTX or leflunomide as monotherapy or in combination)
  • bDMARD-naïve patients for whom bDMARD-therapy is indicated for the first time: TNF-alfa-inhibitor (adalimumab or etanercept or golimumab or infliximab) possibly in combination with MTX
  • Patients who have responded inadequately to or who are intolerant to prior bDMARD therapy: therapy change to another bDMARD (adalimumab or etanercept or golimumab or infliximab) possibly in combination with MTX

Subject:

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

Time table:

  • Start: 01.03.2018
  • Publication of assessment: 01.06.2018
  • End of public hearing: 22.06.2018
  • Final decision by G-BA: expected for the middle of August 2018

Comparative therapy:

  • a. Patients for whom statins are appropriate: maximum tolerable medicinal and dietetic therapy to lower lipids
  • b. Patients for whom statins are inappropriate due to contraindications or therapy-limiting side effects: another lipid-lowering medicinal product (fibrates, anion exchanger, cholesterol absorption inhibitor) as monotherapy and dietetic therapy to lower lipids
  • c. Patients whose medicinal and dietetic therapy options to lower lipids have been exhausted: LDL apheresis (as “ultima ratio”) with additional medicinal lipid-lowering treatment when appropriate

 

Completed (final decision published)

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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