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Ongoing (preliminary decision published)

Subject:

  • Active Substance: Ropeginterferon alfa-2b
  • Name: Besremi®
  • Therapeutic area: Polycythaemia vera
  • Pharmaceutical company: AOP Orphan Pharmaceuticals AG

Time table:

  • Start: 15.09.2019
  • Publication of assessment: 16.12.2019
  • End of public hearing: 06.01.2020
  • Final decision by G-BA: expected for the beginning of March 2020

Comparative therapy:

  • Treatment-naïve patients or patients pretreated with hydroxycarbamide without resistance or intolerance against hydroxycarbamide: Hydroxycarbamide
  • Patients pretreated with hydroxycarbamide who are resistant or intolerant against hydroxycarbamide: Ruxolitinib

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.10.2019
  • Publication of assessment: 02.01.2020
  • End of public hearing: 23.01.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Anthracycline and/or taxane containing systemic therapy under consideration of the authorization status

Subject:

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

Time table:

  • Start: 01.10.2019
  • Publication of assessment: 02.01.2020
  • End of public hearing: 23.01.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Patients with tumor proportion score (TPS ≥ 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors: pembrolizumab (monotherapy)
  • Patients with TPS < 50% (PD-L1 expression) or EGFR mutant or ALK-positive tumors after prior mutation-directed therapy:
    – cisplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) under consideration of the authorization status OR
    – carboplatin in combination with a third generation cytostatic (only patients with increased risk for cisplatin induced adverse events) OR
    – carboplatin in combination with nab-paclitaxel

Subject:

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

Time table:

  • Start: 01.10.2019
  • Publication of assessment: 02.01.2020
  • End of public hearing: 23.01.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Patients with tumor proportion score (TPS ≥ 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors: pembrolizumab (monotherapy)
  • Patients with TPS < 50% (PD-L1 expression) or EGFR mutant or ALK-positive tumors:
    – cisplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) OR
    – carboplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) OR
    – carboplatin in combination with nab-paclitaxel

Subject:

  • Active Substance: Elotuzumab
  • Name: Empliciti®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.10.2019
  • Publication of assessment: 02.01.2020
  • End of public hearing: 23.01.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Bortezomib in combination with dexamethasone OR
  • Lenalidomide in combination with dexamethasone OR
  • Pomalidomide in combination with dexamethasone OR
  • Elotuzumab in combination with lenalidomide and dexamethasone OR
  • Carfilzomib in combination with lenalidomide and dexamethasone OR
  • Carfilzomib in combination with dexamethasone OR
  • Daratumumab in combination with lenalidomide and dexamethasone OR
  • Daratumumab in combination with bortezomib and dexamethasone

Subject:

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

Time table:

  • Start: 01.10.2019
  • Publication of assessment: 02.01.2020
  • End of public hearing: 23.01.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

  • Active Substance: Cannabidiol
  • Name: Epidyolex®
  • Therapeutic area: Dravet syndrome
  • Pharmaceutical company: GW Pharmaceuticals plc

Time table:

  • Start: 15.10.2019
  • Publication of assessment: 15.01.2020
  • End of public hearing: 05.02.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

  • Active Substance: Cannabidiol
  • Name: Epidyolex®
  • Therapeutic area: Lennox-Gastaut syndrome
  • Pharmaceutical company: GW Pharmaceuticals plc

Time table:

  • Start: 15.10.2019
  • Publication of assessment: 15.01.2020
  • End of public hearing: 05.02.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.10.2019
  • Publication of assessment: 15.01.2020
  • End of public hearing: 05.02.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Olaparib OR watchful waiting

Subject:

  • Active Substance: Larotrectinib
  • Name: Vitrakvi®
  • Therapeutic area: Solid tumors
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 15.10.2019
  • Publication of assessment: 15.01.2020
  • End of public hearing: 05.02.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Best supportive care

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq®
  • Therapeutic area: Small cell lung cancer (SCLC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.10.2019
  • Publication of assessment: 15.01.2020
  • End of public hearing: 05.02.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Cisplatin and etoposide OR carboplatin and etoposide

Subject:

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

Time table:

  • Start: 15.10.2019
  • Publication of assessment: 15.01.2020
  • End of public hearing: 05.02.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Best supportive care

Subject:

  • Active Substance: Asfotase alfa
  • Name: Strensiq®
  • Therapeutic area: Hypophosphatasia
  • Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

  • Start: 15.10.2019
  • Publication of assessment: 15.01.2020
  • End of public hearing: 05.02.2020
  • Final decision by G-BA: expected for the beginning of April 2020

Comparative therapy:

  • Best supportive care

Subject:

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

Time table:

  • Start: 15.11.2019
  • Publication of assessment: 17.02.2020
  • End of public hearing: 09.03.2020
  • Final decision by G-BA: expected for the middle of May 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.11.2019
  • Publication of assessment: 17.02.2020
  • End of public hearing: 09.03.2020
  • Final decision by G-BA: expected for the middle of May 2020

Comparative therapy:

  • Patient-individual therapy considering hydroxychloroquine, chloroquine, nonsteroidal antirheumatic drugs (NSAIDs), glucocorticoids, azathioprine, mycophenolate mofetil (when heavy kidney involvement), under consideration of the respective organ manifestation, pre-treatment and disease activity)

 

Completed (final decision published)

Subject:

  • Active Substance: Volanesorsen
  • Name: Waylivra®
  • Therapeutic area: Familial chylomicronaemia syndrome (FCS)
  • Pharmaceutical company: Akcea Therapeutics Germany GmbH

Time table:

  • Start: 15.08.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

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

Subject:

  • Active Substance: Ibrutinib
  • Name: Imbruvica®
  • Therapeutic area: Waldenström’s macroglobulinaemia
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ibrutinib
  • Name: Imbruvica®
  • Therapeutic area: Chronic lymphocytic leukaemia (CLL)
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Patients for whom a therapy with fludarabine in combination with cyclophosphamide and rituximab (FCR) is indicated: No additional benefit proved
  • Patients for whom a therapy with FCR is not indicated: Hint for a minor additional benefit
  • Patients with 17p depletion and/or TP53 mutation or who are not indicated for a chemo-immunotherapy due to other reasons: No additional benefit proved

Subject:

  • Active Substance: Andexanet alfa
  • Name: Ondexxya®
  • Therapeutic area: Stopping of bleeding due to anticoagulants
  • Pharmaceutical company: Portola Deutschland GmbH

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020
  • This decision remains valid until: 01.11.2023

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Pre-treated adolescents (12–17 years): No additional benefit proved
  • Pre-treated adults: No additional benefit proved

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision by G-BA: 20.02.2020:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Patients aged 6 – 11 years: hint for a non-quantifiable additional benefit
  • Patients aged 12 years and older: hint for a considerable additional benefit

Subject:

  • Active Substance: Ramucirumab
  • Name: Cyramza®
  • Therapeutic area: Hepatocellular carcinoma (HCC)
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.09.2019
  • Final decision by G-BA: 20.02.2020

Final decision:

  • Proof for a minor additional benefit

Subject:

  • Active Substance: Turoctocog alfa pegol
  • Name: Esperoct®
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.08.2019
  • Final decision by G-BA: 06.02.2020

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.08.2019
  • Final decision by G-BA: 06.02.2020

Final decision:

  • Therapy-naïve adults: No additional benefit proved
  • Pre-treated patients adults: No additional benefit proved
  • Therapy-naïve adolescents at the age of ≥ 12 years: No additional benefit proved
  • Pre-treated adolescent patients at the age of ≥ 12 years: No additional benefit proved

Subject:

  • Active Substance: Ravulizumab
  • Name: Ultomiris®
  • Therapeutic area: Paroxysmal nocturnal haemoglobinuria (PNH)
  • Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

  • Start: 01.08.2019
  • Final decision by G-BA: 06.02.2020

Final decision:

  • Patients with high disease activity: No additional benefit proved
  • Patients receiving eculizumab for ≥ 6 months and who are clinically stable:: No additional benefit proved

Subject:

  • Active Substance: Cemiplimab
  • Name: Libtayo®
  • Therapeutic area: Cutaneous squamous cell carcinoma
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.08.2019
  • Final decision by G-BA: 06.02.2020

Final decision:

  • Patients who have not been treated with medicinal products yet: No additional benefit proved
  • Patients whose carcinoma has progressed after treatment with medicinal products: No additional benefit proved

Subject:

  • Active Substance: Olaparib
  • Name: Lynparza®
  • Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.07.2019
  • Final decision by G-BA: 16.01.2020
  • The decision remains valid until: 01.04.2024

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Olaparib
  • Name: Lynparza®
  • Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.07.2019
  • Final decision by G-BA: 16.01.2020

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Vigabatrine
  • Name: Kigabeq®
  • Therapeutic area: West syndrome
  • Pharmaceutical company: Desitin Arzneimittel GmbH

Time table:

  • Start: 01.07.2019
  • Final decision by G-BA: 19.12.2019

Final decision:

  • No additional benefit proved (no dossier submitted)

Subject:

  • Active Substance: Vigabatrine
  • Name: Kigabeq®
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: Desitin Arzneimittel GmbH

Time table:

  • Start: 01.07.2019
  • Final decision by G-BA: 19.12.2019

Final decision:

  • No additional benefit proved (no dossier submitted)

Subject:

  • Active Substance: Pegvaliase
  • Name: Palynziq
  • Therapeutic area: Phenylketonuria
  • Pharmaceutical company: BioMarin International Limited

Time table:

  • Start: 01.07.2019
  • Final decision by G-BA: 19.12.2019

Final decision:

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

Subject:

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

Time table:

  • Start: 01.07.2019
  • Final decision by G-BA: 19.12.2019

Final decision:

  • Patients whose blood sugar is not sufficiently controlled by one other antidiabetic treatment (except insulin, here: metformin)
    a1) Patients with high CV risk: Hint for a minor additional benefit
    a2) Patients without high CV risk: No additional benefit proved
  • b) Patients whose blood sugar is not sufficiently controlled by at least two antidiabetic treatments (amongst metformin, except insulin)
    b1) Patients with high CV risk: Hint for a minor additional benefit
    b2) Patients without high CV risk: No additional benefit proved
  • c) Patients whose blood sugar is not sufficiently controlled by insulin (with another antidiabetic treatment, here: metformin)
    c1) Patients with high CV risk: Hint for a minor additional benefit
    c2) Patients without high risk: No additional benefit proved

Subject:

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

Time table:

  • Start: 01.07.2019
  • Final decision by G-BA: 19.12.2019

Final decision:

  • Patients whose blood sugar is not sufficiently controlled by diet and exercise and who are not indicated for metformin due to intolerance:
    a1) Patients with high CV risk: No additional benefit proved
    a2) Patients without high CV risk: No additional benefit proved
  • Patients whose blood sugar is not sufficiently controlled by one other antidiabetic treatment (except insulin, here: metformin)
    b1) Patients with high CV risk: Hint for a minor additional benefit
    b2) Patients without high CV risk: No additional benefit proved
  • Patients whose blood sugar is not sufficiently controlled by at least two antidiabetic treatments (amongst metformin, except insulin)
    c1) Patients with high CV risk: Hint for a minor additional benefit
    c2) Patients without high CV risk: No additional benefit proved
  • Patients whose blood sugar is not sufficiently controlled by insulin (with another antidiabetic treatment, here: metformin)
    d1) Patients with high CV risk: Hint for a minor additional benefit
    d2) Patients without high CV risk: No additional benefit proved

Subject:

  • Active Substance: Pomalidomide
  • Name: Imnovid®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Celgene GmbH

Time table:

  • Start: 15.06.2019
  • Final decision by G-BA: 05.12.2019

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Empagliflozin/linagliptin
  • Name: Glyxambi®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 01.06.2019
  • Final decision by G-BA: 22.11.2019

Final decision: No additional benefit proved

Subject:

  • Active Substance: Risankizumab
  • Name: SkyriziTM
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.06.2019
  • Final decision by G-BA: 22.11.2019

Final decision:

  • Patients that are not eligible for a conventional therapy as part of the first systemic treatment: No additional benefit proved
  • Patients that have responded insufficiently to or are intolerant to a systemic treatment: Proof for a considerable additional benefit

Subject:

  • Active Substance: Lorlatinib
  • Name: Lorviqua®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.06.2019
  • Final decision by G-BA: 22.11.2019

Final decision:

  • a) Patients eligible for another antineoplastic systemic therapy: No additional benefit proved
  • b) Patients not eligible for another antineoplastic systemic therapy: No additional benefit proved

Subject:

  • Active Substance: Fremanezumab
  • Name: Ajovy®
  • Therapeutic area: Migraine prophylaxis
  • Pharmaceutical company: Teva GmbH

Time table:

  • Start: 15.05.2019
  • Final decision by G-BA: 07.11.2019

Final decision:

  • Treatment-naïve adult patients with inadequate response or who are intolerant or contraindicated to at least one prophylactic therapy: No additional benefit proved
  • Adult patients who show no response or are intolerant or contraindicated to the medicinal products/substance classes metoprolol, propranolol, flunarizine, topiramate, amitriptyline: No additional benefit proved
  • Adult patients who show now response or are intolerant or contraindicated to any of the above-mentioned substance classes: Hint for a considerable additional benefit

Subject:

  • Active Substance: Prasterone
  • Name: Intrarosa®
  • Therapeutic area: Post menopause
  • Pharmaceutical company: Endoceutics, Inc.

Time table:

  • Start: 01.05.2019
  • Final decision by G-BA: 17.10.2019

Final decision:

  • The assessment has been stopped because the launched package is not reimbursable by SHI

Subject:

  • Active Substance: Dacomitinib
  • Name: Vizimpro®
  • Therapeutic area: Non-small cell lung cancer
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.05.2019
  • Final decision by G-BA: 17.10.2019

Final decision:

  • a) Adult patients with the activating EGFR mutations K858R or del19: No additional benefit proven
    b) Adult patients with lother activating EGFR mutations than K858R or del19: No additional benefit proven

Subject:

  • Active Substance: Lisdexamfetamine dimesilate
  • Name: Elvanse Adult®
  • Therapeutic area: Adults with Attention Deficit Hyperactivity Disorder (ADHD)
  • Pharmaceutical company: Shire Deutschland GmbH, now part of Takeda Group

Time table:

  • Start: 01.05.2019
  • Final decision by G-BA: 17.10.2019

Final decision:

  • a) Adults with ADHD since childhood with at least moderate severity and pre-treatment with one medicinal therapy: No additional benefit proven
    b) Adults with ADHD since childhood with at least moderate severity who have not received a medicinal therapy yet: No additional benefit proven

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga®
  • Therapeutic area: Diabetes mellitus type 1
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.05.2019
  • Final decision by G-BA: 17.10.2019

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Voretigene neparvovec
  • Name: Luxturna®
  • Therapeutic area: Retinal dystrophy
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.04.2019
  • Final decision by G-BA: 17.10.2019
  • The decision is limited until: 31.12.2021

Final decision:

  • Hint for a considerable additional benefit (orphan drug designation)

Subject:

  • Active Substance: Radium-223 dichloride
  • Name: Xofigo®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 15.04.2019
  • Final decision by G-BA: 17.10.2019

Final decision:

  • Patients with progression of disease after treatment with at least two prior systemic therapy lines: No additional benefit proven
  • Patients for whom no other systemic mCRPC treatment is appropriate: No additional benefit proven

Subject:

  • Active Substance: Glecaprevir/pibrentasvir
  • Name: Maviret®
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 15.04.2019
  • Final decision by G-BA: 17.10.2019

Final decision:

  • Patients with genotype 1, 4, 5, or 6: No additional benefit proven
  • Patients with genotype 2 or 3: No additional benefit proven

Subject:

  • Active Substance: Nintedanib
  • Name: Ofev®
  • Therapeutic area: Idiopathic pulmonary fibrosis (IPF)
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.04.2019
  • Final decision by G-BA: 17.10.2019

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: NSCLC
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Start: 01.04.2019
  • Final decision by G-BA: 19.09.2019

Final decision:

  • Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS): no additional benefit proved
  • Patients with PD-L1 expression < 50 % (TPS): hint for a considerable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: NSCLC
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Start: 01.04.2019
  • Final decision by G-BA: 19.09.2019

Final decision:

  • Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS): hint for a non-quantifiable additional benefit
  • Patients with PD-L1 expression < 50 % (TPS): hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Start: 01.04.2019
  • Final decision by G-BA: 19.09.2019
  • The decision remains valid until: 01.04.2024

Final decision:

  • Indication for a non-quantifiable additional benefit

Subject:

  • Active Substance: Galcanezumab
  • Name: Emgality®
  • Therapeutic area: Prophylaxis of migraine
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.04.2019
  • Final decision by G-BA: 19.09.2019

Final decision:

  • Treatment-naïve patients and patients that have responded insufficiently, have not tolerated, or are not suitable for at least one prophylactic medication: no additional benefit proved
  • Patients ineligible, intolerant or irresponsive to any of the above drug classes: no additional benefit proved
  • Patients ineligible, intolerant or irresponsive to any of the above drug classes: hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 15.03.2019
  • Final decision by G-BA: 05.09.2019

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Brentuximab vedotin
  • Name: Adcetris®
  • Therapeutic area: Hodgkin’s lymphoma
  • Pharmaceutical company: Takeda GmbH & Co. KG

Time table:

  • Start: 15.03.2019
  • Final decision by G-BA: 05.09.2019

Final decision:

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

Subject:

  • Active Substance: Lumacaftor/ ivacaftor (new indication: patients at the age of 2 to 5 years)
  • Name: Orkambi®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

  • Start: 15.02.2019
  • Final decision by G-BA: 15.08.2019
  • Decision remains valid until: 01.10.2021

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Blinatumomab (new indication: ALL, MRD-positive patients)
  • Name: Blincyto®
  • Therapeutic area: Acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.02.2019
  • Final decision by G-BA: 15.08.2019

Final decision:

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

Subject:

  • Active Substance: Blinatumomab (new indication: ALL, pediatric patients)
  • Name: Blincyto®
  • Therapeutic area: Acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.02.2019
  • Final decision by G-BA: 15.08.2019

Final decision:

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

Subject:

  • Active Substance: Ipilimumab (new indication: renal cell carcinoma, in combination with nivolumab, 1st line)
  • Name: Yervoy®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.02.2019
  • Final decision by G-BA: 15.08.2019

Final decision:

  • Patients with intermediate risk profile (IMDS score 1-2): Indication for a considerable additional benefit
  • Patients with unfavourable risk profile (IMDS score ≥ 3): Indication for a considerable additional benefit

Subject:

  • Active Substance: Nivolumab (new indication: renal cell carcinoma, in combination with ipilimumab, 1st line)
  • Name: Opdivo®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start:15.02.2019
  • Final decision by G-BA: 15.08.2019

Final decision:

  • Patients with intermediate risk profile (IMDS score 1-2): Indication for a considerable additional benefit
  • Patients with unfavourable risk profile (IMDS score ≥ 3): Indication for a considerable additional benefit

Subject:

  • Active Substance: Lenvatinib (repeal of orphan drug designation)
  • Name: Lenvima®
  • Therapeutic area: Thyroid carcinoma
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 15.02.2019
  • Final decision by G-BA: 15.08.2019

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Regadenoson
  • Name: Rapiscan®
  • Therapeutic area: Measurement of fractional flow reserve (FFR) of stenosis
  • Pharmaceutical company: GE Healthcare Buchler GmbH & Co. KG

Time table:

  • Start: 01.03.2019
  • Final decision by G-BA: 15.08.2019

Final decision:

  • Additional benefit not proved (no dossier submitted)

Subject:

  • Active Substance: Rucaparib
  • Name: Rubraca®
  • Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
  • Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

  • Start: 01.03.2019
  • Final decision by G-BA: 15.08.2019
  • The decision remains valid until: 01.04.2023

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Rucaparib
  • Name: Rubraca®
  • Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
  • Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

  • Start: 01.03.2019
  • Final decision by G-BA: 15.08.2019

Final decision:

  • Additional benefit not proved

Subject:

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

Time table:

  • Start: 01.02.2019
  • Final decision by G-BA: 01.08.2019
  • The decision remains valid until: 01.04.2020

Final decision:

  • Hint for minor additional benefit

Subject:

  • Active Substance: Lanadelumab
  • Name: Takhzyro®
  • Therapeutic area: Hereditary Angioedemas
  • Pharmaceutical company: Shire Deutschland GmbH, part of the Takeda Group

Time table:

  • Start: 01.02.2019
  • Final decision by G-BA: 01.08.2019

Final decision:

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

Subject:

  • Active Substance: Mexiletine
  • Name: Namuscla®
  • Therapeutic area: Myotonic Disorders
  • Pharmaceutical company: Lupin Europe GmbH

Time table:

  • Start: 01.02.2019
  • Final decision by G-BA: 01.08.2019

Final decision:

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

Subject:

  • Active Substance: Glycerol phenylbutyrate
  • Name: Ravicti®
  • Therapeutic area: Urea cycle disorders
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019

Final decision:

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

Subject:

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

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Bedaquilin
  • Name: Sirturo®
  • Therapeutic area: Tuberculosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019
  • This decision remains valid until: 30.06.2021

Final decision:

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

Subject:

  • Active Substance: Melatonin
  • Name: Slenyto®
  • Therapeutic area: Insomnia
  • Pharmaceutical company: InfectoPharm Arzneimittel und Consilium GmbH

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019
  • This decision remains valid until: 01.03.2022

Final decision:

  • A) For women who are not pre-treated with an endocrine therapy:
  • A1) post-menopausal women: no additional benefit proved
  • A2) pre- and peri-menopausal women: no additional benefit proved
  • B) For women who are pre-treated with an endocrine therapy:
  • B1) post-menopausal women with progress after endocrine therapy: no additional benefit proved
  • B2) pre- and peri-menopausal women with progress after endocrine therapy: no additional benefit proved

Subject:

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

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019
  • This decision remains valid until: 01.03.2022

Final decision:

  • A) For women who are not pre-treated with an endocrine therapy:
  • A2) pre- and peri-menopausal women: no additional benefit proved
  • B) For women who are pre-treated with an endocrine therapy:
  • B2) pre- and peri-menopausal women with progress after endocrine therapy: no additional benefit proved

Subject:

  • Active Substance: Doravirine/ lamivudine/ tenofovir disproxil
  • Name: Delstrigo®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: MSD SHARH & DOHME GMBH

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019

Final decision:

  • Therapy-naïve patients: no additional benefit proved
  • Pre-treated patients: no additional benefit proved

Subject:

  • Active Substance: Doravirine
  • Name: Pifeltro®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: MSD SHARH & DOHME GMBH

Time table:

  • Start: 15.01.2019
  • Final decision by G-BA: 04.07.2019

Final decision:

  • Therapy-naïve patients: no additional benefit proved
  • Pre-treated patients: no additional benefit proved

 

Ansprechpartner

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