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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: Zynteglo^TM
• 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)

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: Skyrizi^TM
• 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