Current benefit assessments

These are the current benefit assessments in Germany. For more information follow substances ›› or contact us.

 

Ongoing (preliminary decision published)

Subject:

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

Time table:

  • Start: 01.02.2020
  • Publication of assessment: 04.05.2020
  • End of public hearing: 25.05.2020
  • Final decision by G-BA: expected for the middle of July 2020

Comparative therapy:

Monotherapy

a) monotherapy: sulfonyl urea (glibenclamide or glimepiride)

Combination therapy

b) in combination with another antidiabetic (except for 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) or
  • Human insulin, if metformin is not appropriate due to intolerance or contraindication according to the SmPC

c) in combination with two other antidiabetics (except for insulin):

  • insulin + metformin or
  • insulin + empagliflozin or
  • insulin + liraglutide (liraglutide and empagliflozin only in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease or
  • Human insulin, if the specified combination partners are not appropriate due to intolerance or contraindication or advanced diabetes mellitus type 2 according to the SmPC

d) in combination with insulin (with or w/o another antidiabetic): optimization of human insulin regimen (+ metformin or empagliflozin or liraglutide, if appropriate) (liraglutide and empagliflozin in combination with standard of care of treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)

Subject:

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

Time table:

  • Start: 01.02.2020
  • Publication of assessment: 04.05.2020
  • End of public hearing: 25.05.2020
  • Final decision by G-BA: expected for the middle of July 2020

Comparative therapy:

  • insufficiency pretreated patients with one standard DMARD and without unfavorable prognostic factors: alternative classical DMARDs (such as MTX, leflunomide) as mono and combination therapy
  • binsufficiently pre-treated patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARD (tsDMARD): bDMARDs or tsDMARDS (adalimumab or abatacept or baricitinib or sarilumab or etanercept or certolizumab pegol or golimumab or tocilizumab or tofacitinib; in combination with MTX, or as monotherapy but only if appropriate)
  • insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs: change of bDMARD(s) or tsDMARD(s) (adalimumab or abatacept or baricitinib or sarilumab or etanercept or certolizumab pegol or golimumab or tocilizumab or tofacitinib; in combination with MTX (as monotherapy only if appropriate) or rituximab for patients with severe rheumatoid arthritis) under consideration of pre-treatment

Subject:

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

Time table:

  • Start: 15.02.2020
  • Publication of assessment: 15.05.2020
  • End of public hearing: 05.06.2020
  • Final decision by G-BA: beginning of August 2020

Comparative therapy:

  • Patients with activating EGFR mutations L858R (exon 21 substitution mutation) or del 19 (exon 19 deletion): afatinib or gefitinib or erlotinib or osimertinib
  • Patients with other activating EGFR mutations than L858R or del 19 (exon 19 deletion): a patient-individual therapy under consideration of the activating EGFR mutation and choosing from:
    - afatinib or gefitinib or erlotinib or osimertinib
    - cisplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed)
    - carboplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed)
    - carboplatin in combination with nab-paclitaxel
    - and
    - monotherapy with gemcitabine or vinorelbine

Subject:

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

Time table:

  • Start: 15.02.2020
  • Publication of assessment: 15.05.2020
  • End of public hearing: 05.06.2020
  • Final decision by G-BA: beginning of August 2020

Comparative therapy:

  • Induction therapy consisting of a bortezomib-dexamethasone-based triple combination therapy at the discretion of the physician
  • followed by high-dose therapy with melphalan, leading to autologous stem cell transplant
  • followed by maintenance therapy consisting of lenalidomide

Subject:

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

Time table:

  • Start: 15.02.2020
  • Publication of assessment: 15.05.2020
  • End of public hearing: 05.06.2020
  • Final decision by G-BA: beginning of August 2020

Comparative therapy:

  • Daratumumab in combination with bortezomib, melphalan, and prednisolone
    OR
  • bortezomib in combination with melphalan and prednisolone
    OR
  • thalidomide in combination with melphalan and prednisone
    OR
  • lenalidomide in combination with dexamethasone

Subject:

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

Time table:

  • Start: 15.02.2020
  • Publication of assessment: 15.05.2020
  • End of public hearing: 05.06.2020
  • Final decision by G-BA: beginning of August 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.02.2020
  • Publication of assessment: 15.05.2020
  • End of public hearing: 05.06.2020
  • Final decision by G-BA: beginning of August 2020

Comparative therapy:

  • Patients with SPMS with relapses: interferon beta-1a or interferon beta-1b or ocrelizumab
  • Patients with SPMS without relapses: best supportive care

Subject:

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

Time table:

  • Start: 15.02.2020
  • Publication of assessment: 15.05.2020
  • End of public hearing: 05.06.2020
  • Final decision by G-BA: beginning of August 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.03.2020
  • Publication of assessment: 02.06.2020
  • End of public hearing: 23.06.2020
  • Final decision by G-BA: middle of August 2020

Comparative therapy:

  • 1. post-menopausal women who are not pre-treated with an endocrine therapy: anastrozole OR letrozole OR fulvestrant OR tamoxifen (if appropriate, only if aromatase inhibitors are not indicated)
  • 1. post-menopausal women who are pre-treated with an endocrine therapy: another endocrine therapy under consideration of prior treatments with:
    • tamoxifen OR
    • anastrozole OR
    • fulvestrant (only for patients with recurrence or progress after anti-estrogen treatment) OR
    • letrozole (only for patients with recurrence or progress after anti-estrogen treatment) OR
    • exemestane (only for patients with progress after anti-estrogen treatment) OR
    • everolimus in combination with exemestane (only for patients without symptomatic visceral metastasis after progress with a non-steroidal aromatase inhibitor)

Subject:

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

Time table:

  • Start: 01.03.2020
  • Publication of assessment: 02.06.2020
  • End of public hearing: 23.06.2020
  • Final decision by G-BA: middle of August 2020

Comparative therapy:

  • Anastrozole OR letrozole OR fulvestrant OR tamoxifen (if appropriate, only when aromatase inhibitors are not indicated)

Subject:

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

Time table:

  • Start: 01.03.2020
  • Publication of assessment: 02.06.2020
  • End of public hearing: 23.06.2020
  • Final decision by G-BA: middle of August 2020

Comparative therapy:

  • Conventional androgen deprivation therapy (ADT) in combination with docetaxel and prednisone or prednisolone (only for patients with distant metastasis (M1) and good general health status (accord. to ECOG/WHO 0–1 or Karnofsky Index ≥ 70%) OR
  • conventional androgen deprivation therapy (ADT) in combination with abiraterone acetate and prednisone or prednisolone (only for patients with newly diagnosed high-risk-mHSPC)

Subject:

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

Time table:

  • Start: 01.03.2020
  • Publication of assessment: 02.06.2020
  • End of public hearing: 23.06.2020
  • Final decision by G-BA: middle of August 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 15.06.2020
  • End of public hearing: 06.07.2020
  • Final decision by G-BA: beginning of September 2020

Comparative therapy:

  • a) as initial endocrine therapy: anastrozole or letrozole or fulvestrant or tamoxifen (if appropriate, i.e. only when aromatase inhibitors are not indicated)
  • b) with endocrine therapy pre-treated
  • b1) for postmenopausal women: tamoxifen or anastrozole or fulvestrant (only for patients with relapse or progress after estrogen therapy) or letrozole (only for patients with relapse or progress after anti estrogen therapy) or everolimus in combination with exemestane (only for patients without symptomatic visceral metastasis, after progress with a non-steroidal aromatase inhibitor)
    b2) for pre- and perimenopausal women: endocrine therapy at the physician's discretion (approved are: tamoxifen, letrozole, exemestane, megestrol acetate and medroxyprogesterone acetate)

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 15.06.2020
  • End of public hearing: 06.07.2020
  • Final decision by G-BA: beginning of September 2020

Comparative therapy:

  • Best supportive care

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 15.06.2020
  • End of public hearing: 06.07.2020
  • Final decision by G-BA: beginning of September 2020

Comparative therapy:

  • Patient-individual optimized medicinal therapy under consideration of previous therapies and health status, considering the following:
    – Endothelin receptor antagonists (ambrisentan, bosentan, macitentan)
    – Phosphodiesterase type 5 (PDE₅) inhibitors (sildenafil, tadalafil)
    – Prostacyclin analogs (PGI₂) (iloprost)
    – Selective prostacyclin receptor analogs (selexipag)

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 15.06.2020
  • End of public hearing: 06.07.2020
  • Final decision by G-BA: beginning of September 2020

Comparative therapy:

  • a) Patients with mild C. difficile-associated diarrhea (CDAD) that requires treatment: metronidazole or vancomycin
  • b) Patients with severe or recurrent CDAD: vancomycin

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 15.06.2020
  • End of public hearing: 06.07.2020
  • Final decision by G-BA: beginning of September 2020

Comparative therapy:

  • Alendronic acid or risedronic acid or zoledronic acid or denosumab or teriparatide

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 15.06.2020
  • End of public hearing: 06.07.2020
  • Final decision by G-BA: beginning of September 2020

Comparative therapy:

  • Ranibizumab or aflibercept

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • A patient-individual antibiotic therapy considering the following:
    - local spectrum of pathogens
    - (local) resistance profile
    - risk for infections with multi-drug-resistant pathogens according to general accepted status of scientific knowledge
    - sensitivity of pathogens (when antibiogram is available)

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • A patient-individual antibiotic therapy considering the following:
    - local spectrum of pathogens
    - (local) resistance profile
    - risk for infections with multi-drug-resistant pathogens according to general accepted status of scientific knowledge
    - sensitivity of pathogens (when antibiogram is available)

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • A patient-individual antibiotic therapy considering the following:
    - local spectrum of pathogens
    - (local) resistance profile
    - risk for infections with multi-drug-resistant pathogens according to general accepted status of scientific knowledge
    - sensitivity of pathogens (when antibiogram is available)

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • A patient-individual antibiotic therapy considering the following:
    - local spectrum of pathogens
    - (local) resistance profile
    - risk for infections with multi-drug-resistant pathogens according to general accepted status of scientific knowledge
    - sensitivity of pathogens (when antibiogram is available)

Subject:

  • Active Substance: Tisagene lecleucel
  • Name: Kymriah®
  • Therapeutic area: Acute lymphocytic leukaemia
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 15.03.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

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

Time table:

  • Start: 01.04.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • Ritonavir

Subject:

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

Time table:

  • Start: 01.04.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • Watchful waiting with continuation of existing conventional androgen deprivation therapy (ADT)

Subject:

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

Time table:

  • Start: 01.04.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • Best supportive care

Subject:

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

Time table:

  • Start: 01.04.2020
  • Publication of assessment: 01.07.2020
  • End of public hearing: 22.07.2020
  • Final decision by G-BA: middle of September 2020

Comparative therapy:

  • Therapy at the physician`s discretion

 

Completed (final decision published)

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Hint for considerable additional benefit

Subject:

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

Time table:

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

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

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

Final decision:

  • Indication for a considerable additional benefit

Subject:

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

Time table:

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

Final decision:

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

Subject:

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

Time table:

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

Final decision:

  • Hint for a considerable additional benefit (orphan drug)

Subject:

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

Time table:

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

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

  • Start: 01.10.2019
  • Final decision by G-BA: 02.04.2020

Final decision:

  • Hint for non-quantifiable additional benefit

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
  • Final decision by G-BA: 02.04.2020

Final decision:

  • Patients with tumor proportion score (TPS ≥ 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors (first-line therapy): no additional benefit proved
  • Patients with TPS < 50% (PD-L1 expression)(first-line therapy) or EGFR mutant or ALK-positive tumors after prior mutation-directed therapy: no additional benefit proved

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
  • Final decision by G-BA: 02.04.2020

Final decision:

  • Patients with tumor proportion score (TPS ≥ 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors: no additional benefit proved
  • Patients with TPS < 50% (PD-L1 expression) and without EGFR mutant or ALK-positive tumors: no additional benefit proved

Subject:

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

Time table:

  • Start: 01.10.2019
  • Final decision by G-BA: 02.04.2020
  • The decision remains valid until: 01.07.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 01.10.2019
  • Final decision by G-BA: 02.04.2020

Final decision:

  • Hint for a non-quantifiable additional benefit (proven because of orphan drug designation). The evidence is not sufficient for a quantification of the additional benefit.

Subject:

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

Time table:

  • Start: 15.10.2019
  • Final decision by G-BA: 02.04.2020
  • The decision remains valid until: 15.10.2020

Final decision:

  • Hint for a non-qunantifiable additional benefit (proven because of orphan drug designation). The evidence is not sufficient for a quantification of the additional benefit.

Subject:

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

Time table:

  • Start: 15.10.2019
  • Final decision by G-BA: 02.04.2020
  • The decision remains valid until: 15.10.2020

Final decision:

  • Hint for a non-qunantifiable additional benefit (proven because of orphan drug designation). The evidence is not sufficient for a quantification of the additional benefit.

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
  • Final decision by G-BA: 02.04.2020
  • The decision remains valid until: 01.10.2020

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 15.10.2019
  • Final decision by G-BA: 02.04.2020

Final decision

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 15.10.2019
  • Final decision by G-BA: 02.04.2020

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

  • Start: 15.10.2019
  • Final decision by G-BA: 02.04.2020

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

  • Start: 15.10.2019
  • Final decision by G-BA: 02.04.2020

Final decision:

  • Infants (younger than 5 years) with perinatal or infantile hypophosphatasia (onset of disease until 6 months of age): hint for a non-quantifiable additional benefit
  • Infants (younger than 5 years) with juvenile hypophosphatasia (onset of disease after 6 months of age): no additional benefit proved
  • Children (older than 5 years), adolescents, or adults with perinatal, infantile or juvenile hypophosphatasia (onset of disease until 18 years of age): no additional benefit proved

Subject:

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

Time table:

  • Start: 15.09.2019
  • Final decision by G-BA: 05.03.2020

Final decision:

  • Treatment-naïve patients or patients pretreated with hydroxycarbamide without resistance or intolerance against hydroxycarbamide: additional benefit not proved
  • Patients pretreated with hydroxycarbamide who are resistant or intolerant against hydroxycarbamide: additional benefit not proved
  • Patients pretreated with hydroxycarbamide who are resistant or intolerant against hydroxycarbamide: Ruxolitinib

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: 15.05.2020

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

 

Please contact

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