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: 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

Subject:

  • Active Substance: Venetoclax
  • Name: Venclyxto®
  • Therapeutic area: Chronic lymphatic leukaemia (CLL)
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 15.04.2020
  • Publication of assessment: 15.07.2020
  • End of public hearing: 05.08.2020
  • Final decision by G-BA: middle of October 2020

Comparative therapy:

  • Treatment-naïve patients who are eligible for fludarabine in combination with cyclophosphamide and rituximab (FCR):
    - fludarabine in combination with cyclophosphamide and rituximab (FCR)
  • Treatment-naïve patients who are ineligible for fludarabine in combination with cyclophosphamide and rituximab (FCR):
    - bendamustine in combination with rituximab or
    - chlorambucil in combination with rituximab and obinutuzumab
  • Treatment-naïve patients with 17p-deletion and/or TP53 mutation or ineligible for chemoimmunotherapy due to other reasons:
    - ibrutinib

Subject:

  • Active Substance: Insulin glargine / lixisenatide
  • Name: Suliqua®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.04.2020
  • Publication of assessment: 15.07.2020
  • End of public hearing: 05.08.2020
  • Final decision by G-BA: middle of October 2020

Comparative therapy:

  • Patients who are insufficiently controlled by treatment with at least 2 blood sugar lowering agents (except insulin):
    - Human insulin + metformin or
    - Human insulin + empagliflozin (in combination with another treatment against cardiovascular risk factors or
    - Human insulin + liraglutide (in combination with another treatment against cardiovascular risk factors or
    - Human insulin, if combination therapies according to the SmPC are not tolerated or contraindicated or not sufficiently active due to advanced diabetes mellitus, type 2
  • Patients who are insufficiently controlled by treatment with insulin (with or without blood sugar lowering agents):
    - Optimisation of human insulin regimen (in combination with metformin or empagliflozin or liraglutide (in combination with another treatment against cardiovascular risk factors), if appropriate

Subject:

  • Active Substance: Givosiran
  • Name: Givlaari®
  • Therapeutic area: Acute hepatic porphyria
  • Pharmaceutical company: Alnylam Germany GmbH

Time table:

  • Start: 15.04.2020
  • Publication of assessment: 15.07.2020
  • End of public hearing: 05.08.2020
  • Final decision by G-BA: middle of October 2020

Comparative therapy:

  • No comparative therapy 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: 01.05.2020
  • Publication of assessment: 03.08.2020
  • End of public hearing: 24.08.2020
  • Final decision by G-BA: middle of October 2020

Comparative therapy:

  • Crizotinib or alectinib

Subject:

  • Active Substance: Darolutamide
  • Name: Nubeqa®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.05.2020
  • Publication of assessment: 03.08.2020
  • End of public hearing: 24.08.2020
  • Final decision by G-BA: middle of October 2020

Comparative therapy:

  • Watchful waiting with continuation of existing conventional androgen-deprivation therapy

Subject:

  • Active Substance: Solriamfetol
  • Name: Sunosi®
  • Therapeutic area: Narcolepsy
  • Pharmaceutical company: Jazz Pharmaceuticals

Time table:

  • Start: 15.05.2020
  • Publication of assessment: 17.08.2020
  • End of public hearing: 07.09.2020
  • Final decision by G-BA: beginning of November 2020

Comparative therapy:

  • Narcolepsy without cataplexy: modafinil or pitolisant
  • Narcolepsy with cataplexy: sodium oxybate or pitolisant

Subject:

  • Active Substance: Enzalutamide
  • Name: Xtandi®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: 15.05.2020
  • Publication of assessment: 17.08.2020
  • End of public hearing: 07.09.2020
  • Final decision by G-BA: beginning of November 2020

Comparative therapy:

  • Watchful waiting with continuation of existing conventional androgen-deprivation therapy

Subject:

  • Active Substance: Apremilast
  • Name: Otezla®
  • Therapeutic area: Behçet’s disease
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.05.2020
  • Publication of assessment: 17.08.2020
  • End of public hearing: 07.09.2020
  • Final decision by G-BA: beginning of November 2020

Comparative therapy:

  • Therapy at the physician's discretion

Subject:

  • Active Substance: Naldemedin
  • Name: Rizmoic®
  • Therapeutic area: Opioid-induced constipation
  • Pharmaceutical company: Hexal AG

Time table:

  • Start: 15.05.2020
  • Publication of assessment: 17.08.2020
  • End of public hearing: 07.09.2020
  • Final decision by G-BA: beginning of November 2020

Comparative therapy:

  • Another laxative not subject to prescription (according to AM-RL annex I nr. 1) or a reimbursable medicinal product for the treatment of constipation (according to AM-RL section J annex V)
  • Patients not eligible for another laxative not subject to prescription or a reimbursable medicinal product for the treatment of constipation: methylnaltrexone, prucalopride or naloxegol

Subject:

  • Active Substance: Ponatinib
  • Name: Iclusig®
  • Therapeutic area: Acute lymphatic leukemia (ALL)
  • Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

  • Start: 01.06.2020
  • Publication of assessment: 01.09.2020
  • End of public hearing: 22.09.2020
  • Final decision by G-BA: middle of November 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

  • Active Substance: Ponatinib
  • Name: Iclusig®
  • Therapeutic area: Chronic myeloid leukemia (CML)
  • Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

  • Start: 01.06.2020
  • Publication of assessment: 01.09.2020
  • End of public hearing: 22.09.2020
  • Final decision by G-BA: middle of November 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

  • Active Substance: Talazoparib
  • Name: Talzenna®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.06.2020
  • Publication of assessment: 01.09.2020
  • End of public hearing: 22.09.2020
  • Final decision by G-BA: middle of November 2020

Comparative therapy:

  • Capecitabin or
  • eribulin or
  • vinorelbine or
  • a therapy containing an anthracycline or a taxane (only for patients who were not yet treated with or who are suitable for another anthracycline or taxane-containing therapy)

Subject:

  • Active Substance: Mogamulizumab
  • Name: Poteligeo®
  • Therapeutic area: Mycosis fungoides; Sézary syndrome
  • Pharmaceutical company: Kyowa Kirin GmbH

Time table:

  • Start: 15.06.2020
  • Publication of assessment: 15.09.2020
  • End of public hearing: 06.10.2020
  • Final decision by G-BA: beginning of December 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

Subject:

  • Active Substance: Brentuximab vedotin
  • Name: Adcetris®
  • Therapeutic area: Non-Hodgkin lymphoma
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.06.2020
  • Publication of assessment: 15.09.2020
  • End of public hearing: 06.10.2020
  • Final decision by G-BA: beginning of December 2020

Comparative therapy:

  • No comparative therapy because of orphan drug designation

 

Completed (final decision published)

Subject:

  • Active Substance: Tisagene lecleucel
  • Name: Kymriah®
  • Therapeutic area: B-cell acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 17.09.2020
  • This decision remains valid until: 01.09.2023

Final decision:

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

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
  • Final decision by G-BA: 17.09.2020
  • This decision remains valid until: 01.09.2023

Final decision:

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

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 17.09.2020

Final decision:

  • Aassessment repealed

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
  • Final decision by G-BA: 17.09.2020

Final decision:

  • Assessment repealed

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
  • Final decision by G-BA: 17.09.2020

Final decision:

  • Assessment repealed

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 17.09.2020

Final decision:

  • Assessment repealed

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 03.09.2020
  • This decision remains valid until:: 01.06.2021

Final decision:

  • a) as initial endocrine therapy: no additional benefit proved
  • b) with endocrine therapy pre-treated
  • b1) for postmenopausal women: hint for a minor additional benefit
    b2) for pre- and perimenopausal women: no additional benefit proved

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 03.09.2020

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 03.09.2020

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 03.09.2020

Final decision:

  • a) Patients with mild C. difficile-associated diarrhea (CDAD) that requires treatment: no additional benefit proved
  • b) Patients with severe and / or recurrent CDAD: hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 03.09.2020

Final decision:

  • Indication for a minor additional benefit

Subject:

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

Time table:

  • Start: 15.03.2020
  • Final decision by G-BA: 03.09.2020
  • This decision remains valid until: 01.11.2023

Final decision:

  • No additional benefit proved

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
  • Final decision by G-BA: 20.08.2020

Final decision:

  • Patients with activating EGFR mutations L858R (exon 21 substitution mutation) or del 19 (exon 19 deletion): no additional benefit proved
  • Patients with other activating EGFR mutations than L858R or del 19 (exon 19 deletion): no additional benefit proved

Subject:

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

Time table:

  • Start: 15.02.2020
  • Final decision by G-BA: 20.08.2020

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 15.02.2020
  • Final decision by G-BA: 20.08.2020

Final decision:

  • Hint for a minor additional benefit

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
  • Final decision by G-BA: 20.08.2020

Final decision:

  • Hint for a non-quantifiable additional benefit due to limited scientific evidence (and orphan drug status)

Subject:

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

Time table:

  • Start: 15.02.2020
  • Final decision by G-BA: beginning of August 2020

Final decision:

  • Patients with SPMS with relapses: no additional benefit proved
  • Patients with SPMS without relapses: no additional benefit proved

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
  • Final decision by G-BA: 20.08.2020

Final decision:

  • Hint for a non-quantifiable additional benefit due to limited scientific evidence (and orphan drug status)

Subject:

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

Time table:

  • Start: 01.03.2020
  • Final decision by G-BA: 20.08.2020

Final decision:

  • Post-menopausal women who are not pre-treated with an endocrine therapy: indication for a minor additional benefit
  • Post-menopausal women who are pre-treated with an endocrine therapy: hint for a minor additional benefit

Subject:

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

Time table:

  • Start: 01.03.2020
  • Final decision by G-BA: 20.08.2020

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

  • Start: 01.03.2020
  • Final decision by G-BA: 20.08.2020

Final decision:

  • No additional benefit proven

Subject:

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

Time table:

  • Start: 01.03.2020
  • Final decision by G-BA: middle of August 2020

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 01.02.2020
  • Final decision by G-BA: 16.07.2020

Final decision:

  • Monotherapy
    a) monotherapy: No additional benefit proved
  • Combination therapy
    b) in combination with another antidiabetic (except for insulin, here: metformin): No additional benefit proved
    c) in combination with two other antidiabetics (except for insulin): No additional benefit proved
    d) in combination with insulin (with or w/o another antidiabetic):
    d1) patients without renal insufficiency: Hint for a minor additional benefit
    d2) patients with moderate or severe renal insufficiency (CKD 3 and 4): Hint for a minor additional benefit

Subject:

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

Time table:

  • Start: 01.02.2020
  • Final decision by G-BA: 16.07.2020

Final decision:

  • a1) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib as monotherapy: No additional benefit proved
  • a2) insufficiently pre-treated patients with one standard DMARD (incl. MTX) and without unfavorable prognostic factors: upadacitinib in combination with MTX: No additional benefit proved
  • b1) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib as monotherapy: No additional benefit proved
  • b2) patients who are treatment-naïve for biotechnologically produced DMARDs (bDMARD) or targeted synthetical DMARDs (tsDMARD), upadacitinib in combination with MTX: Hint for a considerable additional benefit
  • c1) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib as monotherapy: No additional benefit proved
  • c2A) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients with high disease activity [DAS28 CRP > 5.1]: Hint for a minor additional benefit
  • c2B) insufficiently pre-treated patients with one or more bDMARDs and / or tsDMARDs, upadacitinib in combination with MTX, patients without high disease activity [DAS28 CRP ≤ 5.1]: No additional benefit proved

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: 01.02.2021

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
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