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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

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: Zynteglo^TM
• 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