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Ongoing (preliminary decision published)

Subject:

  • Active Substance: Diroximel fumarate
  • Name: Vumerity®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Biogen GmbH

Time table:

  • Start: 01.01.2022
  • Publication of assessment: 01.04.2022
  • End of public hearing: 22.04.2022
  • Final decision by G-BA: Temporarily suspended

Comparative therapy:

  • Interferon β-1a or interferon β-1b or glatiramer acetate or dimethyl fumarate or teriflunomide or ocrelizumab, taking into account the drugs' approval

Subject:

  • Active Substance: Anifrolumab
  • Name: Saphnelo®
  • Therapeutic area: Systemic lupus erythematosus (SLE)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.04.2022
  • Publication of assessment: 01.07.2022
  • End of public hearing: 22.07.2022
  • Final decision by G-BA: middle of September 2022

Comparative therapy:

  • Belimumab

Subject:

  • Active Substance: Glucarpidase
  • Name: Voraxaze®
  • Therapeutic area: Toxic methotrexate plasma concentration
  • Pharmaceutical company: SERB GmbH

Time table:

  • Start: 15.04.2022
  • Publication of assessment: 15.07.2022
  • End of public hearing: 05.08.2022
  • Final decision by G-BA: beginning of October 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

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

Time table:

  • Start: 15.04.2022
  • Publication of assessment: 15.07.2022
  • End of public hearing: 05.08.2022
  • Final decision by G-BA: beginning of October 2022

Comparative therapy:

  • A patient-individual therapy depending on previous therapies choosing from
    - high-dose ICS and LABA and LAMA, if appropriate OR
    - high-dose ICS and LABA and, if appropriate, LAMA and omalizumab, provided that the criteria necessary for the use of omalizumab are met

Subject:

  • Active Substance: Casirivimab / imdevimab
  • Name: Ronapreve®
  • Therapeutic area: COVID-19 infection
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.04.2022
  • Publication of assessment: 15.07.2022
  • End of public hearing: 05.08.2022
  • Final decision by G-BA: beginning of October 2022

Comparative therapy:

  • Therapy at the physician's discretion

Subject:

  • Active Substance: Casirivimab / imdevimab
  • Name: Ronapreve®
  • Therapeutic area: COVID-19 infection
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.04.2022
  • Publication of assessment: 15.07.2022
  • End of public hearing: 05.08.2022
  • Final decision by G-BA: beginning of October 2022

Comparative therapy:

  • Watchful waiting

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Squamous cell carcinoma of the esophagus
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • Cisplatin in combination with 5-fluorouracil

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Squamous cell carcinoma of the esophagus
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • Cisplatin in combination with 5-fluorouracil

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Urothelial carcinoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • Adult patients eligible for cisplatin-containing therapy for adjuvant treatment:
    Cisplatin + gemcitabine OR cisplatin + methotrexate
  • Adult patients not eligible for cisplatin-containing therapy for adjuvant treatment:
    Watchful waiting

Subject:

  • Active Substance: Doravirine
  • Name: Pifeltro®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • Treatment-naïve adolescents: Tenofovir alafenamide + emtricitabine OR abacavir + lamivudine OR abacavir + emtricitabine, each in combination with
    • dolutegravir OR
    • atazanavir / ritonavir OR
    • darunavir / ritonavir OR
    • elvitegravir / cobicistat
  • Treatment-experienced adolescents: A patient-individual antiretroviral therapy using the approved agents depending on previous therapy(ies) and the reason for the change in therapy, in particular therapy failure due to virological failure and any associated development of resistance or due to side effects

Subject:

  • Active Substance: Doravirine / lamivudine / tenofovir disoproxil
  • Name: Delstrigo®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • A patient-individual antiretroviral therapy using the approved agents depending on previous therapy(ies) and the reason for the change in therapy, in particular therapy failure due to virological failure and any associated development of resistance or due to side effects.

Subject:

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

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • a1) Postmenopausal women:
    An aromatase inhibitor (anastrozole or letrozole) alone, in case aromatase inhibitors are not suitable tamoxifen, if appropriate OR an aromatase inhibitor (anastrozole or exemestane) in sequence after tamoxifen
  • a2) Premenopausal women: tamoxifen (if necessary, in addition with ovarian function elimination)
  • a3) Men: tamoxifen

Subject:

  • Active Substance: Brolucizumab
  • Name: Beovu®
  • Therapeutic area: Visual impairment due to diabetic macular edema
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • Ranibizumab or aflibercept

Subject:

  • Active Substance: Tebentafusp
  • Name: Kimmtrak®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Immunocore Ireland Ltd.

Time table:

  • Start: 01.05.2022
  • Publication of assessment: 01.08.2022
  • End of public hearing: 22.08.2022
  • Final decision by G-BA: middle of October 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Sotrovimab
  • Name: Xevudy®
  • Therapeutic area: Coronavirus disease 2019 (COVID-19)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.05.2022
  • Publication of assessment: 15.08.2022
  • End of public hearing: 05.09.2022
  • Final decision by G-BA: beginning of November 2022

Comparative therapy:

  • Therapy at the physician's discretion

Subject:

  • Active Substance: Voxelotor
  • Name: Oxbryta®
  • Therapeutic area: Sickle cell disease
  • Pharmaceutical company: Global Blood Therapeutics Germany GmbH

Time table:

  • Start: 15.05.2022
  • Publication of assessment: 15.08.2022
  • End of public hearing: 05.09.2022
  • Final decision by G-BA: beginning of November 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Axicabtagen-Ciloleucel
  • Name: Yescarta®
  • Therapeutic area: Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL)
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.05.2022
  • Publication of assessment: 15.08.2022
  • End of public hearing: 05.09.2022
  • Final decision by G-BA: beginning of November 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Tisagenlecleucel
  • Name: Kymriah®
  • Therapeutic area: follicular lymphoma (FL)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.06.2022
  • Publication of assessment: 01.09.2022
  • End of public hearing: 22.09.2022
  • Final decision by G-BA: beginning of December 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Polatuzumab vedotin
  • Name: Polivy®
  • Therapeutic area: diffuse large B-cell lymphoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.06.2022
  • Publication of assessment: 01.09.2022
  • End of public hearing: 22.09.2022
  • Final decision by G-BA: beginning of December 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Cabozantinib
  • Name: Cabometyx®
  • Therapeutic area: thyroid carcinoma
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 01.06.2022
  • Publication of assessment: 01.09.2022
  • End of public hearing: 22.09.2022
  • Final decision by G-BA: beginning of December 2022

Comparative therapy:

  • A patient-individual therapy depending on prior therapies and general health choosing from:
    - Sorafenib,
    - lenvatinib and
    - best supportive care

Subject:

  • Active Substance: Setmelanotide
  • Name: Imcivree®
  • Therapeutic area: obesity and the control of hunger
  • Pharmaceutical company: Rhythm Pharmaceuticals Inc.

Time table:

  • Start: 01.06.2022
  • Publication of assessment: 01.09.2022
  • End of public hearing: 22.09.2022
  • Final decision by G-BA: beginning of December 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Enfortumab vedotin
  • Name: Padcev®
  • Therapeutic area: urothelial cancer (UC)
  • Pharmaceutical company: Astellas Pharma Europe B.V.

Time table:

  • Start: 01.06.2022
  • Publication of assessment: 01.09.2022
  • End of public hearing: 22.09.2022
  • Final decision by G-BA: beginning of December 2022

Comparative therapy:

  • Patients who are eligible for a chemotherapy:
    • Vinflunine monotherapy OR
    • cisplatin in combination with gemcitabine
  • Patients who are not eligible for a chemotherapy:
    • Best supportive care

 

Completed (final decision published)

Subject:

  • Active Substance: Avapritinib
  • Name: Ayvakyt®
  • Therapeutic area: Systemic mastocytosis
  • Pharmaceutical company: Blueprint Medicines (Germany) GmbH

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Somatrogon
  • Name: Ngenla®
  • Therapeutic area: Hormonal growth disturbance
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Final decision:

  • Previous decisions remain valid

Subject:

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

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Pegcetacoplan
  • Name: Aspaveli®
  • Therapeutic area: Paroxysmal nocturnal hemoglubinuria (PNH)
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Idebenone
  • Name: Raxone®
  • Therapeutic area: Leber's hereditary optic neuropathy (LHON)
  • Pharmaceutical company: Chiesi GmbH

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Empagliflozin
  • Name: Jardiance®
  • Therapeutic area: Heart failure
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Final decision:

  • Hint for a minor additional benefit

Subject:

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

Time table:

  • Start: 01.04.2022
  • Final decision by G-BA: 15.09.2022

Comparative therapy:

  • Proof for a considerable additional benefit

Subject:

  • Active Substance: Vedolizumab
  • Name: Entyvio®
  • Therapeutic area: Antibiotic-resistant pouchitis
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 01.03.2022
  • Final decision by G-BA: 01.09.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tepotinib
  • Name: Tepmetko®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Merck Europe B.V.

Time table:

  • Start: 01.03.2022
  • Final decision by G-BA: 01.09.2022

Final decision:

  • Patients with a PD-1/PD-L1 antibody monotherapy as first line therapy:
    • No additional benefit proved
  • Patients with a platinum-containing chemotherapy as first line therapy:
    • No additional benefit proved
  • Patients with either a PD-1/PD-L1 antibody in combination with a platinum-containing chemotherapy or a sequential therapy with a PD-1/PD-L1 antibody and a platinum-containing chemotherapy as first line therapy:
    • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.03.2022
  • Final decision by G-BA: 01.09.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Brivaracetam
  • Name: Briviact®
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: UCB Pharma GmbH

Time table:

  • Start: 01.03.2022
  • Final decision by G-BA: 01.09.2022

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: 15.02.2022
  • Final decision by G-BA: 04.08.2022

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: 15.02.2022
  • Final decision by G-BA: 04.08.2022

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: 15.02.2022
  • Final decision by G-BA: 04.08.2022

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: 15.02.2022
  • Final decision by G-BA: 04.08.2022

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: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Sotorasib
  • Name: Lumykras®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Amgen Europe B.V.

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • Patients with PD-1/PD-L1 antibody monotherapy as first line therapy:
    No additional benefit proved
  • Patients with a cytotoxic chemotherapy as first line therapy:
    No additional benefit proved
  • Patients with either a PD-1/PD-L1 antibody in combination with a platinum-based chemotherapy or a sequential therapy with a PD-1/PD-L1 antibody and a platinum-based chemotherapy as first line therapy:
    No additional benefit proved

Subject:

  • Active Substance: Avacopan
  • Name: Tavneos®
  • Therapeutic area: Granulomatosis with polyangiitis or microscopic polyangiitis
  • Pharmaceutical company: Vifor Pharma Deutschland GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • HInt for a minor additional benefit

Subject:

  • Active Substance: Ivacaftor / tezacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: beginning of August 2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / texacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / texacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / texacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Ivacaftor / texacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Sofosbuvir
  • Name: Epclusa®
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.02.2022
  • Final decision by G-BA: 04.08.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Duvelisib
  • Name: Copiktra®
  • Therapeutic area: Chronic lymphatic leukemia
  • Pharmaceutical company: Secura Bio Limited

Time table:

  • Start: 01.02.2022
  • Final decision by G-BA: 21.07.2022

Final decision:

  • Patients who have not yet received a BTK inhibitor and/or BCL2 inhibitor:
    • No additional benefit proved
  • After prior therapy with at least one BTK inhibitor:
    • No additional benefit proved
  • After prior therapy with at least one BCL2 inhibitor:
    • No additional benefit proved
  • After prior therapy with at least one BTK inhibitor and one BCL2 inhibitor:
    • No additional benefit proved

Subject:

  • Active Substance: Duvelisib
  • Name: Copiktra®
  • Therapeutic area: Follicular lymphoma
  • Pharmaceutical company: Secura Bio Limited

Time table:

  • Start: 01.02.2022
  • Final decision by G-BA: 21.07.2022

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.02.2022
  • Final decision by G-BA: 21.07.2022

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.02.2022
  • Final decision by G-BA: 21.07.2022

Final decision:

  • HInt for a non-quantifiable additional benefit

Subject:

  • Active Substance: Isoflurane
  • Name: Sedaconda®
  • Therapeutic area: Sedation of mechanically ventilated patients during intensive care
  • Pharmaceutical company: Sedana Medical AB

Time table:

  • Start: 01.02.2022
  • Final decision by G-BA: 21.07.2022

Final decision:

  • No additional benefit

Subject:

  • Active Substance: Calcifediol
  • Name: Rayaldee®
  • Therapeutic area: Secondary hyperparathyreoidism in chronic renal failure
  • Pharmaceutical company: Fresenius Medical Care Nephrologica Deutschland GmbH

Time table:

  • Start: 01.02.2022
  • Final decision by G-BA: 21.07.2022

No additional benefit proved:

  • No additional benefit proved

Subject:

  • Active Substance: Remdesivir
  • Name: Veklury®
  • Therapeutic area: Coronavirus disease 2019 (COVID-19)
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 07.07.2022

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Amivantamab
  • Name: Rybrevant®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 07.07.2022

Final decision:

  • Patients who are eligible for another chemotherapy:
    • No additional benefit proved
  • Patients who are not eligible for another chemotherapy:
    • No additional benefit proved

Subject:

  • Active Substance: Abrocitinib
  • Name: Cibinqo®
  • Therapeutic area: Atopic dermatitis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 07.07.2022

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Endometrial carcinoma
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 07.07.2022

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Lenvatinib
  • Name: Lenvima®
  • Therapeutic area: Endometrial carcinoma
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 07.07.2022

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Lenvatinib
  • Name: Kisplyx®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 07.07.2022

Final decision:

  • Patients with a favorable risk profile (IMDC Score 0):
    • No additional benefit proved
  • Patients with an intermediary (IMDC Risk Score 1-2) favorable risk profile (IMDC Score ≥ 3):
    • No additional benefit proved

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.01.2022
  • Final decision by G-BA: 07.07.2022

Final decision:

  • Patients with a favorable risk profile (IMDC Score 0):
    • No additional benefit proved
  • Patients with an intermediary (IMDC Risk Score 1-2) favorable risk profile (IMDC Score ≥ 3):
    • No additional benefit proved

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga®
  • Therapeutic area: Type 2 diabetes mellitus
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.12.2021
  • Final decision by G-BA: 16.06.2022

Final decision:

  • Insulin-naive children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate glycemic control with their current drug therapy consisting of at least one blood glucose-lowering drug in addition to diet and exercise:
    No additional benefit proved
  • Insulin-experienced children aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate glycemic control with their previous insulin regimen in addition to diet and exercise:
    No additional benefit proved

Subject:

  • Active Substance: Ozanimod
  • Name: Zeposia®
  • Therapeutic area: Ulcerative colitis
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.12.2021
  • Final decision by G-BA: 16.06.2022

Final decision:

  • Adult patients who have an intolerance or contraindication to conventional therapy:
    No additional benefit proved
  • Adult patients who are intolerant or have an inadequate or no response to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor):
    No additional benefit proved

Subject:

  • Active Substance: Zanubrutinib
  • Name: Brukinsa®
  • Therapeutic area: Waldenström's macroglobulinemia
  • Pharmaceutical company: BeiGene Germany GmbH

Time table:

  • Start: 15.12.2021
  • Final decision by G-BA: 16.06.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Ankylosing spondylitis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.12.2021
  • Final decision by G-BA: 16.06.2022

Final decision:

  • a1) Adult patients who have had an inadequate response to conventional therapy: No additional benefit proved
  • a2) Adult patients who have had an inadequate response to, or intolerance to, prior biologic antirheumatic drug (bDMARD) therapy: No additional benefit proved

Subject:

  • Active Substance: Pralsetinib
  • Name: Gavreto®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Roche Registration GmbH

Time table:

  • Start: 15.12.2021
  • Final decision by G-BA: 16.06.2022

Final decision:

  • Adult patients with PD-L1 expression ≥ 50% of tumor cells; first-line therapy: No additional benefit proved
  • Adult patients with PD-L1 expression ≤ 50% of tumor cells; first-line therapy: No additional benefit proved
  • Adult patients after first-line therapy with a PD-1/PD-L1 antibody as monotherapy: No additional benefit proved
  • Adult patients after first-line therapy with cytotoxic chemotherapy: No additional benefit proved
  • Adult patients after first-line therapy with a PD-1/PD-L1 antibody in combination with platinum-containing chemotherapy or after sequential therapy with a PD-1/PD-L1 antibody and platinum-containing chemotherapy: No additional benefit proved

Subject:

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

Time table:

  • Start: 01.01.2022
  • Final decision by G-BA: 16.06.2022

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Evolocumab
  • Name: Repatha®
  • Therapeutic area: Primary hypercholesterolemia or mixed dislipidemia
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.01.2022
  • Final decision by G-BA: 16.06.2022

Final decision:

  • Patients with heterozygous familial hypercholesterolemia (HeFH)
    a1) Patients aged 10 to 17 years for whom dietary and medical options for lipid lowering have not been exhausted:
    No additional benefit proved
    a2) Patients aged 10 to 17 years for whom dietary and medical options for lipid lowering have been exhausted: No additional benefit proved
  • Patients with homozygous familial hypercholesterolemia (HoFH)
    b1) Patients aged 10 or 11 years for whom dietary and medical options for lipid lowering have not been exhausted:
    No additional benefit proved
    b2) Patients aged 10 or 11 years for whom dietary and medical options for lipid lowering have been exhausted: No additional benefit proved

Subject:

  • Active Substance: Ripretinib
  • Name: Qinlock®
  • Therapeutic area: Gastrointestinal stromal tumor (GIST)
  • Pharmaceutical company: Deciphera Pharmaceuticals (Netherlands) B.V.

Time table:

  • Start: 01.01.2022
  • Final decision by G-BA: 16.06.2022

Final decision:

  • Hint for a major additional benefit

Subject:

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

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • Patients who have not yet received initial endocrine therapy: No additional benefit proved
  • Patients who have received initial endocrine therapy: Indication for a minor additional benefit

Subject:

  • Active Substance: Filgotinib
  • Name: Jyseleca®
  • Therapeutic area: Ulcerative colitis
  • Pharmaceutical company: Galapagos Biopharma Germany GmbH

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • Patients who have responded inadequately to conventional therapy, no longer respond to it, or have an intolerance or contraindication:
    No additional benefit proved
  • Patients who have responded inadequately to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor), no longer respond to it, or have an intolerance to a corresponding treatment:
    No additional benefit proved

Subject:

  • Active Substance: Mepolizumab
  • Name: Nucala®
  • Therapeutic area: Eosinophilic granulomatosis with polyangiitis (EGPA)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Mepolizumab
  • Name: Nucala®
  • Therapeutic area: Rhinosinusitis
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • No addtional benefit proved

Subject:

  • Active Substance: Mepolizumab
  • Name: Nucala®
  • Therapeutic area: Hypereosinophilic syndrome
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • Hint for a considerable additional benefi

Subject:

  • Active Substance: Lusutrombopag
  • Name: Mulpleo®
  • Therapeutic area: Thrombocytopenia
  • Pharmaceutical company: Shionogi GmbH

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Sacituzumab Govitecan
  • Name: Trodelvy®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • Indication for a major additional benefit

Subject:

  • Active Substance: Risankizumab
  • Name: Skyrizi®
  • Therapeutic area: Psoriatic arthritis
  • Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • Patients who have had an inadequate response to or have been intolerant of prior disease-modifying antirheumatic (DMARD) therapy: No additional benefit proved
  • Patients who have had an inadequate response to or have not tolerated, prior therapy with disease-modifying biologic antirheumatic drugs (bDMARDs): No additional benefit proved

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Gastric, gastro-esophageal junction (GEJ) or esophageal adenocarcinoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Ertugliflozin
  • Name: Steglatro®
  • Therapeutic area: Type 2 diabetes mellitus
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

    a1) Insulin-naive patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 1 blood glucose-lowering drug:
    No additional benefit proved
    a2) Insulin-naive patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 1 blood glucose-lowering drug:
    No additional benefit proved
    b1) Insulin-naive patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 2 blood glucose-lowering drugs, for whom there is no indication for insulin therapy:
    No additional benefit proved
    b2) Insulin-naive patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of 2 blood glucose-lowering drugs, for whom there is no indication for insulin therapy:
    No additional benefit proved
    c1) Insulin-naive patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of ≥ 2 blood glucose-lowering drugs, who are indicated for an insulin therapy:
    No additional benefit proved
    c2) Insulin-naive patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their current drug therapy consisting of ≥ 2 blood glucose-lowering drugs, who are indicated for an insulin therapy: No additional benefit proved
    d1) Insulin-experienced patients without manifested cardiovascular disease who have not achieved adequate glycemic control with their existing insulin regimen:
    No additional benefit proved
    d2) Insulin-experienced patients with manifested cardiovascular disease who have not achieved adequate glycemic control with their existing insulin regimen:
    No additional benefit proved

Subject:

  • Active Substance: Ponesimod
  • Name: Ponvory®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.12.2021
  • Final decision by G-BA: 19.05.2022

Final decision:

    a1) Patients with EDSS-Score ≤ 3,5: Indication for a minor additional benefit
    a2) Patients with EDSS-Score > 3,5: No additional benefit proved

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.11.2021
  • Final decision by G-BA: 05.05.2022

Final decision:

  • Pembrolizumab in combination with nab-paclitaxel or paclitaxel in comparison to nab-paclitaxel or paclitaxel: Hint for a considerable additional benefit
  • Pembrolizumab in combination with a chemotherapy except for nab-paclitaxel or paclitaxel: No additional benefit proved

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Carcinoma of the esophagus
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.11.2021
  • Final decision by G-BA: 05.05.2022

Final decision:

  • a) Squamous cell carcinoma of the esophagus which is not amenable to curative treatment: Indication for a considerable additional benefit
  • b1) HER2-negative adenocarcinoma of the esophagus which is not amenable to curative treatment: No additional benefit proved
  • b2) HER2-positive adenocarcinoma of the esophagus or gastrointestinal junction which is not amenable to curative treatment: No additional benefit proved

Subject:

  • Active Substance: Elbasvir / grazoprevir
  • Name: Zepatier®
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: Merck Sharp & Dohme B.V.

Time table:

  • Start: 15.11.2021
  • Final decision by G-BA: 05.05.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Delamanid
  • Name: Deltyba®
  • Therapeutic area: Tuberculosis
  • Pharmaceutical company: Otsuka Novel Products GmbH

Time table:

  • Start: 15.11.2021
  • Final decision by G-BA: 05.05.2022

Final decision:

  • Pediatric patients weighing 10 kg or more: Hint for a non-quantifiable additional benefit (orphan drug)
  • Adult patients: Hint for a non-quantifiable additional benefit (orphan drug)

Subject:

  • Active Substance: Cefiderocol
  • Name: Fetcroja®
  • Therapeutic area: Infections caused by aerobic gram-negative pathogens
  • Pharmaceutical company: Shionogi GmbH

Time table:

  • Start: 15.11.2021
  • Final decision by G-BA: 05.05.2022

Final decision:

  • Additional benefit proved (reserve antibiotic)

Subject:

  • Active Substance: Ixazomib
  • Name: Ninlaro®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 01.11.2021
  • Final decision by G-BA: 21.04.2022

Final decision:

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

Subject:

  • Active Substance: Pitolisant
  • Name: Ozawade®
  • Therapeutic area: Obstructive sleep apnoea
  • Pharmaceutical company: Bioprojet Deutschland GmbH

Time table:

  • Start: 01.11.2021
  • Final decision by G-BA: 21.04.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Sofosbuvir / velpatasvir / voxilaprevir
  • Name: Vosevi®
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.10.2021
  • Final decision by G-BA: 07.04.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Albutrepenonacog alfa
  • Name: Idelvion®
  • Therapeutic area: Hemophilia B
  • Pharmaceutical company: CSL Behring GmbH

Time table:

  • Start: 15.10.2021
  • Final decision by G-BA: 07.04.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Peanut protein as defatted powder of Arachis hypogaea L., semen (peanuts)
  • Name: Palforzia®
  • Therapeutic area: Peanut allergy
  • Pharmaceutical company: Aimmune Therapeutics Germany GmbH

Time table:

  • Start: 15.10.2021
  • Final decision by G-BA: 07.04.2022

Final decision:

  • 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: 01.10.2021
  • Final decision by G-BA: 18.03.2022

Final decision:

  • 1) Pediatric patients weighing 10 kg or more with paroxysmal nocturnal hemoglobinuria (PNH) with high disease activity characterized by clinical symptoms of hemolysis: No additional benefit proved
  • 2) Pediatric patients weighing 10 kg or more with paroxysmal nocturnal hemoglobinuria (PNH) who have been receiving eculizumab for ≥ 6 months and are clinically stable: No additional benefit proved

Subject:

  • Active Substance: Lumacaftor / ivacaftor
  • Name: Orkambi®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

  • Start: 01.10.2021
  • Final decision by G-BA: 18.03.2022

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: 01.10.2021
  • Final decision by G-BA: 18.03.2022

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Vosoritide
  • Name: Voxzogo®
  • Therapeutic area: Achondroplasia
  • Pharmaceutical company: BioMarin International Limited

Time table:

  • Start: 01.10.2021
  • Final decision by G-BA: 18.03.2022

Final decision:

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

Subject:

  • Active Substance: Vandetanib
  • Name: Caprelsa®
  • Therapeutic area: Medullary thyroid cancer
  • Pharmaceutical company: Sanofi Aventis Deutschland GmbH

Time table:

  • Start: 01.10.2021
  • Final decision by G-BA: 18.03.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Solriamfetol
  • Name: Sunosi®
  • Therapeutic area: Obstructive sleep apnoea (OSA)
  • Pharmaceutical company: Jazz Pharmaceuticals Ireland Ltd.

Time table:

  • Start: 01.10.2021
  • Final decision by G-BA: 18.03.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Roxadustat
  • Name: Evrenzo®
  • Therapeutic area: Anaemia
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: 15.09.2021
  • Final decision by G-BA: 03.03.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Bimekizumab
  • Name: Bimzelx®
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: UCB Pharma GmbH

Time table:

  • Start: 15.09.2021
  • Final decision by G-BA: 03.03.2022

Final decision:

  • Patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy in the setting of initial systemic therapy: Indication for a minor additional benefit
  • Patients with moderate to severe plaque psoriasis who have had an inadequate response to or have not tolerated systemic therapy: Indication for a minor additional benefit

Subject:

  • Active Substance: Vericiguat
  • Name: Verquvo®
  • Therapeutic area: Chronic heart failure
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 15.09.2021
  • Final decision by G-BA: 03.03.2022

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Odevixibat
  • Name: Bylvay®
  • Therapeutic area: Cholestasis
  • Pharmaceutical company: Albireo Pharma AB

Time table:

  • Start: 15.09.2021
  • Final decision by G-BA: beginning of March 2022
  • This decision remains valid until: 01.06.2027

Final decision:

  • Hint for a minor additional benefit (orphan drug)

Subject:

  • Active Substance: Tafasitamab
  • Name: Minjuvi®
  • Therapeutic area: Diffuse large B-cell lymphoma
  • Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

  • Start: 15.09.2021
  • Final decision by G-BA: 03.03.2022

Final decision:

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

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.09.2021
  • Final decision by G-BA: 03.03.2022

Final decision:

  • a1) Patients with active PJIA for whom previous treatment with disease-modifying antirheumatic drugs (DMARDs) proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib as monotherapy is indicated:
    No additional benefit proved
  • a2) Patients with active PJIA for whom previous treatment with DMARDs proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib in combination with MTX is indicated:
    No additional benefit proved
  • b1) Patients with active PJIA for whom previous treatment with one or more bDMARDs proved inadequate or was not tolerated and treatment with tofacitinib as monotherapy is indicated:
    No additional benefit proved
  • b2) Patients with active PJIA for whom previous treatment with one or more bDMARDs proved inadequate or was not tolerated and treatment with tofacitinib in combination with MTX is indicated:
    No additional benefit proved
  • c1) Patients with juvenile psoriatic arthritis for whom previous treatment with DMARDs proved inadequate:
    No additional benefit proved

Subject:

  • Active Substance: Upadacitinib
  • Name: Rinvoq®
  • Therapeutic area: Atopic dermatitis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

  • Adult patients for which 30 mg upadacitinib is the appropriate dosage:
    - Indication for a considerable additional benefit
  • Adult patients for which 15 mg upadacitinib is the appropriate dosage:
    - No additional benefit proved
  • Adolescents of 12 - < 18 years of age:
    - No additional benefit proved

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga®
  • Therapeutic area: Chronic kidney diaease
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

  • Patients without symptomatic chronic heart failure as a comorbidity:
    - Hint for a considerable additional benefit
  • Patients with symptomatic heart failure as a comorbidity:
    - Hint for a minor additional benefit

Subject:

  • Active Substance: Relugolix / estradiol / norethisterone acetate
  • Name: Ryeqo®
  • Therapeutic area: Uterine fibroids
  • Pharmaceutical company: Gedeon Richter Pharma GmbH

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

  • Patients for whom watchful waiting is the best suited patient-individual therapy:
    - Hint for a considerable additional benefit
  • Patients for whom watchful waiting is not the best suited patient-individual therapy:
    - No additional benefit proved

Subject:

  • Active Substance: Tirbanibulin
  • Name: Klisyri®
  • Therapeutic area: Actinic keratosis
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Rheumatoid arthritis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

  • a1) Patients who do not have unfavorable prognostic factors and for whom previous treatment with disease-modifying antirheumatic drugs (DMARDs) proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib as monotherapy is indicated:
    - No additional benefit proved
  • a2) Patients who do not have unfavorable prognostic factors and for whom previous treatment with DMARDs proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib in combination with MTX is indicated:
    - No additional benefit proved
  • b1) Patients for whom a therapy with biotechnologically manufactured DMARDs (bDMARDs) or target-oriented synthetic DMARDs (tsDMARDs) is indicated for the first time and for whom and treatment with tofacitinib as monotherapy is indicated:
    - No additional benefit proved
  • b2) Patients for whom a therapy with bDMARDs or tsDMARDs is indicated for the first time and for whom treatment with tofacitinib in combination with MTX is indicated:
    - No additional benefit proved
  • c1) Patients for whom previous treatment with one or more bDMARDs and/or tsDMARDs proved inadequate or was not tolerated and treatment with tofacitinib as monotherapy is indicated:
    - No additional benefit proved
  • c2) Patients for whom previous treatment with one or more bDMARDs and/or tsDMARDs proved inadequate or was not tolerated and treatment with tofacitinib in combination with MTX is indicated:
    - No additional benefit proved

Subject:

  • Active Substance: Icosapent ethyl
  • Name: Vazkepa®
  • Therapeutic area: Dyslipidemia
  • Pharmaceutical company: Amarin Pharmaceuticals Ireland Limited

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Migalastat
  • Name: Galafold®
  • Therapeutic area: Fabry disease
  • Pharmaceutical company: Amicus Therapeutics GmbH

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

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

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Oesophageal or gastro-oesophageal junction cancer
  • Pharmaceutical company: Bristol Myers-Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022
  • This decision remains valid until: 01.10.2024

Final decision:

  • Indication for a non-quantifiable additional benefit

Subject:

  • Active Substance: Misoprostol
  • Name: Angusta®
  • Therapeutic area: Labour induction
  • Pharmaceutical company: Norgine GmbH

Time table:

  • Start: 01.09.2021
  • Final decision by G-BA: 17.02.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Selumetinib
  • Name: Koselugo®
  • Therapeutic area: Neurofibromatosis
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.08.2021
  • Final decision by G-BA: 03.2022
  • This decision remains valid until: 01.07.2023

Final decision:

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

Subject:

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

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 03.02.2022

Final decision:

  • a) Patients with one previous therapy containing a proteasome inhibitor and lenalidomide who became refractory towards lenalidomide: No additional benefit proved
  • b1) Patients with ≥ two previous therapies containing a proteasome inhibitor and lenalidomide who showed disease progression during the last therapy: Hint for a minor additional benefit
  • b2) Patients with ≥ two previous therapies containing a proteasome inhibitor and lenalidomide who showed disease progression after the last therapy: No additional benefit proved

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Colorectal cancer (CRC)
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 20.01.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Daratumumab
  • Name: Darzalex®
  • Therapeutic area: Systemic light-chain amyloidosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 20.01.2022
  • This decision remains valid until: 01.03.2025

Final decision:

  • Patients for whom bortezomib in combination with cyclophosphamide and dexamethasone is the patient-individual therapy: Hint for a minor additional benefit
  • Patients for whom another therapy is the patient-individual therapy: No additional benefit proved

Subject:

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

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 20.01.2022

Final decision:

  • Locally advanced basal cell carcinoma (laBCC): Hint for a minor additional benefit
  • Metastatic basal cell carcinoma (mBCC): No additional benefit proved

Subject:

  • Active Substance: Cemiplimab
  • Name: Libtayo®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 20.01.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Blinatumomab
  • Name: Blincyto®
  • Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 20.01.2022

Final decision:

  • Indication for a major additional benefit (orphan drug)

Subject:

  • Active Substance: Teriflunomide
  • Name: Aubagio®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 20.01.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Angiotensin II acetate
  • Name: Giapreza®
  • Therapeutic area: Hypotension
  • Pharmaceutical company: PAION Deutschland GmbH

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tralokinumab
  • Name: Adtralza®
  • Therapeutic area: Atopic dermatitis
  • Pharmaceutical company: Leo Pharma A/S

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Empagliflozin
  • Name: Jardiance®
  • Therapeutic area: Chronic heart failure
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Satralizumab
  • Name: Enspryng®
  • Therapeutic area: Neuromyelitis optica spectrum disorders
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • Hint for a minor additional benefit (orphan drug)

Subject:

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

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Osimertinib
  • Name: Tagrisso®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021
  • This resolution remains valid until: 01.07.2024

Final decision:

  • Patients without prior adjuvant platin-based chemotherapy: No additional benefit proved
  • Patients with or who are not eligible for prior adjuvant platin-based chemotherapy: Indication for a non-quantifiable additional benefit

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Malignant pleural mesothelioma (MPM)
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

  • Patients with epithelioid tumor histology: No additional benefit proved
  • Patients without epithelioid tumor histology: Indication for a considerable additional benefit

Subject:

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

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

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

Subject:

  • Active Substance: Cabozantinib
  • Name: Cometriq®
  • Therapeutic area: Thyroid carcinoma
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

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

Subject:

  • Active Substance: Brentuximab
  • Name: Adcetris®
  • Therapeutic area: Anaplastic large cell lymphoma
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

  • Hint for a minor additional benefit (orphan drug)

Subject:

  • Active Substance: Dostarlimab
  • Name: Jemperli®
  • Therapeutic area: Endometrial cancer (EC)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tagraxofusp
  • Name: Elzonris®
  • Therapeutic area: Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
  • Pharmaceutical company: Stemline Therapeutics B.V.

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

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

Subject:

  • Active Substance: Ponesimod
  • Name: Ponvory®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • Patients who did not yet receive disease modifying therapeutics or who did receive disease modifying therapeutics but have not a highly active disease:
    - No decision on additional benefit yet. G-BA updated the comparative therapy and assigned IQWiG to assess the now relevant study. The final decision on additional benefit is due in 6 months.
  • Patients who received disease modifying therapeutics but still have a highly active disease: No additional benefit proved

Subject:

  • Active Substance: Berotralstat
  • Name: Orladeyo®
  • Therapeutic area: Hereditary angioedema (HAE)
  • Pharmaceutical company: BioCryst Pharma Deutschland GmbH

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Venetoclax
  • Name: Venclyxto®
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Bosutinib
  • Name: Bosulif®
  • Therapeutic area: Chronic myelogenous leukemia (CML)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / tezacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / tezacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / tezacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

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: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

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: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

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: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Cenobamate
  • Name: Ontozry®
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: Angelini Pharma Deutschland GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq®
  • Therapeutic area: Lung cancer, non-small cell
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • Patients with PD-L1 expression ≥ 50% on tumour cells (TC) or ≥10% on immune cells (IC), EGFR/ALK-negative: No additional benefit proved
  • Patients with PD-L1 expression < 50% on tumour cells (TC) or ≥10% on immune cells (IC), EGFR/ALK-negative: No additional benefit proved

Subject:

  • Active Substance: Atidarsagene autotemcel OTL-200
  • Name: Libmeldy®
  • Therapeutic area: Metachromatic leukodystrophy
  • Pharmaceutical company: Orchard Therapeutics GmbH

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 04.11.2021
  • The decision remains valid until: 01.07.2024

Final decsion:

  • Children with late infantile or early juvenile stage of MLD without clinical manifestation of the disease:: Hint for a major additional benefit
  • Children with early juvenile stage of MLD with untimely clinical manifestation of the disease, who are able to walk independently, before cognitive deterioration:: Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Cannabidiol
  • Name: Epidyolex®
  • Therapeutic area: Seizures associated with tuberous sclerosis complex (TSC)
  • Pharmaceutical company: GW Pharmaceuticals plc

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

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

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro®
  • Therapeutic area: Follicular lymphoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro®
  • Therapeutic area: Chronic lymphocytic leukemia (CLL)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro®
  • Therapeutic area: Follicular lymphoma (FL)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Onasemnogene abeparvovec
  • Name: Zolgensma®
  • Therapeutic area: Spinal muscular atrophy (SMA)
  • Pharmaceutical company: Novartis Gene Therapies EU Limited

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • Symptomatic patients with 5q-associated SMA type I: No additional benefit proved
  • Symptomatic patients with 5q-associated SMA type II (up to 3 copies of SMN2 gene: No additional benefit proved
  • Symptomatic patients with 5q-associated SMA type III (up to 3 copies of SMN2 gene: No additional benefit proved
  • Pre-symptomatic patients with 5q-associated SMA (up to 3 copies of SMN2 gene: No additional benefit proved

Subject:

  • Active Substance: Lanadelumab
  • Name: Takhzyro®
  • Therapeutic area: Hereditary angioedema
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Isatuximab
  • Name: Sarclisa®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Isatuximab
  • Name: Sarclisa®
  • Therapeutic area: Hereditary angioedema
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

 

Ansprechpartner

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