Here are the G-BA decisions from the G-BA meeting held on 21 September 2023 on the early benefit assessments of Nubeqa, Spravato, Reblozyl, Wakix, Dupixent, Trulicity, Lynparza, Rubraca, Ondexxya and Ultomiris.
A complete database of all previous G-BA resolutions is available through my membership.
- Nubeqa (darolutamide); new indication: prostate cancer, metastatic, hormone-sensitive, combination with docetaxel and androgen deprivation therapy – Indication of considerable additional benefit
- Spravato (esketamine); re-assessment after expiry of previous resolution: depression, therapy-resistant, in combination with SSRI or SNRI – Hint of considerable additional benefit
- Reblozyl (luspatercept); new indication: β-thalassemia, non-transfusion-dependent anaemia – Orphan drug, indication of minor additional benefit
- Wakix (pitolisant); new indication: narcolepsy, with or without cataplexy, children and adolescents aged 6 – 17 years – Orphan drug; hint of not-quantifiable additional benefit
- Dupixent (dupilumab); new indication: Atopic dermatitis, 6 months up to 5 years – Hint of not-quantifiable additional benefit in 1 of 2 subgroups
- Dupixent (dupilumab); new indication: Eosinophilic esophagitis, ≥ 12 years, at least 40 kg – Additional benefit not proven
- Trulicity (dulaglutide); new indication: diabetes mellitus type 2, ≥ 10 years – Additional benefit not proven
- Lynparza (olaparib); re-assessment after expiry of previous resolution: ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA- mutated, FIGO stages III and IV, maintenance therapy – Additional benefit not proven
- Rubraca (rucaparib); re-assessment after expiry of previous resolution: ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy – Additional benefit not proven
- Ondexxya (andexanet alfa); reversal of anticoagulation by apixaban or rivaroxaban for life-threatening or uncontrollable bleeding) – time restriction of previous resolution extended to 1 Aug 2024
- Ultomiris (ravulizumab); new indication: Myasthenia gravis, AChR antibodies+ – Removal of time restriction of previous resolution
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