Here are the latest G-BA decisions from the G-BA meeting held on 6 March 2025 on the early benefit assessments of Winrevair, Yselty, Tepkinly, and Piasky.
A complete database of all previous G-BA resolutions is in my membership.
- Winrevair (sotatercept); pulmonary arterial hypertension – Orphan drug, but manufacturer requested full assessment – Hint of minor additional benefit
- Yselty (linzagolix); uterine myoma – Additional benefit not proven
- Tepkinly (epcoritamab); relapsed or refractory follicular lymphoma, at least 2 previous therapies – Additional benefit not proven; RWE will not be requested, prescribing is not restricted
- Piasky (crovalimab); paroxysmal nocturnal hemoglobinuria, ≥ 12 years, ≥ 40 kg – Additional benefit not proven across both subgroups
- Ordspono (odronextamab) relapsed or refractory follicular lymphoma, at least 2 previous therapies) – RWE will not be requested, prescribing is not restricted
- Verzenios (abemaciclib); new indication: breast cancer, HR+, HER2-, early with high risk of recurrence, adjuvant, combination with endocrine therapy – Time restriction of previous decision was extended from 1 July 2025 to 1 July 2026
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