Here are the latest G-BA decisions from the G-BA meeting held on 20 November 2025 on the early benefit assessments of Retsevmo, Scemblix, Tremfya, Xydalba, Translarna, Vydura and Datroway. Retsevmo achieved the highest possible rating – MAJOR ADDITIONAL BENEFIT – in its re-assessment.
A database of all previous G-BA resolutions is available in my store.
- Retsevmo (Selpercatinib); Thyroid cancer, RET-mutated, monotherapy, from 12 years of age; re-assessment after expiry of previous decision: – Indication of major additional benefit
- Scemblix (Asciminib); Chronic myeloid leukemia, Ph+, after ≥ 2 prior therapies; orphan drug, re-assessment after exceeding sales threshold of €30 mn – Indication of minor additional benefit in one of two subgroups
- Tremfya (Guselkumab); new indication
- Ulcerative colitis, previously treated – Additional benefit not proven in both subgroups
- Crohn’s disease, previously treated – Indication of minor additional benefit in one of two subgroups
- Xydalba (Dalbavancin); new indication: Acute bacterial skin and soft tissue infections (ABSSSI), from birth to < 3 months – Reserve antibiotic, Additional benefit deemed proven
- Translarna (Ataluren); Duchenne muscular dystrophy, ≥ 5 years – Cancellation of the decision from 1 December 2016, since regulatory approval was lost
- Vydura (Rimegepant);
- Acute migraine treatment – Additional benefit not proven
- Migraine prophylaxis – Additional benefit not proven in both subgroups
- Datroway (Datopotamab deruxtecan); Breast cancer, HR+, HER2-, after at least 1 prior therapy – Additional benefit not proven in all 3 subgroups
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