Here are the latest G-BA decisions from the G-BA meeting held on 20 Aug 2026 on the early benefit assessments of Dawnzera, Colxi, Verzenios, Tepezza, Mounjaro, Elucirem and Tibsovo.
A database of all previous G-BA resolutions is available in my store.
- Dawnzera (donidalorsen); Hereditary angioedema, prophylaxis, ≥ 12 years – Hint of minor additional benefit
- Colxi (colchicine); established active substance with new data exclusivity: prophylaxis of ischemic cardiovascular events in patients with atherosclerotic coronary artery disease following myocardial infarction – Hint of minor additional benefit
- Verzenios (abemaciclib); re-assessmend after expiry of previous resolution: Breast cancer, HR+, HER2-, early-stage with high risk of recurrence, adjuvant therapy, in combination with endocrine therapy – Hint of minor additional benefit in one of 3 subgroups (remains unchanged)
- Tepezza (teprotumumab; Thyroid eye disease – Additional benefit not proven in all 3 subgroups
- Mounjaro (tirzepatide); new indication: Type 2 diabetes mellitus, ≥ 10 to < 18 years – Additional benefit not proven
- Elucirem (gadopiclenol); new indication: contrast-enhanced magnetic resonance imaging, 0 to < 2 years – Additional benefit not proven
- Tibsovo (ivosidenib); re-assessment of an orphan drug after exceeding the €30 million threshold:
- Acute myeloid leukaemia with IDH1-R132 mutation, first-line, in combination with azacitidine – Additional benefit not proven
- Cholangiocarcinoma with IDH1-R132 mutation, after at least one prior therapy – Additional benefit not proven