Here are the latest G-BA decisions from the G-BA meeting held on 15 May 2025 on the early benefit assessments of Zavicefta, Cravykti, Keytruda, Darzalex, Fasenra, Dupixent and Otezla.
A complete database of all previous G-BA resolutions is in my membership.
- Zavicefta (ceftazidime/avibactam); new indication: Bacterial infections, multiple indications, from birth to < 3 months – Reserve antibiotic; Additional benefit deemed proven
- Carvykti (ciltacabtagene autoleucel); New indication/reassessment of an orphan drug after exceeding the €30 million threshold: Multiple myeloma, after at least one prior therapy, refractory to lenalidomide – Hint of considerable additional benefit in one of two subgroups
- Keytruda (pembrolizumab); new indication: Cervical cancer (stage III to IVA), first-line, in combination with chemoradiotherapy – Indication of not-quantifiable additional benefit
- Keytruda (pembrolizumab); new indication: Endometrial cancer, first-line, in combination with carboplatin and paclitaxel – Additional benefit not proven
- Darzalex (daratumumab); new indication: Multiple myeloma, first-line, suitable for stem cell transplantation, in combination with bortezomib, lenalidomide, and dexamethasone – Additional benefit not proven
- Fasenra (benralizumab); new indication: Eosinophilic granulomatosis with polyangiitis – Additional benefit not proven in both subgroups
- Dupixent (dupilumab); new indication: Eosinophilic esophagitis, patients aged ≥ 1 year to < 12 years – Additional benefit not proven
- Otezla (apremilast); new indication: Moderate to severe plaque psoriasis; patients aged 6 to < 18 years – Additional benefit not proven
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