Here are the latest G-BA decisions from the G-BA meeting held on 7 August 2025 on the early benefit assessments of Sarclisa, Jemperli, Jaypirca, Kevzara, Kavigale, Ofev, Vocabria, and Nemluvio – only one minor additional benefit, otherwise all negative…
A complete database of all previous G-BA resolutions is available in my membership.
- Sarclisa (isatuximab); new indication: multiple myeloma, first-line, unsuitable for stem cell transplantation, in combination with bortezomib, lenalidomide, and dexamethasone – Hint of minor additional benefit
- Jemperli (dostarlimab); new indication: primary advanced or recurrent endometrial cancer with pMMR, in combination with carboplatin and paclitaxel – Additional benefit not proven
- Jaypirca (pirtobrutinib); mantle cell lymphoma, previously treated patients – Additional benefit not proven
- Kevzara (sarilumab); new indication:
- polyarticular juvenile idiopathic arthritis (pJIA), ≥ 2 years – Additional benefit not proven in both subgroups
- polymyalgia rheumatica – Additional benefit not proven
- Kavigale (sipavibart); COVID-19, pre-exposure prophylaxis, ≥ 12 years – Additional benefit not proven in both subgroups
- Ofev (nintedanib); new indication:
- clinically significant progressive fibrosing interstitial lung disease, 6 to < 18 years – Additional benefit not proven
- interstitial lung disease with systemic sclerosis, 6 to <18 years – Additional benefit not proven
- Vocabria (cabotegravir); new indication: HIV-1 infection, treatment-experienced adolescents, in combination with rilpivirine – Additional benefit not proven
- Nemluvio (nemolizumab)
- Atopic dermatitis, ≥12 years – Additional benefit not proven
- Prurigo nodularis – Additional benefit not proven
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