Here are the latest G-BA decisions from the G-BA meeting held on 6 February 2025 on the early benefit assessments of Filspari, Livmarli, Dupixent, Tagrisso, Rozlytrek, and Kigabeq.
A complete database of all previous G-BA resolutions is in my membership.
- Filspari (sparsentan) immunoglobulin A – nephropathy, primary – Orphan drug, Hint of minor additional benefit
- Livmarli (maralixibat); new indication: progressive familial intrahepatic cholestasis (PFIC), patients aged ≥ 3 months – Orphan drug, Hint of not-quantifiable additional benefit
- Dupixent (dupilumab); new indication: COPD – Indication of minor additional benefit in one subgroup, none in the other
- Tagrisso (osimertinib); new indication: non-small cell lung cancer, first line, in combination with pemetrexed and platinum-containing chemotherapy – Additional benefit not proven (IQWiG had recommended lesser benefit here)
- Rozlytrek (entrectinib); new indication: solid tumors, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology-independent, patients aged > 1 month to < 12 years – Additional benefit not proven
- Kigabeq (vigabatrin); revoking decisions from 19 Dec 2019, since the benefit assessment was ruled to be unlawful
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