Here are the latest G-BA decisions from the G-BA meeting held on 22 Nov 2024 on the early benefit assessments of Voydeya, Aspaveli, Lytgobi, Bimzelx, Vafseo, and Obgemsa.
A complete database of all previous G-BA resolutions is in my membership.
- Voydeya (danicopan); paroxysmal nocturnal hemoglobinuria with residual hemolytic anaemia, add-on therapy to eculizumab or eculizumab – Orphan drug, hint of not-quantifiable additional benefit
- Aspaveli (pegcetacoplan); new indication: Paroxysmal nocturnal hemoglobinuria, previously untreated patients – Orphan drug, hint of not-quantifiable additional benefit
- Lytgobi (futibatinib); cholangiocarcinoma, with FGFR2 fusion or FGFR2 rearrangement, after at least 1 prior therapy – Additional benefit not proven
- Bimzelx (bimekizumab); new indication: Hidradenitis suppurativa (acne inversa) – Additional benefit not proven
- Vafseo (vadadustat); symptomatic anaemia in chronic kidney disease requiring dialysis – Additional benefit not proven
- Obgemsa (vibegron); overactive bladder – suspension of the benefit assessment procedure; manufacturer submitted dossier for reference group assessment, but full benefit assessment is required
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