Here are the latest G-BA decisions from the G-BA meeting held on 7 May 2026 on the early benefit assessments of Koselugo, Ayvaykt, Voranigo, Tezspire, and Attrogy.
And we saw an unquantifiable additional benefit being assigned based on a single-arm trial!!! The G-BA accepted the benefit of Koselugo in the paediatric indication on reduction in the volume of the target lesion over baseline (27%!), despite the lack of a comparator arm, because a volume reduction of the target lesion is a therapy goal in this indication. Moreover, clinical experts confirmed that no spontaneous remissions would occur in the natural progression of the disease.
A database of all previous G-BA resolutions is available in my store.
- Koselugo; Neurofibromatosis type 1
- patients aged ≥ 3 to < 18 years – Re-assessment of an orphan drug after exceeding the €30 million threshold – Hint of not-quantifiable additional benefit
- patients aged ≥ 18 years – New indication – Indication of minor additional benefit
- Ayvakyt (avapritinib); Indolent systemic mastocytosis (ISM) – Re-assessment of an orphan drug after exceeding the €30 million threshold – Hint of minor additional benefit
- Voranigo (vorasidenib); Astrocytoma or oligodendroglioma, grade 2, IDH1-R132 or IDH2-R172 mutation, after surgical intervention, ≥ 12 years ≥ 40 kg – Orphan drug, Hint of not-quantifiable additional benefit
- Tezspire (tezepelumab); new indication: Chronic rhinosinusitis with nasal polyps – Hint of not-quantifiable additional benefit
- Attrogy (diflunisal); Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2)) – Additional benefit not proven