Here are the latest G-BA decisions from the G-BA meeting held on 4 June 2026 on the early benefit assessments of Opdivo (last one!), Libtayo, Breyanzi, Fabhalta, and Paxlovid.
A database of all previous G-BA resolutions is available in my store.
- Opdivo (nivolumab); urothelial carcinoma, PD-L1 expression ≥ 1%, adjuvant therapy; re-assessment after expiry of previous resolution – Hint of considerable additional benefit
- Libtayo (cemiplimab); new indication: cutaneous squamous cell carcinoma, after resection and radiotherapy, adjuvant therapy – Indication of not-quantifiable additional benefit; Resolution restricted until 1 Nov 2028
- Breyanzi (lisocabtagene maraleucel); new indication: mantle cell lymphoma, after ≥ 2 prior therapies – Additional benefit not proven
- Fabhalta (iptacopan)
- paroxysmal nocturnal haemoglobinuria; Orphan drug, re-assessment after exceeding €30mn annual sales – Additional benefit not proven in both subgroups
- complement-3 glomerulopathy; orphan drug, new indication, exceeding €30mn annual sales – Additional benefit not proven
- Paxlovid (nirmatrelvir/ritonavir); new indication: COVID-19, no need for supplemental oxygen, ≥ 6 years to < 18 years, ≥ 20 kg – Additional benefit not proven
- Jaypirca (pirtobrutinib); relapsed or refractory mantle cell lymphoma – Request for RWE data collection and prescribing restriction
- Anktiva (nogapendekin alfa Inbakicept); bladder cancer – G-BA assesses whether RWE should be requested