Here are the latest G-BA decisions from the G-BA meeting held on 18 June 2025 on the early benefit assessments of Cerdelga, Balversa, Tevimbra (6 indications!), and Hepcludex.
A complete database of all previous G-BA resolutions is in my membership.
- Cerdelga (eliglustat): new indication: Gaucher disease type 1, ≥ 6 to < 18 years, ≥ 15 kg body weight) – Orphan drug, Hint of not-quantifiable additional benefit
- Balversa (erdafitinib): urothelial carcinoma, FGFR3 alterations, previously treated with a PD-(L)1 inhibitor – Additional benefit not proven across all 3 subgroups
- Tevimbra (tislelizumab):
- oesophageal squamous cell carcinoma, PD-L1 expression TAP score ≥ 5%, first-line, combination with platinum-based chemotherapy – Additional benefit not proven across both subgroups
- oesophageal squamous cell carcinoma, after prior therapy – Additional benefit not proven
- non-small cell lung cancer, after prior therapy – Additional benefit not proven across both subgroups
- non-squamous non-small cell lung cancer, PD-L1 expression ≥ 50%, first-line, combination with pemetrexed and platinum-based chemotherapy – Additional benefit not proven
- squamous non-small cell lung cancer, first-line, combination with carboplatin and either paclitaxel or nab-paclitaxel – Additional benefit not proven across both subgroups
- gastric adenocarcinoma or of the gastroesophageal junction, PD-L1 expression, TAP score ≥ 5, HER2, first-line, combination with platinum and fluoropyrimidine-based chemotherapy – Additional benefit not proven
- Hepcludex (bulevirtide)
- reassessment after expiry of previous resolution: hepatitis delta virus (HDV) infection, HDV RNA positive – Orphan drug, discontinuation of current benefit assessment procedure, product exceeded €30mn annual sales – Full assessment was triggered
- new indication: hepatitis delta virus (HDV) infection, HDV RNA positive, ≥ 3 to < 18 years, ≥ 10 kg body weight – Orphan drug, discontinuation of current benefit assessment procedure, product exceeded €30mn annual sales – Full assessment was triggered
- Columvi (glofitamab): relapsed or refractory diffuse large B-cell lymphoma – Previous suggestion of RWE data collection and restriction of prescribing to participating centres was removed
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