Here are the latest G-BA decisions from the G-BA meeting held on 16 October 2025 on the early benefit assessments of Kaftrio, Alhemo, Enhertu, Hetronifly, Emcitate, Keytruda, Augtyro, Wainzua, Lytenava, and Vimizin.
A database of all previous G-BA resolutions is available in my store.
- Kaftrio (Ivacaftor/Tezacaftor/Elexacaftor); new indication: Cystic fibrosis, combination treatment with ivacaftor, ≥ 2 years, non-class I mutation:
- Alhemo (Concizumab);
- haemophilia A, ≥ 12 years, with Factor VIII inhibitors – Additional benefit not proven
- haemophilia B, ≥ 12 years, with Factor IX inhibitors – Hint of considerable additional benefit in one of two subgroups
- Enhertu (Trastuzumab deruxtecan); new indication: breast cancer, HR+, HER2-low or -ultralow, after at least one endocrine therapy – Hint of minor additional benefit
- Hetronifly (Serplulimab); small cell lung cancer, in combination with carboplatin and etoposide, first-line – Orphan drug, Hint of not-quantifiable additional benefit
- Emcitate (Tiratricol); Peripheral thyrotoxicosis due to monocarboxylate transporter 8 deficiency (Allan-Herndon-Dudley syndrome) – Orphan drug, Hint of not-quantifiable additional benefit
- Keytruda (Pembrolizumab); new indication: unresectable non-epithelioid malignant pleural mesothelioma, first-line, in combination with pemetrexed and platinum chemotherapy – Additional benefit not proven
- Augtyro (Repotrectinib);
- solid tumors, NTRK gene fusion, ≥ 12 years – Additional benefit not proven across both subgroups
- non-small cell lung cancer, ROS1-positive – Additional benefit not proven across all three subgroups, Resolution restricted until 1 July 2027
- Wainzua (Eplontersen); hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2) – Additional benefit not proven
- Lytenava (Bevacizumab); Neovascular (wet) age-related macular degeneration (nAMD) – Additional benefit not proven
- Vimizin (Elosulfase alfa); mucopolysaccharidoses (type IVA) – re-assessment of orphan drug after exceeding €30 mn annual sales threshold – Termination of the benefit assessment procedure, since orphan drug status was removed at EMA level
- Amtagvi (Lifileucel); melanoma – Request for RWE data collection removed, as application for marketing authorisation was withdrawn
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