Here are the G-BA decisions from the G-BA meeting held on 20 July 2023 on the early benefit assessments of Enhertu, Imbruvica, Spevigo, Rapiscan, brexucabtagen autoleucel and autologous CD-19 cells.
A complete database of all previous G-BA resolutions is available through my membership.
- Enhertu (trastuzumab deruxtecan); new indication: adenocarcinoma of the stomach or esophagogastric junction, HER2+, after trastuzumab-based therapy – Additional benefit not proven in both subgroups
- Enhertu (trastuzumab deruxtecan); new indication: breast cancer, HER2-low, inoperable or metastatic, previously treated – Indication of considerable additional benefit
- Imbruvica (ibrutinib); new indication: chronic lymphocytic leukaemia, first-line, combination with venetoclax – Additional benefit not proven in both subgroups
- Spevigo (spesolimab); generalized pustular psoriasis, acute treatment – Additional benefit not proven
- Rapiscan (regadenoson) – Annulment of the decision of 15 August 2019
- Brexucabtagen autoleucel; relapsed or refractory B-cell precursor acute lymphocytic leukaemia – No request for RWE collection, no restriction on prescribing
- Autologous anti-CD19-transduced CD3-positive cells; relapsed or refractory mantle cell lymphoma – Review of study protocol and statistical analysis plan for RWE collection
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