Here are the G-BA decisions from the G-BA meeting held on 19 October 2023 on the early benefit assessments of Hemgenix, Libtayo, Rinvoq, Talvey, and Adakveo.
A complete database of all previous G-BA resolutions is available through my membership.
- Hemgenix (etranacogene dezaparvovec): Hemophilia B – Orphan drug, Hint of not-quantifiable additional benefit
- Libtayo (cemiplimab); new indication: cervical cancer, previously treated patients – Indication of considerable additional benefit in 1 of 2 subgroups
- Libtayo (cemiplimab); new indication: Non-small cell lung cancer, first-line, PD-L1 expression ≥ 1%, in combination with platinum-based chemotherapy – No additional benefit proven in either subgroup
- Rinvoq (upadacitinib); new indication: Crohn’s disease, previously treated patients – No additional benefit proven in either subgroup
- Talvey (talquetamab): relapsed and refractory multiple myeloma, at least 3 previous therapies – Request for real-world data collection and restriction of prescribing
- Adakveo (crizanlizumab); Removal of decision from 20 May 2021 due to loss of marketing authorization
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