Here are the G-BA decisions from the G-BA meeting held on 15 February 2024 on the early benefit assessments of Trodelvy, Lonsurf, Voxzogo, Kymriah, Tecvayli, Refixia, and Galafold.
A complete database of all previous G-BA resolutions is available upon request.
- Trodelvy (sacituzumab govitecan); new indication: breast cancer, HR+, HER2-, at least 3 previous therapies – Indication of considerable additional benefit
- Lonsurf (trifluridine/tipiracil); new indication: colorectal cancer, after 2 previous therapies, in combination with bevacizumab – Hint of considerable additional benefit
- Voxzogo (vosoritide); re-assessment of orphan drug after exceeding the €30 million sales limit, achondroplasia, patients aged ≥ 2 years – Indication of not-quantifiable additional benefit
- Kymriah (tisagenlecleucel); re-assessment of orphan drug after expiry of previous decision: diffuse large B-cell lymphoma (DLBCL) – Hint of not-quantifiable additional benefit
- Kymriah (tisagenlecleucel); re-assessment of orphan drug after expiry of previous decisions: B-cell acute lymphoblastic leukaemia, relapsed/refractory, patients aged 0 ≤ 25 years – Hint of not-quantifiable additional benefit
- Tecvayli (teclistamab); multiple myeloma, at least 3 previous therapies – Additional benefit not proven
- Refixia (nonacog beta pegol); new indication: haemophilia B, patients aged < 12 years – Additional benefit not proven
- Galafold (migalastat); re-assessment of an orphan drug after exceeding the €30 million sales limit, fabry disease, patients aged ≥ 12 years – Additional benefit not proven
Follow me on Instagram to never miss the latest G-BA decisions: