Here are the latest G-BA decisions from the G-BA meeting held on 20 March 2025 on the early benefit assessments of Tecentriq, Keytruda, Cresemba, Akantior, Braftovi, Mektovi, Rybelsus/Ozempic and the RWE decision on Fabhalta.
A complete database of all previous G-BA resolutions is in my membership.
- Tecentriq (atezolizumab)
- reassessment after expiry of previous resolution: non-small cell lung cancer, PD-L1 expression ≥ 50%, adjuvant therapy after resection and chemotherapy – Hint of considerable additional benefit
- new indication: non-small cell lung cancer, first-line – Indication of minor additional benefit in one of two subgroups
- Keytruda (pembrolizumab); reassessment after expiry of previous resolution: Breast cancer, triple-negative, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy – Indication of minor additional benefit in one of two subgroups
- Cresemba (isavuconazole); new indication:
- Aspergillosis, patients aged ≥ 1 to ≤ 17 years – Orphan drug, Hint of not-quantifiable additional benefit
- Mucormycosis, patients aged ≥ 1 to ≤ 17 years – Orphan drug, Hint of not-quantifiable additional benefit
- Akantior (polihexanide); known active ingredient with new data protection; acanthamoeba keratitis; patients aged ≥ 12 years – Orphan drug, Hint of not-quantifiable additional benefit
- Braftovi (encorafenib); new indication: advanced non-small cell lung cancer, BRAF V600E mutation, in combination with binimetinib – Additional benefit not proven across all 3 subgroups
- Mektovi (binimetinib); new indication: advanced non-small cell lung cancer, BRAF V600E mutation, in combination with encorafenib – Additional benefit not proven across all 3 subgroups
- Rybelsus/Ozempic (semaglutide); type 2 diabetes mellitus – G-BA resolution from 15 April 2021 was revoked (benefit assessment was unlawful)
- Fabhalta (iptacopan); paroxysmal nocturnal hemoglobinuria) – No RWE data collection; no restriction on prescribing
Follow me on Instagram to never miss the latest G-BA decisions: