Here are the G-BA decisions from the G-BA meeting held on 1 February 2024 on the early benefit assessments of Camzyos, Sirturo, Columvi, Opdivo, Pombiliti, Jardiance, Xydalba, and Alprolix.
A complete database of all previous G-BA resolutions is available through my membership.
- Camzyos (mavacamten); symptomatic hypertrophic obstructive cardiomyopathy (NYHA class II-III) – Hint of considerable additional benefit
- Sirturo (bedaquiline); re-assessment after expiry of previous decision: multi-resistant pulmonary tuberculosis – Orphan drug, Hint of considerable additional benefit
- Columvi (glofitamab); diffuse large B-cell lymphoma (DLBCL), after ≥ 2 previous therapies – Orphan drug, Hint of not-quantifiable additional benefit
- Opdivo (nivolumab); new indication: non-small cell lung cancer (NSCLC), PD-L1 expression ≥1%, neoadjuvant therapy, in combination with platinum-based chemotherapy – Hint of not-quantifiable additional benefit
- Pombiliti (cipaglucosidase alfa); pompe disease, in combination with miglustat – Hint of minor additional benefit
- Jardiance (empagliflozin); new indication: Chronic kidney disease (CKD) – Additional benefit not proven
- Xydalba (dalbavancin); loss of exemption: Acute Bacterial Skin and Soft Tissue Infections (ABSSSI), patients aged ≥ 3 months – Additional benefit not proven
- Alprolix (eftrenonacog alfa); re-assessment of an orphan drug after exceeding the 30 million euro annual sales threshold: haemophilia B – Additional benefit not proven
- Odronextamab; relapsed or refractory follicular lymphoma (R/R FL) – Request for RWE collection and restriction of prescribing
- Odronextamab; relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) – Request for RWE collection and restriction of prescribing
- Exagamglogen Autotemcel: β-thalassemia – Discontinuation of evaluation of RWE collection, no suitable studies found; no further restriction of prescribing
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