Here are the G-BA decisions from the G-BA meeting held on 17 August 2023 on the early benefit assessments of Carvykti, Hemlibra, Forxiga, Triumeq, Kerendia and Lupkynis.
A complete database of all previous G-BA resolutions is available through my membership.
- Carvykti (ciltacabtagen autoleucel); relapsed / refractory multiple myeloma, after at least 3 previous therapies – Orphan drug, Hint of not-quantifiable additional benefit, Resolution restricted until 1 July 2026
- Hemlibra (emicizumab); new indication: moderate haemophilia A, without factor VIII inhibitor, with severe bleeding phenotype – Additional benefit not proven
- Forxiga (dapagliflozin); new indication: chronic heart failure with left ventricular ejection fraction LVEF > 40% – Hint of minor additional benefit
- Triumeq (dolutegravir/abacavir/lamivudine); new indication: HIV infection, ≥ 14 kg to < 12 years – Additional benefit not proven in all 3 subgroups
- Kerendia (finerenone); chronic kidney disease in type 2 diabetes, stage 3 and 4 with albuminuria – Additional benefit not proven
- Kerendia (finerenone); new indication: chronic kidney disease in type 2 diabetes, stages 1 and 2 with albuminuria – Hint of not-quantifiable additional benefit
- Lupkynis (voclosporin); lupus nephritis – Additional benefit not proven
- Tecentriq (atezolizumab); new indication: non-small cell lung carcinoma, PD-L1 expression ≥ 50%, adjuvant therapy after resection and chemotherapy – Time restriction changed to 1 Oct 2024
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