G-BA decisions from 2 November 2023

Here are the G-BA decisions from the G-BA meeting held on 2 November 2023 on the early benefit assessments of Zynlonta, Imcivree, Evusheld, and Reblozyl.

A complete database of all previous G-BA resolutions is available through my membership.

  • Zynlonta (loncastuximab tesirine): diffuse large B-cell lymphoma and high-grade B-cell lymphoma, after ≥ 2 prior therapies – Additional benefit not proven in both subgroups
  • Imcivree (setmelanotide); new indication: obesity and control of hunger, Bardet-Biedl syndrome, patients aged ≥ 6 years – Orphan drug, hint of not-quantifiable additional benefit
  • Evusheld (tixagevimab/cilgavimab); first-time assessment requirement: COVID-19, pre-exposure prophylaxis, patients aged ≥ 12 years – Additional benefit not proven
  • Reblozyl (luspatercept); re-assessment of an orphan drug after exceeding the €30 mn sales threshold:
    • β-thalassemia, transfusion-dependent anaemia – Additional benefit not proven
    • myelodysplastic syndrome with transfusion-dependent anaemia, pretreated patients – Additional benefit not proven

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