G-BA decisions from 17 October 2024

Here are the latest G-BA decisions from the G-BA meeting held on 17 Oct 2024 on the early benefit assessments of Spexotras, Finlee, Reblozyl, Cibinqo, Keytruda, and Slenyto.

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

  • Spexotras (trametinib); malignant glioma, BRAF-V600E mutation, ≥ 1 year, low-grade (LGG)/high-grade (HGG) after at least 1 previous therapy; in combination with dabrafenib) – Orphan drug, Hint of considerable additional benefit in one of three subgroups
  • Finlee (dabrafenib); malignant glioma, BRAF-V600E mutation, ≥ 1 year, low-grade (LGG)/high-grade (HGG) after at least 1 previous therapy; in combination with trametinib – Orphan drug, Hint of considerable additional benefit in one of three subgroups
  • Reblozyl (luspatercept); new indication: myelodysplastic syndromes with transfusion-dependent anaemia, not previously treated, and without ring sideroblasts, previously treated – Orphan drug, full assessment due to exceeding €30mn threshold – Hint of minor additional benefit in one of two subgroups
  • Cibinqo (abrocitinib); new indication: atopic dermatitis, patients aged ≥ 12 to ≤ 17 years – Additional benefit not proven
  • Keytruda (pembrolizumab); new indication: non-small cell lung cancer, adjuvant therapy, after previous chemotherapy – Additional benefit not proven
  • Keytruda (pembrolizumab); new indication: non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with platinum-based chemotherapy – Additional benefit not proven
  • Slenyto (melatonin) – removal of the decision of 4 July 2019
  • Slenyto (melatonin); new indication: sleep disorders in neurogenetic diseases; patients aged ≥ 2 to ≤ 18 years – termination of the benefit assessment

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