G-BA decisions 4 April 2024

Here are the G-BA decisions from the G-BA meeting held on 4 April 2024 on the early benefit assessments of Tepkinly, and other decisions for Marstacimab, Blenrep, Pepaxti, and Evrysdi.

A complete database of all previous G-BA resolutions is available upon request.

  • ​​Tepkinly (epcoritamab); diffuse large B-cell lymphoma, after ≥ 2 previous therapies – Orphan drug assessment, Hint of not-quantifiable additional benefit
  • Tepkinly (epcoritamab); relapsed or refractory follicular lymphoma – Assessment of feasibility of conducting RWE study
  • Marstacimab (haemophilia A and B) – Assessment of feasibility of conducting RWE study
  • Blenrep (belantamab mafodotin) – Orphan drug, decision from 5 October 2023 becomes obsolete due to removal of marketing authorization
  • Pepaxti (melphalan flufenamide); new indication: refractory multiple myeloma, after 2 previous therapies, in combination with dexamethasone – Discontinuation of a benefit assessment procedure, after removal of marketing authorization for new indication
  • Evrysdi (risdiplam); spinal muscular atrophy) – Submission of study protocol and statistical analysis plan for RWE collection

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