G-BA decisions from 18 July 2024

Here are the latest G-BA decisions from the G-BA meeting held on 4 July 2024, which covered only procedural decisions.

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

  • Opdivo (nivolumab): melanoma (stage IIB or IIC), adjuvant therapy, ≥ 12 years, monotherapy – Removal of time restriction of previous decision
  • Carvykti (ciltacabtagene autoleucel): multiple myeloma) – Benefit assessment suspended for up to 8 months
  • Adcetris (brentuximab vedotin): re-assessment of an orphan drug after exceeding €30 mn threshold; new indication: Hodgkin lymphoma, CD30+, stage III, first line – Termination of benefit assessment due to loss of orphan drug status
  • Talvey (talquetamab): multiple myeloma, at least 3 previous therapies – Request for real-world evidence collection and restriction of prescribing to participating centres
  • Hemgenix (etranacogen dezaparvovec): haemophilia B – review of study protocol and statistical analysis plan for RWE data collection
  • Roctavian (valoctocogen roxaparvovec): haemophilia A – review of study protocol and statistical analysis plan for RWE data collection

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