G-BA decisions from 2 May 2024

Here are the G-BA decisions from the G-BA meeting held on 2 May 2024 on the early benefit assessments of Akeega, Orserdu, Sogroya, Mounjuro, Rydapt, Olumiant, and Beovu.

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

  • Akeega (niraparib/abiraterone acetate): prostate cancer, metastatic, castration-resistant, BRCA1/2 mutations, chemotherapy not clinically indicated, in combination with prednis(ol)one – Hint of considerable additional benefit in 1 of 2 subgroups
  • Orserdu (elacestrant); breast cancer, ER+, HER2-, with ESR1 mutation, after at least 1 previous therapy – Hint of considerable additional benefit in 1 of 3 subgroups
  • Sogroya (somapacitan): growth disorder due to growth hormone deficiency, ≥ 3 to < 18 years; growth hormone deficiency in adults – Orphan drug, Hint of not-quantifiable additional benefit across both subgroups
  • Mounjuro (tirzepatide): diabetes mellitus type 2 – Hint of minor additional benefit in 1 of 8 subgroups
  • Rydapt (midostaurin); re-assessment of an orphan drug after exceeding the €30 million threshold
  • Olumiant (baricitinib); new indication
  • Beovu (brolucizumab); neovascular age-related macular degeneration; re-assessment after expiry of previous resolution – Additional benefit not proven
  • Opdivo (nivolumab); new indication: carcinoma of the oesophagus or gastroesophageal junction, previously treated patients, adjuvant therapy – Time restriction of previous resolution extended to 1 July 2025
  • Abecma (idecabtagene vicleucel): multiple myeloma, at least 3 previous therapies; re-assessment of an orphan drug after exceeding the €30 million threshold – Benefit assessment was suspended, since another assessment of the new indication is underway

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