G-BA decisions from 15 Aug 2024

Here are the latest G-BA decisions from the G-BA meeting held on 15 Aug 2024 on the early benefit assessments of Rystiggo, Omjjara, Talzenna, Quviviq, Beyfortus, Zilbrysq, Aqumeldi, and Inaqovi.

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

Good results for orphan drugs, but negative for all other assessed drugs.

  • Rystiggo (rozanolixizumab); myasthenia gravis, AChR antibodies+, MuSK antibodies+ – Orphan drug, Hint of considerable additional benefit in 1 of 2 subgroups, Hint of not-quantifiable additional benefit in other subgroup
  • Omjjara (momelotinib); myelofibrosis – Orphan drug, Hint of minor additional benefit in 1 of 2 subgroups, Hint of not-quantifiable additional benefit in other subgroup
  • Talzenna (talazoparib); new indication: prostate cancer, metastatic, castration-resistant, in combination with enzalutamide – Hint of lesser benefit (!!) than with enzalutamide alone in 1 of 3 subgroups, no additional benefit in the other 2 subgroups
  • Quviviq (daridorexant); reassessment after amendment to Annex III AM-RL sleep disorders, meaning Quviviq is now reimbursable without restrictions on the treatment duration – Additional benefit not proven
  • Beyfortus (nirsevimab); secondary prophylaxis of RSV infections, children during their 1st RSV season – Additional benefit not proven in both subgroups
  • Zilbrysq (zilucoplan); myasthenia gravis, AChR antibodies+ – Additional benefit not proven
  • Aqumeldi (enalapril); heart failure, from birth to ≤ 17 years – Additional benefit not proven in both subgroups
  • Inaqovi (decitabine/cedazuridine); acute myeloid leukaemia, first line – Additional benefit not proven

Follow me on Instagram to never miss the latest G-BA decisions:

Want my free guide about German HTA?

X