G-BA decisions from 20 February 2025

Here are the latest G-BA decisions from the G-BA meeting held on 20 February 2025 on the early benefit assessments of Emblaveo, Adzynma, Lynparza, Imfinzi, Awiqli, Skyrizi, Vabysmo, and Beyfortus.

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

  • Emblaveo (aztreonam/avibactam); bacterial infections, multiple indications) – Reserve antibiotic, thus additional benefit is deemed proven across all 4 subgroups
  • Adzynma (rADAMTS13); ADAMTS13 deficiency in congenital thrombotic thrombocytopenic purpura (cTTP) – Orphan drug, Hint of not-quantifiable additional benefit in both subgroups
  • Lynparza (olaparib); new indication: primary advanced or recurrent endometrial carcinoma with pMMR, combination with durvalumab, maintenance therapy – Indication of considerable additional benefit in one of two subgroups
  • Imfinzi (durvalumab); new indication: primary advanced or recurrent endometrial carcinoma, combination with carboplatin and paclitaxel; maintenance therapy, combination with olaparib – Indication of considerable additional benefit in one of two subgroups
  • Imfinzi (durvalumab); new indication: primary advanced or recurrent endometrial carcinoma, first-line therapy, combination with carboplatin and paclitaxel; maintenance therapy – Additional benefit not proven
  • Awiqli (insulin icodec); diabetes mellitus type 2 – Additional benefit not proven across all 4 subgroups
  • Awiqli (insulin icodec); diabetes mellitus type 1 – Additional benefit not proven
  • Skyrizi (risankizumab); new indication: ulcerative colitis, previously treated – Additional benefit not proven in both subgroups
  • Vabysmo (faricimab); new indication: macular oedema due to retinal vein occlusion – Additional benefit not proven in both subgroups
  • Beyfortus (nirsevimab), new indication: secondary prophylaxis of RSV infections, children during their 2nd RSV season, ≤ 24 months of age – Additional benefit not proven in both subgroups
  • Rezurock (belumosudil); chronic graft-versus-host disease – Request for RWE data collection

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