G-BA decisions from 19 December 2024

Here are the latest G-BA decisions from the G-BA meeting held on 19 Dec 2024 on the early benefit assessments of Tagrisso, Yescarta, Qalsody, Fabhalta, Opdivo, and Trimbow.

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

  • Tagrisso (osimertinib); re-assessment after expiry of previous decision: non-small cell lung cancer, EGFR mutations, adjuvant therapy – Hint of major additional benefit in one subgroup; no additional benefit in the other subgroup
  • Yescarta (axicabtagene-ciloleucel); re-assessment after expiry of previous decision: diffuse large B-cell lymphoma, high-grade B-cell lymphoma, after 1 prior therapy, relapse within 12 months or refractory – Orphan drug, exceeding €30mn annual sales – Hint of minor additional benefit
  • Qalsody (tofersen); amyotrophic lateral sclerosis (ALS) – Orphan drug, Hint of not-quantifiable additional benefit
  • Fabhalta (Iptacopan); paroxysmal nocturnal hemoglobinuria – Orphan drug, Hint of not-quantifiable additional benefit for both subgroups
  • Opdivo (nivolumab); new indication: urothelial carcinoma, first line, in combination with cisplatin and gemcitabine – Additional benefit not proven
  • Trimbow (beclometasone/formoterol/glycopyrronium) – Removal of decisions from 5 August 2021 and 12 October 2021 and designation as combination partner

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