[A23-126] Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, other/unknown mutation, heterozygous) – Benefit assessment according to §35a Social Code Book
Last updated 01.03.2024
Project no.: A23-126
Commission: Commission awarded on 05.12.2023 by the Federal Joint Committee (G-BA).
Report type: Dossier assessment
Status: Commission completed
Department/Division: Drug Assessment
Topic: Digestion, metabolism and hormones
Patients with cystic fibrosis from 2 to 5 years of age who are heterozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene and have a mutation on the second allele other than a minimal function, gating (including R117H), or residual function mutation, or in whom the mutation on the second allele is unknown
Added benefit not proven
After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.
https://doi.org/10.60584/A23-126_en