[A21-74] Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book
Last updated 01.09.2021
Project no.:
A21-74
Commission:
Commission awarded on 27.05.2021 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 aged 12 years and older who are heterozygous for the F508del mutation in the CFTR gene and have a gating mutation (including R117H) on the second allele
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.