[A21-71] Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book
Last updated 01.09.2021
Project no.: A21-71
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.