[A22-19] Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, other/unknown mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
Last updated 16.05.2022
Project no.:
A22-19
Commission:
Commission awarded on 08.02.2022 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 6 to 11 years of age who are heterozygous for the F508del mutation in the CFTR gene and have a mutation on the second allele that is not an MF, gating (including R117H) or RF 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.