[A20-108] Tezacaftor/ivacaftor (combination with ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V
Last updated 01.03.2021
Project no.:
A20-108
Commission:
Commission awarded on 30.11.2020 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Digestion, metabolism and hormones
Patients with cystic fibrosis from 6 to 11 years of age who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G and 3849+10kbC→T
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.