[A19-68] Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V
Last updated 02.12.2019
Commission awarded on 28.08.2019 by the Federal Joint Committee (G-BA).
Airways and respiratory system
Adults with cystic fibrosis (CF) who have an R117H mutation in the CFTR gene
The advantages in the outcome categories of morbidity and health-related quality of life (in women and in positive Pseudomonas aeruginosa infection status) outweigh the disadvantage in one side effect (oropharyngeal pain); overall hint of non-quantifiable added benefit
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.