[A19-70] Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - 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
Cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene
A negative effect in severe/serious symptoms outweighs the positive effect in non-severe/serious side effects; results on serious side effects not usable; overall hint of lesser benefit versus the appropriate comparator therapy
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.
Federal Joint Committee (G-BA)
2020-02-20 A G-BA decision was published.