[A19-69] Ivacaftor (cystic fibrosis, from 12 to < 24 months, with gating mutations) - 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).
Children's and adolescents' health
Cystic fibrosis in children aged 12 to < 24 months and weighing 7 to < 25 kg who have a G551D, G551S, G1244E, G1349D, G178R, S1251N, S1255P, S549N or S549R mutation in the CFTR gene
Transfer of the results from studies with older patients not possible; 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.