[A21-122] Lumacaftor/ivacaftor (cystic fibrosis, homozygous F508del mutation in the CFTR gene, 2-5 years) - Benefit assessment according to §35a Social Code Book V (expiry of the limitation period)
Last updated 03.01.2022
Project no.:
A21-122
Commission:
Commission awarded on 29.09.2021 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 aged 2 to 5 years with cystic fibrosis who are homozygous for the F508del mutation in the CFTR gene
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.
| Project no. | Title | Status |
|---|---|---|
| A19-13 | Lumacaftor/ivacaftor (cystic fibrosis in children aged 2 to 5 years) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A18-08 | Lumacaftor/ivacaftor (cystic fibrosis) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| G15-14 | Lumacaftor/ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V | Commission completed |
| A23-72 | Lumacaftor/ivacaftor (cystic fibrosis, 1 to < 2 years, F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book V | Commission completed |