[A23-72] Lumacaftor/ivacaftor (cystic fibrosis, 1 to < 2 years, F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book V
Last updated 16.10.2023
Project no.:
A23-72
Commission:
Commission awarded on 12.07.2023 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 1 to < 2 years of age 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.
https://dx.doi.org/10.60584/A23-72
| Project no. | Title | Status |
|---|---|---|
| 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) | Commission completed |
| 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 |