[A18-08] Lumacaftor/ivacaftor (cystic fibrosis) - Benefit assessment according to §35a Social Code Book V

Last updated 02.05.2018

Project no.:
A18-08

Commission:
Commission awarded on 01.02.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Digestion, metabolism and hormones

Indication:

Cystic fibrosis (CF) in children aged between 6 and 11 years who are homozygous for the F508del mutation in the CFTR gene

Result of dossier assessment:

Neither positive nor negative effects in comparison with the best possible symptomatic treatment; added benefit not proven

Note:

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)

2018-08-02 A G-BA decision was published.

G-BA documents on this decision

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