[A24-43] vacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 2 to 5 years, F508del mutation, MF mutation, heterozygous) - Addendum to Project A23-122

Last updated 16.05.2024

Project no.:
A24-43

Commission:
Commission awarded on 15.04.2024 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Digestion, metabolism and hormones

Indication:

Patients with cystic fibrosis from 2 to 5 years of age who are heterozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene and have a minimal function mutation on the second allele

Result of dossier assessment:

Unchanged after addendum:
added benefit not proven

Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

DOI:

https://dx.doi.org/10.60584/A24-43

Federal Joint Committee (G-BA)

2024-05-16 A G-BA decision was published.

G-BA documents on this decision

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