Dossier assessment

Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, other/unknown mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A22-25
Last updated

Report documents

  1. Extract of dossier assessment

    Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, other/unknown mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 315 kB, EN, PDF
  2. Dossier assessment

    Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, other/unknown mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 547 kB, DE, PDF

Dossier assessment

Indication:

Patients with cystic fibrosis from 6 to 11 years of age who are heterozygous for the F508del mutation in the CFTR gene and have a mutation on the second allele that is not an MF, gating (including R117H) or RF mutation or in whom the mutation on the second allele is unknown

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A22-25
Commission
Commission awarded on 08.02.2022 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

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