Dossier assessment

Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 12 years and older, diverse mutations) - Benefit assessment according to §35a Social Code Book

Status
Status: Commission completed
Project no.
A21-73
Last updated

Report documents

  1. Extract of dossier assessment

    Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 12 years and older, diverse mutations) - Benefit assessment according to §35a Social Code Book

    published on
    Document type
    PDF document, 349 kB, EN, not accessible
  2. Dossier assessment

    Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 12 years and older, diverse mutations) - Benefit assessment according to §35a Social Code Book

    published on
    Document type
    PDF document, 607 kB, DE, not accessible

Dossier assessment

Indication:

Patients with cystic fibrosis aged 12 years and older 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 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.
A21-73
Commission
Commission awarded on 27.05.2021 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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