Dossier assessment

Ivacaftor (combination with tezacaftor/ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A20-109
Last updated

Report documents

  1. Extract of dossier assessment

    Ivacaftor (combination with tezacaftor/ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 329 kB, EN, PDF
  2. Dossier assessment

    Ivacaftor (combination with tezacaftor/ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 676 kB, DE, PDF

Dossier assessment

Indication:

Patients with cystic fibrosis from 6 to 11 years of age who are homozygous for the F508del mutation in the CFTR gene

Result of dossier assessment:

Added benefit not proven.

Project details

Project no.
A20-109
Commission
Commission awarded on 30.11.2020 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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