Dossier assessment

Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, RF mutation, heterozygous) – Benefit assessment according to §35a Social Code Book

Status
Status: Commission completed
Project no.
A23-125
Last updated

Report documents

  1. Extract of dossier assessment

    Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, RF mutation, heterozygous) – Benefit assessment according to §35a Social Code Book

    published on
    Document type
    PDF document, 309 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-125_en
  2. Dossier assessment

    Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, RF mutation, heterozygous) – Benefit assessment according to §35a Social Code Book

    published on
    Document type
    PDF document, 502 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-125

Dossier assessment

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 residual function mutation on the second allele

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A23-125
Commission
Commission awarded on 05.12.2023 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.

DOI

https://doi.org/10.60584/A23-125_en

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