Dossier assessment

Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, ≥ 2 years, at least 1 non-class I mutation, including gating mutation, excluding F508del mutation) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-62
Last updated

Report documents

  1. Extract of dossier assessment

    Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, ≥ 2 years, at least 1 non-class I mutation, including gating mutation, excluding F508del mutation) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 374 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-62_en
  2. Dossier assessment

    Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, ≥ 2 years, at least 1 non-class I mutation, including gating mutation, excluding F508del mutation) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 572 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-62

Dossier assessment

Indication:

Cystic fibrosis in patients aged 2 years and older who have at least one non-class I mutation, including at least one gating mutation and excluding an F508del mutation, in the cystic fibrosis transmembrane conductance regulator gene

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A25-62
Commission
Commission awarded on 02.05.2025 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/A25-62_en

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