Dossier assessment
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, ≥ 2 years, at least one non-class I mutation, excluding F508del and gating mutations) – Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, ≥ 2 years, at least one non-class I mutation, excluding F508del and gating mutations) – Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, ≥ 2 years, at least one non-class I mutation, excluding F508del and gating mutations) – Benefit assessment according to §35a Social Code Book V
Dossier assessment
Cystic fibrosis (CF) in patients aged 2 years and older who have at least one non-class I mutation, excluding an F508del and gating mutation, in the cystic fibrosis transmembrane conductance regulator gene
- Patients aged 2 to 5 years: added benefit not proven
- Patients aged 6 to 17 years: hint of non-quantifiable added benefit
- Patients from 18 years of age: hint of major added benefit
Project details
- Project no.
- A25-61
- 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
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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/A25-61_en
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