Dossier assessment
Deutivacaftor/tezacaftor/vanzacaftor (cystic fibrosis, at least one non-Class I mutation, >= 6 years) – Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Deutivacaftor/tezacaftor/vanzacaftor (cystic fibrosis, at least one non-Class I mutation, >= 6 years) – Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Deutivacaftor/tezacaftor/vanzacaftor (cystic fibrosis, at least one non-Class I mutation, >= 6 years) – Benefit assessment according to §35a Social Code Book V
Dossier assessment
Patients with cystic fibrosis aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- Patients aged 6 to 11 years: added benefit not proven (no relevant study)
- Patients aged 12 years and older who are heterozygous for F508del and minimal function mutation: indication of a non-quantifiable added benefit (based on the results of the relevant study)
- Patients aged 12 years and older and with F/F, F/G, F/RF genotypes or who have an IVA/TEZ/ELX-responsive mutation, excluding F508del: added benefit not proven (based on the results of the relevant study)
Project details
- Project no.
- A26-79
- Commission
- Commission awarded on 01.07.2026 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/A26-79