[A26-79] Deutivacaftor/tezacaftor/vanzacaftor (cystic fibrosis, at least one non-Class I mutation, >= 6 years) – Benefit assessment according to §35a Social Code Book V
Last updated 01.10.2026
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
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)
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.
https://doi.org/10.60584/A26-79