[A25-62] 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

Last updated 01.08.2025

Project no.:
A25-62

Commission:
Commission awarded on 02.05.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Digestion, metabolism and hormones

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

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.

DOI:

https://doi.org/10.60584/A25-62_en

Project no.	Title	Status
A21-73	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 12 years and older, diverse mutations) - Benefit assessment according to §35a Social Code Book	Commission completed
A21-71	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book	Commission completed
A21-72	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 12 years and older, residual function mutation) - Benefit assessment according to §35a Social Code Book	Commission completed
A22-18	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, RF mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A22-15	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, MF mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A22-17	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A22-19	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, other/unknown mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A23-125	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, RF mutation, heterozygous) – Benefit assessment according to §35a Social Code Book	Commission completed
A23-123	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, homozygous) – Benefit assessment according to §35a Social Code Book	Commission completed
A23-124	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, gating mutation, heterozygous) – Benefit assessment according to §35a	Commission completed
G20-20	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, combination regimen with ivacaftor in patients aged 12 years and older [heterozygous for F508del and MF mutation]) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V	Commission completed
A22-16	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A23-122	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, MF mutation, heterozygous) – Benefit assessment according to §35a Social Code Book	Commission completed
A24-44	Ivacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 2 to 5 years, F508del mutation, homozygous) – Addendum to Project A23-123	Commission completed
A23-126	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 2 to 5 years, F508del mutation, other/unknown mutation, heterozygous) – Benefit assessment according to §35a Social Code Book	Commission completed
A24-43	vacaftor/tezacaftor/elexacaftor (combination with ivacaftor; cystic fibrosis, 2 to 5 years, F508del mutation, MF mutation, heterozygous) - Addendum to Project A23-122	Commission completed
A25-61	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	Commission completed

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