[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

Last updated 01.08.2025

Project no.:
A25-61

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 (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

Result of dossier assessment:

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

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/A25-61

Project no.	Title	Status
G20-18	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, combination regimen with ivacaftor in patients aged 12 years and older [homozygous for the F508del mutation]) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V	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
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
A21-73	Ivacaftor/tezacaftor/elexacaftor (cystic fibrosis, 12 years and older, diverse mutations) - Benefit assessment according to §35a Social Code Book	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
A22-18	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
A22-17	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
A22-21	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, MF mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A22-24	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, RF mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A22-23	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A22-25	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, other/unknown mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A22-22	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 6 to 11 years, F508del mutation, homozygous) - 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
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
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
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	Commission completed
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	Commission completed

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