[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

Last updated 16.05.2022

Project no.:
A22-25

Commission:
Commission awarded on 08.02.2022 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Digestion, metabolism and hormones

Indication:

Patients with cystic fibrosis from 6 to 11 years of age who are heterozygous for the F508del mutation in the CFTR gene and have a mutation on the second allele that is not an MF, gating (including R117H) or RF mutation or in whom the mutation on the second allele is unknown

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.

Project no.	Title	Status
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
A22-22	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
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
A21-76	Ivacaftor (cystic fibrosis, 12 years and older, diverse mutations) - Benefit assessment according to §35a Social Code Book	Commission completed
A21-75	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 12 years and older, residual function mutation) - Benefit assessment according to §35a Social Code Book	Commission completed
A21-74	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, gating mutation, heterozygous) - Benefit assessment according to §35a Social Code Book	Commission completed
A20-110	Ivacaftor (combination with tezacaftor/ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A20-109	Ivacaftor (combination with tezacaftor/ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A20-99	Ivacaftor (cystic fibrosis, 4 to < 6 months, with R117H mutation) - Benefit assessment according to §35a Social Code Book V	Commission completed
A20-100	Ivacaftor (cystic fibrosis, 4 to < 6 months, gating mutation) - Benefit assessment according to §35a Social Code Book V	Commission completed
A20-77	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor, cystic fibrosis, 12 years and older, F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A20-83	Ivacaftor (combination with ivacaftor/tezacaftor/elexacaftor; cystic fibrosis, 12 years and older, F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A20-52	Ivacaftor (cystic fibrosis, 6 months to < 18 years, with R117H mutation)- Benefit assessment according to §35a Social Code Book V	Commission completed
A19-105	Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-69	Ivacaftor (cystic fibrosis, from 12 to < 24 months, with gating mutations) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-68	Ivacaftor (cystic fibrosis, 18 years and older, with R117H mutation) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-67	Ivacaftor (cystic fibrosis, 2 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-66	Ivacaftor (cystic fibrosis, 6 years and older, with gating mutations) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-71	Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-70	Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Benefit assessment according to §35a Social Code Book V	Commission completed
A19-65	Ivacaftor (cystic fibrosis, 6 years and older, with G551D mutation) - Benefit assessment according to §35a Social Code Book V	Commission completed
G18-21	Ivacaftor (cystic fibrosis) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V	Commission completed
G15-13	Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V	Commission completed
G14-09	Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V (dossier assessment)	Commission completed
G12-02	Ivacaftor - Assessment according to § 35a (1), Sentence 10, Social Code Book V (dossier assessment)	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
A23-123	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
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
A23-126	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

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