[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

Last updated 02.12.2019

Project no.:
A19-70

Commission:
Commission awarded on 28.08.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Airways and respiratory system

Indication:

Cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene

Result of dossier assessment:

A negative effect in severe/serious symptoms outweighs the positive effect in non-severe/serious side effects; results on serious side effects not usable; overall hint of lesser benefit versus the appropriate comparator therapy

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
A20-05	Ivacaftor (combination with ivacaftor/tezacaftor, cystic fibrosis, 12 years and older, with F508del mutation, homozygous) - Addendum to Commission A19-70	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
A19-65	Ivacaftor (cystic fibrosis, 6 years and older, with G551D 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
G12-02	Ivacaftor - Assessment according to § 35a (1), Sentence 10, Social Code Book V (dossier assessment)	Commission completed
G18-21	Ivacaftor (cystic fibrosis) - Assessment according to §35a (para. 1., sentence 11) 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
G15-13	Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V	Commission completed
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
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
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
A20-100	Ivacaftor (cystic fibrosis, 4 to < 6 months, gating mutation) - 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
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
A20-52	Ivacaftor (cystic fibrosis, 6 months to < 18 years, with R117H 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
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
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
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
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
A22-22	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

Federal Joint Committee (G-BA)

2020-02-20 A G-BA decision was published.

G-BA documents on this decision

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