Icon of the Instituts for Quality and Efficiency in Health Care

[A20-99] Ivacaftor (cystic fibrosis, 4 to < 6 months, with R117H mutation) - Benefit assessment according to §35a Social Code Book V

Last updated 01.03.2021

Project no.:
A20-99

Commission:
Commission awarded on 27.11.2020 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:

Patients with cystic fibrosis from 4 to < 6 months of age and weighing 5 kg or more who have an R117H mutation in the CFTR 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.

Project no. Title Status
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
G14-09 Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V (dossier assessment) Commission completed
G15-13 Ivacaftor - Assessment according to §35a (para. 1., sentence 10) 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
A19-69 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
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
A20-100 Ivacaftor (cystic fibrosis, 4 to < 6 months, gating mutation) - 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
A22-24 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
A22-25 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
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

Contact

Press contact

+49 221 356850

presse@iqwig.de

Info Service (German)

Subscribe to daily updated information on projects, calls for tender, current vacancies and events as well as our press releases.

Register

Contact form

Questions about commissions, publications and press releases can be sent to us via this form.

Contact form

Print page