Icon of the Instituts for Quality and Efficiency in Health Care

[G14-09] Ivacaftor - Assessment according to §35a (para. 1., sentence 10) Social Code Book V (dossier assessment)

Last updated 01.12.2014

Project no.:
G14-09

Commission:
Commission awarded on 25.08.2014 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Health Economics

Application field:
Digestion, metabolism and hormones

Note:

In accordance with § 35a (para. 1, sentence 10) Social Code Book V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. For the Ivacaftor report commissioned by the Federal Joint Committee (G-BA), IQWiG therefore solely assesses the information on patient numbers and costs in the pharmaceutical company's dossier.
After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. The resolution on the extent of added benefit is passed by the G-BA after the hearing. 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
A19-105 Ivacaftor (cystic fibrosis, 6 to < 12 months, with gating mutations) - 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
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
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
A21-75 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