[A20-108] Tezacaftor/ivacaftor (combination with ivacaftor; cystic fibrosis, 6 to < 12 years, F508del mutation, heterozygous) - Benefit assessment according to §35a Social Code Book V

Last updated 01.03.2021

Project no.:
A20-108

Commission:
Commission awarded on 30.11.2020 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 and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G and 3849+10kbC→T

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.

Contact

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