[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
Last updated 01.12.2020
Commission awarded on 01.09.2020 by the Federal Joint Committee (G-BA).
Airways and respiratory system
In accordance with §35a (1) Sentence 11 Social Code Book (SGB) V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. On behalf of 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.
Federal Joint Committee (G-BA)
2021.02.18 A G-BA decision was published.