Ivacaftor/tezacaftor/elexacaftor (Kaftrio®)

Assessment Status Assessment Process Complete
HTA ID 22022
Drug Ivacaftor/tezacaftor/elexacaftor
Brand Kaftrio®
Indication Ivacaftor/tezacaftor/elexacaftor (Kaftrio®) in combination with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Assessment Process
Rapid review commissioned 12/04/2022
Rapid review completed 10/05/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of ivacaftor/tezacaftor/elexacaftor (Kaftrio®) with a regimen of ivacaftor (Kalydeco®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 16/05/2022
Full submission received from Applicant 21/12/2022
Preliminary review sent to Applicant 29/12/2022
NCPE assessment re-commenced 12/01/2023
Factual accuracy sent to applicant 30/01/2023
NCPE assessment re-commenced 03/02/2023
NCPE assessment completed 09/02/2023
NCPE assessment outcome NCPE assessment completed