Ivacaftor/tezacaftor/elexacaftor (Kaftrio®). HTA ID: 22022

Assessment Status NCPE 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 The NCPE recommends that Kaftrio plus ivacaftor be considered for reimbursement if cost-effectiveness can be improved relative to best supportive care*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.


Reimbursement has been approved following confidential price negotiations. March 2023