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. |
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 |