| 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*. |
*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
