| Assessment Status | Assessment process complete |
| HTA ID | - |
| Drug | Lumacaftor/ivacaftor |
| Brand | Orkambi® |
| Indication | For the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene. |
| Assessment Process | |
| Rapid review commissioned | 26/11/2015 |
| Rapid review completed | 15/12/2015 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 11/03/2016 |
| NCPE assessment completed | 01/06/2016 |
| NCPE assessment outcome | Reimbursement Not Recommended at the submitted price. |
“The manufacturer Vertex Pharmaceuticals have confirmed that patients currently receiving Orkambi under the Managed Access Scheme will continue to receive the drug until reimbursement is finalised in Ireland”
The HSE has approved reimbursement following confidential price negotiations December 2023.