Lumacaftor/ivacaftor (Orkambi®)
Orkambi® is indicated 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.
Rapid Review
| Commenced | Completed | Outcome |
| 26/11/2015 | 15/12/2015 | Full Pharmacoeconomic Evaluation Recommended |
Pharmacoeconomic Evaluation
| Commenced | Completed | Outcome |
| 11/03/2016 | 01/06/2016 | 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.