Lumacaftor/ivacaftor (Orkambi®)

Assessment Status Assessment process complete
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”

Technical Summary

The HSE has approved reimbursement following confidential price negotiations December 2023.