Ivacaftor (Kalydeco®) for patients with CF 2 years +

Assessment Status Assessment process complete
Drug Ivacaftor
Brand Kalydeco®
Indication For the treatment of children with CF aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.
Assessment Process
Rapid review commissioned 19/11/2015
Rapid review completed 18/12/2015
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 18/03/2016
NCPE assessment completed 12/10/2016
NCPE assessment outcome Reimbursement not recommended at the submitted price

Technical Summary

The HSE has approved reimbursement following confidential price negotiations.