Kalydeco® is indicated 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.
Rapid Review
| Commenced | Completed | Outcome |
| 19/11/2015 | 18/12/2015 | Full Pharmaoeconomic Evaluation Recommended |
Pharmacoeconomic Evaluation
| Commenced | Completed | Outcome |
| 18/03/2016 | 12/10/2016 | Reimbursement Not Recommended at the Submitted Price |
The HSE has approved reimbursement following confidential price negotiations.