Sapropterin (Kuvan®) for the treatment of phenylketonuria (PKU).
| NCPE Assessment Process | Complete |
| NCPE assessment completed (2009) | 18/6/09 |
| NCPE assessment outcome (2009) | Reimbursement not recommended |
| Sapropterin (Kuvan) summary 2009 | |
| A new application for reimbursement was made to the HSE and a rapid review was commissioned in July 2015 | |
| Rapid review received | 14/07/2015 |
| Rapid review completed | 14/08/2015 |
| Rapid Review outcome | Full pharmacoeconomic assessment recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 28/06/2016 |
| Pre-submission consultation with Applicant | 19/09/2016 |
| Submission received from Applicant | 01/02/2017 |
| Preliminary review sent to Applicant | 09/05/2017 |
| NCPE assessment re-commenced | 25/05/2017 |
| Applicant Factual Accuracy Check | 14/08/2017 |
| NCPE assessment re-commenced | 29/08/2017 |
| NCPE assessment completed | 15/09/2017 |
| NCPE assessment outcome | Reimbursement not recommended |
Sapropterin (Kuvan) summary 2017
The HSE has approved reimbursement following confidential price negotiations; July 2019