| Assessment Status | Full HTA Assessment |
| HTA ID | - |
| Drug | Sapropterin |
| Brand | Kuvan® |
| Indication | For the treatment of phenylketonuria (PKU). |
| Assessment Process | |
| NCPE assessment completed | 18/06/2009 |
| NCPE assessment outcome | Reimbursement not Recommended |
A new application for reimbursement was made to the HSE and a rapid review was commissioned in July 2015
| Assessment Process | Assessment Process Complete |
| Rapid review commissioned | 14/07/2015 |
| Rapid review completed | 14/08/2015 |
| Rapid review outcome | Full pharmacoeconomic assessment recommended |
| Full pharmacoeconomic assessment commissioned by the 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 |
| Factual accuracy sent to Applicant | 14/08/2017 |
| NCPE assessment re-commenced | 29/08/2017 |
| NCPE assessment completed | 15/09/2017 |
| NCPE assessment outcome | Reimbursement not Recommended |
The HSE has approved reimbursement following confidential price negotiations July 2019.