Sapropterin (Kuvan®)
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