Sapropterin (Kuvan®)

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

Technical Summary 2009

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

Technical Summary

The HSE has approved reimbursement following confidential price negotiations July 2019.