National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

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