Evolocumab (Repatha®)

Assessment Status Assessment process complete
Drug Evolocumab
Brand Repatha®
Indication For both primary hypercholesterolaemia and mixed dyslipidaemia and heterozygous familial hypercholesterolaemia.
Assessment Process
Rapid review commissioned 01/10/2016
Rapid review completed 28/10/2016
Rapid review outcome Reimbursement not recommended
Full pharmacoeconomic assessment commissioned by HSE 31/05/2017
Pre-submission consultation with Applicant 27/06/2017
Full submission received from Applicant 31/10/2017
Preliminary review sent to Applicant 20/11/2017
NCPE assessment re-commenced 02/01/2018
NCPE assessment re-commenced 29/03/2018
Factual accuracy sent to Applicant 13/04/2018
NCPE assessment completed 16/05/2018
NCPE assessment outcome The NCPE recommends that evolocumab should not be reimbursed unless cost effectiveness can be improved relative to existing treatments*

* This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

The HSE has approved reimbursement following confidential price negotiations; anticipated reimbursement date July 2019