Bempedoic acid/Ezetimibe (Nustendi®). HTA ID: 20026b

Assessment Status NCPE Assessment Process Complete
HTA ID 20026b
Drug Bempedoic acid/Ezetimibe
Brand Nustendi®
Indication In adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet (a) in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe (b) alone in patients who are either statin – intolerant or for whom a statin is contraindicated and are unable to reach LDL-C goals with ezetimibe alone and (c) in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without a statin.
Assessment Process
Rapid review commissioned 15/06/2020
Rapid review completed 03/07/2020
Rapid review outcome A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of of bempedoic acid + ezetimibe (Nustendi®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 06/07/2020
Pre-submission consultation with Applicant 22/09/2020
Full submission received from Applicant 30/04/2021
Preliminary review sent to Applicant 22/06/2021
NCPE assessment re-commenced 19/07/2021
Factual accuracy sent to Applicant 28/07/2021
NCPE assessment re-commenced 11/11/2021
NCPE assessment completed 16/11/2021
NCPE assessment outcome The NCPE recommends that bempedoic acid + ezetimibe (Nustendi®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments and that a managed access programme is introduced*.

*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

Plain English Summary