Bempedoic acid (Nilemdo®). HTA ID: 20026a

Assessment Status NCPE Assessment process complete
HTA ID 20026a
Drug Bempedoic acid
Brand Nilemdo®
Indication In adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet: In combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, OR Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
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 bempedoic acid 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 (Nilemdo®) 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