National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Inclisiran (Leqvio®). HTA ID: 20051

Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet (a) in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or (b) alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.


NCPE Assessment Process Complete
Rapid review commissioned 23/11/2020
Rapid review completed 16/12/2020
Rapid Review outcome A full HTA is recommended to assess the clinical and cost-effectiveness compared to the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 06/01/2021
Pre-submission consultation with Applicant 22/02/2021
Full HTA submission received from Applicant 23/07/2021
Preliminary review sent to Applicant 19/10/2021
NCPE assessment recommenced 16/11/2021
Factual accuracy check sent to Applicant 16/02/2022
NCPE assessment recommenced 23/02/2022
NCPE assessment completed 23/03/2022
NCPE assessment outcome The NCPE recommends that inclisiran (Leqvio®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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