Inclisiran (Leqvio®). HTA ID: 20051

Assessment Status Assessment process complete
HTA ID 20051
Drug Inclisiran
Brand Leqvio®
Indication For the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adult patients, 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.
Assessment Process
Rapid review commissioned 23/11/2020
Rapid review completed 16/12/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of inclisiran compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 06/01/2021
Pre-submission consultation with Applicant 22/02/2021
Full submission received from Applicant 23/07/2021
Preliminary review sent to Applicant 19/10/2021
NCPE assessment re-commenced 16/11/2021
Factual accuracy sent to Applicant 16/02/2022
NCPE assessment re-commenced 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*.

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

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