| 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.