| 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.
The HSE has approved reimbursement following confidential price negotiations. September 2024
