| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20026b |
| Drug | Bempedoic acid/Ezetimibe |
| Brand | Nustendi® |
| Indication | In adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet (a) in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe (b) alone in patients who are either statin – intolerant or for whom a statin is contraindicated and are unable to reach LDL-C goals with ezetimibe alone and (c) in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without a statin. |
| 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 of bempedoic acid + ezetimibe (Nustendi®) 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 + ezetimibe (Nustendi®) 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
