| Assessment Status | Rapid Review Complete |
| HTA ID | 25055 |
| Drug | Evolocumab |
| Brand | Repatha® |
| Indication | Evolocumab is indicated for both primary hypercholesterolaemia and mixed dyslipidaemia and heterozygous familial hypercholesterolaemia. In this submission the Applicant is proposing to reduce the LDL-C thresholds specified in the current managed access protocol. The revised patient population includes: • adults with established atherosclerotic cardiovascular disease (i.e. confirmed diagnosis of myocardial infarction +/- revascularisation procedures, non-haemorrhagic stroke or peripheral arterial disease [i.e. secondary prevention] or in those who have undergone coronary artery bypass graft), with a LDL-C persistently ≥ 3.0 mmol/L and • adults with a confirmed diagnosis of heterozygous familial hypercholesterolaemia with a LDL-C persistently ≥ 2.5 mmol/L. |
| Assessment Process | |
| Rapid review commissioned | 28/08/2025 |
| Rapid review completed | 30/09/2025 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that evolocumab not be considered for reimbursement at the submitted price*. |
Next steps: The NCPE Assessment Report and recommendation, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here
Further information on the status of this decision may be found here