| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23006 |
| Drug | Icosapent ethyl |
| Brand | Vazkepa® |
| Indication | Icosapent ethyl (Vazkepa®) is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (?150 mg/dL [?1.7 mmol/L] and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. |
| Assessment Process | |
| Rapid review commissioned | 10/02/2023 |
| Rapid review completed | 10/03/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of icosapent ethyl compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 28/03/2023 |
| Pre-submission consultation with Applicant | 20/06/2023 |
| Full submission received from Applicant | 01/11/2023 |
| Preliminary review sent to Applicant | 18/09/2024 |
| NCPE assessment re-commenced | 25/10/2024 |
| Follow-up to preliminary review sent to Applicant | 22/01/2025 |
| NCPE assessment re-commenced | 30/01/2025 |
| Factual accuracy sent to Applicant | 04/03/2025 |
| NCPE assessment re-commenced | 12/03/2025 |
| NCPE assessment completed | 20/03/2025 |
| NCPE assessment outcome | The NCPE recommends that icosapent ethyl (Vazkepa®) be considered for reimbursement if 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.