icosapent ethyl (Vazkepa)

following a resubmission:

icosapent ethyl (Vazkepa®) is accepted for restricted use within NHSScotland.

Indication under review: to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥1.7mmol/L) and

• established cardiovascular disease, or
• diabetes, and at least one other cardiovascular risk factor.

SMC restriction: use as secondary prevention in patients treated with a stable dose of statins, low-density lipoprotein (LDL) cholesterol levels >1.04mmol/L and ≤2.60mmol/L, raised fasting triglycerides (≥1.7mmol/L) and with established cardiovascular disease defined as a history of any of the following:

• Acute coronary syndrome (ACS) (such as myocardial infarction (MI) or unstable angina needing hospitalisation)
• Coronary or other arterial revascularisation procedures
• Coronary heart disease
• Ischaemic stroke
• Peripheral arterial disease

In a phase III study, icosapent ethyl significantly reduced the risk of major adverse cardiovascular events in statin-treated patients at high-risk of cardiovascular events with elevated triglycerides, compared with a mineral oil placebo.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.