1 Recommendations
1.1 Icosapent ethyl is recommended as an option for reducing the risk of cardiovascular events in adults. It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) and are taking statins, but only if they have:
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established cardiovascular disease (secondary prevention), defined as a history of any of the following:
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acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
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coronary or other arterial revascularisation procedures
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coronary heart disease
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ischaemic stroke
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peripheral arterial disease, and
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low-density lipoprotein cholesterol (LDL‑C) levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre.
1.2 This recommendation is not intended to affect treatment with icosapent ethyl that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
There are currently no treatment options to reduce the risk of cardiovascular events in people taking statins who have controlled levels of LDL-C but raised levels of triglycerides. Icosapent ethyl is licensed for people taking statins who have raised triglycerides and a high risk of cardiovascular events, and who have either:
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established cardiovascular disease (secondary prevention), or
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diabetes and at least one other cardiovascular risk factor (primary prevention).
Clinical trial evidence suggests that icosapent ethyl reduces the risk of cardiovascular events, compared with placebo, in people with raised fasting triglycerides (1.7 mmol/litre or above) who are taking statins. The trial only included people with LDL-C levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre.
The cost-effectiveness estimates for icosapent ethyl are uncertain. Icosapent ethyl is unlikely to be cost effective for primary prevention, so it is not recommended for this. But the most likely cost-effectiveness estimates for secondary prevention are within what NICE normally considers an acceptable use of NHS resources. So, icosapent ethyl is recommended for secondary prevention in people with LDL-C levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre.
People must be taking a statin to have icosapent ethyl. People who cannot have statins are not covered by icosapent ethyl's marketing authorisation, so NICE cannot make any recommendations in this area.