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    Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Icosapent ethyl is not recommended, within its marketing authorisation, for reducing the risk of cardiovascular events in adults who:

  • have a high cardiovascular risk with raised triglycerides (150 mg/dL [1.7 mmol/litre] or more), and

  • are having statins, and

    • have established cardiovascular disease, or

    • diabetes and at least 1 other cardiovascular risk factor.

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 raised triglycerides.

Clinical trial evidence suggests that icosapent ethyl reduces the risk of cardiovascular events in people who have established cardiovascular disease (secondary prevention). The evidence on its use by people without established cardiovascular disease but who have diabetes and at least 1 cardiovascular risk factor (primary prevention) is less clear. It is also uncertain how well icosapent ethyl works because it was compared with a placebo (mineral oil) that may itself increase cardiovascular risk. Also, the trial may not be generalisable to the NHS.

The cost-effectiveness estimates for icosapent ethyl are uncertain. This is because there are several concerns with the company's economic model, including its structure, how treatment effect was modelled and what happens when people stop having treatment. The cost-effectiveness estimates are also likely to be higher than what NICE normally considers an acceptable use of NHS resources. So, icosapent ethyl is not recommended.