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Bempedoic acid for treating primary hypercholesterolaemia or mixed dyslipidaemia

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1 Recommendations

1.1 Bempedoic acid is not recommended, within its marketing authorisations, for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet in adults.

1.2 This recommendation is not intended to affect treatment with bempedoic acid with ezetimibe 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

Current treatment for primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia includes statins for lowering low‑density lipoprotein cholesterol (LDL-C) levels. Ezetimibe and either alirocumab or evolocumab may be added when patients' LDL-C levels are not lowered enough with the maximally tolerated dose of statins. If it had been recommended, bempedoic acid with ezetimibe would be used when satins are contraindicated or not tolerated, and when ezetimibe alone does not control LDL-C well enough.

Clinical trial evidence suggests that bempedoic acid with ezetimibe may help people lower their LDL-C levels when other lipid-lowering therapies have not reduced them enough. But, there is no data directly comparing bempedoic acid with ezetimibe with either alirocumab or evolocumab. An indirect comparison of trials suggests that bempedoic acid with ezetemibe may not be as effective at reducing LDL-C levels as alirocumab or evolocumab.

The cost-effectiveness estimates for bempedoic acid with ezetimibe are not what NICE normally considers an acceptable use of NHS resources. So, it cannot be recommended.