1.1 Bempedoic acid with ezetimibe is recommended as an option for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults. It is recommended only if:
statins are contraindicated or not tolerated
ezetimibe alone does not control low-density lipoprotein cholesterol well enough and
the company provides bempedoic acid and bempedoic acid with ezetimibe according to the commercial arrangement.
Bempedoic acid with ezetimibe can be used as separate tablets or a fixed-dose combination.
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. Bempedoic acid with ezetimibe would be used when statins are contraindicated or not tolerated, and when ezetimibe alone does not control LDL-C well enough. NICE was not able to evaluate the use of bempedoic acid plus ezetimibe with low intensity statins when higher intensity statins are not tolerated.
Clinical trial evidence suggests that bempedoic acid with ezetimibe may help lower 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 ezetimibe may not be as effective at reducing LDL-C levels as alirocumab or evolocumab.
Despite the uncertainty, the cost-effectiveness estimates for bempedoic acid with ezetimibe, when statins are contraindicated or not tolerated, are within what NICE normally considers an acceptable use of NHS resources. So, bempedoic acid with ezetimibe is recommended.