Alirocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if LDL-C concentrations are persistently above the thresholds specified in the table below despite maximal tolerated lipid-lowering therapy1 and the company provides alirocumab with the discount agreed in the patient access scheme.
Table 1. Treatment groups and LDL-C thresholds for alirocumab prescribing (Adapted from NICE TA393)1
|Patient populations||Without CVD||With CVD|
|High risk of CVD†||Very high risk of CVD ‡|
|Primary non-familial hypercholesterolaemia or mixed dyslipidaemia||Not recommended at any LDL-C concentration||Recommended only if LDL-C concentration is persistently above 4.0mmol/L||Recommended only if LDL-C concentration is persistently above 3.5 mmol/L|
|Primary heterozygous-familial hypercholesterolaemia||Recommended only if LDL-C concentration is persistently above 5.0 mmol/L||Recommended only if LDL-C concentration is peristently above 3.5 mmol/L|
NICE recommended lipid-lowering pathway
† High risk of cardiovascular disease is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina requiring hospitalisation), coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke, peripheral arterial disease.
‡ Very high risk of cardiovascular disease is defined as recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease).
Some patients with hypercholesterolaemia or mixed dyslipidaemia, including those with heterozygous familial hypercholesterolaemia (HeFH), do not reach NICE-recommended LDL-C goals despite lifestyle changes and maximal treatment with standard therapy (statins with or without ezetimibe)2-4
NICE did not make separate recommendations for patients with statin intolerance. NICE considered that people who cannot take statins may have higher than average LDL-C levels, and therefore may meet the LDL-C thresholds needed to start treatment with alirocumab.
* LDL-C concentrations must be persistently above defined thresholds
Abbreviations: CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol.