NICE approval for new class of lipid-lowering drugs

NHS clinicians must now have the option to prescribe evolocumab (Repatha) and alirocumab (Praluent) for certain patients with primary hypercholesterolaemia or mixed dyslipidaemia, NICE has ruled.

In trials, evolocumab and alirocumab reduced lipid levels in patients already taking statins. | SCIENCE PHOTO LIBRARY
In trials, evolocumab and alirocumab reduced lipid levels in patients already taking statins. | SCIENCE PHOTO LIBRARY

Further information
View Repatha drug record
View Praluent drug record
NICE technology appraisal TA393
NICE technology appraisal TA394
MIMS Cardiology Clinic

Evolocumab and alirocumab are recommended by NICE as options for treating primary hypercholesterolaemia or mixed dyslipidaemia in patients with persistently raised LDL-C concentrations despite maximal tolerated lipid-lowering therapy.

The two antibodies, which belong to the class of injectable lipid-lowering drugs known as PCSK9 inhibitors, are recommended for NHS use at the following LDL-C thresholds: 

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 4.0 mmol/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 persistently above 3.5 mmol/l

The drugs must be provided with the discount agreed in the patient access schemes, and evolocumab is only approved for NHS use at a dose of 140mg every 2 weeks.

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, chronic 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).

Evolocumab and alirocumab target the PCSK9 (proprotein convertase subtilisin kexin type 9) enzyme, preventing PCSK9-mediated degradation of LDL receptors on the surface of liver cells. This leads to an increase in the number of receptors available to clear LDL, thereby decreasing levels of LDL-C. 

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