NICE approval for alirocumab and evolocumab
Alirocumab (Praluent) and evolocumab (Repatha) have received final approval from NICE for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia to help reduce the risk of cardiovascular disease. Both drugs are given by self-administered injection once every 2 weeks (once a month for the 420 mg dose of evolocumab).
Technology Appraisals have been published for the two PCSK9 inhibitors which recommend evolocumab or alirocumab for patients whose LDL-C persists above levels specified by NICE despite maximal tolerated lipid-lowering therapy (see Table). NICE specifies an LDL-C level >3.5 mmol/l where the patient has existing cardiovascular disease alongside heterozygous familial hypercholesterolaemia (HeFH) or a very high risk of further cardiovascular events without HeFH. It specifies an LDL-C level >4.0 mmol/l for treatment of patients with cardiovascular disease who have a high risk (without HeFH); and an LDL-C level >5.0 mmol/l for patients with HeFH who do not have cardiovascular disease.
Despite the widespread use of statins and other lipid-lowering therapies to reduce raised cholesterol levels, some people in the UK remain at significant risk of having a cardiovascular event and are unable to lower their cholesterol to levels indicated within national guidelines. Both alirocumab and evolocumab reduce levels of LDL-cholesterol by up to 62% compared with placebo, and up to 40% compared with ezetimibe, another commonly used drug to lower cholesterol.
|Without CVD||With CVD|
|High risk of CVD1||Very high risk of CVD2|
|Primary non-familial hypercholesterolaemia or mixed dyslipidaemia||Not recommended at any LDL‑C concentration||Recommended only if LDL‑C concentration is persistently >4.0 mmol/litre||Recommended only if LDL‑C concentration is persistently >3.5 mmol/litre|
|Primary heterozygous-familial hypercholesterolaemia||Recommended only if LDL‑C concentration is persistently >5.0 mmol/litre||Recommended only if LDL‑C concentration is persistently >3.5 mmol/litre|
1 High risk of CVD – a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation); coronary or other arterial revascularisation procedures; chronic heart disease; ischaemic stroke; peripheral arterial disease.
2 Very high risk of CVD – recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease).
CVD, cardiovascular disease; LDL‑C, low-density lipoprotein cholesterol.
Low-density lipoprotein cholesterol concentrations above which evolocumab and alirocumab are recommended.