NICE recommends PCSK9 inhibitors for patients not responding to statins.


The National Institute for Health and Care Excellence (NICE) has recommended the PCSK9 inhibitors alirocumab and evolocumab for patients with primary hypercholesterolaemia or mixed dyslipidaemia that is not controlled with statins, in final draft guidance based onmanufacturers providing the drugs at discounted prices. The drugs are monoclonal antibodies that target proprotein convertase subtilisin/kexin type 9 (PCSK9), which slows the degradation of low density lipoprotein receptors in the liver. This helps to reduce levels of low density lipoprotein (LDL) cholesterol. NICE is recommending the drugs, which are given by subcutaneous injection, as options for treating patients with uncontrolled high levels of LDL cholesterol that put them at extremely high risk of myocardial infarction or stroke. This includes people with primary heterozygous familial hypercholesterolaemia but without cardiovascular disease (CVD) who have LDL cholesterol levels persistently above 5.0mmol/L. And PCSK9 inhibitors can be considered at a lower LDL cholesterol level of 3.5 mmol/L in people with this inherited form of the condition who already have CVD, the guidance adds. People with familial hypercholesterolaemia have higher cholesterol levels from birth, so their risk of cardiovascular disease increases from an early age, reaching as high as 50% in men by age 50 and 30% in women by age 60. The draft NICE guidance also recommends PCSK9 inhibitors for people with primary non-familial hypercholesterolaemia or mixed dyslipidaemia who are at high risk of CVD, including those with a history of acute coronary syndrome, whose LDL cholesterol levels are consistently above 4.0 mmol/L. The drugs can also be considered in patients at very high risk of CVDwith recurrent cardiovascular events and LDL cholesterol levels above 3.5 mmol/L. The companiesmaking alirocumab and evolocumab have agreed patient access schemes to provide them at discounted prices. NICE says that the drugs cost over £4000 (€5050; $5780) per patient per year. “Both drugs are relatively expensive,” said Carole Longson, director of the NICE Centre for Health Technology Evaluation. “Therefore the draft guidance recommends alirocumab and evolocumab as a cost effective use of NHS resources only with the discounts agreed with the companies and only for people with hypercholesterolaemia or mixed dyslipidaemia whose cholesterol is still not under control despite changes to their lifestyle and [despite] taking other cholesterol lowering drugs.” In a comment to the Times, David Preiss, of the University of Oxford, said, “Statins will always be the first option. These are specialised drugs that should only be used in extreme cases.”

DOI: 10.1136/bmj.i2609

Cite this paper

@article{Mayor2016NICERP, title={NICE recommends PCSK9 inhibitors for patients not responding to statins.}, author={Susan Mayor}, journal={BMJ}, year={2016}, volume={353}, pages={i2609} }