The UK National Institute for Health and Care Excellence (NICE) has published a recommendation supporting the use of evolocumab (Repatha, Amgen), alone or in combination with other cholesterol-lowering therapies, for several types of patients at particularly high risk of cardiovascular events with persistently high cholesterol.
Evolocumab is a human monoclonal antibody that blocks PCSK9 from the blood. It was the first in this new class of cholesterol-lowering medicines to gain marketing authorisation in Europe, according to a press release.
The new draft guidance recommends evolocumab for patients whose LDL-C persists above levels specified by NICE despite maximal tolerated lipid-lowering therapy. NICE specifies an LDL-C level above 3.5mmol/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 above 4mmol/l for treatment of patients with cardiovascular disease who have a high risk (without HeFH); and an LDL-C level above 5mmol/l for patients with HeFH who do not have cardiovascular disease.
Derek Connolly, consultant interventional cardiologist at Birmingham City Hospital, Birmingham (UK) says, “Any patient with evidence of existing cardiovascular disease may benefit from cholesterol reduction. By lowering cholesterol in such patients there is real potential to avoid death and disability from heart attacks and strokes – events which are very costly in both personal and financial terms. So today’s news from NICE is excellent for patients and excellent for the NHS.”
The science behind evolocumab is based on genetic insights into people who have especially high, and especially low, levels of PCSK9. Clinical trials have shown that a fortnightly injection of 140mg evolocumab on top of statin treatment reduced LDL-C by between 55 and 75% compared with statins alone.
A study recently published in the Journal of the American Medical Association evaluated evolocumab as a cholesterol-lowering agent for people who are unable to take statins. NICE has defined statin intolerance as ‘the presence of clinically significant adverse effects that represent an unacceptable risk to the patient or that may reduce compliance with therapy’.
“We are very encouraged by the positive draft recommendations of NICE to date,” says Tony Patrikios, executive medical director, Amgen UK and Ireland. “There is a clear clinical need for new medicines that can lower LDL-C in patients who have persistently high cholesterol despite statin therapy, and who are living with a high risk of future cardiovascular disease.”
The effect of evolocumab on cardiovascular morbidity and mortality has not yet been determined. An ongoing study, FOURIER, is exploring the extent to which the LDL-C reductions achieved by evolocumab treatment may prevent future cardiovascular events such as heart attacks and strokes. From a total of 27,564 patients enrolled globally in the trial there are 1,490 in the UK; spread across 74 trial centres nationwide.
The NICE recommendation for evolocumab published today is not NICE’s Final Guidance on evolocumab–it is expected to become Final Guidance to the NHS in England and Wales in June 2016, and then the NHS will have 90 days to ensure it is implemented across the health system.