Draft NICE guidance released on Friday recommends drugs alirocumab and evolocumab to treat patients at an increased risk of heart attack and stroke due to high levels of ‘bad’ LDL cholesterol.
It says the drugs should only be prescribed to patients who are unable to reach their LDL treatment goals taking the maximum tolerated dose of statins or using other lipid-lowering therapies – and only if offered at a discounted rate agreed by NICE with the manufacturers.
But leading GPs warned that the effects of the expensive drugs on cardiovascular morbidity has not been determined, and that NICE should ‘insist on robust evidence’ before spending NHS resources.
NICE approved the drugs based on evidence that alirocumab reduced levels of LDL cholesterol by up to 62% compared to placebo, and up to 40% compared with ezetimibe – a drug commonly used to lower cholesterol.
Trials assessing whether evolocumab reduced LDL cholesterol found it lowered levels by up to 74% compared to placebo and 44% compared to ezetimibe.
But costs of both drugs are high, up to over £4,000 per patient per year compared to around £350 for ezetimibe. NICE therefore concluded they would not be a cost-effective use of NHS resources as a first-line treatment option.
Dr Andrew Green, chairman of the GPC clinical and prescribing committee, said: ‘The manufacturers of these drugs admit that their effect on cardiovascular morbidity has not yet been determined. In other words, they don’t know if they work or not.
‘There is an urgent need to move away from surrogate endpoints as measures of the success of preventative treatments and insist on robust evidence of true benefit before spending scarce NHS resources in this way.’
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: ‘We are very pleased to be able to recommend alirocumab and evolocumab. People with hypercholesterolaemia or mixed dyslipidaemia who have a high risk of a heart attack or stroke despite taking the highest tolerated dose of other cholesterol-lowering drugs, have very few treatment options.
‘The committee concluded that both drugs are effective in reducing levels of "bad cholesterol" when compared with placebo, ezetimibe or statins in people with hypercholesterolaemia or mixed dyslipidaemia.’
Sanofi, the company that manufactures alirocumab under the brand name Praluent, welcomed the recommendation.
It said the effect of alirocumab on cardiovascular morbidity and mortality had ‘not yet been determined’, but confirmed it has been authorised as a treatment option for people at high risk of cardiovascular events or raised levels of LDL cholesterol.
Dr Tunde Falode, director of Sanofi’s cardiovascular division, said: ‘Sanofi is pleased with today’s positive recommendation from NICE as it will allow healthcare professionals to better manage their patients at a significant level of risk of cardiovascular disease.’