NICE says no to Amgen cholesterol drug Repatha

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The National Institute for Health and Care Excellence has rejected Amgen’s Repatha as an option for people with high cholesterol and mixed dyslipidaemia.

Repatha (evolocumab), which belongs to the closely-watched PCSK9 inhibitor class, was recently approved the drug as a treatment for patients with uncontrolled cholesterol. However in issuing draft guidance, NICE said there have been no clinical trials to measure its direct effect on cardiovascular events, and that the question of whether reducing LDL cholesterol with Repatha (evolocumab) would reduce angina, heart attacks and strokes “remains unanswered”.

NICE also said it was concerned that Amgen used so-called Framingham risk equations, “which have been shown to overestimate CVD risk in a UK population, instead of the NICE-recommended and UK-validated QRISK2 assessment tool”. The cost watchdog added that “the degree of uncertainty in the cost-effectiveness evidence was too high”.

Repatha’s annual cost per patient comes in at around £4,448.60 for 140mg every two weeks, and £6,123.60 for 420mg monthly.

Expressing his disappointment, Tony Patrikios, executive medical director at Amgen UK & Ireland, noted that access to new treatment options for lowering low-density lipoprotein in patients who remain at high risk of CVD “is of critical importance”. He noted that the Department of Health recognises CVD mortality as the largest cause of death in the UK “and an area where England underperforms compared to other similar countries. Evidence strongly indicates that high cholesterol is linked to heart attacks and strokes”.

Dr Patrikios concluded by saying that Amgen will continue to work with NICE “to provide further data and analyses to demonstrate the cost-effectiveness of Repatha for relevant groups of patients”.