Cholesterol charity HEART UK is calling on NICE to reverse its rejection of Amgen’s cholesterol-busting drug Repatha for use on the National Health Service in England and Wales, slamming the move for leaving high-risk patients in danger of suffering heart attack or stroke.

Repatha (evolocumab) belongs to a closely-watched new class of medicines called PCSK9 inhibitors, which allow the liver to rid the body of LDL (bad) cholesterol by more than 60%. But its annual cost per patient comes in at around £4,448 for 140mg every two weeks and £6,123 for 420mg monthly, which, given the large number of patients that would be eligible for treatment, represents a substantial chunk of NHS resources.

Earlier this month, the cost-regulator issued preliminary guidelines barring NHS patients with high cholesterol and mixed dyslipidaemia from access to the drug, because there have been no clinical trials to measure its direct effect on cardiovascular events and the question of whether reducing LDL cholesterol with Repatha would reduce angina, heart attacks and strokes “remains unanswered”.

But Dev Datta, Consultant in Biochemistry and Metabolic Medicine at University Hospital Llandough, said NICE’s stance is “disappointing, particularly when the evidence that high cholesterol causes cardiovascular disease is so overwhelming”.

More than seven million people in the UK take statins daily to help them lower LDL cholesterol in the blood, but a significant number report side effects such as joint pain, fatigue, and nausea and, according to Amgen, in up to 60% of cases statins alone are not enough to control their high cholesterol.

Decision makes 'no sense'

“It makes no sense that NICE would take this choice away from patients. HEART UK believes that this decision will leave a significant portion of patients without sufficient treatment and at risk of complications, which will put more pressure on the already-stretch NHS when the solution could save lives,” said the charity’s chief executive Jules Payne.

"Denying patients access to new medications in this way is not only moving away from the Government’s promise to invest in science and technology but more importantly leaving high risk patients in danger of having a heart attack or stroke,” she warned.

NICE’s second consultation on the preliminary guidance will close on December 8, which will then be reviewed early next year.