Amgen is launching its cholesterol-buster Repatha Europe at a fraction of its cost in the US, but experts still fear that use of the drug in the UK will still be heavily restricted by National Health Service cost regulators.

The US biotech giant is pricing the PCSK9 inhibitor at around £340 a month in the UK, reports Reuters. This equates to around $6,780 a year, and so substantially lower than its US list price of $14,100. Similarly, in Austria and Finland, the drug’s cost equates to around $8,220 and $8,820 a year, respectively, still hugely cheaper than across the pond.

More than seven million people in the UK take statin pills daily, but a significant number report side effects such as joint pain, fatigue, and nausea, and, according to Amgen, more than 60% of high-risk patients across Europe are still unable to adequately lower their bad cholesterol levels despite treatment, a figure which is thought to be more than 80% in very high risk patients.

Repatha (evolocumab) received European clearance in July and is currently under review by the National Institute for Health and Care Excellence for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia, with guidance for the NHS in England and Wales expected next April.

The cost watchdog will be considering clinical data showing that the drug induced a reduction in low-density lipoprotein cholesterol of some 55%-75% versus a placebo, and by around 35% to 45% compared with ezetimibe (Merck & Co’s Zetia), in patients with primary hyperlipidaemia and mixed dyslipidaemia. 

But Peter Weissberg, Medical Director at the British Heart Foundation, told The Independent that while “there is no question” of efficacy, “I can’t imagine that NICE is going to approve [Repatha] for everyone at the moment”. 

“I think the manufacturers are trying to tap into a market of people who suffer side-effects, and that really isn’t right. This should be used for people who have a genetic pre-disposition to high cholesterol and for whom statins aren’t working,” he said.