'Hugely expensive' cholesterol drug prescribed on NHS does not prevent fatal heart attacks or strokes, say experts
A coalition of doctors last night called on patients to be told that evolocumab, which was hailed as a “game changer” and “better than statins”, does nothing to prevent fatal heart attacks and strokes.
But campaigners argue it is precisely because the death rate was higher among Repatha patients that the trial was wound up early.
Rival pharma company Pfizer abandoned its trial of a similar PCSK9 inhibitor drug last year, conceding it was “not likely to provide value to patients”.
Unlike statins, which slow the production of cholesterol, drugs like evolocumab block a protein which hampers the liver's ability to clear cholesterol from the blood.
The Amgen-sponsored trial of 27,000 people found it could lower cholesterol by almost 60 per cent compared with existing treatments.
Despite this, the NHS, which was told it should provide evolocumab by the National Institute for Health and Care Excellence (NICE) last year, would have to treat 74 people for two years with the drug to delay a single stroke or heart attack. These could be very minor events.
Sir Richard Thompson, former President of the Royal College of Physician and physician to the Queen, said: “You have to contrast the enormous expense and the difficulty of injecting this medicine with an amazingly small benefit to patients.
There is, however, a controversy over the extent to which LDL cholesterol contributes to cardiovascular ill health. One of those campaigning against the orthodox view of a causal link is NHS Consultant Cardiologist Dr Aseem Malhotra.
“NICE needs to urgently revise its recommendations on the prescription of the drug to include information that the drug will not prevent a fatal heart attack or increase a patient’s lifespan by one day,” he said.
As well as an absent mortality benefit, researchers have said that the Amgen trial, which used participants in a range of countries, showed evocolumab did not benefit the European patients.
Professor Sherif Sultan, President of the International Society of Vascular Surgeons, said there was “no evidence of benefit to UK patients”, describing the NICE guidelines as “crazy”.
However, a spokesman for Amgen disagreed, saying: “We remain confident that Repatha is a clinically effective and cost-effective treatment in the very high risk patient group stipulated by NICE."
A spokesman for NICE, which claims to enjoy an unspecified commercial discount from evolocumab, said the organisation could not comment because of the general election campaign.