Drug deemed useless
Experts are arguing for an expensive cholesterol drug to be withdrawn for use on the NHS, claiming it does not significantly improve survival rates for patients with heart disease.
The drug, which is manufactured by Amgen under the brand name Repatha, is an injectable therapy prescribed to patients with high cholesterol who are not experiencing a lowered cholesterol level with statins. It costs £4,400 per patient, per year and was approved for use in England and Ireland by NICE in June 2016.
Amgen conducted a clinical trial (FOURIER) involving over 27,000 patients with high cholesterol who had already experienced a heart attack or stroke.
The trial showed a 60% reduction in LDL-cholesterol (Low-density lipoprotein) and reductions in heart attacks and strokes. Patients involved with the trial were already taking statins and other treatments to help reduce their cholesterol levels.
However despite a reduction in cholesterol levels, the trial also showed a higher death rate among those taking Repatha than those in the placebo control group. The FOURIER trial, however, revealed that the rates between the two groups were not of statistical significance. More so the drug did not highlight a survival benefit, similar to other lipid-lowering studies.
Now, numerous doctors are criticising Repatha, claiming that the benefits of the drug do not appropriate the high price tag it comes with.
Whilst Amgen state that the drug helps reduce LDL-cholesterol, the NHS would have to treat 74 people over two years for Repatha to delay one stroke or heart attack.
The Telegraph reports that sir Richard Thompson, former President of the Royal College of Physicians said: “You have to contrast the enormous expense and the difficulty of injecting this medicine with an amazingly small benefit to patients. Is it really worth it? Amgen said Repatha decreases low-density lipoprotein, or “bad”, cholesterol to “unprecedented low levels” and that there was a “well established relationship" between LDL-C reduction and cardiovascular events”. Thompson said.
The relationship between cholesterol and heart disease has also been criticised in the past, with research pertaining to tenuous links between the two.
Dr Assem Malhotra, NHS consultant cardiologist argued against the drug’s transparency in benefitting patients saying: “NICE needs to urgently revise its recommendations on the prescription of the drug to include information that the drug will not prevent fatal heart attack or increase the patient’s lifespan by one day.”
Amgen say that sceptics should consider that cholesterol build up occurs over a lifetime. According to the FOURIER trial, the clinical benefits of Repatha will increase over the time it is taken.
Amgen state: “Thousands of patients are admitted to UK hospitals every week following heart attacks and strokes. We remain confident that evolocumab represents a cost-effective option in a subset of patients, approved by NICE, with raised cholesterol who remain at high risk of further debilitating and life-changing events despite currently available treatments."
Marc S. Sabatine lead author of the FOURIER trial said: “ We now show for the first time in a dedicated outcomes study that decreasing LDL cholesterol with PCSK9 inhibition results in clinically meaningful cardiovascular benefit. These benefits were achieved with lowering LDL cholesterol down to a median of 30 mg/dL (0.78mmol/l), which is well below current targets, and the magnitude of risk reduction increased the longer patients were on therapy. These results support the need for long-term, vigorous LDL cholesterol reduction in our patients with cardiovascular disease.”