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The Pharmaceutical Journal Vol 267 No 7175 p740
24 November 2001

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News feature

If statins are the new aspirin what might it cost the National Health Service?

The number of patients being prescribed statins may increase as a result of findings from a new cholesterol lowering study. Zoë Gross investigates the cost implications of any potential change in prescribing practice


The cost of statins will fall as patents expire

Preliminary results of a new study presented at the American Heart Association's annual conference, this month, show that cholesterol lowering with statins reduces the risk of heart attacks and strokes by about a third in all people at risk of vascular disease (see PJ, 17 November, p701). Researchers from Oxford University found that a far wider range of people benefit from statin therapy than was previously thought. As well as those who already have coronary disease, patients with diabetes, those with narrowing of arteries in their legs and those with a previous history of stroke might benefit.

Study design

The Heart Protection Study involved:

  • 20,536 patients in 69 hospitals in the United Kingdom
  • Targeting groups of patients for whom there was little evidence of benefit from cholesterol-lowering therapy
  • Patients with type 1 or type 2 diabetes, those aged over 70 years, women, those with non-coronary vascular disease and those with average or below-average cholesterol levels
  • Treatment with either simvastatin 40mg daily or placebo

Further details can be found at www.hpsinfo.org.

Over 10,000 people in the study had been assigned to receive simvastatin (Zocor). The researchers say that an estimated 25 million people world wide are currently being treated with statins and World Health Organization statistics indicate that about 200 million people worldwide have coronary heart disease, stroke or diabetes. The study shows that simvastatin has the potential to prevent 70,000 to 100,000 heart attacks, strokes or revascularisation operations and 20,000 to 30,000 deaths for every million patients treated for five years. It also reduces hospital admissions for worsening angina and there are 30 fewer admissions to hospital per thousand patients treated with simvastatin for five years.

Lead researcher, Professor Rory Collins of Oxford University says that if an extra 10 million high-risk people worldwide were treated with statins as a result of the study, about 50,000 lives would be saved per year.

This suggests that based on a 40mg daily dose of simvastatin, as used in the study, at the current cost of £29.69 for a 28-day supply, an extra £3.87bn will need to be spent per year on treating these people.

The British Heart Foundation estimates that if all the 6 million people in the UK that have cardiovascular disease or diabetes are treated with statins, 25,000 lives would be saved per year. However, it is unlikely that all will be treated with statins.

Dr Alan Rees, senior member, British Hyperlipidaemia Association and consultant physician, University Hospital of Wales, says that the cost effectiveness of prescribing statins depends on the price of the drug being prescribed. At the moment it is difficult to quantify the future cost of prescribing statins because of a number of variables. Simvastatin is expected to come off patent in May 2003. Also, a new statin, rosuvastatin (Crestor) is expected to be launched by AstraZeneca during the second half of next year. The launch price of this drug will have to be competitive with the current price of other statins and that in turn may influence the future market price of other statins, he says. He thinks that the cost of statins will reduce with time and that "it will need to as they are relatively expensive drugs." He adds that "the results of the study are very encouraging" and that "the usage of simvastatin will increase significantly which will have cost implications."

Dr Jane Armitage, senior research fellow, Oxford University, also involved in the study, says that increased prescribing of statins is "unlikely to have a big impact on GPs' time". The patients in the trial had known vascular disease or diabetes and were already under the care of their GP. She said that many of them would already be having their cholesterol levels measured. However, although testing will continue, cholesterol levels are not important in determining who should receive treatment and it is unlikely that cholesterol testing will increase as a result of the study. She added that if additional patients are put on statins and consequently have fewer coronary events, there are likely to be cost savings in the future.

Dr Armitage also comments that the benefits of simvastatin are additional to those of other treatments, such as aspirin and antihypertensive agents, used to treat patients at high risk of vascular disease. None of the previous concerns about the safety of cholesterol lowering therapy were substantiated, she adds.

Dr Brian Curwain, prescribing advisor, New Forest Primary Care Group, says that the study extends what is already known about statins reducing the risk of heart disease and stroke. However, he thinks that spending on lipid lowering therapy will increase as a result of the primary prevention outcomes of the study.

The New Forest PCG, which has 182,000 patients, is currently spending at least £1.47m on statins a year. This accounts for 7.25 per cent of the PCG's total drug budget of about £20m and is increasing at a rate of about 35 per cent per year.

Dr Roger Boyle, the Government's national director for heart disease, says that increased prescribing of statins in particular is a key priority in the National Service Framework for coronary heart disease (CHD), both for people with CHD and for those at risk of developing it. He adds: "The number of prescriptions for statins is already rising steadily, with an increase of over 770,000 in a year to over 10 million prescriptions." According to IMS MediPlus statistics, between August 2000 and August 2001 there were 4.9 million prescriptions in the United Kingdom for all doses of simvastatin.

Helen Liddell, pharmaceutical and prescribing advisor, Rotherham Health Authority says that the the prescribing support team is busy trying to fulfil current NSF requirements (see panel) and that until the new research gets incorporated into NSF "we are not going to do anything about it".

NSF requirements

The National Service Framework for coronary heart disease states that people with diagnosed coronary heart disease or other occlusive arterial disease should receive, unless contraindicated, statins and dietary advice to lower serum cholesterol concentrations either to less than 5mmol/L (low density lipoprotein to below 3mmol/L) or by 30 per cent (whichever is greater). One of the immediate priorities is, by April 2002, to improve the use of effective medicines after heart attacks (especially the use of aspirin, beta blockers and statins) so that 80 to 90 per cent of people discharged from hospital following a heart attack will receive these drugs.

An analysis of the the cost implications of the results of the Heart Protection Study is planned, according to Dr Armitage.

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Zoë Gross is on the staff of The Pharmaceutical Journal


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