Could the cost of the increasing use of statins to reduce heart disease and stroke undermine the chancellor's plans for a better NHS? Wendy Moore reports
The cost of cholesterol lowering drugs was probably not uppermost in Chancellor Gordon Brown's mind when he announced future funding for public services in his comprehensive spending review last week. That may soon change.
The rising bill for statins could make a sizeable dent in the 7.3% annual average growth promised to the NHS for the next six years. The latest findings from the UK's 20000 patient heart protection study, published in the Lancet this month, showed that statins could protect a much larger pool of people at risk of heart attacks and stroke than previously accepted (BMJ 2002;325:5). Calling for new prescribing guidelines, the authors said that statins could benefit three times the number of patients currently receiving them—thus tripling the statins drugs bill.
On the other side of the balance sheet, the wider prescribing of statins would save 10000 lives from cardiovascular disease, argues the study. This would go a long way towards helping the NHS meet its target of cutting mortality from heart disease by 40% in people aged under 75 by 2010, which was underlined in last week's Treasury package. Curbing the death toll from heart disease, as the heart protection study team is at pains to point out, could save substantial sums not just in NHS treatment but also in long term care and wider social costs.
Weighing up the figures in both columns is likely to provide heated debate for clinicians and accountants alike over coming months. Whether the NHS can afford to triple use of statins will be a key question.
Professor Rory Collins, who leads the heart protection study team, is unequivocal: “I think the benefits are very big.” Policy makers must set the cost of the drug against the substantial likely savings in reduced hospitalisation and other NHS costs, he argues. His team is crunching those numbers right now to produce an analysis of the financial implications of its recommendations, which it aims to publish at the American Heart Association's annual conference in November.
Collins predicts that the drugs will emerge from the analysis with flying colours—if not pointing to net savings, then at least coming fairly close. “We cannot say at the moment whether there are savings, but we can say the benefits are really very big, the costs of the drug are not unreasonable for the size of the benefits, and they are certainly comparable with costs of other treatments used widely,” he said.
So how are the figures likely to stack up? Currently statins are generally restricted to people with heart disease and raised cholesterol concentrations. However, not all of these eligible patients are receiving the drugs. A study at St George's Hospital, London, recently released by the British Heart Foundation, found that three quarters of men with angina and two thirds of men who have had a heart attack are not being prescribed cholesterol lowering drugs (Heart 2002;88:25-9)
The heart protection study estimates that about a million people in the United Kingdom are currently prescribed statins. The British Heart Foundation puts the figure higher, pointing out that prescriptions for statins increased by about a third in England in 2001.
This already steeply rising gradient would rise still faster under the heart protection study's recommendations. The study team suggests statins should be offered to everyone at increased risk of heart disease or stroke, irrespective of their cholesterol reading. This would extend statins to about three million people in the United Kingdom. However, tripling statins use does not directly equate to trebling the statins drugs bill.
Figures from the market analysts Datamonitor show the United Kingdom spent £469m ($740m; €730) on the five leading statins in 2001—a 43% rise on 2000. The UK market leader, simvastatin (Zocor), which was also the statin used in the heart protection study, costs around £1 ($1.57; €1.55) a day in the United Kingdom. It costs $4 in the United States.
Yet as prescribing has risen, so the unit cost of statins has fallen. Criticism of the expense of statins has already led to a 30% price cut in the past 12 months. When the patent for simvastatin runs out in mid-2003 and generic drugs arrive on the market, costs will tumble. “Prices are likely to come down straight away,” said Katy Wynn, a cardiovascular analyst for Datamonitor. Professor Collins predicts that generic statins could cost as little as a quarter of the current prices.
Professor Sir Charles George, medical director of the British Heart Foundation, said, “Although the costs will increase with usage, they will be to some extent offset by price reductions. Some have taken place this year and others will follow next year.”
Derek Wanless, the former banker who reviewed NHS finances, certainly perused the sums in his final report in April (BMJ2002;324:998). He estimated the NHS would spend around £700m this financial year through increased prescribing of statins. This would climb to £2.1bn by 2010, on the assumption of prescriptions for everyone with at least 15% risk of heart disease and 80% compliance, offset by fewer hospital admissions and reduced smoking.
However, the review did not take account of the heart protection study's findings, which, Sir Charles argues, would cut medical costs as well as increase the overall spending on statins as a result of an increase in the volume of drugs dispensed. Fewer admissions for angina, fewer revascularisations and endarterectomies, fewer amputations from diabetes, and an overall drop in bed days would save significant sums, he says.
“It is not going to be much of a total saving, but the net increase in cost is going to be quite considerably less than many people have forecast.”
Professor Shah Ebrahim, coordinating editor of the Cochrane Heart Group, says that statins are relatively cost effective. “This is potentially one of the best bargains going,” he said. “In the fourth richest country in the world it does seem a counsel of despair to say we cannot afford these drugs.”
The national service framework for coronary heart disease recommends statins for most patients identified by the study. Prescribing has risen by 78% since the framework's launch in 2000.
However, the Department of Health is considering whether to revise current guidance in the light of the heart protection study's findings and may refer the issue for review by the National Institute for Clinical Evidence.