Paying for statins
http://www.100md.com
《英国医生杂志》
1 Health Centre, University of East Anglia, Norwich NR4 7TJ, 2 Health Economics and Ethics Group School of Medicine, Health Policy and Practice, University of East Anglia
Correspondence to: N Raithatha N.Raithatha@uea.ac.uk
Should UK general practitioners be able to offer private prescriptions for statins to patients below 3% risk of heart disease?
Coronary heart disease is a major cause of illness in Britain, with around 100 000 deaths from 300 000 heart attacks annually.1 2 Raised cholesterol concentration is an important risk factor for coronary heart disease.3 Treatment with 3-hydroxy-3-methylglutaryl coenzyme reductase inhibitors (statins) significantly reduces cholesterol concentrations, decreasing the risk of heart attack by at least 33%4 and as much as 61% in the long term.5 Statins are relatively safe,6 and their benefit is additive to other preventive measures, such as aspirin.7 However, many people who could benefit from them are not currently receiving them, largely for economic reasons. This article explains the rationale for increasing prescribing of statins and suggests one way in which this could be afforded.
Cost of treatment
Current evidence shows that statins reduce the risk of developing coronary heart disease in people with a greater than 0.6% a year chance of developing the disease.8 However, the national service framework that establishes standards for the prevention of coronary heart disease recommends treatment only for people with a risk of over 3% a year.1 The cost effectiveness of statins (based on a benefit of 33%) has been estimated at ￡4500 ($8250, 6460) per life year gained for a year's treatment of people at a 3% annual risk of coronary heart disease and ￡6100 a year for people at a 1.5% annual risk; the net discounted cost per life year saved to the NHS is ￡7500 and ￡11 800 respectively.9 The marginal cost to the NHS of expanding treatment from those at 3% risk to those at 1.5% risk would be ￡12 500 per life year saved.9 This is well within the threshold of ￡30 000 per life year gained that the National Institute for Clinical Excellence seems to use.10
But this is not necessarily the good news that it sounds. Cost effectiveness analysis does not take account of total budgetary impact; prescribing statins for those whose annual risk is over 3% would lead to treating 8.2% of the adult British population, whereas treatment for those whose risk is greater than 0.6% would lead to treatment of over 40% of the adult population.11 The annual cost of statins to the NHS, based on a daily dose of 40 mg of simvastatin, is ￡337 for each patient.12 Forty per cent of the adult British population is around 18 million.13 Thus, if all eligible adults were treated, the total drug cost would be over ￡6bn—about 10% of the total NHS budget.
Simvastatin has now lost its patent, and its price is likely to fall. However, if we take the recent example of fluoxetine, generic competition reduced the price only to ￡66 a year.12 Even at this price, treating all eligible patients would still cost over ￡1bn.
Polarised light micrograph of cholesterol crystals
Credit: SPL
Ethical problem
All of this raises ethical issues for general practitioners. They can treat all patients with raised blood pressure and give advice about smoking, exercise, and diet, but they can prescribe statins only to those with a risk of greater than 3% a year despite knowing that many more would benefit.1 Clearly, if all general practitioners prescribed statins based on effectiveness, or even cost effectiveness, they could bankrupt the NHS.
The problem is compounded by the ban on general practitioners giving private prescription to their NHS patients. Private prescriptions break the core NHS principle to "provide a universal service for all based on clinical need, not ability to pay."14 However, although private prescription would increase inequality in access to health care, is this necessarily unethical? We suggest not. Rather, we believe it is both economically and ethically justifiable to allow general practitioners to prescribe statins privately, not only because of the benefit to the person taking statins but because of the broader positive effects that will accrue to the rest of society.
The key issue is that patients who are currently ineligible for statins are invariably not informed of this form of rationing and as such are not able to choose other, private, means of obtaining treatment. However, many patients, if told that they could benefit from statins might be willing to pay for a private prescription. This will depend on the individual's valuation of (the benefit derived from) statins relative to other potential subjects of expenditure and income.15
We have estimated that the cost of private treatment with monitoring by a NHS practice nurse working within a protocol, is ￡93.66 a year (table).16 This is far less than median household expenditure on, for example, alcohol (￡320), clothes (￡380), and motoring (￡920).13 Statins may therefore be quite affordable to people on average earnings.
Estimated cost of private treatment with statins using NHS infrastructure
Ethics of private prescriptions
Under our proposed scenario, people with a cholesterol concentration corresponding to a risk of coronary heart disease of between 0.6% and 3% a year would be offered private treatment and monitoring by their own primary care team. This would ensure a patient specific holistic approach to managing risk. In addition to the benefits to the individual, the total incidence of coronary heart disease would fall because more people would be treated with statins. This would, at the very least, make no one worse off, but it may save NHS expenditure on treating coronary heart disease, releasing money to spend elsewhere. In this case, it would be possible for the NHS, through primary care trusts, to target such savings to poorer areas—for example, for primary prevention of coronary heart disease. Allowing those who can afford private prescriptions for statins to have them could therefore also benefit those who cannot afford them.
Although increasing inequality, this is ethically justifiable under the difference principle.17 This is a form of inequality whereby all members of society gain, which has been argued to be ethically just by John Rawls and others.17 Although relative inequality in access would increase, absolute levels of health care would increase, which would benefit all individuals in society irrespective of their ability to pay. The pursuit of equity under the current situation simply ensures that everyone is equally worse off than they could be under our proposed scenario.
Summary points
Statins are cost effective in reducing coronary heart disease
Prescribing under the NHS to all patients who would benefit from them is not affordable
Current medical practice denies effective treatment to 32% of the adult population
Private prescriptions by general practitioners would be ethical as they would benefit all members of society
Conclusions
The debate concerning access to statins is a parable for the future of the NHS. Under current guidelines many people are being denied not only effective treatment but also the choice of obtaining that treatment though their own expense within the NHS (in itself paradoxical given the current emphasis of government on promoting patient choice).18 The government has proposed making statins available over the counter, but there is considerable resistance to this because treatment would be unmonitored. The current option of treatment through a private consultant would be prohibitively expensive for many. We suggest that unless patients who are excluded from effective treatment (because of rationing) are offered the option of obtaining this treatment privately, it is this inequity that will threaten the future of the NHS.
Contributors and sources: NR has been a general practitioner at the University of East Anglia Health Centre for 10 years. He has a MSc in health policy and practice with a special interest in modern concepts of justice and fairness. He regularly comes across patients from Europe and America who challenge his values of the NHS. RDS is an honorary professor of health economics at the University of Hong Kong. He has over 100 publications, ranging across aspects of health service reform, the valuation of health benefits, and ethics and health policy.
Competing interests: None declared.
References
Department of Health. National service framework for coronary heart disease. London: Stationery Office, 2000.
Department of Health. Saving lives: our healthier nation. London: Stationery Office, 1999.
Jackson R. Guidelines on preventing cardiovascular disease in clinical practice. BMJ 2000;320: 659-61.
Pignone M, Phillips C, Mulrow C. Use of lipid lowering drugs for primary prevention of coronary heart disease: meta-analysis of randomised trials. BMJ 2000;321: 983-6.
Law MR, Wald NJ, Rudnicka A. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003;326: 1423-7.
Hulley S, Grady DB, Browner WS. Statins: underused by those who would benefit. BMJ 2000;321: 971-2.
British Cardiac Society, British Hyperlipidaemia Association, British Hypertension Society, British Diabetic Association. Joint British recommendations on prevention of coronary heart disease. Heart 1998;80(suppl 2): S1-29.
Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of Air Force/Texas coronary atherosclerosis prevention study. JAMA 1998;279: 1615-22.
Pickin DM, McCabe CJ, Ramsay LE, Payne N, Haq IU, Yeo, WW, et al. Cost effectiveness of HMG-CoA reductase inhibitor (statin) treatment related to the risk of coronary heart disease and cost of drug treatment. Heart 1999;82: 325-32.
Timmins N. Drugs and the NHS's ￡30 000 question. Financial Times 2001 Aug 10.
Haq IU, Ramsay LE, Wallis EJ, Isles CG, Jackson PR. Population implication of lipid lowering for prevention of coronary heart disease: data from the 1995 Scottish health survey. Heart 2001;86: 289-95.
British Medical Association, Royal Pharmaceutical Society of Great Britain. British national formulary. London: BMA, RPS, 2003: 128, 194. (No 45.)
National Statistics. Census 2001. www.statistics.gov.uk/census2001/demographic_uk.asp (accessed 5 Dec 2003).
NHS core principles 2000. www.nhs.uk/nhsguide/1_coreprinciples.htm (accessed 5 Dec 2003).
Beattie J, Covey J, Dolan P, Hopkins L, Jones-Lee M, Loomes G, Pidgeon N, et al. On the contingent valuation of safety and the safety of contingent valuation. Part 1: caveat investigator. J Risk Uncertain 1998;17: 5-26.
Marks D, Wonderling D, Thorogood, M, Lambert, H. Screening for hypercholesterolaemia versus case finding for familial hypercholesterolaemia: a systematic review and cost-effectiveness analysis. Health Technol Assess 2000;4(29): 1-123.
Rawls J. A theory of justice. Oxford: Oxford University Press, 1972.
Department of Health. Fair for all, personal to you: choice, responsiveness and equity in the NHS and social care. London: Stationery Office, 2003.(Nick Raithatha, general p)
Correspondence to: N Raithatha N.Raithatha@uea.ac.uk
Should UK general practitioners be able to offer private prescriptions for statins to patients below 3% risk of heart disease?
Coronary heart disease is a major cause of illness in Britain, with around 100 000 deaths from 300 000 heart attacks annually.1 2 Raised cholesterol concentration is an important risk factor for coronary heart disease.3 Treatment with 3-hydroxy-3-methylglutaryl coenzyme reductase inhibitors (statins) significantly reduces cholesterol concentrations, decreasing the risk of heart attack by at least 33%4 and as much as 61% in the long term.5 Statins are relatively safe,6 and their benefit is additive to other preventive measures, such as aspirin.7 However, many people who could benefit from them are not currently receiving them, largely for economic reasons. This article explains the rationale for increasing prescribing of statins and suggests one way in which this could be afforded.
Cost of treatment
Current evidence shows that statins reduce the risk of developing coronary heart disease in people with a greater than 0.6% a year chance of developing the disease.8 However, the national service framework that establishes standards for the prevention of coronary heart disease recommends treatment only for people with a risk of over 3% a year.1 The cost effectiveness of statins (based on a benefit of 33%) has been estimated at ￡4500 ($8250, 6460) per life year gained for a year's treatment of people at a 3% annual risk of coronary heart disease and ￡6100 a year for people at a 1.5% annual risk; the net discounted cost per life year saved to the NHS is ￡7500 and ￡11 800 respectively.9 The marginal cost to the NHS of expanding treatment from those at 3% risk to those at 1.5% risk would be ￡12 500 per life year saved.9 This is well within the threshold of ￡30 000 per life year gained that the National Institute for Clinical Excellence seems to use.10
But this is not necessarily the good news that it sounds. Cost effectiveness analysis does not take account of total budgetary impact; prescribing statins for those whose annual risk is over 3% would lead to treating 8.2% of the adult British population, whereas treatment for those whose risk is greater than 0.6% would lead to treatment of over 40% of the adult population.11 The annual cost of statins to the NHS, based on a daily dose of 40 mg of simvastatin, is ￡337 for each patient.12 Forty per cent of the adult British population is around 18 million.13 Thus, if all eligible adults were treated, the total drug cost would be over ￡6bn—about 10% of the total NHS budget.
Simvastatin has now lost its patent, and its price is likely to fall. However, if we take the recent example of fluoxetine, generic competition reduced the price only to ￡66 a year.12 Even at this price, treating all eligible patients would still cost over ￡1bn.
Polarised light micrograph of cholesterol crystals
Credit: SPL
Ethical problem
All of this raises ethical issues for general practitioners. They can treat all patients with raised blood pressure and give advice about smoking, exercise, and diet, but they can prescribe statins only to those with a risk of greater than 3% a year despite knowing that many more would benefit.1 Clearly, if all general practitioners prescribed statins based on effectiveness, or even cost effectiveness, they could bankrupt the NHS.
The problem is compounded by the ban on general practitioners giving private prescription to their NHS patients. Private prescriptions break the core NHS principle to "provide a universal service for all based on clinical need, not ability to pay."14 However, although private prescription would increase inequality in access to health care, is this necessarily unethical? We suggest not. Rather, we believe it is both economically and ethically justifiable to allow general practitioners to prescribe statins privately, not only because of the benefit to the person taking statins but because of the broader positive effects that will accrue to the rest of society.
The key issue is that patients who are currently ineligible for statins are invariably not informed of this form of rationing and as such are not able to choose other, private, means of obtaining treatment. However, many patients, if told that they could benefit from statins might be willing to pay for a private prescription. This will depend on the individual's valuation of (the benefit derived from) statins relative to other potential subjects of expenditure and income.15
We have estimated that the cost of private treatment with monitoring by a NHS practice nurse working within a protocol, is ￡93.66 a year (table).16 This is far less than median household expenditure on, for example, alcohol (￡320), clothes (￡380), and motoring (￡920).13 Statins may therefore be quite affordable to people on average earnings.
Estimated cost of private treatment with statins using NHS infrastructure
Ethics of private prescriptions
Under our proposed scenario, people with a cholesterol concentration corresponding to a risk of coronary heart disease of between 0.6% and 3% a year would be offered private treatment and monitoring by their own primary care team. This would ensure a patient specific holistic approach to managing risk. In addition to the benefits to the individual, the total incidence of coronary heart disease would fall because more people would be treated with statins. This would, at the very least, make no one worse off, but it may save NHS expenditure on treating coronary heart disease, releasing money to spend elsewhere. In this case, it would be possible for the NHS, through primary care trusts, to target such savings to poorer areas—for example, for primary prevention of coronary heart disease. Allowing those who can afford private prescriptions for statins to have them could therefore also benefit those who cannot afford them.
Although increasing inequality, this is ethically justifiable under the difference principle.17 This is a form of inequality whereby all members of society gain, which has been argued to be ethically just by John Rawls and others.17 Although relative inequality in access would increase, absolute levels of health care would increase, which would benefit all individuals in society irrespective of their ability to pay. The pursuit of equity under the current situation simply ensures that everyone is equally worse off than they could be under our proposed scenario.
Summary points
Statins are cost effective in reducing coronary heart disease
Prescribing under the NHS to all patients who would benefit from them is not affordable
Current medical practice denies effective treatment to 32% of the adult population
Private prescriptions by general practitioners would be ethical as they would benefit all members of society
Conclusions
The debate concerning access to statins is a parable for the future of the NHS. Under current guidelines many people are being denied not only effective treatment but also the choice of obtaining that treatment though their own expense within the NHS (in itself paradoxical given the current emphasis of government on promoting patient choice).18 The government has proposed making statins available over the counter, but there is considerable resistance to this because treatment would be unmonitored. The current option of treatment through a private consultant would be prohibitively expensive for many. We suggest that unless patients who are excluded from effective treatment (because of rationing) are offered the option of obtaining this treatment privately, it is this inequity that will threaten the future of the NHS.
Contributors and sources: NR has been a general practitioner at the University of East Anglia Health Centre for 10 years. He has a MSc in health policy and practice with a special interest in modern concepts of justice and fairness. He regularly comes across patients from Europe and America who challenge his values of the NHS. RDS is an honorary professor of health economics at the University of Hong Kong. He has over 100 publications, ranging across aspects of health service reform, the valuation of health benefits, and ethics and health policy.
Competing interests: None declared.
References
Department of Health. National service framework for coronary heart disease. London: Stationery Office, 2000.
Department of Health. Saving lives: our healthier nation. London: Stationery Office, 1999.
Jackson R. Guidelines on preventing cardiovascular disease in clinical practice. BMJ 2000;320: 659-61.
Pignone M, Phillips C, Mulrow C. Use of lipid lowering drugs for primary prevention of coronary heart disease: meta-analysis of randomised trials. BMJ 2000;321: 983-6.
Law MR, Wald NJ, Rudnicka A. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003;326: 1423-7.
Hulley S, Grady DB, Browner WS. Statins: underused by those who would benefit. BMJ 2000;321: 971-2.
British Cardiac Society, British Hyperlipidaemia Association, British Hypertension Society, British Diabetic Association. Joint British recommendations on prevention of coronary heart disease. Heart 1998;80(suppl 2): S1-29.
Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of Air Force/Texas coronary atherosclerosis prevention study. JAMA 1998;279: 1615-22.
Pickin DM, McCabe CJ, Ramsay LE, Payne N, Haq IU, Yeo, WW, et al. Cost effectiveness of HMG-CoA reductase inhibitor (statin) treatment related to the risk of coronary heart disease and cost of drug treatment. Heart 1999;82: 325-32.
Timmins N. Drugs and the NHS's ￡30 000 question. Financial Times 2001 Aug 10.
Haq IU, Ramsay LE, Wallis EJ, Isles CG, Jackson PR. Population implication of lipid lowering for prevention of coronary heart disease: data from the 1995 Scottish health survey. Heart 2001;86: 289-95.
British Medical Association, Royal Pharmaceutical Society of Great Britain. British national formulary. London: BMA, RPS, 2003: 128, 194. (No 45.)
National Statistics. Census 2001. www.statistics.gov.uk/census2001/demographic_uk.asp (accessed 5 Dec 2003).
NHS core principles 2000. www.nhs.uk/nhsguide/1_coreprinciples.htm (accessed 5 Dec 2003).
Beattie J, Covey J, Dolan P, Hopkins L, Jones-Lee M, Loomes G, Pidgeon N, et al. On the contingent valuation of safety and the safety of contingent valuation. Part 1: caveat investigator. J Risk Uncertain 1998;17: 5-26.
Marks D, Wonderling D, Thorogood, M, Lambert, H. Screening for hypercholesterolaemia versus case finding for familial hypercholesterolaemia: a systematic review and cost-effectiveness analysis. Health Technol Assess 2000;4(29): 1-123.
Rawls J. A theory of justice. Oxford: Oxford University Press, 1972.
Department of Health. Fair for all, personal to you: choice, responsiveness and equity in the NHS and social care. London: Stationery Office, 2003.(Nick Raithatha, general p)