Task Force #2—the cost of prevention: can we afford it? Can we afford not to do it?

JACC Vol. 40, No. 4, 2002 August 21, 2002:579–651 Clinical Cardiology, American Heart Association. Circulation 2000; 101:461–5. 131. Grady KL, Dracup K, Kennedy G, et al. Team management of patients with heart failure: a statement for healthcare professionals from the Cardiovascular Nursing Council of the American Heart Association. Circulation 2000;102:2443–56. 132. Curry SJ. Organizational interventions to encourage guideline implementation. Chest 2000;118:40S–6S.

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133. Mar J, Rodriguez-Artalejo F. Which is more important for the efficiency of hypertension treatment: hypertension stage, type of drug or therapeutic compliance? J Hypertens 2001;19:149 –55. 134. David SP, Greer DS. Social marketing: application to medical education. Ann Intern Med 2001;134:125–7. 135. Green LW, Kreuter MW. Health Promotion Planning: An Educational and Environmental Approach. 2nd edition. Mountain View, CA: Mayfield Publishing Company, 1991:150.

Task Force #2—The Cost of Prevention: Can We Afford It? Can We Afford Not To Do It? Harlan M. Krumholz, MD, FACC, Co-Chair, William S. Weintraub, MD, FACC, Co-Chair, W. David Bradford, PHD, Paul A. Heidenreich, MD, MS, FACC, Daniel B. Mark, MD, MPH, FACC, A. David Paltiel, MBA, PHD The development of many strategies for the prevention of cardiovascular disease (CVD) presents an important policy question for society: do the benefits of these programs and interventions justify the investment in them? Preventive strategies may provide attractive opportunities to avoid or defer disease and disability, but they may have substantial costs and must often be applied to many subjects in order to reach the few in the group who will benefit the most. Whether and how limited health care dollars should be allocated to these activities is therefore an important area of inquiry for health care policy makers and practitioners. Economic considerations now dominate the health care policy debate. Purchasers of health care have limited resources and thus must determine the “value” of the services of their spending decisions. The expanding array of CVD preventive options, including novel markers of risk, new imaging modalities, and innovative interventions, has drawn particular attention as the pressure on health care budgets increases. Currently, the U.S. uses almost 14% of its gross domestic product (GDP) on health care reaching more than $1.5 trillion per year (1). Health care inflation, initially stabilizing in the mid-1990s, is again increasing at a more rapid rate than the general consumer price index (2), leading to marked increases in health insurance premiums (3). In this economic environment, the failure of cardiologists to take economic issues seriously may place their patients at a distinct disadvantage in competing for scarce health care resources with patients who have, or are at risk for, other disease. Arguments in favor of the allocation of resources for CVD prevention will increasingly need to be supported by evidence of the value of the investment. Guideline committees need to consider the economic implications of their recommendations and appeal not only to evidence of the effectiveness of specific strategies but also to their value from a societal perspective. Policy will not be based on this information alone, but the information will be necessary to persuade care purchasers of the worthiness of these activities. In this discussion, what is currently known about the

value of selected preventive strategies for atherosclerotic disease is reviewed, referring to the extra dollars spent on a given program or intervention to produce extra health benefits. In this context, what extra benefits these strategies are producing, what they cost to produce these benefits, and the ratio of the cost to the benefit are examined. Controversies in this field that relate to valuing health care are also considered. A proposal for an integrated policy designed to determine the value of CVD prevention is presented in conclusion.

COST-EFFECTIVENESS ANALYSIS OF PREVENTIVE STRATEGIES: BRIEF OVERVIEW A challenge for a society with finite resources is to determine which interventions and programs have the most value. An approach to measuring value is to determine which interventions yield the best extra or incremental benefits (e.g., most quality-adjusted life-years [QALYs], most years free from pain, and longest life in years) relative to the extra resources (costs) required to produce those benefits. Cost-effectiveness analysis is the most widely used approach for the economic analysis of medical strategies and interventions. It provides a way to compare incremental costs and benefits, typically summarized as a costeffectiveness ratio (cost per unit of health outcomes achieved). Interventions that improve outcomes and decrease, or do not change, costs are ideal yet all too rare. Strategies that increase costs and worsen outcomes are easy to reject. The challenge involves those strategies that improve outcomes but require extra resources. Cost-effectiveness analysis provides an approach for the ranking of the relative value of these options. When common definitions of health outcomes are employed, it is possible to compare the opportunity costs of various choices. “Opportunity costs” are the value forgone by devoting resources to a given activity rather than to their best alternative use. For these ratios, no specific value ensures that a designation will be “cost-effective”—the distinction is relative and

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depends largely on the amount of money available to spend on health care. For example, countries that spend a low proportion of their GDP on health care (such as the United Kingdom) would be expected to use a much lower threshold to define what is economically attractive or “cost-effective” than countries such as the U.S., that invest many more dollars in health care. Regardless of the absolute benchmarks used, the important concept is one of comparative value. With a certain, fixed amount of money allocated to health care, a policy maker is concerned with getting the greatest health return on the investment. Therefore, spending on health interventions that produce many benefits for a modest investment would always be preferred, in theory at least, over expensive interventions that produce modest benefits. Moreover, meaningful comparisons of value cannot be made against an absolute benchmark; rather, they must be measured in terms of alternative investment opportunities forgone. Thus, cost-effectiveness studies—when conducted correctly—are incremental in that they compare the added cost of achieving an additional unit of outcome by switching between therapeutic options. A judgment about what constitutes a reasonable return on investment depends on the total budget available and a person’s role (e.g., purchaser, patient, caregiver, patient family member). Many studies have pursued economic analyses of CVDpreventive strategies. These studies have generally focused on the incremental cost of an intervention per incremental unit of health outcome and thus may be compared with other common medical interventions (4). To provide a survey of cost-effectiveness analyses performed for strategies to prevent CVD, articles were identified describing costeffectiveness of lipid lowering, hypertension treatment, smoking cessation, diabetes treatment, and exercise using Medline covering the period from 1967 to 2001. The review of the bibliographies of retrieved articles was used to identify additional candidate articles. Studies of cost-effectiveness were included if they calculated an incremental costeffectiveness ratio in terms of cost per year of life saved or QALY gained. All costs were converted to 2001 U.S. dollars using time-specific currency conversion rates and the U.S. GDP deflator inflation index. Lipid lowering. Several economic analyses of randomized trial data have documented the economic attractiveness of drug treatment compared with placebo (Tables 1 and 2). The cost-effectiveness of the drug treatment is strongly associated with the underlying risk for the patients, the effectiveness of the drug and its cost. In general, pre-statin drug therapy studies showed very modest lipid lowering and equally modest reductions in major clinical events. In contrast, 3-hydroxy-3-methylglutaryl– coenzyme A reductase inhibitors (“statins”) are much more effective in reducing low-density lipoprotein (LDL)-cholesterol, with average reductions in the range of 20% to 25%. Corresponding relative reductions have been seen in clinical events. In economics, however, absolute rather than relative differences determine the results of cost-effectiveness analysis.

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Thus, a 20% reduction in mortality may save one life per thousand treated in a very low-risk population and five lives per hundred in a high-risk population. Granted that the cost of a year of statin therapy will be about the same in these two cases, it is clear that the 20% reduction in the high-risk patients will be much more economically attractive. In published studies, statins save lives at what is considered a reasonable cost (less than $50,000 per year of life saved) except for primary prevention in non-high-risk individuals. The cost of the drug is the other important factor, and the cost-effectiveness of this intervention will improve as less expensive generic drugs become available. Non-pharmacological therapy has also been shown to be economically attractive. A low-cholesterol, low-fat diet has been shown to be an efficient first step in treatment for primary prevention for individuals with additional risk factors (5). An analysis of numerous combinations of risk factors by Prosser et al. (5) found that diet therapy was highly cost-effective compared with no therapy for elderly men age 75 to 84 with four risk factors (cost-effectiveness ratio $2,000/QALY) and moderately cost-effective for young women age 35 to 44 if they had three or more risk factors (smoking, elevated blood pressure, elevated LDL, low high-density lipoprotein [HDL]). However, the addition of a statin to a step 1 diet can be expensive. The cost-effectiveness ratio was less than $50,000/QALY only in patients with multiple risk factors, and in those without risk factors it was greater than $140,000/QALY. The cost of lipid lowering used in these analyses was usually the wholesale price. However, the studies did not routinely examine the impact of a statin cost when the patent expires. A study using the Coronary Heart Disease Policy Model estimated that a 50% decrease in drug cost would reduce the cost-effectiveness ratio by 44% to 55% (5). Thus, the cost-effectiveness of statin treatment will be more favorable as generic drugs become available. Smoking cessation. All published studies of smoking cessation interventions indicate that the cost per year of life saved is small compared with other accepted medical interventions (Table 3). Minimal physician counseling (4 min initially, then 3 to 6 min during follow-up at $2.40 per min), more intensive physician counseling (15 min), and nicotine replacement therapy (patch or gum) have all been shown to be relatively inexpensive per year of life saved. Lightwood and Glantz (6) estimated that over 98,000 hospitalizations (and over $3 billion of resource consumption) would be prevented in the U.S. over seven years with a 1% reduction in smoking. Krumholz et al. (7) found that the cost per year of life saved with a nurse-based educational program was less than $300. Hypertension treatment. Numerous cost-effectiveness studies of hypertensive treatment and screening have been published (Table 4). However, different methodologies preclude direct comparisons of their results. Many studies were stated to be from a societal perspective, yet few studies

Study, Year

Age Group (Yrs)

Cholesterol (mg/dl)

Gender

Time Horizon

Treatment

Comparator

Cost-Effectiveness

Weinstein and Stason, 1985 (38)

45–50

Male

greater than 265

Unclear

Cholestyramine

No treatment

$190,000/LY

Oster and Epstein, 1987 (39)

55–59

Male

290

Lifetime

Cholestyramine

No treatment

$250,000/LY

Kinosian and Eisenberg, 1988 (40)

Adult

Male

greater than 265

7 years

Diet (oat bran)

No treatment

$25,400/LY

Martens et al., 1989 (41)

Adult

Male

310

Lifetime

Simvastatin

No treatment

$36,000-83,000/LY

Goldman et al., 1991 (42)

55–64

Male

Age 85

$75,000/LY

Female

55–64

Male

250–299

Age 85

45–64

Male

greater than 145

10 years

Lovastatin 20 mg/day Lovastatin 20 mg/day Lovastatin 20 mg/day Pravastatin

No treatment

55–64

greater than 300 mg/dl greater than 300

No treatment

$239,000/LY

Age 85

Education

Usual care

$3,700/LY

Pharoah and Hollingworth, 1996 (43)

Tosteson et al., 1997 (44)

U.S. population

Age 85

$121,000/LY

Male

LDL ⬎ 155

Lifetime

Pravastatin

Placebo

$34,000/LY

Pickin et al., 1999 (46)

Adult

Both

Lifetime

Simvastatin

No treatment

$22,000/LY

Prosser et al., 2000 (5)

35–44* 35–44* 65–74* 75–84* 35–44* 35–44* 65–74* 65–74* Non-diabetic adult Diabetic adult

1.5% chance of coronary events/ year greater than 160 greater than 160 greater than 160 greater than 160 greater than 160 greater than 160 greater than 160 greater than 160 LDL 135 HDL 39 LDL 135 HDL 39

30 years 30 years 30 years 30 years 30 years 30 years 30 years 30 years Lifetime

Diet Diet Diet Diet Pravastatin Pravastatin Pravastatin Pravastatin Pravastatin Pravastatin

No treatment No treatment No treatment No treatment Diet Diet Diet Diet No treatment No treatment

$87,000/QALY $251,000/QALY $39,000/QALY $40,000/QALY $271,000/QALY $775,000/QALY $148,000/QALY $159,000/QALY $26,000–43,000/LY $8,000–16,000/LY

Assumptions from British Health Care System. Used lipid lowering but not economic data from WOSCOPS. $5.69 per person, 2% reduction in cholesterol, uses Coronary Heart Disease Policy Model. Did not include extra costs due to prolonged survival. Effectiveness data based on WOSCOPS. Based on Coronary Heart Disease Policy Model, assumes 7.7% decrease in LDL with diet. Data provided for patients with no other risk factors.

Based on pravastatin effects on lipids from the Cholesterol and Recurrent Events (CARE) trial.

*Non-smoker, diastolic BP greater than 95 mm Hg. CVA ⫽ cerebrovascular accident; HDL ⫽ high-density lipoprotein; LDL ⫽ low-density lipoprotein; LY ⫽ life years gained; LRC-CPPT ⫽ Lipid Research Clinics Coronary Primary Prevention Trial; QALY ⫽ quality adjusted life years gained; WOSCOPS ⫽ West of Scotland Coronary Prevention Study.

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45–64

Grover et al., 2000 (10)

Based on Framingham risk data and LRC-CPPT protocol. Based on Framingham risk data and LRC-CPPT trial includes cost of prolonged survival. Based on Framingham risk data and LRC-CPPT trial. Based on Framingham risk data and LRC-CPPT trial and Dutch data. Based on Coronary Heart Disease Policy Model.

$169,000/LY

WOSCOPS, 1997 (45)

Male Female Male Female Male Female Male Female Male Male

Comments

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Table 1. Lipid-Lowering: Primary Prevention Cost-Effectiveness Studies

605

Simvastatin Pravastatin Pravastatin Pravastatin Pravastatin Lifetime 30 years 30 years 30 years 30 years LDL/HDL ratio of 5 LDL greater than 160 LDL greater than 160 LDL greater than 160 LDL greater than 160 Female Male Female Male Female 40–70 35–44* 35–44* 65–74* 65–74* Prosser et al., 2000 (5)

JACC Vol. 40, No. 4, 2002 August 21, 2002:579–651 *Non-smoker, diastolic BP greater than 95 mm Hg. 4S ⫽ Scandinavian Simvastatin Survival Study; CVA ⫽ cerebrovascular accident; HDL ⫽ high-density lipoprotein; LDL ⫽ low-density lipoprotein; LRC-CPPT ⫽ Lipid Research Clinics Coronary Primary Prevention Trial; LY ⫽ life years gained; PLAC I ⫽ Pravastatin Limitation of Atherosclerosis in the Coronary Arteries; PLAC II ⫽ Pravastatin, Lipids, and Atherosclerosis in the Carotids; QALY ⫽ quality adjusted life years gained.

Based on Coronary Heart Disease Policy Model, assumes 7.7% decrease in LDL with diet. $10,200–14,900/LY $4,800/QALY $42,500/QALY $7,100/QALY $10,100/QALY treatment treatment treatment treatment treatment No No No No No

No treatment $5,800–10,300/LY Lifetime Simvastatin LDL/HDL ratio of 5 Male 40–70 Grover et al., 1999 (49)

Comments

Cost/effectiveness lower when indirect costs accounted for. Costs attributable to increased length of life were not included. Included benefits of CVA reduction.

$2,100/LY $10,500/LY $22,000/LY $46,700/LY $7,800/LY $14,000/LY $7,700/LY $18,100/LY

Cost-Effectiveness Comparator

No treatment No treatment No treatment No treatment Placebo Placebo Placebo Placebo mg/day mg/day mg/day mg/day

Treatment

Lovastatin 20 Lovastatin 20 Lovastatin 20 Lovastatin 20 Pravastatin Pravastatin Simvastatin Simvastatin greater than or equal to 250 Age 85 greater than or equal to 250 Age 85 less than 250 Age 85 less than 250 Age 85 Not stated 10 years Not stated 10 years Median 213 Age 110 Median 213 Age 110 Male Female Male Female 1 risk factor Male 3 risk factors* Female 59 Male 59 Female Goldman et al., 1991 (42) 55–64 55–64 55–64 55–64 PLAC1,2, 1996 (47) 60 with 60 with 4S Study, 1997 (48) Median Median

Time Horizon Cholesterol (mg/dl) Gender Age Group (Yrs) Study, Year

Table 2. Lipid-Lowering: Secondary Prevention Cost-Effectiveness Studies

Based on Coronary Heart Disease Policy Model.

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included indirect costs (decreased employment) or costs arising from prolonged survival. Those that included indirect costs found treatment to be more cost-effective than studies including only direct medical costs. The assumed treatment duration varied widely, and several studies did not estimate costs and outcomes for the life of the patient. The few consistent findings are that: 1) screening for, and treatment of, mild or greater hypertension is cost-effective when compared with other accepted health care interventions ($10,000 to $40,000 per QALY gained); 2) treatment is less cost-effective in young women than in young men, and in the young than in the elderly; and 3) treatment becomes more cost-effective as pre-treatment blood pressure rises. Diabetes treatment. The cost-effectiveness analyses of diabetes treatment indicate that intensive glucose control improves outcome at a cost that is below other accepted health care interventions (Table 5). Because diabetic patients are at a high risk for coronary artery disease, treatment of hypertension and elevated lipids in these patients is particularly economically attractive (8 –11). The study, based on the Diabetes Control and Complications Trial Research Group (DCCT) Study, found that including the extra cost of living longer with intensive therapy increased the cost-effectiveness ratio from $32,000 to $34,000 per year of life gained (12). If indirect costs are also accounted for, the cost-effectiveness ratio drops (treatment becomes more cost-effective) to $10,800 per year of life gained (13). Although it is not directed at glucose metabolism, treatment of middle-aged type II diabetics with angiotensinconverting enzyme inhibitors was found to be economically attractive (14). Exercise programs. There is relatively little trial data on the long-term effects of exercise, and consequently, few studies have attempted to estimate the cost-effectiveness of exercise programs. Assuming that sedentary behavior increases the risk of heart disease by 1.9-fold, $6.4 billion would be saved if the entire U.S. sedentary population began a program of regular walking (15). Other studies estimate that exercise programs cost money, particularly when time lost to exercise is included, but that the benefits are large and the cost per year of life gained remains well below $20,000 (Table 6). Little is known about the cost-effectiveness of simultaneous risk-factor modification. However, several studies have examined the cost-effectiveness of cardiac rehabilitation after acute myocardial infarction. These programs use a variety of interventions, including exercise, risk-factor management, and psychosocial counseling (16). A study from Sweden found cardiac rehabilitation to be cost-saving when indirect costs of work productivity were included (17). Studies from the U.S. have estimated that cardiac rehabilitation increases direct costs by $5,500 to $11,100 per life-year gained (18,19).

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Table 3. Smoking Cessation Cost-Effectiveness Studies

Study, Year Oster et al., 1986 (50)

Population

Treatment

Comparator

Increased Cessation Rate

Cost-Effectiveness

Nicotine gum plus counseling

Counseling

1.6%

$6,000–9,500/LY

Females ages 35–69

Nicotine gum plus counseling

Counseling

1.6%

$10,000–13,900/LY

Krumholz et al., 1993 (7)

Males ages 35–69 Females ages 35–69 Post MI

Physician counseling Physician counseling Nurse-mediated education leading to 2.6% reduction in smoking

Usual care Usual care Usual care

2.7% 2.7% 26%

Fiscella and Franks, 1996 (52)

Males ages 35–69

Nicotine patch plus counseling

Counseling

6.4%

$4,800–12,000/QALY

Females ages 35–69

Nicotine patch plus counseling

Counseling

6.4%

$5,800–7,700/QALY

Lightwood and Glantz, 1997 (6)

U.S. smokers

Usual care

1%

Program dominates*

Cromwell et al., 1997 (53)

U.S. smokers U.S. smokers U.S. smokers

Hypothetical program with 1% cessation rate Minimal counseling Full counseling Transdermal nicotine and minimal counseling Transdermal nicotine and full counseling Nicotine gum and minimal counseling Nicotine gum and intensive counseling Program including nicotine replacement In-hospital cessation and relapse prevention Nicotine patch plus counseling

Usual care Usual care Usual care

1.2% 9.3% 21%

$4,400/QALY $1,700/QALY $2,600/QALY

Usual care

60%

$1,500/QALY

Cummings et al., 1989 (51)

U.S. smokers U.S. smokers U.S. smokers Croghan et al., 1997 (54)

Adults

Meenan et al., 1998 (55)

Hospitalized patients

Stapleton et al., 1999 (56)

Adults

*Less expensive and more effective. LY ⫽ life years; MI ⫽ myocardial infarction; QALY ⫽ quality adjusted life years.

Usual care

2.3%

$1,000–1,400/LY $1,800–3,000/LY $260/LY

Assumed 12 min of physician’s time. Cost-effectiveness less than $24,000/LY even with program cost of $10,000 or success rate of only 0.3%.

3.32 billion saved and 13,000 deaths prevented over 7 years. Cost per minute of physician’s time: $2.40.

$5,000/QALY

Usual care

12%

$2,300/QALY

Usual care

22.2%

$7,900/LY

Usual care

8%

$1,900/LY

Counseling

5.1%

$600–1,400/LY

Intervention data from a Kaiser-based randomized trial. Based on United Kingdom costs.

Krumholz and Weintraub et al. Task Force #2—The Cost of Prevention

Males ages 35–69

Comments

607

608

Table 4. Hypertension Treatment and Screening: Cost-Effectiveness Studies

Stason and Weinstein, 1977 (57)

Stevens et al., 1984 (58) Nissinen et al., 1986 (59) Littenberg et al., 1990 (60)

Edelson et al., 1990 (61)

Lasser and Wenzel, 1990 (62)

Population

Cost-Effectiveness

20-year-old male, diastolic BP 100 mm Hg Lifetime Lifetime 60-year-old female, diastolic BP Lifetime Lifetime 100 mm Hg 35-year-old male Lifetime Lifetime

No No

Drug treatment $71,300/QALY Drug treatment $38,000/QALY

No

Based on North Karelia Hypertension program (Finland) 40-year-old female

Yes

Lifetime Lifetime

No

60-year-old male

Lifetime Lifetime

No

Patients 35–64 yrs with diastolic blood pressure greater than or equal to 95 mm Hg Patients 35–64 yrs with diastolic blood pressure greater than or equal to 95 mm Hg Patients 35–64 yrs with diastolic blood pressure greater than or equal to 95 mm Hg Patients 35–64 yrs with diastolic blood pressure greater than or equal to 95 mm Hg German hypertensive men age 55–64 yrs

20

20

No

Screening and treatment Screening and treatment Screening and treatment Screening and treatment Propranolol

$13,600/QALY

20

20

No

HCTZ

$20,500/QALY

20

20

No

Nifedipine

$39,500/QALY

20

20

No

Captopril

$90,200/QALY

Lifetime Lifetime

No

Drug treatment $39,200/LY

Age 64

No

Drug treatment $64,200/QALY

Kawachi and Malcolm, 1991 (63)

5

5

Assumed treatment of elderly is less beneficial than treatment of young, estimates based on Framingham Heart Study. Used Stason model with local costs and effectiveness.

$8,500/QALY $30,000/QALY

Estimates based on trial data, results highly sensitive to costs of anti-hypertensives.

$10,900/QALY Based on the Coronary Heart Disease Policy Model.

Assumptions not clearly stated, no discounting. Assumed no effect of treatment on coronary heart disease. Based on Framingham risk data and Swedish cost data.

Lifetime Lifetime

Yes

Drug treatment $23,000/LY

Johannesson et al., 1993 (65)

Swedish Trial in Old Patients with Hypertension (STOP) Men aged 70–84 yrs Swedish Trial in Old Patients with Hypertension (STOP) Women aged 70–84 yrs Metoprolol Atherosclerosis Prevention in Hypertensives (MAPHY) study Male 45–70 yrs diastolic BP 95–99

Lifetime 2

Yes

Diuretics, $980/LY Beta-blockers

Lifetime 2

Yes

Diuretics, $3,100/LY Beta-blockers

Lifetime 5

Yes

Lifetime 1

Yes

Female 45–70 yrs diastolic BP 95–99

Lifetime 1

Yes

Metoprolol Metoprolol dominant (thiazides) Drug treatment $142/LY Meta-analysis of trial data used to determine treatment benefit; Framingham data used Drug treatment $190/LY for risk of stroke and CHD.

Johannesson, 1995 (67)

*Comparator is no treatment unless otherwise indicated. Costs adjusted to 2001 U.S. dollars using the GDP deflator. BP ⫽ blood pressure; CHD ⫽ coronary heart disease; HCTZ ⫽ hydrochlorothiazide; LY ⫽ life years; QALY ⫽ quality adjusted life years.

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40-year-old men with diastolic blood pressure 100 mm Hg Johannesson and Jonsson, 1991 (64) 35-year-old male

Johannesson et al., 1993 (66)

Age 64

$38,000/QALY

Comments

Krumholz and Weintraub et al. Task Force #2—The Cost of Prevention

Study, Year

Time Treatment Horizon Duration Indirect Treatment (yrs) (yrs) Costs (Comparator)*

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609

Table 5. Diabetes Treatment and Screening: Cost-Effectiveness Studies

Study, Year DCCT, 1996 (12)

Golan et al., 1999 (14)

Gray et al., 2000 (68) Almbrand et al., 2000 (69)

Clarke et al., 2001 (11)

Time Horizon (yrs)

Treatment

Candidates for the DCCT trial 17% of diabetics on insulin 50-year-old patients with new type II diabetes Type II diabetics

Lifetime

Intensive therapy

Conventional therapy

$31,600/LY

Lifetime

ACE inhibitors for all

Screening for microalbuminuria

$7,700/QALY

10

Intensive therapy

Diabetics with acute MI

Lifetime

$2,000/event-free LY $18,300/QALY

Cost estimates from United Kingdom. Based on DIGAMI trial. Included indirect and future costs.

Type II diabetics greater than 120% of ideal body weight

Lifetime

Glucose-insulin infusion followed by SQ insulin Metformin

Conventional therapy Conventional therapy

Conventional therapy

Metformin dominates*

Cost estimates from United Kingdom. Effectiveness from randomized trial data. Metformin saved 258 pounds (1997) over 10.8 years.

Population

Comparator

Cost-Effectiveness

Comments

*Less expensive and more effective. ACE ⫽ angiotensin converting enzyme; DCCT ⫽ Diabetes Control and Complications Trial Research Group; DIGAMI ⫽ Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infarction; LY ⫽ life years; MI ⫽ myocardial infarction; QALY ⫽ quality adjusted life years; SQ ⫽ subcutaneous.

ISSUES IN COST-EFFECTIVENESS ANALYSES Several methodological issues in cost-effectiveness analyses are relevant to the assessment of preventive programs and can affect how these programs are rated relative to alternative uses of funds. In this section, the issues of discounting, the perspective of the analysis, the choice of effectiveness measures, and the use of indirect costs are briefly reviewed. The approach with regard to these issues may slant economic analyses away from preventive interventions relative to more acute care. Discounting of future benefit. Discounting is employed in economic analysis to take into account the time value of costs and benefits. In general, people prefer to receive desirable benefits as soon as possible and to delay costs indefinitely. Discounting quantitatively incorporates these preferences into economic analyses by weighing costs and benefits less heavily the further into the future they occur.

Thus, a benefit in the future is not as attractive as an immediate benefit, and a cost in the future does not weigh as heavily as an immediate outlay. To illustrate the crucial role of time preferences, consider the case of two hypothetical means of achieving the same health objective: Program A involves an immediate outlay of $25,000, whereas alternative Program B requires no investment today but a $50,000 outlay 20 years from now (Table 7). Assuming that the two interventions are otherwise identical, the decision as to which program is most attractive depends solely upon the decision maker’s time preference. A decision maker who is indifferent to the timing of events would clearly prefer Program A, because $25,000 is less than $50,000. To the contrary, a decision maker who discounts future income streams at a 5% annual rate would find Program B more attractive. To see why this is so, consider an investor who can earn a 5% annual return on savings.

Table 6. Exercise Programs: Cost-Effectiveness Studies

Study, Year

Population

Time Horizon (yrs)

Treatment

Comparator

Cost-Effectiveness

Hatziandreu et al., 1988 (70)

Men age 35

30

Jogging

No exercise

$15,400/QALY

Munro et al., 1997 (71)

Men and women over age 65

Lifetime

Supervised exercise twice weekly

No exercise

$533/LY

Lowensteyn et al., 2000 (72)

U.S. population

Lifetime

Unsupervised exercise

No exercise

less than $13,000/LY

Men with cardiovascular disease

Lifetime

Supervised exercise

No exercise

less than $16,000/LY

LY ⫽ life years; QALY ⫽ Quality adjusted life years.

Comments Includes indirect costs from time lost due to exercising.

Based on the Cardiovascular Disease Life Expectancy Model.

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Table 7. Impact of Time Value on Preferences Year

Program A

Program B

0 20 Total outlay NPV at 3% NPV at 5%

$25,000 $0 $25,000 $25,000 $25,000

$0 $50,000 $50,000 $27,684 $18,844

NPV ⫽ net present value.

This investor could take the $25,000 that he might otherwise invest in Program A and place it in an interest-bearing bank account. In 20 years, the original $25,000 would have grown to $66,332 ($66,332 equals the sum of $25,000 times 1.0520), thus permitting the investor to invest in Program B while pocketing the remaining $16,332. Indeed, Program B is preferred to Program A by any decision maker whose discount rate is in excess of roughly 3.5%, because at any discount rate above 3.5%, the discounted value of $50,000 in 20 years is less than $25,000. The fact that individuals and society value the present more highly than the future significantly affects decisions regarding preventive interventions. If a program incurs costs immediately but its health effects accrue in the future, the positive effects of the program are significantly smaller when discounting is taken into account, whereas the full effect of the current costs is felt. Thus, many programs that incur substantial benefits may not be cost-effective, because those benefits may arise too far into the future. Some experts advocate discounting costs but not benefits (20,21). However, a practical problem emerges in this situation. Discounting costs but not benefits can lead to the peculiar result of improving the cost-effectiveness of many programs by the indefinite delay of their implementation. That is, discounting costs but not benefits suggests that any program would be better implemented “next year.” This phenomenon of “policy paralysis” or the “infinitely delayed splurge” also emerges when any discount rate lower than that applied to resource costs is applied to the health benefits (22). Using the approach of discounting future costs and benefits, can it ever be more efficient to invest today’s dollars in the uncertain hope of a benefit some time in the future? The answer is mixed. Some preventive interventions are highly cost-effective; others are less so. Some immediate treatment interventions compare favorably with prevention; others do not. A 1995 analysis of 500 different life-saving interventions found that neither form of health investment dominates the other (4). Nevertheless, the issue of whether to value future benefits less than current benefits, which may place preventive programs at a relative disadvantage compared with acute interventions, results in some serious tension in the economic analysis of preventive interventions. Perspective of the analysis. Preventive interventions affect patients, families, providers, developers of new drugs and other medical technologies, insurers, managed care organizations, governments, taxpayers, and society. More often

than not, the implementation of a new medical technology or intervention— or its inclusion in a health maintenance organization formulary—serves to redistribute costs and benefits among these groups. Assessments of any intervention’s appropriateness and cost-effectiveness may differ dramatically depending on a group’s perspective. For example, an intervention designed to reduce hospital lengths of stay may benefit health care institutions and payers by lowering inpatient hospital costs, while simultaneously imposing additional time and productivity burdens on patients and their families. Depending on the perspective of the analysis, assessments of the program’s attractiveness may differ not only in magnitude but even in direction. Published academic evaluations typically focus on public health and global resource allocation decisions. For this reason, the U.S. Panel on Cost-effectiveness Analysis in Health and Medicine recommends that analysts adopt a societal perspective in which all costs and benefits are taken into account, regardless of whom they affect (23). The societal perspective is the only one that does not require some party in the treatment decision to lose in order that someone else might gain. The hospital perspective, for example, focuses on short-term cost and benefits. What happens to patients after being discharged is irrelevant to this perspective. The managed care company’s perspective takes into account the fact that an individual patient is likely to keep health insurance with that company for only two to three years on average. Paying for interventions that might yield benefits a decade or more in the future is of no value from this perspective. Thus, while individuals in health care rarely look at the societal perspective, it is in the public interest to keep this perspective in the forefront of the discussion while other perspectives are considered. One issue that often evolves in this context is that the societal perspective ignores important transfer payments (such as the cost shift from health care purchasers to patients in the length-of-stay example) from one member of society to another: although such redistributions are irrelevant from a societal viewpoint, they may be of paramount importance to the parties affected. Given the fragmented nature of the U.S. health care system and the painful transfers that must inevitably result from any re-allocation of scarce resources, it is unlikely that cost-effectiveness criteria, administered from the societal perspective, will emerge any time soon as blueprints for public decision making. Nevertheless, an efficiency-based analysis can help to illuminate the clinical and economic costs that society incurs by failing to apportion its health care resources where they will do the greatest good. Such an approach can add support to the development of more ethically defensible prevention policies. Deciding on the effectiveness measure. An advantage of economic analysis is that expectations about the effectiveness of a given strategy must be explicitly stated. If evidence about the effectiveness of a given intervention is weak (or non-existent), then it will be revealed in the methods and exposed for the knowledgeable reader.

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The choice of measure of benefit on an intervention may determine its implementation. The prevention of death due to one disease may not be a valuable outcome if overall life expectancy is unchanged because of competing risks due to other illnesses. Preventing sudden death so that people instead die of cancer, without a significant net gain in quantity or quality of life, is not an economically attractive investment, even if the intervention is efficient in reducing sudden death. As a result, many analyses favor more global estimates of benefit that go beyond disease-specific metrics. In addition, patients may value quality of life more than survival. Economic analyses have attempted to incorporate patient preferences (also called utilities)— or how patients value different states of disease and disability—in their evaluations of preventive or other interventions. These preferences allow the calculation of QALYs and arithmetically incorporate both quality and quantity of life. Unfortunately, the methods available to assess patient preferences are still rudimentary. In the evaluation of preventive services, it is particularly important to value appropriately the transition from being well to being ill. Much of the value of preventive programs consists in preventing this transition and in allowing individuals to avoid disability. Underestimating the preference for wellness is another challenge to the proper evaluation of preventive services. Measuring indirect costs. Another challenge in performing these economic analyses is fully accounting for indirect costs, those resources expended that are not directly related to medical care. These costs include days lost from work, time diverted from other (non-work) productive activity, dollars devoted to caregiving activities, the value of caregiver time when provided outside the labor force (e.g., by family caregivers), or lost enjoyment associated with the intervention (e.g., losing the pleasure associated with smoking as a result of adherence to a smoking cessation regime). These costs can be considerable and may offset much of the investment in the preventive intervention. Despite the importance of these costs, they are often not included in cost-effectiveness analyses and are mostly invisible to those who purchase care. However, there are economic analyses that have measured many of these, and there are economic methodologies to measure all of them. From a societal perspective, they may account for the greatest recovery of costs from investments in prevention.

COST EFFECTIVENESS VERSUS PUBLIC POLICY Health policy decisions often appear inconsistent with economic analyses for at least three reasons. First, the assumptions underlying economic analysis are that decision makers will behave in a rational fashion. Specifically, they will always choose to do the most efficient thing regardless of who gains and who loses. This is clearly not the case. Americans frequently support expensive programs that promise little health benefit while, at the same time, forgoing opportunities to invest in much more cost-effective

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strategies for health improvement (24). To cite just a few examples, the U.S. spends approximately $115 million per year on benzene emission control to save an estimated five years of life (25). If this same amount were instead spent on collapsible automobile steering columns, the nation could save an additional 1,684 years of life (26). Similarly, adhering to the 1990 amendments to the Clean Air Act will cost more than $5 million for each year of life that is saved as a result of reduced emission of toxic pollutants. These inconsistencies can have important consequences both for the public health and for the public purse. Tengs and Graham (27) performed an analysis of 287 lifesaving interventions for which information on both costeffectiveness and current levels of implementation was available. They determined that a simple redistribution of resources among those programs could prevent 60,000 premature deaths (resulting in a long-run gain of over 600,000 life-years) each year in the U.S., with no net increase in resource consumption. Viewed another way, these findings suggest that a re-allocation of lifesaving resources to the most cost-effective activities would free up $31 billion per year in the U.S., with no net loss of life. What explains this inefficiency in the public prioritization of health risks? Part of the answer lies in the diffusion of authority. Lifesaving resources are not easily transferred from one domain of intervention (such as occupational safety, environmental health, or infectious disease control) to another. A single policy maker rarely has the authority to shift funds from pollution abatement to childhood immunization or from mammography for pre-menopausal women to automobile airbag installation. Indeed, entirely different funding mechanisms operate from one domain to the next; the compliance costs of many environmental interventions, for example, are borne by private businesses and their customers, whereas other health programs (such as epidemiological outbreak investigations) are funded directly with tax dollars. In addition, while some public health measures can be implemented at the behest of individual decision makers, many others (such as treatment of hyperlipidemia) rely on the participation of millions of independent decision makers with widely varying priorities, information, and resources. A second reason why results of economic analysis often do not drive public policy is the lack of adequate data to perform credible economic analyses. In the state of Oregon, for example, policy makers undertook—and then more or less ignored—an ambitious, formal evaluation in 1989 to guide them in rationing the state’s Medicaid services. A draft priority list, derived on the basis of the costeffectiveness criterion, was revealed in May 1990. In the presence of overwhelming criticism and ridicule, it was almost immediately withdrawn. Commissioners went back to the drawing board and began work on a revised ranking scheme. By March 1993, the commission members had virtually abandoned the priorities suggested by the formal analysis in favor of a softer, intuitive apportionment process

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(28 –31). The effort in this case was well intentioned, but the available data were simply not adequate to support a global ranking of medical interventions. The third reason why economic analysis does not determine public policy has been called “the rule of rescue” (29). Simply put, medical professionals are unable to stand by while an identifiable person’s life is threatened if some possibly effective therapy is available to treat that person. The concept that “we did everything we could” is not rational from a decision-making point of view, but it is very human. Policy makers are not immune to this effect. Political lobbies and special interests can greatly influence resource allocation decisions. Good cases in point include the creation of the federally funded Acquired Immune Deficiency Syndrome Drug Assistance Programs, the federal government’s decision to finance dialysis therapy for all U.S. endstage renal failure patients, and the broad political support of mammograms for women between the ages of 40 and 49 years. Clearly, the principles of cost-effective resource allocation do not capture all the essential elements that influence policy decisions. The recognition of the various issues that are important in influencing perceptions of the value of preventive programs is essential in understanding the barriers to making decisions about programs solely by using cost-effectiveness ratios. It is these issues that make it difficult to answer directly whether we can afford prevention programs and what role they should play in our portfolio of health care expenditures. In the following section, selected issues that influence the debate and perceptions about the value of these interventions are reviewed.

COST EFFECTIVENESS VERSUS TOTAL SYSTEM COSTS Despite the opportunity to make an economically attractive investment, society may resist devoting a large, disproportionate pool of resources to one condition or group of individuals. For example, the use of statins is an economically attractive intervention for many people with, or at risk for, CVD. In May 2001, the National Cholesterol Education Program published a report outlining revised guidelines for cholesterol control. In addition to many dietary and behavioral changes, the panel recommended a significant increase in the number of people who take lipid-lowering drugs (32). Applying the panel’s recommendations to the population of the U.S., it is estimated that 36 million Americans should be taking a lipid-lowering agent. The report, however, did not consider the system cost of implementing the recommendation. Taking the monthly retail price of an inexpensive statin as an example, and assuming a 5% rate of discounting costs in future years, this recommendation would cost society more than $500 billion in direct drug costs over the next 20 years. This allocation of resources would cost nearly $1,200 per person per year; that is, 29% of the current annual per capita (average) spending on health care in total (33). The allocation of these resources

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is expected to result in a lower rate of vascular disease and possibly other disease conditions, but it will almost certainly be at the expense of other potential medical investments. Finding that a therapy is economically attractive is not enough to ensure that it will be widely adopted. There must also be enough money in the budget to pay for it. The American Heart Association (AHA), in concert with the Centers for Disease Control, has committed itself to achieve a 25% reduction in CVD by 2010. The AHA has not explicitly considered what the country should be willing to spend to achieve this goal, what it will cost to reach this target, or what other investments would be passed over as a result. Is it presumed that the country should meet this goal at any cost? If the most efficient use of prevention dollars (assuming that a finite amount is available) is to devote them to the prevention of CVD, should it be done at the expense of efforts to prevent other conditions? Pure economic analysis would favor the efficiency of that approach; however, politics and human nature would not. Issues of blame and controllability. The attribution of death to a voluntary, controllable cause or behavior (like smoking) appears to play an important role in determining the degree of social sympathy that is likely to be provoked and, correspondingly, the level of difficulty experienced in securing financial support for prevention and treatment programs (34). Public funding for programs to prevent the spread of human immunodeficiency virus (widely perceived to be a voluntary, controllable risk) generally meets a great deal of opposition despite overwhelming evidence that many such programs actually save society money as well as lives. By contrast, even the specter of cancers from involuntary, uncontrollable sources (such as air pollution, second-hand tobacco smoke, and electromagnetic fields) provokes widespread calls for greater research and funding. The human propensity to feel less charitable toward those perceived to be taking on voluntary or controllable risks is particularly pertinent in view of findings by psychological researchers that people almost universally underestimate the importance of situational (or environmental) factors, as opposed to personal qualities, in determining the behavior of individuals. Indeed, this tendency appears to be so deep-rooted and so widespread that psychologists have termed it the fundamental attribution error (35). Studies also show that the proclivity to over-assign blame to the individual when considering other peoples’ behavior does not extend to the evaluation of one’s own behavior; one usually takes credit for successes while blaming failures on the surrounding environment. With these findings in mind, it is perhaps not surprising that people feel less sympathy for cigarette smokers (a distinct minority of the population) who contract lung cancer than for inactive people with poor dietary habits who fall victim to coronary heart disease. A perverse sense of fairness seems to exist. There is less sympathy for lives in peril when the individuals at risk are judged to have “brought it on themselves.” The problem, once again, is that what is perceived as fair from the point of

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view of causation need not be fair— or efficient—with regard to final outcomes and the efficient allocation of scarce societal resources. Expectations of budget neutrality. Another obstacle conspiring against increased investment in prevention programs is the public expectation that such interventions should pay for themselves. This is a view that is expressed with growing frequency in public discussions on health, social programs, and the environment. Well-intentioned prevention advocates are fond of arguing that a dollar invested today in a particular program produces more than a dollar’s worth of savings later. Recently, public figures have taken up the call, insisting that health, social, and environmental programs should “pay for themselves.” Terms such as “budgetneutrality” and “pay as you go” appear frequently in lawmakers’ discussions of Medicare and Medicaid financing. Indeed, the idea that new health initiatives should pay for themselves has the force of law. According to the Balanced Budget Act of 1997, no Medicaid waivers under Section 1115 of the Social Security Act may be granted unless states can demonstrate the “budget neutrality” of their proposed initiatives. This same law requires that all base-year Prospective Payment Service Medicare outlays be “budgetneutral” in their impact. The phrase “budget-neutral” appears 18 times in the text of the recently enacted congressional budget appropriations law concerning Medicare, Medicaid, and the Children’s Health Insurance Program. The idea that “an ounce of prevention is worth a pound of cure” is well entrenched in the human psyche, makes an excellent media sound bite, yet is rarely true. A recent compilation of 500 economic evaluations of lifesaving interventions found only a small fraction of instances in which a medical prevention program paid for itself (4). In the large majority of situations, increased survival carried with it new long-term competing risks and additional resource costs that wiped out any short-term savings attributable to the prevention program. To a cost-effectiveness analyst, budget neutrality is not a reasonable expectation nor is it good policy. When it comes to most public—and virtually all private— expenditures, people recognize that they must sometimes draw down their wealth to pay for the things they most desire. Nobody objects to spending good money when the benefits are believed to exceed the costs. People understand the idea of return on investment. Budget neutrality, however, demands return without investment (i.e., a free lunch). It is the search for a money-making program disguised as a health intervention, which if used as a public-policy hurdle, will force individuals to cast aside many sound investments in health promotion and disease prevention (36,37). For instance, suppose that a new therapy is shown to safely and reliably decrease cigarette smoking at a cost of $10,000 per QALY gained. With budget neutrality, either the therapy could not be adopted or some other health care service would have to be cut back or eliminated.

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CONCLUSIONS In summary, this task force has reviewed the major evidence on the value of preventive therapies. As in other areas of medicine, prevention is a complex mix of different strategies and technologies with widely varying economic attractiveness. Although primary prevention is more attractive on an emotional level, economic analysis usually finds secondary prevention to be more efficient. This is due to the rather simple fact that patients who have clinical disease are at higher risk, and therefore more likely to benefit, than a group of lower-risk subjects, only a few of whom will ever develop disease. The number needed to treat to save a life is much smaller in secondary prevention, and hence the cost to save a life is also smaller (more favorable). The decision to implement a preventive strategy on a widespread scale depends not only on the economic attractiveness but also on the cost of the whole program to the health system. The purchasers’ perspective may also “tilt” a decision because benefits of a long-term prevention strategy may not accrue to the organization required to make the initial investment. Also, an economically attractive intervention is no bargain if there is no money in the budget to pay for it or if it diverts money away from other important social priorities such as housing and education. Finally, economic analysis is just one part of the complex equation of clinical and policy decision making and often is trumped by other considerations. Policy makers do not display the “steely” rationality implicit in economic theory, and physicians cannot sit by and do nothing if a patient’s life is threatened, even if all they can do is very expensive and may have only potential for benefit. PII S0735-1097(02)02083-1

TASK FORCE 2 REFERENCE LIST 1. Heffler S, Smith S, Won G, Clemens MK, Keehan S, Zezza M. Health spending projections for 2001–2011: the latest outlook. Faster health spending growth and a slowing economy drive the health spending projection for 2001 up sharply. Health Aff (Millwood) 2002;21:207–18. 2. U.S. Department of Labor Statistics Web site. Consumer Price Index. Available at: http://www.bls.gov/cpi/home.htm. Accessed February 5, 2002. 3. Robaton A. Firms Pare Health Benefits; Coverage Cut, Workers Pay More As Healthcare Inflation Rises. Crain’s New York Business, 2000. 4. Tengs TO, Adams ME, Pliskin JS, et al. Five-hundred life-saving interventions and their cost-effectiveness. Risk Anal 1995;15:369 –90. 5. Prosser LA, Stinnett AA, Goldman PA, et al. Cost-effectiveness of cholesterol-lowering therapies according to selected patient characteristics. Ann Intern Med 2000;132:769 –79. 6. Lightwood JM, Glantz SA. Short-term economic and health benefits of smoking cessation: myocardial infarction and stroke. Circulation 1997;96:1089 –96. 7. Krumholz HM, Cohen BJ, Tsevat J, Pasternak RC, Weinstein MC. Cost-effectiveness of a smoking cessation program after myocardial infarction. J Am Coll Cardiol 1993;22:1697–702. 8. UK Prospective Diabetes Study Group. Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes: UKPDS 40. BMJ 1998;317:720 –6. 9. Elliott WJ, Weir DR, Black HR. Cost-effectiveness of the lower treatment goal (of JNC VI) for diabetic hypertensive patients. Joint

614

10. 11.

12. 13.

14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27.

28. 29. 30. 31. 32.

33. 34. 35.

Krumholz and Weintraub et al. Task Force #2—The Cost of Prevention

National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med 2000;160:1277– 83. Grover SA, Coupal L, Zowall H, Dorais M. Cost-effectiveness of treating hyperlipidemia in the presence of diabetes: who should be treated? Circulation 2000;102:722–7. Clarke P, Gray A, Adler A, et al. Cost-effectiveness analysis of intensive blood-glucose control with metformin in overweight patients with type II diabetes (UKPDS No. 51). Diabetologia 2001;44:298 – 304. The Diabetes Control and Complications Trial Research Group. Lifetime benefits and costs of intensive therapy as practiced in the diabetes control and complications trial. JAMA 1996;276:1409 –15. Meltzer D, Egleston B, Stoffel D, Dasbach E. Effect of future costs on cost-effectiveness of medical interventions among young adults: the example of intensive therapy for type 1 diabetes mellitus. Med Care 2000;38:679 –85. Golan L, Birkmeyer JD, Welch HG. The cost-effectiveness of treating all patients with type 2 diabetes with angiotensin-converting enzyme inhibitors. Ann Intern Med 1999;131:660 –7. Jones TF, Eaton CB. Cost-benefit analysis of walking to prevent coronary heart disease. Arch Fam Med 1994;3:703–10. Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med 2001;345:892–902. Levin LA, Perk J, Hedback B. Cardiac rehabilitation—a cost analysis. J Intern Med 1991;230:427–34. Ades PA, Pashkow FJ, Nestor JR. Cost-effectiveness of cardiac rehabilitation after myocardial infarction. J Cardiopulm Rehabil 1997; 17:222–31. Oldridge N, Furlong W, Feeny D, et al. Economic evaluation of cardiac rehabilitation soon after acute myocardial infarction. Am J Cardiol 1993;72:154 –61. Smith DH, Gravelle H. The practice of discounting in economic evaluations of healthcare interventions. Int J Technol Assess Health Care 2001;17:236 –43. Sheldon TA. Discounting in health care decision-making: time for a change? J Public Health Med 1992;14:250 –6. Keeler EB, Cretin S. Discounting of lifesaving and other nonmonetary effects. Management Science 1983;29:300 –6. Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-Effectiveness in Health and Medicine. New York, NY: Oxford University Press, 1996:3. Graham JD, Vaupel J. Value of a life: what difference does it make? Risk Analysis 1981;1:89 –95. Van Houtven G, Cropper M. When is a life too costly to save: evidence from U.S. environmental regulations. WPS1260, 1-41. 3-311994. World Bank Research Paper. Graham JD. How to save 60,000 lives. Electric Perspectives 1995;20: 14 –21. Tengs TO, Graham JD. The opportunity costs of haphazard social investments in life-saving: In: Hahn RW, editor. Risks, Costs, and Lives Saved: Getting Better Results From Regulation. New York, NY: Oxford University Press, 1996:167–79. Tengs TO, Meyer G, Siegel JE, Pliskin JS, Graham JD, Weinstein MC. Oregon’s Medicaid ranking and cost-effectiveness: is there any relationship? Med Decis Making 1996;16:99 –107. Hadorn DC. Setting health care priorities in Oregon. Costeffectiveness meets the rule of rescue. JAMA 1991;265:2218 –25. Eddy DM. Oregon’s methods. Did cost-effectiveness analysis fail? JAMA 1991;266:2135–41. Hadorn D. The Oregon priority-setting exercise: cost-effectiveness and the rule of rescue, revisited. Med Decis Making 1996;16:117–9. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285:2486 –97. U.S. Census Bureau Web site. Statistical abstract of the United States; 2000. Available at: http://www.census.gov/statab/www/. Accessed February 5, 2002. Slovic P. Perception of risk. Science 1987;236:280 –5. Jones E, Harris V. The attribution of attitudes. J Exp Soc Psychology 1967:1–24.

JACC Vol. 40, No. 4, 2002 August 21, 2002:579–651 36. Paltiel AD. Five minutes with the Governor. Med Decis Making 2000;20:239 –42. 37. Weinstein MC. The costs of prevention. J Gen Intern Med 1990;5: S89 –S92. 38. Weinstein MC, Stason WB. Cost-effectiveness of interventions to prevent or treat coronary heart disease. Annu Rev Public Health 1985;6:41–63. 39. Oster G, Epstein AM. Cost-effectiveness of antihyperlipemic therapy in the prevention of coronary heart disease. The case of cholestyramine. JAMA 1987;258:2381–7. 40. Kinosian BP, Eisenberg JM. Cutting into cholesterol. Cost-effective alternatives for treating hypercholesterolemia. JAMA 1988;259:2249 – 54. 41. Martens LL, Rutten FF, Erkelens DW, Ascoop CA. Cost effectiveness of cholesterol-lowering therapy in the Netherlands. Simvastatin versus cholestyramine. Am J Med 1989;87:54S–8S. 42. Goldman L, Weinstein MC, Goldman PA, Williams LW. Costeffectiveness of HMG-CoA reductase inhibition for primary and secondary prevention of coronary heart disease. JAMA 1991;265: 1145–51. 43. Pharoah PD, Hollingworth W. Cost effectiveness of lowering cholesterol concentration with statins in patients with and without preexisting coronary heart disease: life table method applied to health authority population. BMJ 1996;312:1443–8. 44. Tosteson AN, Weinstein MC, Hunink MG, et al. Cost-effectiveness of population-wide educational approaches to reduce serum cholesterol levels. Circulation 1997;95:24 –30. 45. Caro J, Klittich W, McGuire A, et al. The West of Scotland coronary prevention study: economic benefit analysis of primary prevention with pravastatin. BMJ 1997;315:1577–82. 46. Pickin DM, McCabe CJ, Ramsay LE, 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. 47. Ashraf T, Hay JW, Pitt B, et al. Cost-effectiveness of pravastatin in secondary prevention of coronary artery disease. Am J Cardiol 1996; 78:409 –14. 48. Johannesson M, Jonsson B, Kjekshus J, Olsson AG, Pedersen TR, Wedel H. Cost effectiveness of simvastatin treatment to lower cholesterol levels in patients with coronary heart disease. Scandinavian Simvastatin Survival Study Group. N Engl J Med 1997;336:332–6. 49. Grover SA, Coupal L, Paquet S, Zowall H. Cost-effectiveness of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the secondary prevention of cardiovascular disease: forecasting the incremental benefits of preventing coronary and cerebrovascular events. Arch Intern Med 1999;159:593–600. 50. Oster G, Huse DM, Delea TE, Colditz GA. Cost-effectiveness of nicotine gum as an adjunct to physician’s advice against cigarette smoking. JAMA 1986;256:1315–8. 51. Cummings SR, Rubin SM, Oster G. The cost-effectiveness of counseling smokers to quit. JAMA 1989;261:75–9. 52. Fiscella K, Franks P. Cost-effectiveness of the transdermal nicotine patch as an adjunct to physicians’ smoking cessation counseling. JAMA 1996;275:1247–51. 53. Cromwell J, Bartosch WJ, Fiore MC, Hasselblad V, Baker T. Cost-effectiveness of the clinical practice recommendations in the AHCPR guideline for smoking cessation. Agency for Health Care Policy and Research. JAMA 1997;278:1759 –66. 54. Croghan IT, Offord KP, Evans RW, et al. Cost-effectiveness of treating nicotine dependence: the Mayo Clinic experience. Mayo Clin Proc 1997;72:917–24. 55. Meenan RT, Stevens VJ, Hornbrook MC, et al. Cost-effectiveness of a hospital-based smoking cessation intervention. Med Care 1998;36: 670 –8. 56. Stapleton JA, Lowin A, Russell MA. Prescription of transdermal nicotine patches for smoking cessation in general practice: evaluation of cost-effectiveness. Lancet 1999;354:210 –5. 57. Stason WB, Weinstein MC. Public-health rounds at the Harvard School of Public Health. Allocation of resources to manage hypertension. N Engl J Med 1977;296:732–9. 58. Stevens RD, Bingley LJ, Jr., Boger M, El Wanni J, Kaston J. Variability in the management of hypertension and cost-effectiveness: methodology, community care results and potential cost reductions. Soc Sci Med 1984;18:767–74.

Ades and Kottke et al. Task Force #3—Getting Results

JACC Vol. 40, No. 4, 2002 August 21, 2002:579–651 59. Nissinen A, Tuomilehto J, Kottke TE, Puska P. Cost-effectiveness of the North Karelia Hypertension Program, 1972–1977. Med Care 1986;24:767–80. 60. Littenberg B, Garber AM, Sox HC, Jr. Screening for hypertension. Ann Intern Med 1990;112:192–202. 61. Edelson JT, Weinstein MC, Tosteson AN, Williams L, Lee TH, Goldman L. Long-term cost-effectiveness of various initial monotherapies for mild to moderate hypertension. JAMA 1990;263:407– 13. 62. Laaser U, Wenzel H. Antihypertensive treatment in Germany, subjected to a cost-effectiveness analysis. J Hum Hypertens 1990;4:436 –40. 63. Kawachi I, Malcolm LA. The cost-effectiveness of treating mild-tomoderate hypertension: a reappraisal. J Hypertens 1991;9:199 –208. 64. Johannesson M, Jonsson B. Cost-effectiveness analysis of hypertension treatment—a review of methodological issues. Health Policy 1991;19: 55–77. 65. Johannesson M, Dahlof B, Lindholm LH, et al. The cost-effectiveness of treating hypertension in elderly people—an analysis of the Swedish Trial in Old Patients with Hypertension (STOP Hypertension). J Intern Med 1993;234:317–23. 66. Johannesson M, Wikstrand J, Jonsson B, Berglund G, Tuomilehto J.

67. 68.

69.

70. 71. 72.

615

Cost-effectiveness of antihypertensive treatment: metoprolol versus thiazide diuretics. Pharmacoeconomics 1993;3:36 –44. Johannesson M. The cost effectiveness of hypertension treatment in Sweden. Pharmacoeconomics 1995;7:242–50. Gray A, Raikou M, McGuire A, et al. Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41). United Kingdom Prospective Diabetes Study Group. BMJ 2000;320: 1373–8. Almbrand B, Johannesson M, Sjostrand B, Malmberg K, Ryden L. Cost-effectiveness of intense insulin treatment after acute myocardial infarction in patients with diabetes mellitus: results from the DIGAMI study. Eur Heart J 2000;21:733–9. Hatziandreu EI, Koplan JP, Weinstein MC, Caspersen CJ, Warner KE. A cost-effectiveness analysis of exercise as a health promotion activity. Am J Public Health 1988;78:1417–21. Munro J, Brazier J, Davey R, Nicholl J. Physical activity for the over-65s: could it be a cost-effective exercise for the NHS? J Public Health Med 1997;19:397–402. Lowensteyn I, Coupal L, Zowall H, Grover SA. The cost-effectiveness of exercise training for the primary and secondary prevention of cardiovascular disease. J Cardiopulm Rehabil 2000;20:147–55.

Task Force #3—Getting Results: Who, Where, and How? Philip A. Ades, MD, FACC, Co-Chair, Thomas E. Kottke, MD, FACC, Co-Chair, Nancy Houston Miller, RN, BSN, John C. McGrath, PHD, N. Burgess Record, MD, FACP, Sandra S. Record, RN The provision of preventive cardiology services in the U.S. will require a combination of the medical model of care and of community preventive health programs. These approaches are complementary, synergistic, and each essential, with a goal of “getting results” in the broadest possible population. Organizations such as the American Heart Association (AHA) and the National Heart, Lung, and Blood Institute (NHLBI) have outlined algorithms for the primary and secondary prevention of coronary heart disease (CHD) (1–3), but it is a combination of medical-model and community program approaches that will deliver preventive care. In that the mortality from heart disease has dropped by 40% since 1970, the present approach is not without positive results (4). The goal of this discussion is to describe the types of clinical, community, and media programs that have been effective in decreasing coronary risk in the general public. Because an understanding of the principles of media and communication are crucial to the success of any health promotion program, the principles of effective media and communication are briefly reviewed. Physicians are generally well trained in defining the presence of coronary risk factors and in the medical management of hyperlipidemia, hypertension, and diabetes. Further training of cardiovascular (CV) specialists as leaders in prevention (see Task Force Report #5) will assist in this effort. Physicians are, however, far less capable of managing and influencing lifestyle-related risk factors such as tobacco use, diet, physical inactivity, and the consequences of

obesity. In addition, a brief office encounter does not lend itself to the counseling and follow-up necessary to initiate a change in unhealthy lifestyles. Broadening the physician encounter to include non-physician personnel and community resources will yield a greater impact in reducing coronary risk. Furthermore, a high percentage of young adults do not regularly visit physicians until the presence of lifestyle-related conditions such as CHD or type II diabetes are detected; thus, the role of public policy, school and worksite programs, and mass-media should be emphasized. Physicians, as role models and opinion setters, play a crucial role in supporting the design and development of community programs. Numerous documents and position statements define treatment goals for the prevention of CHD (2,5). Less clear are the processes by which Americans might reach these goals. It is only through a combination of community programs, medical referral and treatment, and mass media approaches to screening and therapy that the majority of Americans will attain appropriate risk factor levels to significantly reduce the incidence of CHD.

PROGRAMS OF GOVERNMENTAL AND NON-GOVERNMENTAL ORGANIZATIONS National Cholesterol Education Program. The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) launched the National Cholesterol Education Program (NCEP) in November 1985 (5).