Value of Primordial and Primary Prevention for Cardiovascular Disease

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Value of Primordial and Primary Prevention for
Cardiovascular Disease
William S. Weintraub, MD John H. Ammon Chair in
Cardiology Christiana Care Health
System Professor of Medicine Thomas Jefferson
University
Disclosures Grants or Consulting from
Sanofi-Aventis, Merck, Pfizer, Otsuka, Gilead,
Abbott, GSK, Astra-Zeneca, Lilly, BMS, Bayer,
Shionogi
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International Comparison of Spending on Health,
19802008
Total expenditures on healthas percent of GDP
Average spending on healthper capita (US PPP)
16
7,538
8.7
2,685
Note US PPP purchasing power parity. Source
Organization for Economic Cooperation and
Development, OECD Health Data 2010 (Paris OECD,
October 2010).
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Do We Need Comparative Cost Effectiveness in
Addition to Clinical Comparative Effectiveness?
What we seek is Value High quality care which
is worth what we pay for it
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Integrating Outcomes
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Cost-Effectiveness Plane CE ?Costs / ?QALYs
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Cost-Effectiveness Plane
6000
Quadrant A
Quadrant D
100,000/ QALY Gained
5000
4000
50,000/ QALY Gained
3000
Incremental Cost of New Procedure in Dollars
2000
1000
-0,1
-0,05
0
0,05
0,1
0,15
0,2
-200
Quadrant B
Quadrant C
-400
Incremental Effectiveness of New Procedure
in Quality Adjusted Life Years
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Limitations of Cost-Effectiveness Analysis
Concerning Prevention

• Costs accrue immediately for delayed benefit
• Cannot easily tie the benefit to any one person
• The benefits to a society of a healthy
  population are difficult to translate into a
  strict CEA analysis

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Prevention is Cost-Effective

• Relatively modest costs, perhaps savings
• Prevent expensive cardiovascular events
• Prolong years of life without disability
• Create a healthier, more productive society

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A Proposition

• Cardiovascular Disease is Largely Preventable
• How Primordial, Primary Secondary Prevention
• Lifetime Risk, Lifetime Prevention

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Atherosclerosis A Progressive Process
PlaqueRupture/Fissure Thrombosis
Occlusive AtheroscleroticPlaque
FattyStreak
FibrousPlaque
Normal
Unstable Angina
MI
Coronary Death
Stroke
Effort Angina or Claudication
Endothelial dysfunction and plaque progression
due to risk factor exposure
Critical Leg Ischemia
Blood levels of inflammatory markers (e.g., CRP)
Clinically silent
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20
30
40
50
Increasing age
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Primordial Prevention

• Prevent risk factors from developing
• Therapeutic Lifestyle is the key
• Begin in childhood or before
• Control of diet, calories, lipids, salt
• Diet includes fruits, vegetables, whole grains
• Regular exercise
• No smoking

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Primary Prevention

• Control risk factors
• Maintain Therapeutic Lifestyle
• Control of diet, calories, lipids, salt
• Diet includes fruits, vegetables, whole grains
• Regular exercise
• No smoking
• Pharmacologic Therapy per Guidelines
• Blood Pressure
• Lipids
• Diabetes Control

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Secondary Prevention

• Control risk factors, Prevent Recurrence
• Maintain Therapeutic Lifestyle
• Control of diet, Calories, Lipids, Salt
• Diet includes fruits, vegetables, whole grains
• Regular exercise
• No smoking
• Pharmacologic Therapy per Guidelines
• Blood Pressure
• Aggressive Lipid Management
• Diabetes Control
• Aspirin, Beta Blockers, ACE/ARB inhibitors in
  Appropriate Populations

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Prevalence of CVD Risk Factors in Adults US,
1961-2001
National Institutes of Health, National Heart,
Lung, and Blood Institute. Fact Book Fiscal Year
2005. 200552.
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Obesity Trends Among U.S. AdultsBRFSS, 1990,
2000, 2010
(BMI ?30, or about 30 lbs. overweight for 54
person)
2000
1990
2010
No Data lt10 1014
1519 2024 2529
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Age-Standardized Prevalence of Diagnosed Diabetes
per 100 Adult Population
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Blood Pressure Risk of CHD with Active Treatment
Veterans Administration, 1967
Veterans Administration, 1970
Hypertension Stroke Study, 1974
USPHS Study, 1977
EWPHE Study, 1985
Coope and Warrender, 1986
SHEP Study, 1991
STOP-Hypertension Study, 1991
MRC Study, 1992
Syst-Eur Study, 1997

Total
0.79 (0.69 to 0.90)
0
0.5
1.0
1.5
2.0
Better than placebo
Worse than placebo
CHDCoronary heart disease
He J et al. Am Heart J 1999138211219.
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Summary of Statin Monotherapy on CHD Events
Trial Drug N Events, n Events, n Risk Reduction, Events not Avoided,
Trial Drug N ControlGroup StatinGroup Risk Reduction, Events not Avoided,
4SWOSCOPSCAREAFCAPSLIPID SimvastatinPravastatinPravastatinLovastatinPravastatin 30,817 2,042 1,490 26 74
HPS Simvastatin 20,586 1,212 898 26 74
PROSPER Pravastatin 5,804 356 292 19 81
ASCOT-LLA Atorvastatin 10,305 154 100 36 64
Total 67,462 3,764 2,780 27 73
Nonfatal MI and CHD death AFCAPS also included
unstable angina Weighted average
Bays H. Expert Rev Cardiovasc Ther 2004289-105.
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Cumulative Impact of Simple Cardiovascular
Protective Medications
Relative Risk 2 Yr. CV Event Rate
None --- 20
Aspirin ? 25 15
Beta Blocker ? 25 11.3
ACE Inhibitor ? 25 8.4
Lipid-lowering Rx ? 30 5.9
LDL-C 100 ?70 mg/dL ? 16 5.0
Cumulative risk reduction if all four therapies
are used 75 Absolute risk reduction 15, NNT
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Cardiovascular (CV) Event CV death, myocardial
infarction, or stroke
LDL-Clow-density lipoprotein cholesterol
Fonarow GC et al. Am J Cardiol 20008510A17A. Yu
suf S. Lancet 200236023.
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Prevention Does Work

• Clinical trial evidence has shown convincingly
  that pharmacological treatment of risk factors
  can prevent events.
• The data are less definitive but also highly
  suggestive that appropriate public policy and
  lifestyle interventions aimed at eliminating
  tobacco use, limiting salt consumption,
  encouraging physical exercise, and improving diet
  can prevent events.

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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Comprehensive Prevention Programs
Community-based programs to increase physical activity, improve nutrition and prevent smoking and other tobacco use Primordial A return on investment of 5.60 for every dollar spent within five years
Comprehensive Worksite Wellness Programs Primordial and Primary Within first 12 to 18 months, medical costs fall by approximately 3.27 for every dollar spent on worksite wellness absenteeism costs fall by about 2.73 for every dollar spent
Comprehensive School-based initiatives to promote healthy eating and physical activity Primordial Cost effectiveness is 900-4305 per QALY saved.
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Comprehensive Prevention Programs
Community-based programs to increase physical activity, improve nutrition and prevent smoking and other tobacco use Primordial A return on investment of 5.60 for every dollar spent within five years
Comprehensive Worksite Wellness Programs Primordial and Primary Within first 12 to 18 months, medical costs fall by approximately 3.27 for every dollar spent on worksite wellness absenteeism costs fall by about 2.73 for every dollar spent
Comprehensive School-based initiatives to promote healthy eating and physical activity Primordial Cost effectiveness is 900-4305 per QALY saved.
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Physical Activity
Building bike and pedestrian trails Primordial and Primary For every 1 invested in building these trails, nearly 3 in medical cost savings
Physical activity interventions such as pedometer and walking programs. Primordial and primary Incremental cost effectiveness ratios (ICERs) ranging from 14,000-69,000 per Quality of Life Year (QALY) gained relative to no intervention, especially in high-risk groups.
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Diet/Nutrition
Reducing sodium in the food supply Primordial and Primary It is estimated that reducing population sodium intake to 1500 mg/day would result in 26.2 billion in health care savings annually.
Obesity Prevention
Obesity Management Program Primary One-year interventions have shown reduction in risk categories such as poor eating and poor physical activity habits as well as in weight for a return on investment of 1.17 for every dollar spent.
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Tobacco Control and Prevention
Excise Taxes Primary A 40 tax-induced cigarette price increase would reduce smoking prevalence to 15.2 by 2025 with large gains in cumulative life years (7 million) and quality adjusted life years (13 million) for a total cost-savings of 682 billion.
Comprehensive Smoke-Free Air Laws in Public Buildings Primordial Eliminating exposure to second-hand smoke would save an estimated 10 billion annually in direct and indirect health care costs.
Tobacco cessation programs Primary ICERs for treatment programs range from a few hundred to a few thousand dollars per QALY saved.
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Tobacco Control and Prevention
Comprehensive Coverage for Tobacco Cessation Programs in Medicaid Programs Primary Comprehensive coverage led to reduced hospitalizations for heart attacks and a net savings of 10.5 million or a 3.07 return on investment for every dollar spent. States offering comprehensive smoking cessation therapy to their employees or in their tobacco control and prevention programs save 1.10-1.40 in healthcare expenditures and productivity for every dollar spent.
Tobacco cessation programs for pregnant women Primary for mother Primordial for fetus Produce a cost benefit ratio as high as 31, (i.e. for every dollar invested in cessation/relapse programs, 3 dollars are saved in downstream health-related costs).
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Diabetes Prevention
Diabetes Screening Primordial Targeted screening for type 2 diabetes based on age and risk was found to be far more cost-effective (ICERs ranging from 46,800-70,500 per QALY gained) when compared with universal screening (ICERs from 70,100-982,000 per QALY gained). Targeted screening for undiagnosed type 2 diabetes in African Americans between 45 and 54 years old was found to be the most cost-effective with an ICER of 19,600 per QALY gained relative to no screening.
Lifestyle changes in diabetes prevention Primary Lifestyle changes reduced the incidence of diabetes by 58 whereas, metformin therapy reduced risk by 31. In patients with impaired glucose tolerance primary prevention in the form of intensive lifestyle modification has median ICERs of 1,500 per QALY gained.
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Cholesterol Screening and Prevention
Widespread use of statins Primary Full adherence to ATP III primary prevention guidelines would prevent 20,000 myocardial infarctions and 10,000 CVD deaths at a total cost 3.6 billion or 42,000 per QALY. If low-intensity statins cost 2.11 per pill (which is substantially higher than the cost of currently available, effective generic statins). At a 50,000 willingess-to-pay threshold, statins are cost effective up to 2.21 per pill.
Blood Pressure
Hypertension Medication Therapy Primary Approximately 37,100 cost per life-year saved.
Polypill Administration Primary Polypill medication treatment in men was less expensive and more effective, with an average cost of 70,000 compared with 93,000 for no treatment, and resulted in 13.62 QALYs when compared with 12.96 QALY without treatment.
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Summary of Cost Savings or Value for Key
Primordial and Primary Prevention Strategies in
the U.S.
Intervention Primordial or Primary Prevention Cost Savings/Value
Diabetes Prevention
Diabetes Screening Primordial Targeted screening for type 2 diabetes based on age and risk was found to be far more cost-effective (ICERs ranging from 46,800-70,500 per QALY gained) when compared with universal screening (ICERs from 70,100-982,000 per QALY gained). Targeted screening for undiagnosed type 2 diabetes in African Americans between 45 and 54 years old was found to be the most cost-effective with an ICER of 19,600 per QALY gained relative to no screening.
Lifestyle changes in diabetes prevention Primary Lifestyle changes reduced the incidence of diabetes by 58 whereas, metformin therapy reduced risk by 31. In patients with impaired glucose tolerance primary prevention in the form of intensive lifestyle modification has median ICERs of 1,500 per QALY gained.
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