Transcript William S. Weintraub - National Forum for Heart Disease and Stroke

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
International Comparison of Spending on Health, 1980–2008
Total expenditures on health
as percent of GDP
Average spending on health
per capita ($US PPP)
16
8000
US
CAN
NETH
GER
AUS
UK
NZ
7000
6000
$7,538
16%
14
12
5000
10
4000
8
3000
6
8.7%
US
GER
CAN
NETH
NZ
UK
AUS
$2,685
2000
4
1000
2
0
0
1980
1984
1988
1992
1996
2000
2004
2008
1980
1984
1988
1992
1996
Note: $US PPP = purchasing power parity.
Source: Organization for Economic Cooperation and Development, OECD Health Data 2010 (Paris: OECD, October 2010).
2000
2004
2008
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
Integrating Outcomes
Potential Outcomes
Disease
Progression
Recurrent
CHF
Arrhythmia
Survival
Quality-Adjusted
Life Years
(QALYs)
Patient’s
“Health Status”
Symptoms
Cost
Patient
Satisfaction
Functional
Status
Quality of Life
Utilities
Cost-Utility
Analysis
Cost-Effectiveness Plane
dominated
 Costs
New Therapy More Costly
CE = Costs / QALYs
 QALYs
dominant
New Therapy More Effective than Comparator
Cost-Effectiveness Plane
Incremental Cost of New Procedure in Dollars
Quadrant D
6000
Quadrant A
$100,000/
QALY Gained
5000
4000
$50,000/
QALY Gained
3000
2000
1000
-0,1
-0,05
0
0,05
0,1
0,15
-200
Quadrant C
Quadrant B
-400
Incremental Effectiveness of New Procedure in
Quality Adjusted Life Years
0,2
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
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
A Proposition
• Cardiovascular Disease is Largely Preventable
• How: Primordial, Primary Secondary Prevention
• Lifetime Risk, Lifetime Prevention
Atherosclerosis: A Progressive Process
Normal
Fatty
Streak
Fibrous
Plaque
Occlusive
Atherosclerotic
Plaque
Plaque
Rupture/
Fissure &
Thrombosis
Unstable
Angina
MI
Coronary
Death
Endothelial dysfunction and plaque
progression due to risk factor
exposure
Effort
Angina or
Claudication
Stroke
Critical Leg
Ischemia
Blood levels of inflammatory
markers (e.g., CRP)
Clinically silent
10
20
30
Increasing age
40
50+
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
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
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
Prevalence of CVD Risk Factors in
Adults: US, 1961-2001
Percent of Population
70
60
50
40
30
Overweight
Hypertension
Smoking
High cholesterol
20
10
0
1960
1965
1970
1975
1980
1985
1990
1995
Year
National Institutes of Health, National Heart, Lung, and Blood Institute. Fact Book Fiscal Year 2005. 2005:52.
2000
2005
Obesity Trends* Among U.S. Adults
BRFSS, 1990, 2000, 2010
(*BMI 30, or about 30 lbs. overweight for 5’4” person)
2000
1990
2010
No Data
<10%
10%–14%
15%–19%
20%–24%
Source: Behavioral Risk Factor Surveillance System, CDC.
25%–29%
≥30%
Age-Standardized Prevalence of Diagnosed Diabetes
per 100 Adult Population
1991
2003
<4%
4%-4.9%
5%-5.9%
6%
Behavioral Risk Factor Surveillance System.
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
0.79
(0.69 to 0.90)
Total
0
CHD=Coronary heart disease
0.5
Better than placebo
He J et al. Am Heart J 1999;138:211219.
1.0
1.5
2.0
Worse than placebo
Summary of Statin Monotherapy on CHD
Events
Events,* n
Trial
Drug
N
Control
Group
Statin
Group
Risk
Reduction,
%†
Events not
Avoided, %
4S
WOSCOPS
CARE
AFCAPS
LIPID
Simvastatin
Pravastatin
Pravastatin
Lovastatin
Pravastatin
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
67,462
3,764
2,780
27
73
Total
* Nonfatal MI and CHD death; AFCAPS also included unstable angina
† Weighted average
Bays H. Expert Rev Cardiovasc Ther 2004;2:89-105.
Cumulative Impact of Simple Cardiovascular
Protective Medications
Relative Risk
2 Yr. CV Event Rate
---
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%
None
Cumulative risk reduction if all four therapies are used: 75%
Absolute risk reduction: 15%, NNT = 6
Cardiovascular (CV) Event = CV death, myocardial infarction, or stroke
LDL-C=low-density lipoprotein cholesterol
Fonarow GC et al. Am J Cardiol 2000;85:10A17A.
Yusuf S. Lancet 2002;360:23.
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.
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
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 Schoolbased initiatives to promote
healthy eating and physical
activity
Primordial
Cost effectiveness is $900-$4305 per QALY saved.
Comprehensive
Prevention Programs
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
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 Schoolbased initiatives to promote
healthy eating and physical
activity
Primordial
Cost effectiveness is $900-$4305 per QALY saved.
Comprehensive
Prevention Programs
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 Primordial and
trails
Primary
For every $1 invested in building these trails, nearly
$3 in medical cost savings
Physical activity
interventions such as
pedometer and walking
programs.
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.
Primordial and
primary
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 Primordial and
supply
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.
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
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.
Tobacco Control and
Prevention
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 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 3:1, (i.e. for
every dollar invested in cessation/relapse programs,
3 dollars are saved in downstream health-related
costs).
Tobacco Control and
Prevention
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 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.
Diabetes
Prevention
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
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.
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.
Cholesterol
Screening and
Prevention
Widespread use of
statins
Blood Pressure
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 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.
Diabetes
Prevention