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Developing Cost EffectiveDeveloping Cost Effective
CHD Screening StrategiesCHD Screening Strategies
Leslee J. Shaw, PhDLeslee J. Shaw, PhD
Department of Imaging and MedicineDepartment of Imaging and Medicine
Cedars-Sinai Medical CenterCedars-Sinai Medical Center
Los Angeles, CaliforniaLos Angeles, California
CHD Detection In Asymptomatic Women & MenCHD Detection In Asymptomatic Women & Men
Traditional approach to detection of CHD risk =Traditional approach to detection of CHD risk =
assessment of typical risk factorsassessment of typical risk factors
Despite many available risk assessmentDespite many available risk assessment
approaches, there’s aapproaches, there’s a detection gapdetection gap forfor
asymptomatic individuals w/ subclinicalasymptomatic individuals w/ subclinical
atherosclerosis.atherosclerosis.
Framingham & European risk scores - usefulFramingham & European risk scores - useful
““guidesguides.”.”
– to predict long term risk of CHD events into predict long term risk of CHD events in
healthy populations.healthy populations.
– Target Population for Screening:Target Population for Screening:
40% of the US Adult Population (or 3640% of the US Adult Population (or 36
million) = Intermediate Riskmillion) = Intermediate Risk
Majority of 1st MIsMajority of 1st MIs
Source: Abrams, Pasternak, Greenland, Houston-Miller, Smaha. BC #34: Taskforce #1 - Identification of CHD and CHD Risk. JACC 2003., Blumenthal,
Becker, Yanek, Aversano, Moy, Kral, Becker. Detecting occult coronary disease in a high-risk asymptomatic population. Circulation 2003;107(5):702-
707., Wilson, D’Agostino, Levy, Belanger, Silbershatz, Kannel. Prediction of CHD using risk factor categories. Circulation 1998;97:1837-1847.
Source: Fletcher et al., 33rd Bethesda Conf: Preventive Cardiology: How Can We Do Better? JACC 2002;40:4:579-651., Wilson et al. Abdominal
aortic calcific deposits are an important predictor of vascular morbidity and mortality. Circulation 2001;103:1529-34., Jaffer et al. Age and Sex
Distribution of Subclinical Aortic Atherosclerosis - A Magnetic Resonance Imaging Examination of the Framingham Heart Study Art, Thromb, Vasc
Biol 2002;22:849.
X
Estimated 10 Yr. Hard CHD Risk FraminghamEstimated 10 Yr. Hard CHD Risk Framingham
Offspring & Cohort Women and MenOffspring & Cohort Women and Men
Source: Abrams, Pasternak, Greenland, Houston-Miller, Smaha. Bethesda Conference #34: Identification of CHD and CHD risk: Is there a detection
gap? JACC 2003
0%
20%
40%
60%
80%
100%
30-39 40-49 50-59 60-69 70-79 30-39 40-49 50-59 60-69 70-79
>20%
10-20%
6-10%
<6%
PercentPercent
Age (years)Age (years)
WomenWomen MenMen
CCS=0 CCS 1-99 CCS 100-399 CCS≥400
40
50
60
70
80
90
100
89
74
65
59
Source: Nasir K, Michos ED, Blumenthal RS, Raggi P. Detection of High-Risk Young Adults and Women by Coronary Calcium and National
Cholesterol Education Panel-III Guidelines. JACC 2005 (in press).
% Not Qualifying For Pharmacotherapy by CACS% Not Qualifying For Pharmacotherapy by CACS
Women as well as young
individuals were less
likely to be considered
candidates for
pharmacotherapy vs.
men & older individuals.
Shaw Atherosclerosis (in
press)
- 45% low risk
reclassified based on
CAC
Estimated Direct & Indirect Costs ofEstimated Direct & Indirect Costs of
Cardiovascular Diseases & StrokeCardiovascular Diseases & Stroke
United States: 2005United States: 2005
Source: Heart Disease and Stroke Statistics – 2005 Update.
254.8
142.1
56.8 59.7
27.9
393.5
0
50
100
150
200
250
300
350
400
450
Heart
Disease
Coronary
Heart
Disease
Stroke
Hypertensive
Disease
Congestive
HeartFailure
TotalCVD*
BillionsofDollars
Current State of Health Care SystemCurrent State of Health Care System
~50% of health care costs are for end-stage or~50% of health care costs are for end-stage or
hospital care.hospital care.
– Avg yrly health expenditure for end stage careAvg yrly health expenditure for end stage care
is ~5-x higher vs. non-end stage care.is ~5-x higher vs. non-end stage care.
Shifting care to early, diagnostic or outpatientShifting care to early, diagnostic or outpatient
sector potential to reduce cost.sector potential to reduce cost.
Source: CMS, Office of the Actuary, National Health Statistics Group. Access date: March 2, 2004.
0 50 100 150 200 250 300 350 400 450
Medical Durables
Other Nondurables
Home Health
Other Personal Health
Other Professionals
Dental
Nursing Home
Drug
MD / Clinical Services
Hospital
Personal Health Spending (Billions of Dollars)
Medicare Spending Other Payers
$412 Billion
Medicare pays 31%
$286 Billion
Medicare pays 21%
$122 Billion
Medicare pays 2%
$92 Billion
Medicare pays 10%
$39 Billion
Medicare pays 12%
$60 Billion
Medicare pays 0%
$37 Billion
Medicare pays 0%
$31 Billion
Medicare pays 4%
$32 Billion
Medicare pays 29%
$19 Billion
Medicare pays 25%
Source: Medicare Standard Analytic File, 1999.
5+ Chronic
Conditions
66%
0 Chronic
Conditions
1%
2 Chronic
Conditions
7%
3 Chronic
Conditions
10%
4 Chronic
Conditions
13%
1 Chronic
Condition
3%
- 2/3rds
of Spending = 5+
Chronic Conditions
- 1/5th
of Spending = 3+
Chronic Conditions
Medicare SpendingMedicare Spending
The Most Expensive Conditions In America:The Most Expensive Conditions In America:
MEPS Population EstimatesMEPS Population Estimates
Billion Billion
1. Ischemic Heart Disease $21.5 9. Cerebrovascular Dz $8.3
2. Motor Vehicle Accidents $21.3 10. Dysrythmias $7.2
3. Acute Resp. Infections $17.9 11. Peripheral Vascular $6.8
4. Arthropathies $15.9 12. COPD $6.4
5. Hypertension $14.8 13. Asthma $5.7
6. Back Problems $12.2 14. CHF $5.2
7. Mood Disorders $10.2 15. Lung Cancer $5.0
8. Diabetes $10.1
The Most Expensive Conditions In America:The Most Expensive Conditions In America:
MEPS Population EstimatesMEPS Population Estimates
Billion Billion
1. Ischemic Heart Disease $21.5 9. Cerebrovascular Dz $8.3
2. Motor Vehicle Accidents $21.3 10. Dysrythmias $7.2
3. Acute Resp. Infections $17.9 11. Peripheral Vascular $6.8
4. Arthropathies $15.9 12. COPD $6.4
5. Hypertension $14.8 13. Asthma $5.7
6. Back Problems $12.2 14. CHF $5.2
7. Mood Disorders $10.2 15. Lung Cancer $5.0
8. Diabetes $10.1
Upfront Test CostUpfront Test Cost
0
200
400
600
800
1000
ABI
TM
ET
C-IM
TEBT
/C
T
EchoO
therC
T
SPEC
T
IVU
S
M
R
C
ath
CholPanelHsC
R
PO
P
VisitAdv
Lipid
Low Cost
Lab / Office Visit
Cardiac Imaging
Source: Mark DB, Shaw LJ, et al. Bethesda Conference #34- Taskforce #5 - Is atherosclerotic imaging cost effective? JACC 2003;41:1906.
Affected by MD Labor, Lab Volume, +/- Add-Ons (Contrast or Radiopharmaceutical),
Equipment (Lease, Age, Shared)
Average Cost Inputs for Adverse Sequelae of CVDAverage Cost Inputs for Adverse Sequelae of CVD
– Out-of-Hospital SCD – Lost ProductivityOut-of-Hospital SCD – Lost Productivity
– In-Hospital Death – in excess of $50k-$100kIn-Hospital Death – in excess of $50k-$100k
– End-Stage Care for CHF – 80% of lifetime care costsEnd-Stage Care for CHF – 80% of lifetime care costs
– AMI or ACSAMI or ACS ≅≅ $15-20k$15-20k
– Chest Pain HospitalizationChest Pain Hospitalization ≅≅ $6k$6k
– StrokeStroke ≅≅ $50k$50k
– Anti-Ischemic RxAnti-Ischemic Rx ≅≅ $1,500 - $5,000 / yr$1,500 - $5,000 / yr
– Out-of-PocketOut-of-Pocket ≅≅ $2,000 / yr$2,000 / yr
– ……..
Medicare Payment Advisory Commission (MedPAC) -Medicare Payment Advisory Commission (MedPAC) -
Growth in Physician ServicesGrowth in Physician Services
0
5
10
15
20
25
30
35
40
45
Major
Procedures
Evaluation &
Management
Other
Procedures
Tests Imaging
22%
Growth of All
Physician Services
%
Includes all Services in the Physician Fee Schedule
Source: MEDPAC Analysis of Medicare Claims Data
March 17, 2005, Executive Director, Medicare Payment Advisory Commission, Mark Miller,.htm
Trends in CV Operations & ProceduresTrends in CV Operations & Procedures
United States: 1979-2000United States: 1979-2000
Unfolding a Body of EvidenceUnfolding a Body of Evidence
Observational
Data
•Risk
identification
•Costs
Clinical Trial
Data
•Vs.
Comparators
Building Building
Cost Effectiveness
•High Risk CEA
•Reimbursement
Disease Management
•Risk Identification
•Cost Efficiency
•Outcomes – Improve
Process of Care
Quality Standards:
Benchmarking / Profiling
•Cost / Charges
•Guiding Providers
•Adherence
Guidelines
Practice Guidelines
/ Critical Pathways
Source: Shaw LJ, Redberg RF. From clinical trials to public health policy: The path from imaging to screening. Am J Cardiol 2001 Jul 19;88(2-A):62E
65E.
Basics of CEABasics of CEA
CEA – technique for selecting among competing choices when resources are limited.CEA – technique for selecting among competing choices when resources are limited.
““Value for Money”Value for Money”
Technique comparing relative value of various clinical strategies. Commonly, a newTechnique comparing relative value of various clinical strategies. Commonly, a new
strategy is compared w/ current practice (i.e., "low-cost alternative") in calculation of CEstrategy is compared w/ current practice (i.e., "low-cost alternative") in calculation of CE
ratio:ratio:
Result = "price" of an additional outcome purchased by switching from current practice toResult = "price" of an additional outcome purchased by switching from current practice to
new strategy (e.g., $10,000 / life year). If the price is low enough, new strategy isnew strategy (e.g., $10,000 / life year). If the price is low enough, new strategy is
considered "cost-effective.“considered "cost-effective.“
Source: http://www.acponline.org/journals/ecp/sepoct00/primer.htm
=Standard: <$50,000 / LYS
Critical Cost Effectiveness (CE) QuestionsCritical Cost Effectiveness (CE) Questions
1. Vs. usual care—i.e., no screening—what is the CE of CHD screening of
asymptomatic adults to reduce risk for CHD-specific morbidity /
mortality?
2. What is the CE of selective screening adults at increased risk for CHD
— e.g., those with a family history of premature CHD, w/ risk factors —
vs. routine screening & usual care?
3. How will differences in rx effectiveness affect CE estimates for CHD
screening?
4. Among individuals w/ subclinical disease on initial screening exam,
what is the CE of periodic surveillance vs. one-time screening?
5. Among individuals w/out subclinical CAD on initial screening exam,
what is the CE of re-screening at varying intervals vs. onetime
screening?
Screening Criteria DiscussedScreening Criteria Discussed
BurdenBurden
– Prevalence of diseasePrevalence of disease
– Years of life lostYears of life lost
– Disability or quality of lifeDisability or quality of life
– Economic burdenEconomic burden
Effectiveness and EfficacyEffectiveness and Efficacy
Cost effectivenessCost effectiveness
Current delivery ratesCurrent delivery rates
Feasibility of increasing delivery ratesFeasibility of increasing delivery rates
Cost Effective CHD ScreeningCost Effective CHD Screening
1. Detection of Risk1. Detection of Risk
2. Early Rx2. Early Rx
3. Improved Outcome3. Improved Outcome
Resulting in Reduction in More Costly, End-Stage CareResulting in Reduction in More Costly, End-Stage Care
Improved Societal ProductivityImproved Societal Productivity
Evaluation CriteriaEvaluation Criteria
Burden of diseaseBurden of disease
– Single measure incorporating mortality & morbiditySingle measure incorporating mortality & morbidity
Effectiveness of ScreeningEffectiveness of Screening
Cost effectivenessCost effectiveness
Feasibility of Increasing Delivery RatesFeasibility of Increasing Delivery Rates
CHD Screening FrameworkCHD Screening Framework
Two Steps:Two Steps:
1.1. Burden and Effectiveness into single measure ofBurden and Effectiveness into single measure of
Clinically Preventable BurdenClinically Preventable Burden (CPB)(CPB)
2.2. Cost EffectivenessCost Effectiveness included to account for resourceincluded to account for resource
consumptionconsumption
Clinically Preventable BurdenClinically Preventable Burden
CPB = Burden x EffectivenessCPB = Burden x Effectiveness
– Burden includes all disease targeted by CHDBurden includes all disease targeted by CHD
– Effectiveness = % of burden reducedEffectiveness = % of burden reduced
Measures burden of CHD preventableMeasures burden of CHD preventable
Burden measured in Quality-Adjusted Life YearsBurden measured in Quality-Adjusted Life Years
Saved (QALYS) -- approximatedSaved (QALYS) -- approximated
Uses effectiveness from RCTUses effectiveness from RCT
– Range of Therapeutic Risk ReductionRange of Therapeutic Risk Reduction
Clinically Preventable BurdenClinically Preventable Burden
Qualitative assessment of CHD screeningQualitative assessment of CHD screening
should consider:should consider:
– CPB - not burden and effectiveness separatelyCPB - not burden and effectiveness separately
focus on fatal or high-prevalence, nonfatal conditionsfocus on fatal or high-prevalence, nonfatal conditions
– Costs of service: medical care, out-of-pocketCosts of service: medical care, out-of-pocket
– Potential for cost savingsPotential for cost savings
Cost Effectiveness (CE) AnalysisCost Effectiveness (CE) Analysis
CECE == costs of screening – costs avertedcosts of screening – costs averted
Net Effectiveness**Net Effectiveness**
ICER =ICER =
– CHD Screening vs. No Testing / Usual CareCHD Screening vs. No Testing / Usual Care
– CHD Screening vs. Global Risk ScoreCHD Screening vs. Global Risk Score
– CHD Screening vs. Alternative TestingCHD Screening vs. Alternative Testing
CAC vs. C-IMTCAC vs. C-IMT
CAC vs. BARTCAC vs. BART
CAC vs. ….CAC vs. ….
** Clinically Preventable Burden reduced** Clinically Preventable Burden reduced
Treatment-Eligible US-PopulationTreatment-Eligible US-Population
under NCEP II, NCEP III, CAC Screeningunder NCEP II, NCEP III, CAC Screening
0
2.5
5
7.5
10
12.5
15
40-59 60-79 40-59 60-79
Millionsofpeople
Men Women
% Increase 142.5 184.3 124.9
85.9
65.0 50.0 65.0
50.0
NCEP II
NCEP III
Age (y)
Source: Fedder DO et al., Circulation 2002;105:152-156, Nasir K, Michos ED, Blumenthal RS, Raggi P. Detection of High-Risk Young Adults and
Women by Coronary Calcium and National Cholesterol Education Panel-III Guidelines. JACC 2005 (in press).
CAC
Treatment Est. 10-Yr Costs from NCEP IIITreatment Est. 10-Yr Costs from NCEP III
to CAC Screeningto CAC Screening
$0
$25,000
$50,000
$75,000
$100,000
$125,000
$150,000
$175,000
$200,000
40-59 60-79 40-59 60-79
Millionsof$
Men Women
NCEP III
Source: Fedder DO et al., Circulation 2002;105:152-156, Nasir K, Michos ED, Blumenthal RS, Raggi P. Detection of High-Risk Young Adults and
Women by Coronary Calcium and National Cholesterol Education Panel-III Guidelines. JACC 2005 (in press).
CAC
CACS RR (95% CI) p ValueSummary RR Ratio
1.5 (0.8-2.9) 24 / 6931 18 / 8503 0.18
0.01
0.01
0.1
0.1
1
1
10
10
100
100
Higher Risk Low Risk
Events / N
Low Risk 2.1 (1.3-3.3) 46 / 2670 26 / 4600 0.003
Moderate Risk 4.1 (2.9-6.0) 102 / 4,428 44 / 9,977 <0.0001
High Risk 6.7 (4.8-9.4) 179 / 3,550 44 / 6,839 <0.0001
Very High Risk* 1,000 10.8 (4.2-27.7) 14 / 196 6 / 905 <0.0001
Very Low Risk 1-44
1-112
100-400
400-999
Lower Risk Higher Risk
Low Risk includes Arad, Greenland, LaMonte
Moderate Risk includes Arad, Greenland, LaMonte, Taylor, Vliegenthart
High Risk includes Arad, Greenland, Kondos, LaMonte, Vliegenthart
Very High Risk includes Vliegenthart
Very Low Risk includes Kondos, LaMonte, Taylor
Relative Risk (RR) Ratios (95% CI) by CACS RiskRelative Risk (RR) Ratios (95% CI) by CACS Risk
When c/w FRS event rates,
Δ LYS with CACS ≅≅ 0.58 for 35% RR
Reduction w/ Rx (0-0.83)
CPB Model Inputs – Disease BurdenCPB Model Inputs – Disease Burden
20022002 CurrentCurrent Post-ScreeningPost-Screening
CHD DeathsCHD Deaths 697,000697,000 ↓↓10% (5%-25%)10% (5%-25%)
MIMI 2,100,0002,100,000 ↓↓ 25% (5%-35%)25% (5%-35%)
Chest Pain SymptomsChest Pain Symptoms 12,000,00012,000,000 ↓↓ 5% (2.5%-25%)5% (2.5%-25%)
Hospital D/C for 1Hospital D/C for 100
DiagnosisDiagnosis
of CVDof CVD
6,373,0006,373,000 ↑↑ 10% (5%-25%)10% (5%-25%)
Hospital D/C for 1Hospital D/C for 100
DiagnosisDiagnosis
of CHFof CHF
970,000970,000 ↓↓ 10% (5%-25%)10% (5%-25%)
Source: MI rates were extrapolated from ARIC, 1987-2000 & does not include silent MIs. CVA data also not included.
CPB Model Inputs – Disease BurdenCPB Model Inputs – Disease Burden
CurrentCurrent Post-Post-
ScreeningScreening
Post-ScreeningPost-Screening
CHD DeathsCHD Deaths 697,000697,000 ↓↓10%10% ($697 m)($697 m)
MIMI 2,100,0002,100,000 ↓↓ 15%15% ($3.7 b)($3.7 b)
Chest Pain SymptomsChest Pain Symptoms 12,000,00012,000,000 ↓↓ 10%10% ($7.2 b)($7.2 b)
Hospital D/C for 1Hospital D/C for 100
DiagnosisDiagnosis
of CVDof CVD
6,373,0006,373,000 ↑↑ 10%10% $3.8 b$3.8 b
Hospital D/C for 1Hospital D/C for 100
DiagnosisDiagnosis
of CHFof CHF
970,000970,000 ↓↓ 10%10% ($9.9 b)($9.9 b)
Source: MI rates were extrapolated from ARIC, 1987-2000 & does not include silent MIs. CVA data also not included.
CPB Model Inputs – Procedure BurdenCPB Model Inputs – Procedure Burden
Pre-Pre-
ScreeningScreening
Post-Post-
ScreeningScreening
Stress ImagingStress Imaging 8,700,0008,700,000 ↑↑ 10%10%
(5%-25%)(5%-25%)
AngiographyAngiography 6,800,0006,800,000 ↑↑ 15% - CTA15% - CTA
(2.5%-25%)(2.5%-25%)
PCIPCI 657,000657,000 ↓↓ 10%10%
(5%-50%)(5%-50%)
CABSCABS 515,000515,000 ↓↓ 5%5%
(2.5%-50%)(2.5%-50%)
Source: CDC/NCHS for 2002. http://www.acc.org/advocacy/word_files/2005ProposedPhysicianPmtRulev3%20web.xls.
CPB Model Inputs – Procedure BurdenCPB Model Inputs – Procedure Burden
Pre-Pre-
ScreeningScreening
Post-Post-
ScreeningScreening
Post-Post-
ScreeningScreening
Stress ImagingStress Imaging 8,700,0008,700,000 ↑↑ 10%10%
(5%-25%)(5%-25%)
$358 m$358 m
AngiographyAngiography 6,800,0006,800,000 ↑↑ 15% - CTA15% - CTA
(2.5%-25%)(2.5%-25%)
$600 m$600 m
PCIPCI 657,000657,000 ↓↓ 10%10%
(5%-50%)(5%-50%)
($580 m)($580 m)
CABSCABS 515,000515,000 ↓↓ 5%5%
(2.5%-50%)(2.5%-50%)
($672 m)($672 m)
Source: CDC/NCHS for 2002. http://www.acc.org/advocacy/word_files/2005ProposedPhysicianPmtRulev3%20web.xls.
Markov Model:Markov Model: Health states - ovals; arrows represent allowed transitions. All ptsHealth states - ovals; arrows represent allowed transitions. All pts
start event-free & can remain, have MI or angina, or die.start event-free & can remain, have MI or angina, or die.
Markov model to estimate the benefits, costs, & incremental cost-effectiveness of CHD screening followed by
targeted statin rx for high risk subclinical dz, vs. usual care alone, for the primary prevention of CV events among
patients ages 45-65 years..
Death
Post-MI
Post-MI &
AP
Post-AP
Event-Free
Source: Blake GJ, Ridker PM, Kuntz KM. Potential Cost-effectiveness of C-Reactive Protein Screening Followed by Targeted Statin Therapy for the
Primary Prevention of Cardiovascular Disease among Patients without Overt Hyperlipidemia. Am J Med 2003;114:485– 494.
Multi-Attribute Cost Markov Model:Multi-Attribute Cost Markov Model: Comparing FRS vs. CACSComparing FRS vs. CACS
for 5 Yrs. Of Observational Follow-up Estimated LYS in Pts. Ages 45-65 yrs.for 5 Yrs. Of Observational Follow-up Estimated LYS in Pts. Ages 45-65 yrs.
Death
FRS
Post-MI &
AP
Event-Free
Death
CACS
Post-MI &
AP
Event-Free
<$50,000 / Events Averted
ConclusionsConclusions
If we can identify w/ a high degree of likelihood pts at risk forIf we can identify w/ a high degree of likelihood pts at risk for
AMI / SCD, then it is likely that a CV screening-driven approachAMI / SCD, then it is likely that a CV screening-driven approach
including prevention (i.e., risk factor modification) can result inincluding prevention (i.e., risk factor modification) can result in
improved outcomes & aversion of costly hospitalizations.improved outcomes & aversion of costly hospitalizations.
Preliminary analyses from the CE models reveal that subclinicalPreliminary analyses from the CE models reveal that subclinical
dz screening can be cost effective when applied to “higher risk”dz screening can be cost effective when applied to “higher risk”
or appropriate patient candidates.or appropriate patient candidates.
– When compared with global risk scores that often underestimate risk inWhen compared with global risk scores that often underestimate risk in
key patient subsets: women, young, international cohorts.key patient subsets: women, young, international cohorts.
Decision models do not replace RCT comparing an array ofDecision models do not replace RCT comparing an array of
imaging modalities, laboratory markers, or global risk scoring.imaging modalities, laboratory markers, or global risk scoring.
Potential Evidence for Priority SettingPotential Evidence for Priority Setting
Priority Criteria Measures
Impact
Condition Disability, Mortality
System Costs, Guideline Adherence, Errors
Societal Indirect Costs
Improvability
Condition Cost-Effectiveness, efficacy
Disparity Impact on vulnerable subgroups
System Effectiveness of quality improvement
Inclusiveness Diffusion across subpopulations
Many preventive services areMany preventive services are
recommendedrecommended
Delivery of effective services isDelivery of effective services is
incompleteincomplete
Resources—time and money—areResources—time and money—are
limitedlimited
Preventive services differ in their healthPreventive services differ in their health
impact and costsimpact and costs
Unmet Expectations & LimitationsUnmet Expectations & Limitations
to CHD Screeningto CHD Screening

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Developing Cost Effective CHD Screening Strategies

  • 1. Developing Cost EffectiveDeveloping Cost Effective CHD Screening StrategiesCHD Screening Strategies Leslee J. Shaw, PhDLeslee J. Shaw, PhD Department of Imaging and MedicineDepartment of Imaging and Medicine Cedars-Sinai Medical CenterCedars-Sinai Medical Center Los Angeles, CaliforniaLos Angeles, California
  • 2. CHD Detection In Asymptomatic Women & MenCHD Detection In Asymptomatic Women & Men Traditional approach to detection of CHD risk =Traditional approach to detection of CHD risk = assessment of typical risk factorsassessment of typical risk factors Despite many available risk assessmentDespite many available risk assessment approaches, there’s aapproaches, there’s a detection gapdetection gap forfor asymptomatic individuals w/ subclinicalasymptomatic individuals w/ subclinical atherosclerosis.atherosclerosis. Framingham & European risk scores - usefulFramingham & European risk scores - useful ““guidesguides.”.” – to predict long term risk of CHD events into predict long term risk of CHD events in healthy populations.healthy populations. – Target Population for Screening:Target Population for Screening: 40% of the US Adult Population (or 3640% of the US Adult Population (or 36 million) = Intermediate Riskmillion) = Intermediate Risk Majority of 1st MIsMajority of 1st MIs Source: Abrams, Pasternak, Greenland, Houston-Miller, Smaha. BC #34: Taskforce #1 - Identification of CHD and CHD Risk. JACC 2003., Blumenthal, Becker, Yanek, Aversano, Moy, Kral, Becker. Detecting occult coronary disease in a high-risk asymptomatic population. Circulation 2003;107(5):702- 707., Wilson, D’Agostino, Levy, Belanger, Silbershatz, Kannel. Prediction of CHD using risk factor categories. Circulation 1998;97:1837-1847.
  • 3. Source: Fletcher et al., 33rd Bethesda Conf: Preventive Cardiology: How Can We Do Better? JACC 2002;40:4:579-651., Wilson et al. Abdominal aortic calcific deposits are an important predictor of vascular morbidity and mortality. Circulation 2001;103:1529-34., Jaffer et al. Age and Sex Distribution of Subclinical Aortic Atherosclerosis - A Magnetic Resonance Imaging Examination of the Framingham Heart Study Art, Thromb, Vasc Biol 2002;22:849. X
  • 4. Estimated 10 Yr. Hard CHD Risk FraminghamEstimated 10 Yr. Hard CHD Risk Framingham Offspring & Cohort Women and MenOffspring & Cohort Women and Men Source: Abrams, Pasternak, Greenland, Houston-Miller, Smaha. Bethesda Conference #34: Identification of CHD and CHD risk: Is there a detection gap? JACC 2003 0% 20% 40% 60% 80% 100% 30-39 40-49 50-59 60-69 70-79 30-39 40-49 50-59 60-69 70-79 >20% 10-20% 6-10% <6% PercentPercent Age (years)Age (years) WomenWomen MenMen
  • 5. CCS=0 CCS 1-99 CCS 100-399 CCS≥400 40 50 60 70 80 90 100 89 74 65 59 Source: Nasir K, Michos ED, Blumenthal RS, Raggi P. Detection of High-Risk Young Adults and Women by Coronary Calcium and National Cholesterol Education Panel-III Guidelines. JACC 2005 (in press). % Not Qualifying For Pharmacotherapy by CACS% Not Qualifying For Pharmacotherapy by CACS Women as well as young individuals were less likely to be considered candidates for pharmacotherapy vs. men & older individuals. Shaw Atherosclerosis (in press) - 45% low risk reclassified based on CAC
  • 6. Estimated Direct & Indirect Costs ofEstimated Direct & Indirect Costs of Cardiovascular Diseases & StrokeCardiovascular Diseases & Stroke United States: 2005United States: 2005 Source: Heart Disease and Stroke Statistics – 2005 Update. 254.8 142.1 56.8 59.7 27.9 393.5 0 50 100 150 200 250 300 350 400 450 Heart Disease Coronary Heart Disease Stroke Hypertensive Disease Congestive HeartFailure TotalCVD* BillionsofDollars
  • 7. Current State of Health Care SystemCurrent State of Health Care System ~50% of health care costs are for end-stage or~50% of health care costs are for end-stage or hospital care.hospital care. – Avg yrly health expenditure for end stage careAvg yrly health expenditure for end stage care is ~5-x higher vs. non-end stage care.is ~5-x higher vs. non-end stage care. Shifting care to early, diagnostic or outpatientShifting care to early, diagnostic or outpatient sector potential to reduce cost.sector potential to reduce cost. Source: CMS, Office of the Actuary, National Health Statistics Group. Access date: March 2, 2004. 0 50 100 150 200 250 300 350 400 450 Medical Durables Other Nondurables Home Health Other Personal Health Other Professionals Dental Nursing Home Drug MD / Clinical Services Hospital Personal Health Spending (Billions of Dollars) Medicare Spending Other Payers $412 Billion Medicare pays 31% $286 Billion Medicare pays 21% $122 Billion Medicare pays 2% $92 Billion Medicare pays 10% $39 Billion Medicare pays 12% $60 Billion Medicare pays 0% $37 Billion Medicare pays 0% $31 Billion Medicare pays 4% $32 Billion Medicare pays 29% $19 Billion Medicare pays 25%
  • 8. Source: Medicare Standard Analytic File, 1999. 5+ Chronic Conditions 66% 0 Chronic Conditions 1% 2 Chronic Conditions 7% 3 Chronic Conditions 10% 4 Chronic Conditions 13% 1 Chronic Condition 3% - 2/3rds of Spending = 5+ Chronic Conditions - 1/5th of Spending = 3+ Chronic Conditions Medicare SpendingMedicare Spending
  • 9. The Most Expensive Conditions In America:The Most Expensive Conditions In America: MEPS Population EstimatesMEPS Population Estimates Billion Billion 1. Ischemic Heart Disease $21.5 9. Cerebrovascular Dz $8.3 2. Motor Vehicle Accidents $21.3 10. Dysrythmias $7.2 3. Acute Resp. Infections $17.9 11. Peripheral Vascular $6.8 4. Arthropathies $15.9 12. COPD $6.4 5. Hypertension $14.8 13. Asthma $5.7 6. Back Problems $12.2 14. CHF $5.2 7. Mood Disorders $10.2 15. Lung Cancer $5.0 8. Diabetes $10.1
  • 10. The Most Expensive Conditions In America:The Most Expensive Conditions In America: MEPS Population EstimatesMEPS Population Estimates Billion Billion 1. Ischemic Heart Disease $21.5 9. Cerebrovascular Dz $8.3 2. Motor Vehicle Accidents $21.3 10. Dysrythmias $7.2 3. Acute Resp. Infections $17.9 11. Peripheral Vascular $6.8 4. Arthropathies $15.9 12. COPD $6.4 5. Hypertension $14.8 13. Asthma $5.7 6. Back Problems $12.2 14. CHF $5.2 7. Mood Disorders $10.2 15. Lung Cancer $5.0 8. Diabetes $10.1
  • 11. Upfront Test CostUpfront Test Cost 0 200 400 600 800 1000 ABI TM ET C-IM TEBT /C T EchoO therC T SPEC T IVU S M R C ath CholPanelHsC R PO P VisitAdv Lipid Low Cost Lab / Office Visit Cardiac Imaging Source: Mark DB, Shaw LJ, et al. Bethesda Conference #34- Taskforce #5 - Is atherosclerotic imaging cost effective? JACC 2003;41:1906. Affected by MD Labor, Lab Volume, +/- Add-Ons (Contrast or Radiopharmaceutical), Equipment (Lease, Age, Shared)
  • 12. Average Cost Inputs for Adverse Sequelae of CVDAverage Cost Inputs for Adverse Sequelae of CVD – Out-of-Hospital SCD – Lost ProductivityOut-of-Hospital SCD – Lost Productivity – In-Hospital Death – in excess of $50k-$100kIn-Hospital Death – in excess of $50k-$100k – End-Stage Care for CHF – 80% of lifetime care costsEnd-Stage Care for CHF – 80% of lifetime care costs – AMI or ACSAMI or ACS ≅≅ $15-20k$15-20k – Chest Pain HospitalizationChest Pain Hospitalization ≅≅ $6k$6k – StrokeStroke ≅≅ $50k$50k – Anti-Ischemic RxAnti-Ischemic Rx ≅≅ $1,500 - $5,000 / yr$1,500 - $5,000 / yr – Out-of-PocketOut-of-Pocket ≅≅ $2,000 / yr$2,000 / yr – ……..
  • 13. Medicare Payment Advisory Commission (MedPAC) -Medicare Payment Advisory Commission (MedPAC) - Growth in Physician ServicesGrowth in Physician Services 0 5 10 15 20 25 30 35 40 45 Major Procedures Evaluation & Management Other Procedures Tests Imaging 22% Growth of All Physician Services % Includes all Services in the Physician Fee Schedule Source: MEDPAC Analysis of Medicare Claims Data March 17, 2005, Executive Director, Medicare Payment Advisory Commission, Mark Miller,.htm
  • 14. Trends in CV Operations & ProceduresTrends in CV Operations & Procedures United States: 1979-2000United States: 1979-2000
  • 15. Unfolding a Body of EvidenceUnfolding a Body of Evidence Observational Data •Risk identification •Costs Clinical Trial Data •Vs. Comparators Building Building Cost Effectiveness •High Risk CEA •Reimbursement Disease Management •Risk Identification •Cost Efficiency •Outcomes – Improve Process of Care Quality Standards: Benchmarking / Profiling •Cost / Charges •Guiding Providers •Adherence Guidelines Practice Guidelines / Critical Pathways Source: Shaw LJ, Redberg RF. From clinical trials to public health policy: The path from imaging to screening. Am J Cardiol 2001 Jul 19;88(2-A):62E 65E.
  • 16. Basics of CEABasics of CEA CEA – technique for selecting among competing choices when resources are limited.CEA – technique for selecting among competing choices when resources are limited. ““Value for Money”Value for Money” Technique comparing relative value of various clinical strategies. Commonly, a newTechnique comparing relative value of various clinical strategies. Commonly, a new strategy is compared w/ current practice (i.e., "low-cost alternative") in calculation of CEstrategy is compared w/ current practice (i.e., "low-cost alternative") in calculation of CE ratio:ratio: Result = "price" of an additional outcome purchased by switching from current practice toResult = "price" of an additional outcome purchased by switching from current practice to new strategy (e.g., $10,000 / life year). If the price is low enough, new strategy isnew strategy (e.g., $10,000 / life year). If the price is low enough, new strategy is considered "cost-effective.“considered "cost-effective.“ Source: http://www.acponline.org/journals/ecp/sepoct00/primer.htm =Standard: <$50,000 / LYS
  • 17. Critical Cost Effectiveness (CE) QuestionsCritical Cost Effectiveness (CE) Questions 1. Vs. usual care—i.e., no screening—what is the CE of CHD screening of asymptomatic adults to reduce risk for CHD-specific morbidity / mortality? 2. What is the CE of selective screening adults at increased risk for CHD — e.g., those with a family history of premature CHD, w/ risk factors — vs. routine screening & usual care? 3. How will differences in rx effectiveness affect CE estimates for CHD screening? 4. Among individuals w/ subclinical disease on initial screening exam, what is the CE of periodic surveillance vs. one-time screening? 5. Among individuals w/out subclinical CAD on initial screening exam, what is the CE of re-screening at varying intervals vs. onetime screening?
  • 18. Screening Criteria DiscussedScreening Criteria Discussed BurdenBurden – Prevalence of diseasePrevalence of disease – Years of life lostYears of life lost – Disability or quality of lifeDisability or quality of life – Economic burdenEconomic burden Effectiveness and EfficacyEffectiveness and Efficacy Cost effectivenessCost effectiveness Current delivery ratesCurrent delivery rates Feasibility of increasing delivery ratesFeasibility of increasing delivery rates
  • 19. Cost Effective CHD ScreeningCost Effective CHD Screening 1. Detection of Risk1. Detection of Risk 2. Early Rx2. Early Rx 3. Improved Outcome3. Improved Outcome Resulting in Reduction in More Costly, End-Stage CareResulting in Reduction in More Costly, End-Stage Care Improved Societal ProductivityImproved Societal Productivity
  • 20. Evaluation CriteriaEvaluation Criteria Burden of diseaseBurden of disease – Single measure incorporating mortality & morbiditySingle measure incorporating mortality & morbidity Effectiveness of ScreeningEffectiveness of Screening Cost effectivenessCost effectiveness Feasibility of Increasing Delivery RatesFeasibility of Increasing Delivery Rates
  • 21. CHD Screening FrameworkCHD Screening Framework Two Steps:Two Steps: 1.1. Burden and Effectiveness into single measure ofBurden and Effectiveness into single measure of Clinically Preventable BurdenClinically Preventable Burden (CPB)(CPB) 2.2. Cost EffectivenessCost Effectiveness included to account for resourceincluded to account for resource consumptionconsumption
  • 22. Clinically Preventable BurdenClinically Preventable Burden CPB = Burden x EffectivenessCPB = Burden x Effectiveness – Burden includes all disease targeted by CHDBurden includes all disease targeted by CHD – Effectiveness = % of burden reducedEffectiveness = % of burden reduced Measures burden of CHD preventableMeasures burden of CHD preventable Burden measured in Quality-Adjusted Life YearsBurden measured in Quality-Adjusted Life Years Saved (QALYS) -- approximatedSaved (QALYS) -- approximated Uses effectiveness from RCTUses effectiveness from RCT – Range of Therapeutic Risk ReductionRange of Therapeutic Risk Reduction
  • 23. Clinically Preventable BurdenClinically Preventable Burden Qualitative assessment of CHD screeningQualitative assessment of CHD screening should consider:should consider: – CPB - not burden and effectiveness separatelyCPB - not burden and effectiveness separately focus on fatal or high-prevalence, nonfatal conditionsfocus on fatal or high-prevalence, nonfatal conditions – Costs of service: medical care, out-of-pocketCosts of service: medical care, out-of-pocket – Potential for cost savingsPotential for cost savings
  • 24. Cost Effectiveness (CE) AnalysisCost Effectiveness (CE) Analysis CECE == costs of screening – costs avertedcosts of screening – costs averted Net Effectiveness**Net Effectiveness** ICER =ICER = – CHD Screening vs. No Testing / Usual CareCHD Screening vs. No Testing / Usual Care – CHD Screening vs. Global Risk ScoreCHD Screening vs. Global Risk Score – CHD Screening vs. Alternative TestingCHD Screening vs. Alternative Testing CAC vs. C-IMTCAC vs. C-IMT CAC vs. BARTCAC vs. BART CAC vs. ….CAC vs. …. ** Clinically Preventable Burden reduced** Clinically Preventable Burden reduced
  • 25. Treatment-Eligible US-PopulationTreatment-Eligible US-Population under NCEP II, NCEP III, CAC Screeningunder NCEP II, NCEP III, CAC Screening 0 2.5 5 7.5 10 12.5 15 40-59 60-79 40-59 60-79 Millionsofpeople Men Women % Increase 142.5 184.3 124.9 85.9 65.0 50.0 65.0 50.0 NCEP II NCEP III Age (y) Source: Fedder DO et al., Circulation 2002;105:152-156, Nasir K, Michos ED, Blumenthal RS, Raggi P. Detection of High-Risk Young Adults and Women by Coronary Calcium and National Cholesterol Education Panel-III Guidelines. JACC 2005 (in press). CAC
  • 26. Treatment Est. 10-Yr Costs from NCEP IIITreatment Est. 10-Yr Costs from NCEP III to CAC Screeningto CAC Screening $0 $25,000 $50,000 $75,000 $100,000 $125,000 $150,000 $175,000 $200,000 40-59 60-79 40-59 60-79 Millionsof$ Men Women NCEP III Source: Fedder DO et al., Circulation 2002;105:152-156, Nasir K, Michos ED, Blumenthal RS, Raggi P. Detection of High-Risk Young Adults and Women by Coronary Calcium and National Cholesterol Education Panel-III Guidelines. JACC 2005 (in press). CAC
  • 27. CACS RR (95% CI) p ValueSummary RR Ratio 1.5 (0.8-2.9) 24 / 6931 18 / 8503 0.18 0.01 0.01 0.1 0.1 1 1 10 10 100 100 Higher Risk Low Risk Events / N Low Risk 2.1 (1.3-3.3) 46 / 2670 26 / 4600 0.003 Moderate Risk 4.1 (2.9-6.0) 102 / 4,428 44 / 9,977 <0.0001 High Risk 6.7 (4.8-9.4) 179 / 3,550 44 / 6,839 <0.0001 Very High Risk* 1,000 10.8 (4.2-27.7) 14 / 196 6 / 905 <0.0001 Very Low Risk 1-44 1-112 100-400 400-999 Lower Risk Higher Risk Low Risk includes Arad, Greenland, LaMonte Moderate Risk includes Arad, Greenland, LaMonte, Taylor, Vliegenthart High Risk includes Arad, Greenland, Kondos, LaMonte, Vliegenthart Very High Risk includes Vliegenthart Very Low Risk includes Kondos, LaMonte, Taylor Relative Risk (RR) Ratios (95% CI) by CACS RiskRelative Risk (RR) Ratios (95% CI) by CACS Risk When c/w FRS event rates, Δ LYS with CACS ≅≅ 0.58 for 35% RR Reduction w/ Rx (0-0.83)
  • 28. CPB Model Inputs – Disease BurdenCPB Model Inputs – Disease Burden 20022002 CurrentCurrent Post-ScreeningPost-Screening CHD DeathsCHD Deaths 697,000697,000 ↓↓10% (5%-25%)10% (5%-25%) MIMI 2,100,0002,100,000 ↓↓ 25% (5%-35%)25% (5%-35%) Chest Pain SymptomsChest Pain Symptoms 12,000,00012,000,000 ↓↓ 5% (2.5%-25%)5% (2.5%-25%) Hospital D/C for 1Hospital D/C for 100 DiagnosisDiagnosis of CVDof CVD 6,373,0006,373,000 ↑↑ 10% (5%-25%)10% (5%-25%) Hospital D/C for 1Hospital D/C for 100 DiagnosisDiagnosis of CHFof CHF 970,000970,000 ↓↓ 10% (5%-25%)10% (5%-25%) Source: MI rates were extrapolated from ARIC, 1987-2000 & does not include silent MIs. CVA data also not included.
  • 29. CPB Model Inputs – Disease BurdenCPB Model Inputs – Disease Burden CurrentCurrent Post-Post- ScreeningScreening Post-ScreeningPost-Screening CHD DeathsCHD Deaths 697,000697,000 ↓↓10%10% ($697 m)($697 m) MIMI 2,100,0002,100,000 ↓↓ 15%15% ($3.7 b)($3.7 b) Chest Pain SymptomsChest Pain Symptoms 12,000,00012,000,000 ↓↓ 10%10% ($7.2 b)($7.2 b) Hospital D/C for 1Hospital D/C for 100 DiagnosisDiagnosis of CVDof CVD 6,373,0006,373,000 ↑↑ 10%10% $3.8 b$3.8 b Hospital D/C for 1Hospital D/C for 100 DiagnosisDiagnosis of CHFof CHF 970,000970,000 ↓↓ 10%10% ($9.9 b)($9.9 b) Source: MI rates were extrapolated from ARIC, 1987-2000 & does not include silent MIs. CVA data also not included.
  • 30. CPB Model Inputs – Procedure BurdenCPB Model Inputs – Procedure Burden Pre-Pre- ScreeningScreening Post-Post- ScreeningScreening Stress ImagingStress Imaging 8,700,0008,700,000 ↑↑ 10%10% (5%-25%)(5%-25%) AngiographyAngiography 6,800,0006,800,000 ↑↑ 15% - CTA15% - CTA (2.5%-25%)(2.5%-25%) PCIPCI 657,000657,000 ↓↓ 10%10% (5%-50%)(5%-50%) CABSCABS 515,000515,000 ↓↓ 5%5% (2.5%-50%)(2.5%-50%) Source: CDC/NCHS for 2002. http://www.acc.org/advocacy/word_files/2005ProposedPhysicianPmtRulev3%20web.xls.
  • 31. CPB Model Inputs – Procedure BurdenCPB Model Inputs – Procedure Burden Pre-Pre- ScreeningScreening Post-Post- ScreeningScreening Post-Post- ScreeningScreening Stress ImagingStress Imaging 8,700,0008,700,000 ↑↑ 10%10% (5%-25%)(5%-25%) $358 m$358 m AngiographyAngiography 6,800,0006,800,000 ↑↑ 15% - CTA15% - CTA (2.5%-25%)(2.5%-25%) $600 m$600 m PCIPCI 657,000657,000 ↓↓ 10%10% (5%-50%)(5%-50%) ($580 m)($580 m) CABSCABS 515,000515,000 ↓↓ 5%5% (2.5%-50%)(2.5%-50%) ($672 m)($672 m) Source: CDC/NCHS for 2002. http://www.acc.org/advocacy/word_files/2005ProposedPhysicianPmtRulev3%20web.xls.
  • 32. Markov Model:Markov Model: Health states - ovals; arrows represent allowed transitions. All ptsHealth states - ovals; arrows represent allowed transitions. All pts start event-free & can remain, have MI or angina, or die.start event-free & can remain, have MI or angina, or die. Markov model to estimate the benefits, costs, & incremental cost-effectiveness of CHD screening followed by targeted statin rx for high risk subclinical dz, vs. usual care alone, for the primary prevention of CV events among patients ages 45-65 years.. Death Post-MI Post-MI & AP Post-AP Event-Free Source: Blake GJ, Ridker PM, Kuntz KM. Potential Cost-effectiveness of C-Reactive Protein Screening Followed by Targeted Statin Therapy for the Primary Prevention of Cardiovascular Disease among Patients without Overt Hyperlipidemia. Am J Med 2003;114:485– 494.
  • 33. Multi-Attribute Cost Markov Model:Multi-Attribute Cost Markov Model: Comparing FRS vs. CACSComparing FRS vs. CACS for 5 Yrs. Of Observational Follow-up Estimated LYS in Pts. Ages 45-65 yrs.for 5 Yrs. Of Observational Follow-up Estimated LYS in Pts. Ages 45-65 yrs. Death FRS Post-MI & AP Event-Free Death CACS Post-MI & AP Event-Free <$50,000 / Events Averted
  • 34. ConclusionsConclusions If we can identify w/ a high degree of likelihood pts at risk forIf we can identify w/ a high degree of likelihood pts at risk for AMI / SCD, then it is likely that a CV screening-driven approachAMI / SCD, then it is likely that a CV screening-driven approach including prevention (i.e., risk factor modification) can result inincluding prevention (i.e., risk factor modification) can result in improved outcomes & aversion of costly hospitalizations.improved outcomes & aversion of costly hospitalizations. Preliminary analyses from the CE models reveal that subclinicalPreliminary analyses from the CE models reveal that subclinical dz screening can be cost effective when applied to “higher risk”dz screening can be cost effective when applied to “higher risk” or appropriate patient candidates.or appropriate patient candidates. – When compared with global risk scores that often underestimate risk inWhen compared with global risk scores that often underestimate risk in key patient subsets: women, young, international cohorts.key patient subsets: women, young, international cohorts. Decision models do not replace RCT comparing an array ofDecision models do not replace RCT comparing an array of imaging modalities, laboratory markers, or global risk scoring.imaging modalities, laboratory markers, or global risk scoring.
  • 35. Potential Evidence for Priority SettingPotential Evidence for Priority Setting Priority Criteria Measures Impact Condition Disability, Mortality System Costs, Guideline Adherence, Errors Societal Indirect Costs Improvability Condition Cost-Effectiveness, efficacy Disparity Impact on vulnerable subgroups System Effectiveness of quality improvement Inclusiveness Diffusion across subpopulations
  • 36. Many preventive services areMany preventive services are recommendedrecommended Delivery of effective services isDelivery of effective services is incompleteincomplete Resources—time and money—areResources—time and money—are limitedlimited Preventive services differ in their healthPreventive services differ in their health impact and costsimpact and costs Unmet Expectations & LimitationsUnmet Expectations & Limitations to CHD Screeningto CHD Screening