Developing Cost Effective Developing Cost Effective CHD Screening StrategiesCHD Screening Strategies
Leslee J. Shaw, PhDLeslee J. Shaw, PhDDepartment of Imaging and MedicineDepartment of Imaging and Medicine
Cedars-Sinai Medical CenterCedars-Sinai Medical CenterLos Angeles, CaliforniaLos Angeles, California
CHD Detection In Asymptomatic Women & CHD Detection In Asymptomatic Women & MenMen
Traditional approach to detection of CHD risk = Traditional approach to detection of CHD risk = assessment of typical risk factors assessment of typical risk factors Despite many available risk assessment Despite many available risk assessment approaches, there’s a approaches, there’s a detection gapdetection gap for for asymptomatic individuals w/ subclinical asymptomatic individuals w/ subclinical atherosclerosis. atherosclerosis. Framingham & European risk scores - useful Framingham & European risk scores - useful ““guidesguides.” .” – to predict long term risk of CHD events in to 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 36 40% 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 Estimated 10 Yr. Hard CHD Risk Framingham Offspring & Cohort Women Framingham Offspring & Cohort Women
and Menand 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%
Perc
ent
Perc
ent
Age (years)Age (years)
WomenWomen MenMen
CCS=0 CCS 1-99 CCS 100-399 CCS400
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 % Not Qualifying For Pharmacotherapy by CACSCACS
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 of Estimated Direct & Indirect Costs of Cardiovascular Diseases & StrokeCardiovascular Diseases & StrokeUnited States: 2005United States: 2005
Source: Heart Disease and Stroke Statistics – 2005 Update.
254.8
142.1
56.8 59.727.9
393.5
0
50
100
150
200250
300
350
400
450
Hea
rtD
isea
se
Cor
onar
yH
eart
Dis
ease
Str
oke
Hyp
erte
nsiv
eD
isea
se
Con
gest
ive
Hea
rt F
ailu
re
Tot
al C
VD
*
Bil
lio
ns
of
Do
llar
s
Current State of Health Care SystemCurrent State of Health Care System
~50% of health care costs are for ~50% of health care costs are for end-stage or hospital care.end-stage or hospital care.– Avg yrly health expenditure for Avg yrly health expenditure for
end stage care is ~5-x higher end stage care is ~5-x higher vs. non-end stage care.vs. non-end stage care.
Shifting care to early, Shifting care to early, diagnostic or outpatient sector diagnostic or outpatient sector potential to reduce cost.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 BillionMedicare pays 31%
$286 BillionMedicare pays 21%
$122 BillionMedicare pays 2%
$92 BillionMedicare pays 10%
$39 BillionMedicare pays 12%
$60 BillionMedicare pays 0%
$37 BillionMedicare pays 0%
$31 BillionMedicare pays 4%
$32 BillionMedicare pays 29%
$19 BillionMedicare 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 The Most Expensive Conditions In America: America:
MEPS Population Estimates MEPS 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 The Most Expensive Conditions In America: America:
MEPS Population Estimates MEPS 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
TMET
C-IMT
EBT / CT
Echo
Oth
er C
T
SPECTIV
USM
RCat
h
Chol P
anel
HsCRP
OP V
isit
Adv L
ipid
Low CostLab / 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 Average Cost Inputs for Adverse Sequelae of CVDSequelae 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 ACS AMI or ACS $15-20k $15-20k– Chest Pain Hospitalization Chest Pain Hospitalization $6k $6k– Stroke Stroke $50k $50k– Anti-Ischemic Rx Anti-Ischemic Rx $1,500 - $5,000 / yr $1,500 - $5,000 / yr– Out-of-Pocket Out-of-Pocket $2,000 / yr $2,000 / yr– ……..
Medicare Payment Advisory Commission Medicare Payment Advisory Commission (MedPAC) - Growth in Physician Services(MedPAC) - Growth in Physician Services
0
5
10
15
20
25
30
35
40
45
MajorProcedures
Evaluation &Management
OtherProcedures
Tests Imaging
22%
Growth of All Physician Services
%
Includes all Services in the Physician Fee ScheduleSource: MEDPAC Analysis of Medicare Claims DataMarch 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 TrialData•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):62E65E.
Basics of CEABasics of CEACEA – 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 new Technique comparing relative value of various clinical strategies. Commonly, a new strategy is compared w/ current practice (i.e., "low-cost alternative") in calculation of CE strategy 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 to Result = "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 is new 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 Discussed Screening 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 rates Feasibility 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 Criteria Evaluation 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 Framework CHD Screening Framework
Two Steps:Two Steps:
1.1. Burden and Effectiveness into single measure of Burden and Effectiveness into single measure of Clinically Preventable BurdenClinically Preventable Burden (CPB) (CPB)
2.2. Cost EffectivenessCost Effectiveness included to account for resource included to account for resource consumptionconsumption
Clinically Preventable Burden Clinically Preventable Burden
CPB = Burden x Effectiveness CPB = 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 Years Burden 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 screening Qualitative assessment of CHD screening should consider:should consider:
– CPB - not burden and effectiveness separatelyCPB - not burden and effectiveness separatelyfocus 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
CE CE = = 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
Million
s o
f p
eop
leMen 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 III Treatment 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
Million
s o
f $
Men WomenNCEP 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 1-441-112
100-400400-999
Lower Risk Higher Risk
Low Risk includes Arad, Greenland, LaMonte
Moderate Risk includes Arad, Greenland, LaMonte, Taylor, VliegenthartHigh 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 10 0 Diagnosis Diagnosis of CVDof CVD
6,373,0006,373,000 ↑ ↑ 10% (5%-25%)10% (5%-25%)
Hospital D/C for 1Hospital D/C for 10 0 Diagnosis Diagnosis 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 10 0 Diagnosis Diagnosis of CVDof CVD
6,373,0006,373,000 ↑ ↑ 10%10% $3.8 b$3.8 b
Hospital D/C for 1Hospital D/C for 10 0 Diagnosis Diagnosis 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 pts Health 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..
DeathPost-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 thePrimary 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. CACS Comparing 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.
DeathFRS
Post-MI &AP
Event-Free
DeathCACS
Post-MI &AP
Event-Free
<$50,000 / Events Averted
ConclusionsConclusions
If we can identify w/ a high degree of likelihood pts at risk for If we can identify w/ a high degree of likelihood pts at risk for AMI / SCD, then it is likely that a CV screening-driven approach AMI / SCD, then it is likely that a CV screening-driven approach including prevention (i.e., risk factor modification) can result in including 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 subclinical Preliminary 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 in When 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 of Decision 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 Potential Evidence for Priority SettingSetting
Priority Criteria Measures Impact
Condition Disability, Mortality System Costs, Guideline Adherence,
ErrorsSocietal Indirect Costs
ImprovabilityCondition Cost-Effectiveness, efficacyDisparity Impact on vulnerable subgroupsSystem Effectiveness of quality
improvement
Inclusiveness Diffusion across subpopulations
Many preventive services are Many preventive services are recommendedrecommended
Delivery of effective services is Delivery of effective services is incompleteincomplete
Resources—time and money—are Resources—time and money—are limitedlimited
Preventive services differ in their health Preventive services differ in their health impact and costsimpact and costs
Unmet Expectations & Limitations Unmet Expectations & Limitations to CHD Screeningto CHD Screening