Developing Cost Effective CHD Screening Strategies

1. Developing Cost Effective CHD Screening Strategies Leslee J. Shaw, PhD Department of Imaging and Medicine Cedars-Sinai Medical Center Los Angeles, California

2. CHD Detection In Asymptomatic Women & Men • Traditional approach to detection of CHD risk = assessment of typical risk factors • Despite many available risk assessment approaches, there’s a detection gapfor asymptomatic individuals w/ subclinical atherosclerosis. • Framingham & European risk scores - useful “guides.” • to predict long term risk of CHD events in healthy populations. • Target Population for Screening: • 40% of the US Adult Population (or 36 million) = Intermediate Risk • Majority 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. X 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.

4. Estimated 10 Yr. Hard CHD Risk Framingham Offspring & Cohort Women and Men Percent Women Men Age (years) Source: Abrams, Pasternak, Greenland, Houston-Miller, Smaha. Bethesda Conference #34: Identification of CHD and CHD risk: Is there a detection gap? JACC 2003

5. % 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 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).

6. Estimated Direct & Indirect Costs of Cardiovascular Diseases & Stroke United States: 2005 Source: Heart Disease and Stroke Statistics – 2005 Update.

7. Current State of Health Care System • ~50% of health care costs are for end-stage or hospital care. • Avg yrly health expenditure for end stage care is ~5-x higher vs. non-end stage care. • Shifting care to early, diagnostic or outpatient sector potential to reduce cost. $412 Billion Medicare pays 31% $286 Billion Medicare pays 21% $122 Billion Medicare pays 2% $92 Billion Medicare pays 10% $60 Billion Medicare pays 0% $39 Billion Medicare pays 12% $37 Billion Medicare pays 0% $32 Billion Medicare pays 29% $31 Billion Medicare pays 4% $19 Billion Medicare pays 25% Source: CMS, Office of the Actuary, National Health Statistics Group. Access date: March 2, 2004.

8. Medicare Spending - 2/3rds of Spending = 5+ Chronic Conditions - 1/5th of Spending = 3+ Chronic Conditions Source: Medicare Standard Analytic File, 1999.

9. The Most Expensive Conditions In America: MEPS Population Estimates BillionBillion 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: MEPS Population Estimates BillionBillion 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 Cost Affected by MD Labor, Lab Volume, +/- Add-Ons (Contrast or Radiopharmaceutical), Equipment (Lease, Age, Shared) 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.

12. Average Cost Inputs for Adverse Sequelae of CVD • Out-of-Hospital SCD – Lost Productivity • In-Hospital Death – in excess of $50k-$100k • End-Stage Care for CHF – 80% of lifetime care costs • AMI or ACS  $15-20k • Chest Pain Hospitalization  $6k • Stroke  $50k • Anti-Ischemic Rx  $1,500 - $5,000 / yr • Out-of-Pocket  $2,000 / yr • ….

13. Medicare Payment Advisory Commission (MedPAC) - Growth in Physician Services Growth of All Physician Services % 22% 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 & Procedures United States: 1979-2000

15. Unfolding a Body of Evidence Building Building • Observational • Data • Risk identification • Costs • Cost Effectiveness • High Risk CEA • Reimbursement • Clinical Trial • Data • Vs. Comparators • 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 CEA • CEA – technique for selecting among competing choices when resources are limited. • “Value for Money” • 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 ratio: • 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 considered "cost-effective.“ • =Standard: <$50,000 / LYS Source: http://www.acponline.org/journals/ecp/sepoct00/primer.htm

17. Critical 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 Discussed • Burden • Prevalence of disease • Years of life lost • Disability or quality of life • Economic burden • Effectiveness and Efficacy • Cost effectiveness • Current delivery rates • Feasibility of increasing delivery rates

19. Cost Effective CHD Screening • 1. Detection of Risk • 2. Early Rx • 3. Improved Outcome • Resulting in Reduction in More Costly, End-Stage Care • Improved Societal Productivity

20. Evaluation Criteria • Burden of disease • Single measure incorporating mortality & morbidity • Effectiveness of Screening • Cost effectiveness • Feasibility of Increasing Delivery Rates

21. CHD Screening Framework Two Steps: • Burden and Effectiveness into single measure of Clinically Preventable Burden (CPB) • Cost Effectiveness included to account for resource consumption

22. Clinically Preventable Burden • CPB = Burden x Effectiveness • Burden includes all disease targeted by CHD • Effectiveness = % of burden reduced • Measures burden of CHD preventable • Burden measured in Quality-Adjusted Life Years Saved (QALYS) -- approximated • Uses effectiveness from RCT • Range of Therapeutic Risk Reduction

23. Clinically Preventable Burden • Qualitative assessment of CHD screening should consider: • CPB - not burden and effectiveness separately • focus on fatal or high-prevalence, nonfatal conditions • Costs of service: medical care, out-of-pocket • Potential for cost savings

24. Cost Effectiveness (CE) Analysis • CE = costs of screening – costs averted Net Effectiveness** • ICER = • CHD Screening vs. No Testing / Usual Care • CHD Screening vs. Global Risk Score • CHD Screening vs. Alternative Testing • CAC vs. C-IMT • CAC vs. BART • CAC vs. …. • ** Clinically Preventable Burden reduced

25. Treatment-Eligible US-Population under NCEP II, NCEP III, CAC Screening Men Women NCEP II NCEP III CAC Millions of people Age (y) % Increase 142.5 184.3 124.9 85.9 65.0 50.0 65.0 50.0 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).

26. Treatment Est. 10-Yr Costs from NCEP III to CAC Screening Men Women NCEP III CAC Millions of $ 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).

27. Relative Risk (RR) Ratios (95% CI) by CACS Risk Events / N CACS RR (95% CI) p Value 0.01 0.1 1 10 100 Summary RR Ratio Higher Risk Low Risk Very Low Risk 1-44 1.5 (0.8-2.9) 24 / 6931 18 / 8503 0.18 Low Risk 1-112 2.1 (1.3-3.3) 46 / 2670 26 / 4600 0.003 Moderate Risk 100-400 4.1 (2.9-6.0) 102 / 4,428 44 / 9,977 <0.0001 High Risk 400-999 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 0.01 0.1 1 10 100 Lower Risk Higher Risk Very Low Risk includes Kondos, LaMonte, Taylor When c/w FRS event rates, Δ LYS with CACS 0.58 for 35% RR Reduction w/ Rx (0-0.83) 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

28. CPB Model Inputs – Disease Burden Source: MI rates were extrapolated from ARIC, 1987-2000 & does not include silent MIs. CVA data also not included.

29. CPB Model Inputs – Disease Burden Source: MI rates were extrapolated from ARIC, 1987-2000 & does not include silent MIs. CVA data also not included.

30. CPB Model Inputs – Procedure Burden Source: CDC/NCHS for 2002. http://www.acc.org/advocacy/word_files/2005ProposedPhysicianPmtRulev3%20web.xls.

31. CPB Model Inputs – Procedure Burden Source: CDC/NCHS for 2002. http://www.acc.org/advocacy/word_files/2005ProposedPhysicianPmtRulev3%20web.xls.

32. Markov Model:Health states - ovals; arrows represent allowed transitions. All pts start event-free & can remain, have MI or angina, or die. Event-Free Post-MI Post-AP Death Post-MI & AP 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.. 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:Comparing FRS vs. CACS for 5 Yrs. Of Observational Follow-up Estimated LYS in Pts. Ages 45-65 yrs. Event-Free Event-Free FRS CACS Death Death Post-MI & AP Post-MI & AP <$50,000 / Events Averted

34. Conclusions • 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 including prevention (i.e., risk factor modification) can result in improved outcomes & aversion of costly hospitalizations. • Preliminary analyses from the CE models reveal that subclinical dz screening can be cost effective when applied to “higher risk” or appropriate patient candidates. • When compared with global risk scores that often underestimate risk in key patient subsets: women, young, international cohorts. • Decision models do not replace RCT comparing an array of imaging modalities, laboratory markers, or global risk scoring.

35. Potential 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. Unmet Expectations & Limitations to CHD Screening • Many preventive services are recommended • Delivery of effective services is incomplete • Resources—time and money—are limited • Preventive services differ in their health impact and costs