Leslee J. Shaw Associate Professor Director, Outcomes Research Cardiovascular Research Institute

1. Framing the Public Policy Debate on Screening for CVD: Forming a Foundation with Clinical & Cost Effective-Based Medicine Leslee J. Shaw Associate Professor Director, Outcomes Research Cardiovascular Research Institute

2. Presenter Disclosure Information Disclosure Information... The following relationships exist related to this presentation: Leslee J. Shaw, PhD No relationships to disclose

3. U.S. Preventive Services Task Force: Screening for CHD (Release Date: February 2004) • Recommendation: TF recommends against routine screening with rest or Ex ECG, or EBT for detection of severe coronary stenosis or predicting CHD events in low risk asymptomatic adults. • Rationale: TF found insufficient evidence for or against routine screening. • …Absence of evidence that detection improves outcomes, TF concluded that potential harms exceed benefits. • …evidence is inadequate to determine how testing changes treatment! • False + tests are common among asymptomatic adults, especially women, & lead to unnecessary diagnostic testing, over-treatment, and labeling. • False + results, cause psychological distress & anxiety, often lead to invasive tests, such as angio or treatment with unnecessary meds. • Test sensitivity is limited, screening could result in False - results. False - results can mislead those with CHD and result in delayed rx. Source: http://www.ahrq.gov/clinic/uspstf/uspsacad.htm, Access date: March 2, 2004.

4. What is the real potential value to society for CVD screening? Common arguments have been employed for all screening tests: false -/+ costs, anxiety, labeling, … Source: Belch JJF, Topol EJ, Agnelli G, et al. Critical issues in peripheral arterial disease detection and management. Arch Int Med 2003;163:884-892.

5. Technology Hierarchy

6. 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 ~4.6 fold higher than non-end stage care. • Shifting care to OP sector reduces cost. • Although prescription drug costs are rising, only 3.3% of change is due to increased utilization. $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.

7. Cost Effective Screening • Cost effective screening may be defined as …  Cost  Life Years Saved Source: Mark DB, Shaw LJ, Lauer MS, O’Malley P, Heidenreich P. 34th Bethesda Conference: Task force #5 – Is atherosclerotic imaging cost effective? J Am Coll Cardiol 2003;41:1906-17., Shaw LJ, Raggi P, Berman DS et al. Cost effectiveness of screening for CVD with measures of coronary calcium. Prog Cardiov Dis 2003;46:171-84.

8. Shifting the Paradigm to Screening • Early detection leads to: • …improved life expectancy. • …less costly, less invasive care, less hospitalizations with shorter lengths of stay • …improved societal productivity • Cost – Benefit Ratio is: • Does a more productive, asymptomatic individual reduce costs of care in relation to symptomatic presentation? • Despite improvements in CVD mortality, is there still a detection gap? Source: Pasternak RC, Abrams J, Greenland P, Smaha LA, Wilson PW, Houston-Miller N. 34th Bethesda Conference: Task force #1--Identification of coronary heart disease risk: is there a detection gap? J Am Coll Cardiol 2003 Jun 4; 41(11): 1863-74.

9. High Risk Cost Effectiveness • Selecting higher risk cohorts results in a more effective test. • Risk reduction w/ Rx is greater in higher risk populations. • Clinical effectiveness drives cost effectiveness • Focus on Intermediate Risk Individuals • Improved Resource Allocation • Requires Selective Screening with optimal clinical effectiveness (i.e., added value) • Accurate detection of high risk • Exclusion of treatment in low risk • Low cost test that can be widely utilized Source: Greenland P, LaBree L, Azen SP, et al. Coronary artery calcium combined with Framingham score for risk prediction in asymptomatic individuals. JAMA 2004;291:210-215., Budoff MJ, Blumenthal RS, Carr JJ, et al. Assessment of Coronary Artery Calcification by Electron Beam and Multidetector Computed Tomography. Circulation 2004. Shaw LJ, Raggi P, Schisterman E, et al. Prognostic value of cardiac risk factors and coronary artery calcium screening for all-cause mortality. Radiol 2003;228:826-33.,