1. Comparative Effectiveness Research Scott R. Smith, PhD Director, Pharmaceutical Outcomes Research Agency for Healthcare Research & Quality

2. Medicare Modernization Act 2003 3

3. Section 1013 of the MMA • To improve the quality, effectiveness and efficiency of health care delivered through Medicare, Medicaid and the S-CHIP programs • $15 million was appropriated in fiscal years 2005, 2006, 2007 (pending) for AHRQ to conduct and support research with a focus on • outcomes • comparative clinical effectiveness and • appropriateness of health care items and services (including pharmaceutical drugs), • including strategies for how these items and services are organized, managed and delivered.

4. Types of comparisons • Drug vs drug. • Surgery vs watchful waiting. • Inpatient versus outpatient treatment. • Implantable device versus drug therapy. • Specialty approach 1 versus specialty approach 2. • Models of care (12-step, case management, skills training).

5. Working Framework for Comparative Effectiveness 6

6. Effective Health Care Program • Evidence synthesis (EPC program) • Systematically reviewing, synthesizing, comparing existing evidence on treatment effectiveness. • Identifying relevant knowledge gaps. • Evidence generation (DEcIDE, CERTs) • Development of new scientific knowledge to address knowledge gaps. • Accelerate practical studies. • Evidence communication/translation (Eisenberg Center) • Translate evidence into improvements • Communication of scientific information in plain language to policymakers, patients, and providers. 8

7. 9

8. First Published Comparative Effectiveness Reviews • Management strategies for gastroesophageal reflux disease. • Benefits and safety of analgesics for osteoarthritis. • New diagnostic technologies for breast cancer screening. • Epoetin and darbepoetin for managing anemia in cancer. • Off-label use of atypical anti-psychotic medications • Renal artery stenting for mild renal artery stenosis. • Therapies for localized prostate cancer. • Oral medications for diabetes management. • Medications for depression management. • Drug therapies and other interventions for osteoporosis.

9. Published Monday: Emerging Methods in Comparative Effectiveness & Safety • A series of 23 articles by AHRQ researchers on new approaches in comparative effectiveness methods are compiled in a special October edition of Medical Care. • A valuable new resource for scientists committed to advancing the comparative effectiveness and safety research. • All articles available for free download on AHRQ’s website or from AHRQ’s Clearinghouse (Pub. No. OM07-0085). DEcIDE programhttp://effectivehealthcare.ahrq.gov/reports/med-care-report.cfm

10. 28

11. Comparative Side Effect Information for Antidepressants • Based on systematic review of literature from EPC program. 30

12. More Information? • Clancy CM, Slutsky JR. Commentary: A Progress Report on AHRQ's Effective Health Care Program. Health Serv Res. 2007 Oct;42(5):xi-xix. • Clancy C. The effective health care program: evidence-based medicine joins the consumer age. MedGenMed. 2006 Feb 27;8(1):56. -------------------------------------------------------------------------------------------------------------- • Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report. Value Health. 2007 Sep-Oct;10(5):326-35. • From the Institute of Medicine… Institute of Medicine. 2007. Learning What Works Best: The Nations Need for Evidence on Comparative Effectiveness in Health Care. http://www.iom.edu/ebm-effectiveness. http://www.iom.edu/Object.File/Master/43/390/Comparative%20Effectiveness%20White%20Paper%20(F).pdf

13. Even More Information http://effectivehealthcare.ahrq.gov/ Scott R. Smith, PhDScott.Smith@ahrq.hhs.gov 35

14. Thank you! 36