1. Engaging Decision Makers in Comparative Effectiveness Research Sean Tunis MD, MSc July 11, 2008

2. Calls for a National Institute of Comparative Effectiveness Research (NICER) MMA Section 1013 (2003) Gail Wilenksy, Health Affairs (11/06) Health Industry Forum (11/06) AHIP, BCBSA proposals (early 2007) MedPAC report, CBO testimony (6/07) Obama, Clinton, Edwards reform plans (mid 2007) CBO final report (12/07) Commonwealth ‘Bending the Curve’ report (12/07) House and Senate legislative proposals

3. Medicare Spending per Capita in the United States, 2003 Source: Dartmouth Atlas of Health Care. $7,000 to to11,352 (63) (63) 6,500 to < to <7,000 (53) (53) 6,000 to < to <6,500 (56) (56) 5,500 to < to <6,000 (64) (64) 4,272 to < to <5,500 (70) (70) Not Populated Source: www.dartmouthatlas.org.

4. CER Definition “Research evaluating and comparing the implications and outcomes of 2 or more health care strategies to address a particular medical condition” Primary focus on drugs, devices, procedures, diagnostics

5. Methods Systematic reviews / HTA Retrospective studies –with claims and/or EMR data Modeling (+/- cost data) Prospective observational or experimental studies

6. How is CER Different More political insulation Oversight by multi-stakeholder board Increased transparency Improved observational methods Adoption of electronic health records Much more money Greater determination (and panic)

7. Built By and For Decision Makers Evidence enterprise designed around the needs and use of decision makers –Patients, clinicians, payers, policymakers They must be meaningfully engaged in all aspects (priority setting, study design, etc) Limited success with meaningfully engaging decision makers –some notable exceptions: CUE, NBCC, JDRF –limited effort to broadly, systematically improve

8. Center for Medical Technology Policy Structure: private, non-profit –First 2 years: foundations, government –2008+: diverse membership Primary Mission: to support collaborative efforts that will improve the quality and efficiency of prospective studies of new and existing medical technologies Focus: Evidence development guided by decision makers (DBEM) –Patients, clinicians, payers, policy makers

9. Applied POLICY and METHODS Projects PRIORITIES for Evidence Development PRIORITIES for Evidence Development Trial DESIGN and IMPLEMENTATION Effectiveness GUIDANCE Documents Effectiveness GUIDANCE Documents I MPROVE THE Q UALITY AND E FFICIENCY OF R ESEARCH FOR D ECISION M AKING CMTP Project Categories

10. Coronary CTA Protocol Development Workgroup Members and Observers Aetna Kaiser Permanente UnitedHealth MN Medicaid BCBSA GE Healthcare Siemens Medical Philips Medical Toshiba AHA Patient reps ACC, ACRIN FDA, CMS AHRQ Clinical researchers Health economist

11. Coverage for Evidence Development Workgroup Members General Electric Blue Shield of California Wellpoint/Anthem Aircraft Gear Fidelity Kaiser Permanente Washington State Office of TA SEIU University of Michigan MD Anderson Oklahoma Medical Authority PacFed Benefits Administrators Patient Advocates in Research Center for Medical Consumers Harvard University Aetna United Healthcare California Association of Physician Groups National Business Group on Health California Pacific Medical Ctr

12. Engaging Patients - 1 There is not a natural patient advocacy group for every topic. (Tele-ICU workgroup) If there is group, members have to care about research. –For some patient groups, it’s all about access, all the time. Technical nature of work requires belief that the results will matter

13. Engaging Patients - 2 Need subject-specific patient advocates as well as more general advocates – each brings a different perspective to the table One of the most important characteristics of an effective and engaged advocate is “strong intellectual curiosity” Smart people get energized by other smart people – bringing a variety of perspectives to the table makes the “stew” a lot spicier

14. Clinician Advisors Meeting Multi-stakeholder clinician group convened to discuss how to engage clinicians in CER practicing MDs (community and academic), medical group medical directors, nurses, hospital system CMO Broad agreement on willingness to help Time pressure, money, and unfamiliarity with research were key constraints

15. Key Take Home Messages Decision makers will engage in evidence review and development if –they believe their perspective is valued –they believe that the activity will have some impact –Carefully selected for being smart, energetic We (academics, researchers, etc) need to be more systematic learning to do this well If we don’t meaningfully engage the decision makers, the enterprise will always struggle

16. Contact Info sean.tunis@cmtpnet.org www.cmptnet.org 410-963-8876