Value of Personalized Health Care

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Kathryn Phillips, PhD presents "Value of Personalized Health Care: What is it? How to measure it? Why Care" at the 2009 Personalized Health Care National Conference at Ohio State University.

Dr. Phillips is Professor of Health Economics and Health Services Research and director/founder of the Center for Translational and Policy Research on Personalized Medicine at the University of California San Francisco.

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  • Plan to expand to other cancers & conditions Focusing on BC & CRC: PM is becoming widely used in tx of these diseases Great need for targeted interventions Team has expertise on topics
  • Thus no benefit
  • Value of Personalized Health Care

    1. 1. Value of Personalized Medicine: What is it? How to measure it? Why care? Kathryn A. Phillips, PhD Professor of Health Economics & Health Services Research Director & Principal Investigator Center for Translational & Policy Research on Personalized Medicine (TRANSPERS) University of California, San Francisco e
    2. 2. <ul><li>What have we learned about adoption of personalized medicine? </li></ul><ul><li>Value </li></ul><ul><li>Evidence </li></ul><ul><li>What needs to occur for personalized medicine to be adopted? </li></ul><ul><li>Value </li></ul><ul><li>Evidence </li></ul>
    3. 3. Key Challenges for Personalized Medicine <ul><li>Aligning Incentives for Maximal Benefit & Efficiency </li></ul><ul><li>Balancing Regulation & Innovation </li></ul><ul><li>Designing Appropriate Reimbursement Policies </li></ul><ul><li>Building an Evidence Base </li></ul><ul><li>Measuring & Demonstrating Value </li></ul>
    4. 4. Today’s Discussion <ul><li>Understanding perspectives </li></ul><ul><li>Defining and measuring “value” </li></ul><ul><li>Two case studies </li></ul><ul><ul><li>HER2 testing for trastuzumab (Herceptin) </li></ul></ul><ul><ul><li>Gene expression profiling for breast cancer recurrence (Oncotype and Mammaprint) </li></ul></ul>
    5. 5. Understanding Perspectives
    6. 6. VALUE FDA Public Payers Government/Evidence Groups/”Society” Industry Patients “ Value” is in Eyes of Beholder Physicians Private Payers PBMs Employers
    7. 7. Goal : Develop evidence of how personalized medicine can be translated to improve health outcomes Focus: Breast and colorectal cancer initially The Center for Translational and Policy Research on Personalized Medicine
    8. 8. Academia Stakeholders Society
    9. 9. Critical Questions for the Center <ul><li>Translation into improved health outcomes requires evidence on: </li></ul><ul><ul><li>Who has access to the newest technologies ? </li></ul></ul><ul><ul><li>Do the underserved have equal access ? </li></ul></ul><ul><ul><li>What approaches do patients & providers prefer ? </li></ul></ul><ul><ul><li>What interventions have the most value ? </li></ul></ul><ul><ul><li>How can research be translated to the real world ? </li></ul></ul>
    10. 10. Private Payer Perspective <ul><li>TRANSPERS Reimbursement Board </li></ul><ul><ul><li>Senior executives </li></ul></ul><ul><ul><ul><li>6 of 7 largest US private health plans </li></ul></ul></ul><ul><ul><ul><li>Regional plans </li></ul></ul></ul><ul><ul><ul><li>Others, e.g., PBM, self-insured employers, consultants </li></ul></ul></ul><ul><ul><li>Blue Shield of CA Foundation & NIH funding </li></ul></ul><ul><ul><li>2006 – ongoing </li></ul></ul><ul><ul><li>Three meetings & multiple interviews </li></ul></ul>
    11. 11. Challenges to Establishing Value
    12. 12. “ Poor Step-Child” <ul><li>Diagnostic industry historically “secondary” </li></ul><ul><li>to pharma industry – but no longer </li></ul><ul><ul><li>Oncotype is “darling” </li></ul></ul><ul><li>Integration of historically divided industries & regulatory mechanisms </li></ul><ul><li>Focus on diagnostics in drug development </li></ul>
    13. 13. “ Flying Under the Radar ” <ul><li>Reimbursement system is challenging </li></ul><ul><ul><li>Traditionally not “value-based” reimbursement for diagnostics </li></ul></ul><ul><ul><li>Personalized medicine can be either “screening” or “diagnosis” or both </li></ul></ul><ul><li>Payers want evidence of value - but can’t track use & outcomes of diagnostics </li></ul>
    14. 14. “ The Black Box” <ul><li>Little data on clinical utility of diagnostics </li></ul><ul><li>Few economic analyses </li></ul><ul><li>Linking targeting to improved outcomes </li></ul><ul><ul><li>Testing then treatment then outcomes </li></ul></ul><ul><ul><li>Impact on family members </li></ul></ul>
    15. 15. Wall Street Journal FRIDAY, JANUARY 4, 2008 Bad Cancer Tests Drawing Scrutiny
    16. 16. HER2/neu testing for Herceptin Clinical Practice Patterns and Cost-Effectiveness of HER2 Testing Strategies in Breast Cancer Patients. Phillips KA, Marshall DA, Haas JS, Elkin EB, Liang SY, Hassett MJ, Ferrusi I, Brock JE, Van Bebber SL , 2009
    17. 17. <ul><ul><li>~ 30% of breast cancer patients overexpress HER2/neu and can benefit from Herceptin </li></ul></ul><ul><ul><ul><li>Testing is required to determine who can benefit </li></ul></ul></ul><ul><ul><li>Herceptin a clinical success – but gaps remain in translation </li></ul></ul>Oldest Example of Personalized Medicine Portends Promises & Challenges
    18. 18. Evidence Gap: Who Tested? <ul><li>NO data on uninsured, Medicaid recipients, or minorities </li></ul><ul><li>2/3 of eligible Medicare patients had no documentation of testing in claims records </li></ul>
    19. 19. Implementation Gap: Accuracy? <ul><li>Substantial percentage of HER2 tests performed by community laboratories are inaccurate </li></ul><ul><ul><li>20% inaccurate based on comparison to central labs </li></ul></ul>
    20. 20. Translation Gap: Treatment? <ul><li>- Patients may receive Herceptin despite test results </li></ul><ul><ul><li>Large health plan data: up to 20% of patients </li></ul></ul>
    21. 21. Economic Gap: Efficiency? <ul><li>No analyses of most efficient testing strategies </li></ul><ul><ul><li>Cost-effectiveness studies assume perfect testing </li></ul></ul>
    22. 22. “ Oncotype DX is the most commercially successful genomic based prognostic test to date”
    23. 23. Gene Expression Profiling Tests <ul><li>To determine risk of recurrence & benefit from chemotherapy for breast cancer </li></ul><ul><li>Adoption & coverage spanned several years </li></ul><ul><li>Two studies </li></ul><ul><ul><li>Factors influencing adoption </li></ul></ul><ul><ul><li>Factors influencing coverage decisions </li></ul></ul>
    24. 24. Factors Influencing Adoption <ul><li>Test characteristics </li></ul><ul><ul><li>Sample collection: ease & availability </li></ul></ul><ul><ul><li>Adequate test performance </li></ul></ul><ul><li>Clinical characteristics </li></ul><ul><ul><li>Clinical need </li></ul></ul><ul><ul><li>Highly visibility study results </li></ul></ul><ul><ul><li>Recommendations </li></ul></ul><ul><li>Market factors </li></ul><ul><ul><li>Reimbursement strategy </li></ul></ul><ul><ul><li>Lack of regulation </li></ul></ul><ul><ul><li>Cost-effectiveness analyses </li></ul></ul>
    25. 25. Factors Influencing Coverage <ul><li>All consider clinical utility – impact on outcomes – as primary determinant </li></ul><ul><ul><li>Although definition & interpretation varies </li></ul></ul><ul><li>All consider market factors </li></ul><ul><ul><li>But which factors & when varies </li></ul></ul><ul><ul><li>Payers must consider how market factors intersect w/ clinical utility </li></ul></ul><ul><ul><ul><li>Patient & provider demand </li></ul></ul></ul><ul><ul><ul><li>Regulatory issues </li></ul></ul></ul><ul><ul><ul><li>Guidelines </li></ul></ul></ul><ul><ul><ul><li>Other payers </li></ul></ul></ul><ul><ul><ul><li>Economic issues </li></ul></ul></ul>
    26. 26. Tip of the Iceberg <ul><li>ASCO 2009: New Oncotype DX Assay Predicts Risk for Recurrence in Stage 2 Colon Cancer </li></ul><ul><li>ASCO Supports KRAS Testing </li></ul><ul><li>Before Anti-EGFR Therapy (1/15/09) </li></ul>
    27. 27. Conclusion <ul><li>Inevitable trend </li></ul><ul><li>Evidence of value is critical to adoption </li></ul><ul><ul><li>But “slippery” </li></ul></ul><ul><ul><li>What you see depends on where you sit </li></ul></ul><ul><ul><li>Increasingly available </li></ul></ul><ul><ul><li>“ There’s a wonderful rule of thumb for American health care: Shift happens” </li></ul></ul><ul><li>Uwe Reinhardt </li></ul>

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