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Value of Personalized Medicine:Value of Personalized Medicine:What is it?What is it?
How to measure it?How to measure it?Why care?Why care?
Kathryn A. Phillips, PhDProfessor of Health Economics & Health
Services Research
Director & Principal Investigator Center for Translational & Policy Research Center for Translational & Policy Research
on Personalized Medicine (TRANSPERS)on Personalized Medicine (TRANSPERS)
University of California, San Francisco
e
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What have we learned about adoption of personalized medicine?
• Value• Evidence
What needs to occur for personalized medicine to be adopted?
• Value• Evidence
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Key Challenges for Personalized Medicine
1. Aligning Incentives for Maximal Benefit & Efficiency
2. Balancing Regulation & Innovation3. Designing Appropriate Reimbursement
Policies4. Building an Evidence Base5. Measuring & Demonstrating Value
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Today’s Discussion
• Understanding perspectives
• Defining and measuring “value”
• Two case studies– HER2 testing for trastuzumab (Herceptin)– Gene expression profiling for breast cancer
recurrence (Oncotype and Mammaprint)
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Understanding Perspectives
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VALUE
FDA
Public Payers
Government/Evidence Groups/”Society”
Industry
Patients
“Value” is in Eyes of Beholder
Physicians
Private PayersPBMs Employers
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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
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Academia
Stakeholders
Society
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Critical Questions for the Center
Translation into improved health outcomes requires evidence on:
•Who has access to the newest technologies?
•Do the underserved have equal access?
•What approaches do patients & providers prefer?
•What interventions have the most value?
•How can research be translated to the real world?
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Private Payer Perspective
• TRANSPERS Reimbursement Board– Senior executives
• 6 of 7 largest US private health plans• Regional plans• Others, e.g., PBM, self-insured employers,
consultants
– Blue Shield of CA Foundation & NIH funding– 2006 – ongoing– Three meetings & multiple interviews
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Challenges to Establishing Value
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“Poor Step-Child”
• Diagnostic industry historically “secondary” to pharma industry – but no longer
– Oncotype is “darling”
• Integration of historically divided industries & regulatory mechanisms
• Focus on diagnostics in drug development
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“Flying Under the Radar”
• Reimbursement system is challenging– Traditionally not “value-based”
reimbursement for diagnostics– Personalized medicine can be either
“screening” or “diagnosis” or both
• Payers want evidence of value - but can’t track use & outcomes of diagnostics
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“The Black Box”
• Little data on clinical utility of diagnostics
• Few economic analyses
• Linking targeting to improved outcomes– Testing then treatment then outcomes– Impact on family members
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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
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– ~ 30% of breast cancer patients overexpress HER2/neu and can benefit from Herceptin• Testing is required to determine who can
benefit
– Herceptin a clinical success – but gaps remain in translation
Oldest Example of Personalized Medicine Portends Promises &
Challenges
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Evidence Gap: Who Tested?
• NO data on uninsured, Medicaid recipients, or minorities
• 2/3 of eligible Medicare patients had no documentation of testing in claims records
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Implementation Gap: Accuracy?
• Substantial percentage of HER2 tests performed by community laboratories are inaccurate
• 20% inaccurate based on comparison to central labs
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Translation Gap: Treatment?
-Patients may receive Herceptin despite test results
• Large health plan data: up to 20% of patients
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Economic Gap: Efficiency?
• No analyses of most efficient testing strategies
• Cost-effectiveness studies assume perfect testing
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“Oncotype DX is the most commercially successful genomic
based prognostic test to date”
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Gene Expression Profiling Tests
• To determine risk of recurrence & benefit from chemotherapy for breast cancer
• Adoption & coverage spanned several years• Two studies
– Factors influencing adoption– Factors influencing coverage decisions
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Factors Influencing Adoption• Test characteristics
– Sample collection: ease & availability– Adequate test performance
• Clinical characteristics– Clinical need– Highly visibility study results– Recommendations
• Market factors– Reimbursement strategy– Lack of regulation– Cost-effectiveness analyses
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Factors Influencing Coverage• All consider clinical utility – impact on outcomes – as
primary determinant– Although definition & interpretation varies
• All consider market factors– But which factors & when varies– Payers must consider how market factors intersect w/ clinical
utility• Patient & provider demand• Regulatory issues• Guidelines• Other payers• Economic issues
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Tip of the Iceberg
ASCO 2009: New Oncotype DX Assay Predicts Risk for Recurrence in Stage 2 Colon Cancer
ASCO Supports KRAS Testing Before Anti-EGFR Therapy (1/15/09)
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Conclusion• Inevitable trend• Evidence of value is critical to adoption
• But “slippery”• What you see depends on where you sit• Increasingly available
“There’s a wonderful rule of thumb for American health care: Shift happens”
Uwe Reinhardt