value of personalized health care
DESCRIPTION
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.TRANSCRIPT
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
What have we learned about adoption of personalized medicine?
• Value• Evidence
What needs to occur for personalized medicine to be adopted?
• Value• Evidence
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
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)
Understanding Perspectives
VALUE
FDA
Public Payers
Government/Evidence Groups/”Society”
Industry
Patients
“Value” is in Eyes of Beholder
Physicians
Private PayersPBMs Employers
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
Academia
Stakeholders
Society
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?
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
Challenges to Establishing Value
“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
“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
“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
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
– ~ 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
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
Implementation Gap: Accuracy?
• Substantial percentage of HER2 tests performed by community laboratories are inaccurate
• 20% inaccurate based on comparison to central labs
Translation Gap: Treatment?
-Patients may receive Herceptin despite test results
• Large health plan data: up to 20% of patients
Economic Gap: Efficiency?
• No analyses of most efficient testing strategies
• Cost-effectiveness studies assume perfect testing
“Oncotype DX is the most commercially successful genomic
based prognostic test to date”
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
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
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
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)
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