”show me the money ” what is the “real” value of personalized medicine for cancer care ?
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School of Pharmacy. ”Show Me the Money ” What is the “Real” Value of Personalized Medicine for Cancer Care ? Kathryn A. Phillips PhD Professor of Health Economics and Health Services Research - PowerPoint PPT PresentationTRANSCRIPT
”Show Me the Money” What is the “Real” Value of
Personalized Medicine for Cancer Care?
Kathryn A. Phillips PhDProfessor of Health Economics and Health Services Research
Director and Founder, UCSF Center for Translational and Policy Research on Personalized Medicine
University of California, San Francisco
School of Pharmacy
Today’s Conversation
• What is the value of personalized medicine in cancer care?
• How are payers considering coverage and reimbursement policies?
• How may new sequencing technologies change the playing field?
2008: TRANSPERS Born
• Objective: Develop evidence of how personalized medicine can be beneficial and efficient
– Who has access to the newest technologies? – How do patients and providers make decisions about using
personalized tests or drugs?– What information do insurers need to make the most appropriate
decisions about coverage policies?– How can we design better policies to encourage the most
effective use of technologies?
NCI (P01) NHGRI Aetna Foundation Blue Shield Foundation of CA
Department of Veterans Affairs UCSF Comprehensive Cancer Center UCSF CTSI
TRANSPERS Talks with Payers to Understand Reimbursement
• Evidence & Reimbursement Council• Founded 2007• Senior executives:
– All 7 largest US plans & leading regional plans– Thought leaders with industry (bio, pharma, lab,
PBMs), government, & Medicare perspectives
• Semi-annual meetings• Funded by multiple NIH grants & foundations
Why is a Health Economist/Health Services Researcher Working on
Personalized Medicine?
Using Toolbox of Social Science Approaches & Methods…
…To Understand Health Policy Issues…
…In the Brave New World of New Technologies & Personalized Medicine
Academia
Wearing Four Hats
Government
Industry
Patients & Providers
What is the value of personalized medicine in cancer care?
Challenges/Opportunities for Personalized Medicine
Shifting Industry Paradigms
Determining Value & Reimbursement
Balancing Innovation & Regulation
Building Evidence Base
Research on HER2/neu Testing for Herceptin – Paradigm for the Future
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
Translating HER2 Testing to Practice & Policy
No data on uninsured, Medicaid recipients, or minorities
~20% of IHC tests at community labs may be inaccurate
Claims & medical records for testing do not match 25% of time
Some women get IHC, some FISH, some both
Up to 20% of negative women still get Herceptin
60% of positive women – esp. lower income – do not get Herceptin
Cost-effectiveness analyses assume perfect testing
The economic value of personalized medicine tests: what we know and what we need to know
Summary of policy implications
• Information on clinical utility, economic value, affordability, and public health implications is essential for appropriately assessing new technologies.
• Methods are needed to prioritize and conduct early and rapid assessments of clinical utility and economic value, before widespread adoption of new technologies.
• It is critical to consider the true value of diagnostics and not impede the need for innovation because of the need to consider economic value.
• Balancing innovation and affordability is a shared responsibility.
How are payers considering coverage and reimbursement policies?
Long Adoption Curve for Plan Coverage for OncotypeDx
• OncotypeDX took four years to be adopted by all payers– Payers considered same evidence but
weighted factors differently– Tipping points:
• How clinical evidence interpreted • Health care system factors (patient & provider
demand, Medicare coverage, guidelines)• Lack of FDA approval not deal-breaker
Variation in Health Technology Assessments Used by Payers
P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11 # of payers
BCBS TEC 10
USPSTF 9
ICER 7
Hayes 5
EGAPP 5
ECRI 3UP-TO-DATE 2
Total per payer
7 6 6 5 3 3 3 3 2 2 1
How may new sequencing technologies change the playing field?
Many Different Types of Sequencing
Single Gene Testing
Gene PanelsWhole Exome Sequencing
Whole Genome Sequencing
- Inherited/germline vs. acquired/somatic
- Disease specific vs. general genomic medicine
Tumor vs. Germline Sequencing
“Person” sequencing – germlineTumor sequencing
Individual gene tests
Whole genome
sequencing
Multi-gene susceptibility
panels
Tumor Sequencing
panels
Individual tumor targets
Whole tumor –ome sequencing
Incidental findings
Sequencing = Sequencing
Sequencing of tumors for immediate treatment decisions using established gene panel to look for variants with known clinical utility
VS
Sequencing in general population to look for any variants that may be predictive of future risk of disease regardless of lack of any known clinical utility for those variants
2008, $1.5M, 4 monthsMutation inhibiting beta-blockers – but fatal illness?
2011, $100KMoney well-spent?
8 babies in extended family died before sequencing identified cause
Sequencing found genetic risk for diabetes – but then couldn’t get life insurance
Cost of Whole Genome Sequencing is Falling
Emerging Debates: Should Sequencing Be Widely Used?
“We will only achieve the promises of sequencing if the information gathered is “useful, cost-effective, and welcomed”
• Jim Evans, Science, 2011
Emerging Debates:Who Will Pay?
“It would be very, very challenging to collect and analyze enough information to convince CMS that whole-genome sequencing should be covered by Medicare”
• Jeffrey Roche, CMS medical officer, 2011
Emerging Debates:Who Will Decide What Results are
Returned?
• Whole genome sequencing will find “incidental” or secondary findings that are not the primary reason for testing
- Patients should decide prior to testing? OR- Experts should determine a standard set of
results to be returned based on evidence of clinical utility?
TRADE-OFFS: No Free Lunch
• Would you get sequenced if no cost?– 81%
• Would you want to know everything?– 74%
Emerging Debate:Will We Open Pandora’s Box?
Clinically actionable
WGS Test
No WGS Test
OutcomesTreatment Decisions
WGS testing
Decision
No additional information
Not directly clinically actionable
Unknown or no clinical significance
Health Benefits
Costs
Tests
Anxiety
Regret
Side Effects
Treat
Do Not Treat
Types of Information
Initial Findings about Sequencing Reimbursement
• Payers are very interested in sequencing– Game-changing technology
• Concerns:– Complexity– Clinical utility & potential costs– Is sequencing just a bundle of tests– How will be delivered – infrastructure, stored
results, pan-cancer/off-label uses– Distinguishing research vs. clinical use
Our Ongoing NIH Study: Benefit-Risk Tradeoffs for Genomic Sequencing
• What matters to patients and physicians when they make decisions about sequencing?
• How can payers, guideline organizations, & society facilitate appropriate & efficient use of sequencing?
– With Harvard Medical School MedSeq study• Conducting 1st RCT of whole genome sequencing in
general population