This document discusses the value of personalized medicine and some key challenges in measuring and demonstrating its value. It provides two case studies of HER2 testing for breast cancer treatment with Herceptin and gene expression profiling tests for breast cancer recurrence risk. While these show promise for personalized medicine, challenges remain around ensuring access, accuracy of tests, linking tests to treatment and outcomes, and demonstrating cost-effectiveness. Overall, measuring the value of personalized medicine requires consideration of multiple stakeholder perspectives and building an evidence base around clinical utility, economic impacts, and real-world implementation.

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

5. Understanding Perspectives

6. VALUE FDA Public Payers Government/Evidence Groups/”Society” Industry Patients “ Value” is in Eyes of Beholder Physicians Private Payers PBMs Employers

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. Academia Stakeholders Society

11. Challenges to Establishing Value

15. Wall Street Journal FRIDAY, JANUARY 4, 2008 Bad Cancer Tests Drawing Scrutiny

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

22. “ Oncotype DX is the most commercially successful genomic based prognostic test to date”