Session Abstract

Session Synopsis: Adoption and insurer coverage of precision medicine will require evidence that it improves patient outcomes. In this session, we will discuss progress toward achieving research that produces more personalized evidence for more personalized care, consistent and predictable insurer coverage of precision medicine, and next steps towards improving clinical evidence.

Speaker Profile

Ph.D., Professor of Health Economics and Founding Director, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, UCSF
Biography

Kathryn Phillips examines how new technologies can be effectively and efficiently translated into clinical care and health policy. A particular focus is reimbursement policies and economic analyses of precision medicine. Current project include an R01 on benefit/risk tradeoffs for multigene tests; the value of precision medicine and digital medicine in a global context (supported by the Rockefeller Foundation); and a review of comparative effectiveness research on precision medicine (with PCORI). Her work spans multiple disciplines, including basic, clinical and social sciences, and brings together leading experts from academia, industry, insurers, and government. Kathryn has published >130 articles in major journals (e.g., JAMA, New England Journal of Medicine, Health Affairs) and has had continuous funding as an NIH Principal Investigator for >25 years. She serves on the editorial boards for Health Affairs and leading journals on precision medicine, and has served as an advisor to >35 biotechnology and venture capital firms.

Talk

Reimbursement for Multigene Tests: The Good, The Bad, and The Ugly
Reimbursement is critical to the adoption of new genomic technologies. We will discuss new findings from a unique Payer Coverage Policy Registry that examines what multigene tests are covered and the evidence used in coverage decisions. We will report lessons learned from case studies of tests covered or not covered.

Speaker Profile

M.D., MPH, Executive Director, PCORI
Biography

After obtaining his MD Degree from Northwestern, Dr. Selby moved to Northern California for internship and a family medicine residency and eventually an MPH at UC Berkeley. His fellowship project concerned Behavioral Factors in Cardiovascular Disease. He stayed in the bay area at Kaiser Permanente for 27 years, including 13 as Director of Research supervising up to 50 investigators and 500 staff members. He has had academic appointments at UC Berkeley, UCSF and Stanford. He has authored more than 200 peer reviewed articles on far ranging topics such as quality measurement and improvement, primary care delivery, colorectal cancer screening and many studies that could be classified under the heading of “comparative effectiveness” – largely in the areas of diabetes, HTN and cardiovascular disease. He has received honors from the Public Health Service, the American Epidemiological Society, Kaiser Permanente and in 2009 he was elected into the Institute of Medicine. In July 2011 Dr. Selby became the first Executive Director of the Patient-Centered Outcome Research Institute (PCORI). PCORI’s mandate is to improve the quality and relevance of the evidence available in order to help patients, caregivers, employers, insurers and policy makers make informed healthcare decisions.

Talk

Patient-Centered Outcomes Research – in Support of Personalized Care
Patient-centered outcomes research is comparative research that emphasizes the search for personal markers of treatment response: both positive response and adverse effects. There has been recent progress toward achieving research that produces more personalized evidence for more personalized care.

Speaker Profile

M.D., MS, MBE, Principal Researcher at the American Institutes for Research
Biography

Dr. Deverka conducts health policy studies at AIR, primarily in the area of personalized medicine with projects funded by NHGRI and PCORI. She is a recognized expert in the area of coverage and reimbursement for new genomic-based technologies and has worked collaboratively with stakeholders to recommend standards for a more predictable reimbursement pathway. Recently, she has analyzed data from a private payer coverage policy registry for NGS-based tests and led a study of policy barriers for NIPT. Dr. Deverka leads the public deliberation component of an NHGRI-funded grant to examine policy issues surrounding genomic data sharing in a medical information commons. Prior to working in the non-profit sector, she spent nearly 15 years in the pharmaceutical and PBM industries leading departments of outcomes research. She has a master’s degree in bioethics from the University of Pennsylvania and completed a policy fellowship at Duke University’s Institute for Genome Sciences and Policy.

Talk

Pursuing Clinical Utility for Multi-Gene Tests and Genome-Scale Testing
The current evidentiary framework for clinical practice guidelines and coverage decisions for genetic tests is built on an assessment of analytic and clinical validity as well as clinical utility. This talk will describe recent efforts by NHGRI, IOM and non-profit groups to expand the methods for evaluating the clinical utility of multi-gene tests.