Genomics-based individualized care, often referred to as personalized medicine (PM), is undergoing a revolution. Soon sequencing of an individual patient's entire genome will be feasible in routine clinical care. Patients will be confronted with the possibility of receiving tens or even hundreds of genomic results that have important clinical implications - from treatment response to disease risk to implications for family members. Given the wide scope of possible results from PM, developing and evaluating evidence to support the use of this information to guide individualized care will be challenging. We propose to address these challenges by conducting a broad range of health economics based research activities. The overall goal of this project is to move the field of PM forward in an efficient and appropriate manner by developing novel approaches to assess the value of PM and prioritize PM research. We will organize our approach using our previously developed Expected Value of Individualized Care (EVIC) conceptual framework. One of the crucial assumptions in EVIC computations is that individualized care is perfectly implemented when corresponding evidence or tests are available. As we have learned from the adoption of the genomic tests to date, this does not hold true in practice. In the proposed work, we will extend the EVIC framework to fundamental aspects of decision-making at the patient, physician, and payer levels to capture implementations rates and the complexity of PM in the whole genome sequencing era. We will illustrate how such an expanded EVIC model can provide a common basis for prioritizing research investments in developing new genomic tests and generating evidence for existing tests by private and public investors. We will assess population, provider, and payer preferences, including personal utility and willingness to pay, by conducting national surveys. Data from these surveys will be used to refine the EVIC framework. Lastly, we will develop a pragmatic framework to address evidence uncertainty in the development of clinical guideline and reimbursement policies for existing PM applications. We will accomplish this aim by assessing the value of conducting future research on PM case studies identified in collaboration with policymakers, including guidelines groups and payers. Based on these case studies, we will use a consensus-based approach to develop a pragmatic framework to help decision makers assess 'insufficient'vs. 'sufficient'evidence for making a recommendation. In summary, this research project will provide: 1) an encompassing approach to assess optimal research opportunities in PM, 2) a better understanding of the value of PM, including personal utility, and 3) a more consistent approach for developing PM clinical guideline recommendations and reimbursement policies.

Public Health Relevance

Our proposed research is relevant to public health because it will provide a foundation for assessing the value of genomic-based individualized care and identifying optimal opportunities for future research. In this way, genomic applications that provide the greatest benefit to patients will be identified and utilized, and genomics research that provides the greatest return on investment to patients and our healthcare system will be pursued.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AG047109-01
Application #
8627852
Study Section
Special Emphasis Panel (ZRG1-HDM-W (52))
Program Officer
Baker, Colin S
Project Start
2013-09-30
Project End
2018-06-30
Budget Start
2013-09-30
Budget End
2014-06-30
Support Year
1
Fiscal Year
2013
Total Cost
$413,046
Indirect Cost
$135,494
Name
University of Washington
Department
Other Health Professions
Type
Schools of Pharmacy
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195