Developing the Value Proposition for Personalized Medicine
Standard methodological approaches have successfully been applied to evaluate the cost-effectiveness of numerous personalized medicine tests, particularly for companion diagnostics developed in the context of a clinical trial. However, disagreement has emerged about the extent to which existing methods can characterize the value of personalized medicine. This chapter provides an overview of cost-effectiveness analysis and the factors determining the value of personalized medicine. The authors identify limitations of the traditional cost-effectiveness analysis framework and methodological issues that will arise with increasing use of multiple "omics" profiles to guide individualized selection of treatments.