The application of economics concepts to stratified medicine--use of health economics data to support market access for stratified medicine interventions.

Stratified medicine (SM), as opposed to empirical medicine, is the practice of using biomarkers or diagnostic tests to guide the choice of therapeutic treatments. The link between the diagnostic test and the therapy provides new opportunities for value creation and may strengthen the value proposition to pricing and reimbursement authorities. However, SM provides new challenges for the value assessment process, in particular health technology assessment (HTA) and pricing and reimbursement (P&R) decisions. Although health economics (HE) should be relevant for all stakeholders, not all stakeholders are comfortable with analysis/interpretation of economic data relevant to SM interventions as this approach is still in an early/emergent stage in most markets. This article addresses how different stakeholders are using health economic data in the overall value of information analysis to inform prioritization and reimbursement of SM interventions. Findings of an expert discussion outlines key challenges affecting various stakeholders when applying health economic data in the healthcare decision-making process for SM interventions.