Establishing the Value of Diagnostic and Prognostic Tests in Health Technology Assessment.

BACKGROUND In recent years, Health Technology Assessment (HTA) processes specific to diagnostics and prognostic tests have been created in response to the increased pressure on health systems to decide not only which tests should be used in practice but also the best way to proceed, clinically, from the information they provide. These technologies differ in the way value is accrued to the population of users, depending critically on the value of downstream health care choices. This paper defines an analytical framework for establishing the value of diagnostic and prognostic tests for HTA in a way that is consistent with methods used for the evaluation of other health care technologies. It assumes a linked-evidence approach where modeling is required, and incorporates considerations regarding several different areas of policy, such as personalized medicine. We initially focus on diagnostic technologies with dichotomous results, and then extend the framework by considering diagnostic tests that provide more complex information, such as continuous measures (for example, blood glucose measurements) or multiple categories (such as tumor classification systems). We also consider how the methods of assessment differ for prognostic information or for diagnostics without a reference standard. Throughout, we propose innovative graphical ways of summarizing the results of such complex assessments of value.