Diagnostic testing and patient monitoring are important to diagnose potential diseases and to evaluate treatment regimens. Since diagnosis and treatment monitoring have no intrinsic effects, an economic evaluation of biomarkers is inevitably linked to the resulting therapeutic interventions, which depend on both physicians’ decisions and diagnostic accuracy of the test (i.e., sensitivity, specificity). In this review we analyzed the methodology of economic studies evaluating the management of the five most relevant non-communicable diseases, that is, obesity, cancer, diabetes, cardiovascular and chronic respiratory diseases.

A systematic search in Medline and the National Health Service Economic Evaluation Database (NHS EED) covering the last ten years served to identify health economic analyses of biomarkers used in diagnosing / monitoring. Findings were reviewed with respect to analytical method, reported outcomes and comparability.

The search yielded 680 abstracts in total out of which 280 full texts were reviewed and 77 sources included following predefined criteria. Most economic analyses (94%) evaluated the clinical outcome and costs of testing / monitoring in correlation to a corresponding intervention, 6 percent of the sources focused on the accuracy of the test or monitoring methods only. There were 61 studies that included an economic model; overall, 15 sources presented the outcome as cost per life year gained (CEA), 37 sources as cost per QALY gained (CUA), and 12 provided the outcome as both a CEA and CUA. In 16 analyses the outcome was presented in other economic terms as, for example, cost per additional case detected.

Determining the value of biomarkers requires consideration of the clinical consequences of a test result (incorrect treatment decisions, impact on morbidity, mortality, or quality of life) as well as the corresponding economic outcomes. Most of the identified studies considered at least one of these aspects. Results are presented in manifold ways but do not necessarily address decision makers’ needs. Thus, clear guidelines on economic evaluations of biomarkers are needed and should include broader health system views like affordability or the number of unnecessary interventions avoided.