OBJECTIVES: Diagnostic tests and patient monitoring are essential to medical care. As the benefits of these procedures are inevitably linked to the resulting therapeutic interventions, diagnostic accuracy (i.e. sensitivity, specificity) and the consecutive medical decisions are of key interest. To answer the question of how many of the economic analyses meet the requirements of a transparent and comprehensible methodology, a literature-based evaluation was conducted. To evaluate the quality and usefulness of these studies the EUnetHTA Methods for health economic evaluations were applied.

METHODS: To identify health economic studies of biomarkers to diagnose or monitor patients with a non-transmissible disease (i.e., cardiovascular and chronic respiratory diseases, cancer, diabetes, and obesity-related diseases), a systematic search in Medline has been conducted between 2010 and June 2022. The results were reviewed with regard to the health economic method applied and the results reported.

RESULTS: 855 abstracts were identified, of which 337 full texts were screened and 92 sources were included. More than 90% of the economic analyses put the economic outcomes of testing or monitoring in a relation to a treatment decision. The remaining studies examined the costs of a diagnostic procedure / monitoring system. The most commonly applied (80%) economic methods were: Cost-utility analyses (CUA) and cost-effectiveness analyses (CEA). More than 75% of the evaluation were transparent with regard to the research question, the sources used and the perspective of the underlying analysis. With 75%, oncological diseases were the most frequent topic of an economic analysis, followed by cardiovascular diseases (15%) and diabetes (9%).

CONCLUSIONS: Determining the value of biomarkers requires the consideration of not only the costs but also the clinical consequences of a test result i.e. correct vs incorrect treatment decisions leading to over- or mistreatment with increased mortality or reduced quality of life. The analyses identified show that the majority take this into account.