Challenges of Health Economic Evaluations of In-Vitro Diagnostic Tests

Health economic evaluations are critical for demonstrating the value of in-vitro diagnostic (IVD) tests to payers, policymakers, and health technology assessment (HTA) bodies. Unlike pharmaceuticals or traditional medical devices, IVDs provide actionable clinical insights rather than direct therapeutic effects, creating unique challenges in economic modeling. Their impact is indirect, influencing clinical decision-making, treatment pathways, and patient management, which complicates the generation of robust health economic evidence.

This white paper examines the unique challenges involved in conducting health economic evaluations of IVD tests and outlines practical best practices. It dives into critical considerations such as selecting the most appropriate comparators, defining suitable time horizons, addressing sequential testing strategies, determining the right perspective of the analysis, and more.