OBJECTIVES: Health technology assessments (HTAs) focus primarily on the strictly regulated pharmaceutical industry. With the introduction of the Medical Device Regulation and In-Vitro Device Regulation, the medical device industry is rapidly evolving and the importance of HTAs are increasingly being recognized, especially for medical tests. A medical test is often assessed on its cost, rather than the value it brings: a formal market access process is lacking and a test should fit within current reimbursement structures. Simply applying pharmaceutical-focused health economic modelling approaches will fail to capture the actual value of a medical test, which is highly context specific and dynamic.

METHODS: Drawing upon the review of relevant literature and recent study cases, we highlighted the key themes that need to be considered in the economic evaluation of medical tests.

RESULTS: We identified five overarching themes that could impact the value of a test: 1) disease characteristics, influencing the value of a test by sojourn time, disease severity, transmission effect and case fatality rate; 2) test characteristics, with positive predictive value (PPV) and negative predictive value (NPV) as most important but also highly dynamic accuracy variables; 3) epidemiology, including the disease prevalence which directly affects the PPV and NPV of a test; 4) test algorithm, which introduces implementation focused variables as test interdependency and test access; and 5) subsequent treatment pathways, covering direct effects (e.g. psychological distress, adverse events), and indirect effects (treatment costs and effects) for both true and false test results.

CONCLUSIONS: Medical tests have unique characteristics, which are dynamic and make health economic evaluations of medical tests less straightforward compared to pharmaceuticals. Future efforts should focus on the development and implementation of a consensus driven practical guide that exhausts the list of overarching themes and provides guidance to make dynamicity inherently part of decision analytical modelling of medical tests.