Objectives: There is little specific guidance on performing an early cost-effectiveness analysis (CEA) of medical tests. We developed a framework with general steps and applied it to two cases.

Methods: Step 1 is to narrow down the scope of analysis by defining the test's application, target population, outcome measures, and investigating current test strategies and test strategies if the new test were available. Step 2 is to collect evidence on the current test strategy. Step 3 is to develop a conceptual model of the current and new test strategies. Step 4 is to conduct the early-CEA by evaluating the potential (cost-)effectiveness of the new test in clinical practice. Step 5 involves a decision about the further development of the test.

Results: The first case illustrated the impact of varying the test performance on the headroom (maximum possible price) of an add-on test for patients with an intermediate-risk of having rheumatoid arthritis. Analyses showed that the headroom is particularly dependent on test performance. The second case estimated the minimum performance of a confirmatory imaging test to predict individual stroke risk. Different combinations of sensitivity and specificity were found to be cost-effective; if these combinations are attainable, the medical test developer can feel more confident about the value of further development of the test.

Conclusions: A well-designed early-CEA methodology can improve the ability to develop (cost-)effective medical tests in an efficient manner. Early-CEAs should continuously integrate insights and evidence that arise through feedback, which may convince developers to return to earlier steps.

Additional Metadata
Keywords Early cost-effectiveness analysis, Medical test, Decision support, Research and development, Manufacturer, Test developer
Persistent URL dx.doi.org/10.1017/S0266462316000064, hdl.handle.net/1765/93158
Journal International Journal of Technology Assessment in Health Care
Note This research was performed within the framework of CTMM, the Center for Translational Molecular Medicine (www.ctmm.nl), projects PARISk (grant 01C-202) and TRACER (grant 04I-202), and supported by the Dutch Heart Foundation and the Dutch Arthritis Foundation.
Buisman, L.R, Rutten-van Mölken, M.P.M.H, Postmus, D, Luime, J.J, Uyl-de Groot, C.A, & Redekop, W.K. (2016). The early bird catches the worm: early cost-effectiveness analysis of new medical tests. International Journal of Technology Assessment in Health Care, 32(1-2), 46–53. doi:10.1017/S0266462316000064