Over the past decades, policy makers in the healthcare sector have tried to control the rising costs of pharmaceuticals in different ways. To assess the value of diagnostic interventions in clinical practice, cost-effectiveness analyses can be used; however, we previously identified some gaps in the design and reporting of these studies. Compared with pharmaceutical interventions, assessing the cost effectiveness of diagnostic strategies can be more challenging, as various diseases or treatment options may be important to consider. The new VALUE-Dx publication provides eight recommendations on the reporting and design of CEAs of diagnostics, which can be used in addition to more general guidelines.
The first recommendation is to specify the target population of the test, including the symptoms patients experience and other relevant determinants that may influence the clinician when diagnosing patients. Clearly state whether the aim of the intervention is to screen, diagnose or monitor patients. The second recommendation is to specify the clinical setting in which the clinician operates, and where the diagnostic test is performed. Next to that you should specify the diagnostic algorithm, including clinicians’ decision processes (decision to perform the test), the diagnostic tests (including brand, type and frequency), and the relevant treatment options (the outcome of the diagnostic algorithm). It is also important that the assessed time horizon should be similar to the time horizon over which costs and consequences of treatment following the diagnostic process are typically evaluated.
The fifth recommendation is to include either QALYs or DALYs when assessing the cost effectiveness of diagnostics. Consider the economy (or diseconomy) of scale related to collecting, transporting and performing more (or fewer) tests on the same equipment, as opposed to a fixed price per test. Use an efficiency frontier to visualize the incremental costs and outcomes of the different strategies, if several diagnostic algorithms are assessed simultaneously. Finally, define the perspective of the economic evaluation and identify which payers are included in the budget impact analysis. Calculate the budget impact of implementing the assessed diagnostic algorithm within the overall clinical care pathway and consider setting-specific reimbursement regulations
These recommendations can be used in addition to other, more general, recommendations, such as the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) or the reference case for economic evaluation by the international decision support initiative. Although we expect the issues raised in the paper to be generalizable to diagnostics or all disease areas, some issues relevant for specific disease areas may not have been included. However, this research could be used as a starting point for a follow-up project to further develop diagnostic-specific guidelines or a reference case for diagnostic CEAs.