Evidence about the health economic outcomes of a diagnostic test is often lacking and has been mentioned as a common reason for diagnostics failing to obtain appropriate coverage.

Evaluating the cost effectiveness of diagnostic biomarkers is challenging because diagnostics themselves do not influence long-term outcomes directly, but rather impact on therapeutic decisions and the subsequent care process.

Economic evaluations on diagnostic biomarkers typically require comprehensive models to deal with all possible test–treatment combinations in various populations to assess their value in terms of health economic outcomes.

More effort should be made to align the choice of health economic evaluation designs and outcomes with the actual information needs of the various public and private payers and care provider decision makers.

Incorporating the results of non-health outcomes and patient preferences and improving the evidence base of other input parameters is crucial to fully capture the potential value of diagnostic biomarkers.