Medical Considerations

On the level of medical considerations, in the narrowest sense of the term, clinical utility refers to the ability of a screening or diagnostic test to prevent or ameliorate adverse health outcomes such as mortality, morbidity, or disability through the adoption of efficacious treatments conditioned on test results. A screening or diagnostic test in isolation does not have inherent utility; because it is the adoption of therapeutic or preventive interventions that influence health outcomes, the clinical utility of a test depends on effective access to appropriate interventions, or to the way it can beneficially affect the choice of an intervention. This use of the term utility is consistent with standard practice in evidence-based medicine, which focuses on objective measures of health status to evaluate interventions. Clinical utility can more broadly refer to any use of test results to inform clinical decision making. Finally, in its broadest sense, the medical interpretation of clinical utility can refer to any outcome considered important to individuals and their families, as well as to other societal strata.

Medical-Economic Considerations

If economic considerations are included in the definition of clinical utility, the question of whether the actual medical benefit derived from the use of the test indeed results in good value for the cost incurred becomes part of the consideration. Value in this context can be assessed by either cost-benefit or cost-effectiveness/utility analyses. In the case of a cost-benefit analysis, costs and benefits are expressed in the same units of measurement, usually monetary. Cost-effectiveness and cost-utility analyses compare the respective monetary cost of using or not using the test with defined clinical outcomes, either in physical terms or by using an index that also includes quality-of-life aspects.

As summarized in Table 3 , when considering such cost-benefit analysis to evaluate the utility of a companion diagnostic that aids in the selection of a particular treatment, one would compare the aggregate costs of testing all eligible patients, of treating test-positive patients with the associated therapy, and of treating those that are test-negative with the conventional standard-of-care approach against the cost of using the standard of care, without any testing, on all patients. In a cost-benefit analysis, the net (pecuniary) gain or loss of the two approaches would be calculated based on direct medical and nonmedical, and on indirect (productivity) costs of either alternative. As an example, if the test is intended to increase the efficacy of a particular treatment, the cost-benefit ratio may be advantageous if the savings in productivity losses due to faster recovery from an illness based on the test-guided stratification of treatments offsets the added cost of testing and use of test-directed treatment alternatives (which may have a greater direct medical cost than the standard of care). Similarly, if a test is used to avoid serious adverse effects, the cost-benefit analysis may indicate advantages if the cost savings realized by avoiding the treatment of adverse reactions outweighs the cost of testing.

In a cost-effectiveness analysis, typically the overall cost per outcome unit (such as relapses or survival years), adjusted for a global quality of life in the case of a cost-utility analysis, is compared among the treatment alternatives. In the case of a companion diagnostic, the incremental cost of using the test in all patients and then treating only those in whom the test-driven therapy is either effective or safe may result in an acceptable cost-effectiveness ratio (as

TABLE 3 Cost-Benefit Considerations for Companion Diagnostics"
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