Table 1.

Characteristics of Technologies, Challenges for Economic Evaluations, and Application to Multigene Tests and Digital Biomarker Technologies

Characteristics of Technologies	Challenges for Economic Evaluations	Multigene Testing Examples	Digital Medicine Examples
Measures multiple biomarkers, thus providing multiple results	Complicated analyses are required that may be infeasible due to large number of possible pathways and outcomes	Whole genome sequencing can provides multiple results, with multiple clinical pathways, costs, and outcomes	Activity monitors can provide multiple types of data (steps, heart rate, sleep patterns, etc.) with multiple clinical pathways, costs, and outcomes
Results have different utilities: clinically actionable, personal utility only, harmful, and/or unknown significance	Personal utility is difficult to value; costs of harmful results and/or results with unknown significance may not be incorporated into analyses	Multigene tests may provide information with personal utility or disutility only (e.g., knowing that one is at risk for a non-preventable condition) or that has unknown significance leading to unwarranted interventions (e.g., a genetic variation that has not been validated but leads to further testing)	Activity monitors may provide information that is unlikely to be clinically actionable, e.g., whether you move during the night, and technologies that encourage physical activity such as pedometers may produce unexpected harms (e.g., joint injury)
Results may include secondary findings (potentially actionable findings unrelated to the reason for using the technology)	Complicated analyses required to capture potentially low probability events and associated utilities; often lack of data on costs and outcomes of secondary findings	Multigene testing for one inherited condition (e.g., cardiovascular risk) may reveal previously undiagnosed risk for another condition (e.g., BRCA1/2, which confers a high risk of breast and ovarian cancer)	Technologies for measuring continuous blood pressure may provide results on heart disease but could also indicate unrelated findings (e.g., mood and emotion)
Downstream impact on costs and outcomes, including impact on family members	Complicated analyses required to examine impact over time; impact on family members may not be incorporated into analyses	Costs and outcomes for multigene panels for inherited conditions, such as Lynch Syndrome, depend to a large extent on downstream follow-up by family members, e.g., increased colorectal cancer screening	Technologies used to diagnose Atrial Fibrillation (AF) may impact family members (30% of individuals with AF have a family member with the condition)
Results may have interactive effects such that the “sum is greater than the parts”	Complicated analyses required to estimate interactive effects	Tumor profiling measures multiple genes that together may provide a more comprehensive assessment of a tumor and treatment options than if testing were done individually	Technologies such as smart watches provide multiple types of seemingly unrelated data (e.g. standing time, walking/steps, heart rate, weight) and the sum valuation of these on outcomes such as preventing obesity is likely greater than each individual measurement