Abstract

Digital therapeutics (DTx), a subset of digital health, deliver software-generated therapeutic interventions directly to patients to prevent, manage, or treat a disease. While the role of DTx in mainstream healthcare is evolving, there is little information on whether such technologies efficiently use resources or improve patient outcomes. To better understand the methodological challenges in assessing the value of DTx, we reviewed the current landscape of health economic studies on DTx. A targeted review of literature published between January 2011 and December 2019 was conducted using prespecified search terms in multiple scientific literature databases. Studies that employed economic methods in evaluation of DTx were included, such as cost-effectiveness, cost-consequence, or cost-benefit analysis. For each included study, information on costs, quality-adjusted life years (QALYs), perspective, time horizon and method of economic evaluation was assessed. Our initial search identified 243 studies, and 235 were excluded based on a review of their titles or abstracts. Among the economic studies meeting the pre-defined inclusion criteria (n=8), only 2 studies were conducted in the United States. The most common medical condition studied was cardiovascular diseases (n=3), followed by physical activity (n=2), asthma (n=1), diabetes (n=1), and stress urinary incontinence (n=1). Notably, 5 of the 8 studies concluded DTx was cost-effective. This review found that time horizons used in these economic studies were relatively short in duration (1-3 years). Lastly, these analyses did not capture the QALYs or costs associated with program attrition, any harmful results, or the impact of DTx on indirect measures such as employment or caregiver burden. Although clinical evidence for DTx is growing, this study demonstrates health economic evidence associated with DTx is inadequate. Future research should prioritize generation of real-world evidence and facilitate improved measurement of patient-centered and value-based outcomes in economic evaluations of DTx.

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