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BACKGROUND A new class of interventions called digital therapeutics (DTx) is emerging and shows promise in the treatment of a spectrum of medical disorders and diseases. DTx are software-based interventions which could deliver unprecedented portability and scalability for patients. Their adoption and implementation were accelerated by the need for remote care during the COVID-19 pandemic, and awareness about their utility grew among health care providers, payers, and regulators. Yet, despite increasing clinical evidence that DTx can prevent, manage, or treat chronic conditions and disorders, the digital nature of these technologies creates a new set of challenges to evaluating their cost-effectiveness. As a result, little is known regarding the capacity of DTx to provide economic value to payers, providers, and health systems. OBJECTIVE This study aims to systematically review and summarize published evidence regarding the cost-effectiveness of clinical-grade mobile application-based DTx, as well as explore factors affecting such evaluations. METHODS A systematic review of economic evaluations of clinical-grade mobile application-based DTx was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Major electronic databases (including PubMed, Cochrane Library, and Web of Science) were searched for eligible studies published from inception to October 28, 2022. Two independent reviewers evaluated the eligibility of all retrieved articles for inclusion. The methodological quality and risk of bias were assessed for included studies. RESULTS The search yielded 11,228 abstracts, of which 18 studies are included in this review. Of the 18 studies, 7 (39%) are non-randomized studies-based economic evaluations, 6 (33%) are model-based evaluations and 5 (28%) are randomized clinical trials-based evaluations. Twelve of the studies (67%) used a payer perspective for the economic analysis, while the rest (33%) used a societal perspective. Thirteen of the studies (72%) conducted a full economic evaluation, and 12 of those (92%) found the DTx intervention under assessment to be cost-effective; one study (8%) found the intervention to be cost-effective in only one of the three countries of study. The remaining 5 studies (28%), which focused on a partial economic evaluation, found the DTx intervention under assessment to be cost-saving. Across the 18 studies included in this review, health care resource utilization was the most often reported cost impacting the DTx economic value of the DTx interventions (16/18, 89%), followed by the cost of the pharmaceutical treatment (12/18, 67%). The participants’ baseline characteristics was the most often reported factors influencing DTx economic impact in 12 of the studies (67%). By way of limitations, qualitative deficits in methodology and significant potential biases, including risks of performance bias and of selection bias in participant recruitment, were identified across some of the studies. CONCLUSIONS This systematic review supports the thesis that DTx interventions have potential economic benefits. However, the distinctive nature of DTx creates a new set of challenges to evaluating such novel technologies, which were not consistently addressed across studies. To provide evidence of economic impact, which is required for DTx adoption and deployment, further evaluations leveraging more comprehensive and standardized economic analyses across settings will be necessary. CLINICALTRIAL PROSPERO Registration No. CRD42022358616 |
