Abstract
Digital therapeutics (DTx) are a rapidly growing therapeutic category with more than 150 clinical trials evaluating US Food and Drug Administration-regulated DTx to develop additional evidence by the end of 2022. Investments in DTx development have doubled since 2019, reaching $14.7 billion in 2021. Prescription DTx are regulated by the US Food and Drug Administration and require demonstration of efficacy and safety prior to commercialization and reimbursement by payers. Drawing insights from the Massachusetts Medicaid program's early experience with prescription DTx, we provide an overview of this new category of therapeutics and suggest a roadmap for payers and policymakers to evaluate the value of prescription DTx for their member population. Finally, we propose solutions to potential challenges that may be encountered in the DTx coverage and reimbursement management.