Abstract
Digital Therapeutics (DTx) are medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. Randomized clinical trials are a source of DTx evidence, similar to pharmaceuticals or medical devices. In addition, the use of real-world evidence (RWE) has been increasingly explored for DTx value demonstration. Key concerns around the use of RWE in DTx, has thus far limited its acceptance and applicability, including the robustness of data, and a lack of consensus over an evaluation framework for DTx. This study aims to understand the current trends in evidence development for DTx, and to evaluate how this may impact the assessment of these therapies. The analysis will describe the strength and influence that different types of evidence and endpoints have had in the value assessment, coverage, reimbursement, and adoption of DTx.
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