Digital therapeutics (DTx)—software that delivers a clinical mechanism of action, either alone or in combination with other standard-of-care treatments to improve outcomes—is an emerging class of therapeutic interventions that poses many questions for the health care system. To examine the systems and processes that will support the adoption and utilization of DTx, AMCP convened a multidisciplinary stakeholder forum September 17-18, 2019, in Alexandria, Virginia. The goals of the forum were to (a) describe DTx and how managed care organizations evaluate their value; (b) identify where DTx fits within a covered benefit; (c) outline evidentiary standards needed for coverage of DTx; and (d) outline how payers and managed care organizations may leverage DTx for value-based care and patient engagement. Health care leaders representing academia, health plans, integrated delivery systems, DTx manufacturers and industry leaders, pharmaceutical manufacturers, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations participated in the forum.
Participants identified characteristics of DTx to develop a better understanding of the spectrum of solutions and how they are distinct from other digital health products, such as mobile health devices, monitoring, care coordination, or electronic health records. The evidence needed to evaluate DTx will likely be tiered based on its medical claim or function and should align with standards for clinical evidence. Clinical evidence must be evaluated by appropriate health authorities (e.g., the U.S. Food and Drug Administration) and receive market authorization (e.g., clearance, approval) with a regulatory label.
Various benefit coverage options were discussed. While some participants suggested that the unique features of DTx could be best addressed by a novel digital benefit, others argued that creating an additional benefit would result in further health care system fragmentation. They observed that the increasing focus on compensating providers for outcomes supports integrating DTx within existing benefit structures. They noted that some DTx might be more appropriate for the medical benefit and others might be better aligned with the pharmacy benefit. Finally, many participants observed that, while additional DTx-specific education may be needed, pharmacists are trained to have the knowledge and skills that make them well suited to play a key role in guiding appropriate use of DTx.
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