What are digital therapeutics? What evidence is needed to support their value? How should we pay for them?
I participated in Academy of Managed Care Pharmacy (AMCP) Partnership Forum: Digital Therapeutics which took place in September 2019. The findings from that forum are presented in a recent JMCP article. An excerpt from the article is below:
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.
Read the whole article here.