OBJECTIVES: To review US payer policies and rationale for coverage of approved digital therapeutics (DTx) in order to better understand the likely evolution of payer management and future outlook for DTx with anticipated future growth in the space.

METHODS: Information on coverage and management of FDA approved prescription DTx from top 20 largest US public and commercial payers and Pharmacy Benefit Managers (PBM) were obtained in a review of literature, websites, press releases, and public domain sources. Using this information, anticipated payer evidence requirements for DTx were considered based on current trends and developments identified.

RESULTS: The first example of US payers managing DTx came when the PBM Express Scripts announced the introduction of a digital health formulary (2019). The formulary includes 15 solutions from digital health developers including remote monitoring services and digital therapeutics for eight common chronic conditions. The digital health options are for caregiver care, COVID-19 care, diabetes care, cardiovascular care, pulmonary care, behavioral health care, women’s health care, and musculoskeletal care. A case study for Livongo, the preferred diabetes care DTx solution, demonstrates improved outcomes related to hyperglycemic events and cost savings. Another case study for asthma and COPD DTx solution, Propeller, showed improved adherence and lower utilization of rescue medication, which reduces hospitalization. The review of case studies for approved and covered DTx helps to understand study design and outcome measures needed.

CONCLUSIONS: The COVID-19 pandemic has transformed the digital health space by accelerating acceptance and usage of DTx and this trend is likely to continue into the future. As a result, US payers that have not already done so will need to develop policies to manage coverage and payment for DTx. With increased payer management, manufacturers should track outcomes of assessments for DTx to be informed of clinical trial and real-world evidence needs to support approval and coverage.