OBJECTIVES: The purpose of this study was to qualitatively evaluate factors affecting health insurance coverage and reimbursement of digital therapeutic (DTx) products by United States payers and coverage decision-makers.

METHODS: This cross-sectional study used both online surveys and focus group sessions from August to October 2022. Managed care pharmacy and medical directors, health benefit consultants, and pharmacy benefit managers were recruited by snowball sampling. The focus group interviews evaluated the following eight topics: (1) evidence to evaluate DTx, (2) circumstances/attributes needed for DTx coverage, (3) barriers to DTx coverage, (4) coding issues and other factors influencing coverage as pharmacy or medical benefit, (5) benefit designs of DTx coverage, (6) indication and duration for DTx coverage, (7) reimbursement issues of DTx, (8) Food and Drug Administration (FDA) approval/policies associated with DTx. Rules and rubrics of coding were applied to evaluate the interview transcripts using qualitative coding system software, Atlas.ti. The results for categorical data were primarily presented as frequencies (%) of topic coding discussed during group interviews.

RESULTS: A total of 22 participants with at least 16 years of experience participated. Most were employed by managed care organizations (n = 10, 45.5%) or pharmacy benefit managers (n = 4, 18.2%). Most common topics influencing DTx reimbursement mentioned by participants included evidence of effectiveness (n = 127, 17.3%) and circumstances/attributes driving the decision to cover DTx (n = 104, 14.1%). Other factors frequently mentioned included review by FDA, issues with payment for DTx, and lack of long-term outcomes in real-world settings.

CONCLUSIONS: When assessing DTx coverage policies, payers will need to consider multitudes of factors such as effectiveness evidence. Benefit designs will have to be adapted to accommodate DTx products.