CURRENT AND ANTICIPATED DIGITAL THERAPEUTICS PAYER PERSPECTIVES IN THE COVID-19 ERA

ABSTRACT

BACKGROUND: Digital therapeutics (DTx) have grown in recent years in terms of market size and influence. Despite increasing interest, managed care organizations face barriers around DTx management. Disparate DTx coverage has led to unequal uptake and discrepancies around utilization management (UM) strategies. Thus, an unmet need exists for elucidating DTx coverage criteria and the evidence that shapes policy development. OBJECTIVE: To understand current DTx payer coverage policy patterns and anticipated future trends. METHODS: DTx medical policy research was conducted August to September 2020 using Canary Insights (Lakewood, CO). Following this surveillance, an online survey was fielded to payers from Xcenda's Managed Care Network. Respondents familiar with DTx were asked about DTx coverage, UM, policy criteria, and COVID-19 implications for DTx management. RESULTS: Fifty respondents (54% represent health plans, 26% pharmacy benefit managers, 20% integrated delivery network) completed the survey, and 88% evaluated ≥ 1 DTx in the past 12 to 18 months. Respondents reported that mobile apps (48%) and medication adherence platforms (40%) were the most reviewed and were expected to have the greatest increase in coverage demand over the next 12 to 18 months. Respondents indicated diabetes as the highest priority (66%) with the greatest impact in addressing unmet needs (52%). For UM, DTx coverage fell under medical benefit (41%) or was product dependent (43%). In evaluating DTx, clinical effectiveness (94%), safety (82%), and FDA-approved or cleared use (78%) were indicated as absolutely needed while clinical benefit (98%), peer-reviewed publications (94%), and return on investment (88%) were most useful for coverage decisions. The most cited rationale for either covering or denying DTx was evaluation of existing efficacy and safety data vs a lack of outcomes and cost data. For reauthorization, most respondents indicated documentation of positive clinical response (80%) and total cost of care reduction (71%) as requirements for re-authorization, while citing lack of long-term clinical data (73%) as the largest barrier for establishing re-authorization criteria, and 52% of respondents were interested in subscription-based or alternative pricing models for re-authorization. Respondents indicated that the COVID-19 pandemic has not impacted DTx coverage (58%), with no changes expected in the next 12 to 18 months (46%). CONCLUSIONS: Inconsistencies in DTx payer evaluation, coverage, and UM highlight the unmet need for establishing a standardized format for DTx appraisal.