Survey Provides Insight Into US Payers' Evidence Considerations for Digital Therapeutics Coverage

A poster presented at AMCP Nexus 2023 provided insight into US payers' expectations for evidence regarding digital therapeutics (DTx) and prescription digital therapeutics (PDT) when considering coverage.

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In this study, researchers aimed to understand payer perspectives based on evidence-based factors regarding product evaluation and coverage determinations for DTx.

This quantitative survey was conducted in January 2023 and included regional health plan (40%), pharmacy benefit manager (PBM; 24%), national health plan (16%), integrated delivery network (IDN; 19%), ultimate decision maker (48%), and Pharmacy and Therapeutics (PT) member (52%) responders. The surveys included topics on minimal evidence requirements for coverage consideration, the impact of evidence-related factors on coverage determination, and preferences for the timing of preapproval information exchange (PIE).

A total of 62 individuals completed the survey. Most responders were medical directors or chief medical officers (79%), as well as individuals from health plan organizations and ultimate decision makers in the formulary process at their organizations.

Additionally, 68% and 69% of responders stated that at least 1 randomized control trial (RCT) was required for coverage consideration of DTx and PDTs, respectively, and 23% and 28% of individuals indicated that real-world evidence (RWE) was also expected. Furthermore, payers were more likely to suggest that a RCT and RWE would be required for DTx (28%) compared with PDTs (23%).

Payers also indicated that evidence related to quality and functionality (52%), usability (49%), FDA authorization (49%), and engagement (42%) would have a positive impact on determining coverage to a very high degree. Other factors that had very high degree of coverage impact included tools, publications, and models related to patient reported outcome (58%), as well as cost-effectiveness analyses (43%), Institute for Clinical and Economic Review (ICER) evaluations (41%), and RWE (40%). The use of a budget impact model was also considered highly impactful by most respondents (86%).

Furthermore, payers believed that evidence requirements were very highly impacted by the product’s target patient population (39%), overall cost of the therapeutic area (31%), and duration of recommended use (27%).

Nearly all responders also believed the minimum time to horizon to support efficacy durability was 6 months to 1 year (89%), while most payers (84%) preferred to engage at least 12 months before FDA authorization or approval for PIE.

These findings suggest that most payers share similar perceptions and requirement expectations regarding coverage for DTx, including clinical evidence supported by RWE. However, it is important to note that evidence requirements for DTx differed by product characteristics and market factors.

Overall, the researchers believe this study provides important insights and perspectives on DTx evidence and expectations for US managed care organizations, in which these factors should be considered by manufacturers of DTx products to cultivate early evidence and communication strategies to accelerate product review and patient access to these therapies.

Reference

Bannister B, Sudol V, Lee J. Digital therapeutics coverage and reimbursements evidence expectations among US payers. Poster presented at: AMCP Nexus 2023; October 16-19, 2023; Orlando, FL.