The Digital Therapeutics Alliance defines a digital therapeutic (DTx) as “evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease.” One key question is what factors US payers consider when evaluating DTx and how it differs from pharmaceuticals. In a study by Gomez Lumbreras et al. (2024), 21 US payers were interviewed to provide insights. Key considerations include:
- Need for Evidence: Nearly all respondents (90%) stated the need for clinical trials to assess product coverage, including efficacy, effectiveness, and value.
- DTx Coverage Allocation: Uncertainty exists on whether reimbursement should fall under medical or pharmacy benefits. While most lean towards the pharmacy and therapeutics committee (71%), others suggest alternative routes (29%).
- FDA Regulation and Legislation: Two-thirds of respondents require FDA evaluation for coverage, with considerations beyond FDA requirements such as effectiveness and value.
- Reimbursement Methods: Participants deem a prescription necessary for reimbursement, favoring CPT or NDC codes for efficient reimbursement processes.
- Barriers: Challenges include treatment durability, costs, and reimbursement systems. Some perceive DTx as inferior due to the availability of free apps online.
- Payer Management: Suggestions include utilizing utilization management policies and integrating DTx products into care management programs.
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