Will the Growing Number of Prescription Digital Therapeutics Expand Usage and Coverage?

The number of digital therapeutics, including prescription digital therapeutics (PDTs), continues to expand. Sources indicate that by the end of 2022, more than 150 clinical trials were exploring FDA-regulated PDTs. This innovative class of therapeutics is swiftly mounting, with investments in research and development doubling since 2019.¹

In a recent publication in JMCP, authors sought to provide a summary of PDTs, offer suggestions that payers and policy makers can employ to assess the value of PDTs for their clients, and recommend solutions to possible challenges, including formulary management that may occur with regard to coverage and reimbursement of PDTs.

The authors wrote, “Unlike prescription drugs approved by the FDA, which must be reimbursed by Medicaid if the pharmaceutical manufacturer is enrolled in the Medicaid Drug Rebate Program, coverage of [PDTs] is not mandatory and, with limited resources, this may be a lower priority.” The authors indicated that they employed knowledge acquired from the Massachusetts Medicaid program’s early experience with PDTs.

The authors wrote, “In the absence of current best practices for payers in determining coverage of [PDT] products, we provide our recommendations based on experience with Massachusetts Medicaid program. We propose that DTx coverage approach focus on [PDT] products that (1) intend to treat, manage, and/or prevent disease and (2) are cleared by the FDA through either the De Novo or 510(k) premarket notification pathway.”

The authors also indicated that PDTs can significantly improve clinical outcomes and address gaps in care for various medical conditions and proposed criteria to consider when reviewing PDTs, such as the prevalence of conditions, efficacy and safety of PDTs, and costs. Examples of recommended supplemental criteria included:

• Does it improve adherence after use?
• Does the PDT have multiple clinical trial results with clinically meaningful outcomes?
• Does the real-world data align with clinical data?
• Does the PDT address gaps in care in patient populations with limited treatment options
• Does the PDT foster health equity, reduce health care disparities, and improve access to care?
• Does its use decrease avoidable health care utilization such as ER visits and hospitalizations?
• Is the PDT easy to use and provide patients with access to secure therapy addressing the needs of various patient populations?
• Does the PDT improve the patient’s health-related quality of life?

The authors concluded, “With the lack of robust frameworks to assist in the decision-making process for coverage and reimbursement of [PDTs], it is of great importance for payers and benefit managers to create standardized frameworks that can prioritize [PDT] products. Our current proposed criteria for assessing [PDTs] provide a starting point to assess the value of products and initiate conversations with manufacturers. The criteria also set expectations for manufacturers in supporting the use and impact of their product for the diverse payer, provider, and patient populations.”

Conclusion

There is still a need to expand awareness about the clinical benefits associated with the use of PDTs, however, the limited clinical data available provides promising results. PDTs also offer the potential to improve adherence and clinical outcomes while decreasing direct and indirect costs, addressing gaps in care, and enabling patients to take an active role in their care. Since digital technology is an integral part of everyday life for various tasks, using PDTs to treat multiple conditions can also be beneficial for patients when applicable. Hopefully, more real-world data demonstrating their efficacy and safety will expand usage and coverage.

Reference

1. Salsabili M, Tesell M, Alcusky M, Greenwood BC, et al. Prescription digital therapeutics: Applying Medicaid experience to value assessment and formulary management. J Manag Care Spec Pharm. 2023;29(6):685-691. doi:10.18553/jmcp.2023.29.6.685