Recent Study Reveals More Data Needed to Expand Use of Prescription Digital Therapeutics

While the field of prescription digital therapeutics (PDTs) continues to evolve, available data indicates that these novel modes of FDA-approved therapies are associated with numerous clinical and economic benefits. Unfortunately, their integration into clinical practice faces innumerable challenges, particularly a lack of awareness about their availability, issues with reimbursement and coverage, and the need for more long-term data to establish efficacy and safety.1,2 According to the Digital Therapeutics Alliance, examples of potential advantages of PDTs include the ability to improve clinical outcomes, provide a user-friendly mode of therapy that engages patients, assist patients and clinicians in establishing patient-centered goals, positively impact clinical outcomes and expand patient access to safe and effective therapies, address gaps in care, provide therapies for conditions that did not have therapies and can lower costs for both the patient and health care system.^1,2 The Digital Therapeutics Alliance also indicates that there are also benefits to payers, including reducing overall cost, improving provider network efficiency, improving patient experience and satisfaction, supporting value and outcomes-based care initiatives, and expanding health care delivery beyond traditional health care settings.³ To expand awareness about the value of PDTs in clinical care, identifying and addressing barriers to their use among patients and prescribers is paramount.

In a recent publication in Health Affairs,⁴ researchers conducted the first retrospective cross-sectional analysis of clinical studies of 20 FDA-approved PDTs available on the market as of November 2022. The authors wrote, “Prescription digital therapeutics have been developed to address a diverse set of medical conditions. They can help make care more accessible and customized to patients’ clinical needs, and they often are used as supplements to traditional treatments or diagnostic modalities.⁴ The author also wrote, “Our analysis found that just two prescription digital therapeutics had been evaluated in at least one study that was randomized and blinded and that used other rigorous standards of evidence.”⁴ Additionally, two-thirds of clinical studies of PDTs were performed on a post-market basis, with less rigorous standards of evidence than the standards employed in premarket studies. The authors discovered that although the field of PDTs continues to grow, there is a need for more “rigorous standards” of clinical studies. Based on their findings, the authors concluded, “these steps to improve study rigor and generalizability are needed to better inform payer coverage and clinical adoption.”⁴

Conclusion

PDTs allow patients and prescribers to work collaboratively and to use ongoing technological advances to diagnose, treat, and manage various conditions effectively. Unfortunately, it appears that a lack of awareness about the availability of FDA-approved PDTs is one of the significant obstacles to their integration into clinical practice. More efforts are needed to expand knowledge about the clinical and economic benefits of these novel products, and the findings from the study above reveal that more efficacy and safety data are needed to improve confidence in PDTs and to expand their integration into clinical practice.

References

1. New effective therapy options. Digital Therapeutics Alliance. Accessed December 14, 2023. https://dtxalliance.org/value-of-dtx/patients-caregivers/
2. Trustworthy and effective therapy options. Digital Therapeutics Alliance. Accessed December 14, 2023. https://dtxalliance.org/value-of-dtx/clinicians/
3. Clinical and financial value. Digital Therapeutics Alliance. Accessed December 14, 2023. https://dtxalliance.org/value-of-dtx/payors/
4. Kumar A, Ross JS, Patel NA, Rathi V, Redberg RF, Dhruva SS. Studies of prescription digital therapeutics often lack rigor and inclusivity. Health Aff (Millwood). 2023;42(11):1559-1567. doi:10.1377/hlthaff.2023.00384