Evaluating Coverage for Prescription Digital Therapeutics

Digital health is a new frontier in health care, continually bringing new tools to the market, with the promise of many more in the near future. A presentation at AMCP Nexus 2023 offered insights into the process of reviewing prescription digital therapeutics (PDTs) for inclusion on a formulary.

PDTs are software-based medical interventions prescribed by health care professionals to treat specific medical conditions. They are reviewed and approved by the FDA and require a prescription. Examples include Regulora for irritable bowel syndrome and reSET-O for opioid use disorder. Many PDTs allow patients to access treatments from anywhere via their personal devices (e.g., smartphones, tablets), reducing in-person visits. They often aim to enhance engagement through gamification, progress reports, and real-time feedback. They may even offer data to health care providers via remote monitoring or provider dashboards, allowing prescribing providers to assess adherence and outcomes.

“PDTs can empower patients to take an active role in managing their own health,” according to speakers Mahsa Salsabili, PharmD, PhD, pharmacoeconomics specialist for health consulting at UMass Chan Medical School; Neha Kashalikar, PharmD, manager of strategic pharmacy contacting at forHealth Consulting in the UMass Chan Medical School; and Kimberly Lenz, PharmD, MBA, FAMCP, chief pharmacy officer at forHealth Consulting. “[They] may complement existing treatments by providing additional support, reinforcement, or practice outside of therapy sessions.”

The industry has to consider when and how to include specific PDTs in formularies. The authors recommended the following core considerations:

  • Prevalence: the number of members with the condition for which the product is indicated.
  • Efficacy: data from clinical studies demonstrating efficacy, clinical benefit, and/or medical necessity.
  • Safety: potential adverse effects.
  • Cost: estimated cost per member per year.

The speakers also offered many secondary issues an organization may consider when evaluating a PDT for a formulary, such as whether the intervention can help a population with otherwise limited treatment options or reduce health care disparities. Perhaps the PDT in question can reduce emergency department visits, hospitalizations, and readmissions; enhance adherence to other treatments; or improve patients’ physical, psychological, and/or social functioning, they added.

The speakers offered a case study illustrating their experience implementing reSET® and reSET-O® at their institution. They encouraged payers to use creative contracting solutions and rebates to increase adoption of PDTs while offsetting potential costs.


Salsabili M, Kashalikar N, Lenz K. Evaluating Coverage for Digital Therapeutics: A Case Study and Lessons Learned. Session M2. Presented at AMCP Nexus 2023; Oct. 16‒19, 2023; Orlando, Fla.