The Digital Therapeutics Alliance defines digital therapies (DTx) as “evidence-based therapeutic interventions driven by high-quality software programs for the prevention, management, or treatment of medical conditions or diseases.” A key question is how U.S. payers are evaluating DTx What factors are taken into account and how it differs from standard medicines.A paper by Gómez Lumbreras et al. (2024) Held virtual focus groups with 21 U.S. payers to find out. Key considerations include:
- Evidence is needed. Nearly all survey respondents (n = 19/21 90%) said they would need to conduct clinical trials to consider product coverage. Evidence includes data on efficacy, effectiveness and value (including a cost-effectiveness perspective)
- DTx Coverage: Medical, Pharmacy, Other? Many respondents were unsure whether reimbursement should be through medical or pharmaceutical benefits. The majority thought it might be the Pharmacy and Therapeutics Committee (n = 15/21, 71%), however, some participants answered “other” (n = 6/21, 29%) [see Figure below]
- FDA regulations and pending legislation. Overall, 14/21 (66.7%) of respondents asked the FDA to evaluate DTx products for consideration for coverage (especially under drug benefit coverage). Other respondents stated that FDA assessments are useful but not always necessary for coverage. Some payers noted that evidence beyond what FDA requires is needed to consider coverage of DTx products (eg, effectiveness, value).
- Reimbursement: NDC vs. CPT. Given that many policies do not cover reimbursement for over-the-counter products, many health plans require a prescription to reimburse DTx products. Participants generally agreed that a coding system is needed and that Current Procedural Terminology (CPT) codes or National Drug Codes (NDCs) would be the most effective ways to ensure reimbursement.
- obstacle. Barriers cited included durability of treatment effects, product cost, and reimbursement/payment mechanisms. Other issues include the impact of DTx products on patient engagement and treatment compliance. Many people believe that DTx is not a “real” treatment, in part because some people think they are just “apps” and similar versions can be downloaded online for free.
- Payer Management. Some claim that usage management policies (e.g., prior authorization, step editing, quantity limits) can be used for DTx just as they are for prescription drugs. Others have suggested that DTx products could be part of a care management plan, rather than covering it separately. Several participants explained that their organizations are currently using DTx products as part of clinical programs.
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