The field of prescription digital therapeutics has grown substantially over the past few years. These innovative products use software to provide interventions that treat, manage, or prevent a disease or disorder. Unlike general wellness or fitness apps, many of these products are developed using quality best practices, evaluated by the FDA to support claims of efficacy, and intended use, and have clinical trial data showing meaningful clinical outcomes. Unfortunately, Medicare does not have a clear benefit category for these products, creating coding and reimbursement uncertainty that can hamper patient access.

A US-based digital therapeutics developer focused on cardiometabolic disorders created a solution that uses cognitive behavioral therapy to help people with Type 2 diabetes improve glycemic control and lower HbA1c levels. The digital therapeutics developer turned to ADVI Health to help navigate their reimbursement strategy supporting the company’s efforts to improve access to these promising new therapies.

The Strategy

Drawing from its extensive range of experience with coding, coverage, reimbursement, and policy support to help clients understand the current and potential future landscape, ADVI was well positioned to help the client achieve their goals to inform future planning considerations against its projected product launch. Working closely with the digital therapeutics’ developer, ADVI designed and completed an assessment to help them understand existing coverage and reimbursement environment for their product. The synthesized report also provided broader insights on the challenges and opportunities in the field of prescription digital therapeutics, overall.

The Results

Within two months, ADVI designed an assessment to support the expected launch date of the product by mid-to-late 2023. In addition, the strategic roadmap ADVI developed provided invaluable insights supporting both short-term reimbursement strategy as well as long-term strategy, inclusive of key milestones and opportunities.