ISSUE: COVID-19 has highlighted the value of new digital technologies, which—in the case of digital therapeutics—have the potential to replace pharmaceuticals as a treatment for certain conditions. Digital therapeutics offer much promise: they allow better tracking real-world treatment use, permit for direct communication on treatment progress with clinicians, and the user experience can be improved over time. At the same time, digital therapeutics introduce new challenges: clinicians may not be able to distinguish treatments with high vs. low quality evidence, provider time reviewing digital therapeutics output may not be reimbursed, and there are data privacy concerns. What regulatory, payer and institutional policies need to be enacted to ensure that clinical trial results translate into the real-world?

OVERVIEW: This panel aims to identify barriers to and opportunities for maximizing the effectiveness of digital therapeutics in the real world. Dr. Shafrin will moderate the panel, providing a brief overview of some recent digital therapeutics and some of the key challenges and opportunities. Dr. Schueller will provide the academic and policy perspective, describing the unmet need for digital solutions in mental health, the need for regulatory clarity, reimbursement needs, and his digital mental health initiative known as the Day One Project. Dr. Cañadas will represent the perspective of the digital therapeutics’ manufacturer, describing opportunities where digital therapeutics can improve on pill-based treatment, as well as exploring challenges her company has faced. Finally, Dr. Burton will provide the employer and payer perspective, describing the type of evidence that would help support the case that a given digital therapeutic will be effective in the real world.