ISSUE: There is a disconnect between digital innovators, payers, and patients as it relates to the value offered by DTx (software or software-based products intended to help prevent, treat, or manage a disease or medical condition). Payers seek adequate evidence in comparison to other interventions. In the digital era, manufacturers contest that evidence standards such as RCTs are not practical while patients request access to DTx to improve quality of life. What is feasible to expedite DTx coverage decision making and improve patient care?

OVERVIEW: Biopharma companies have embraced DTx and studies have shown to improve outcomes from DTx, either alone or in conjunction with conventional protocols. While there is some optimism in DTx circles that COVID-19 will accelerate acceptance and use of these promising treatment options, the DTx sector as a whole is still in the early stages of development and the needs for payers to evaluate these products is not well understood. Each panelist will present information from current practice and survey results (15 mins each) to debate:

• What role does regulatory approval for DTx play?
• How can we measure, analyze and interpret improvements from DTx?
• What are the competencies needed for evaluation?
• How could RWE improve certainty for payers?
• How can evidence be communicated between payers and manufacturers?
• What are the issues around implementation for healthcare systems?

An interactive discussion around these topics with participants will follow the presentations. Participants from payers, DTx manufacturers and HTA bodies will benefit from attending. The feedback collected will provide opportunities to define further research questions and examine recommendations for the next steps with a new focus on the challenges of DTx solutions.