Pocket-Sized Solutions: How Can We Balance Value, Evidence, and Stakeholder Needs for Digital Therapeutics?

ISSUE:

The Digital Therapeutics (DTx) Alliance defines DTx as delivering interventions directly to patients using evidence-based, clinically evaluated software. Yet, there are thousands of apps on the market that claim to function as DTx with no regulatory approval or clinical evaluation, creating a significant challenge for end-users and health-care decision makers. Patient-consumers are the primary users of DTx, while funding may come from many sources (e.g., direct consumer payments, health insurance, public funds, employers, or industry or third-sector patient support). Different stakeholders are likely to have different priorities for evidence and evaluation. This diversity in development rigor, end-customer, and remunerator makes centralized regulation and value assessment infeasible, and both funders and patient-consumers must make decisions about the value of these technologies. Traditional evidence standards and value assessment frameworks for pharmaceuticals do not address this challenge.

OVERVIEW:

Karen Robinson will introduce the framework developed for the AHRQ Evidence-Based Practice Center Program to evaluate mental health apps, including effectiveness, privacy/security, risk/safety, and technical functionality. The framework is intended for advocacy organizations, payers, healthcare systems, and other stakeholders selecting mental health mobile apps.

Chris Sampson will describe his research evaluating Sleepio, the first DTx recommended by NICE in the UK. He will summarise NICE’s evidence standards framework for digital health technologies and consumer-facing guidance in the UK, highlighting the limitations of current guidance.

Suhas Krishna will describe how Bristol Myers Squibb evaluates the value to the company, patients, and providers of DTx which complement drug therapies and provide support to patients.

We will then have an interactive discussion with the panelists and audience about what questions are important for different stakeholders, the feasibility of collecting and sharing evidence, and practical ways forward to make it easy for patient-consumers to pick the “right” app.