Value of DTx  /  Clinicians

Digital therapeutics undergo robust clinical trials and are held to similar standards of safety and clinical evidence as traditional medical treatments. These include the proper trial design, utilization of standardized endpoints, alignment with Good Clinical Practices, appropriate reporting of outcomes, publication of results in peer-reviewed journals, and the generation and application of real-world evidence. This rigorous process enables DTx products to:

• Demonstrate safety and efficacy across the relevant and target populations
• Establish credibility
• Deliver clinically meaningful results
• Be considered as or among current standards-of-care

Digital therapeutics are regulated as medical devices. Regulatory oversight is based on product risk levels and includes:

• Compliance with national regulatory agencies, notified bodies, and manufacturing requirements
• Registration with the applicable product regulatory agency or notified body
• Affirmation that product claims are factual and supported by clinical validation, regulatory status, and marketing authorization
• Adherence to appropriate labeling and advertising regulations

Patient access to DTx products may be granted through:

• Prescription from a qualified healthcare provider
• Authorization or referral by a clinician or payor
• Eligibility determination via a validated screening tool or clinical guideline
• Delivery of an activation code via a payor or employer

DTx products are designed to generate and assess patient engagement and clinical outcomes. Data related to how many patients are accessing the technology, how often a product is used, and relevant clinical data may be delivered as appropriate to the treating clinician or payor in accordance with privacy measures. Well-established industry standards for a particular disease or disorder are used to define all relevant metrics for measuring and assessing meaningful clinical improvements.

In the United States, DTx products are increasingly covered by private payors, employers, and health systems. Public programs such as Medicare and Medicaid are still working to determine how to formally recognize and provide patients with access to DTx products.

Frameworks for national or regional payments are currently being implemented in Germany, Belgium, France, and the United Kingdom.

When evaluating whether to prescribe or authorize a DTx product, consider the following:

• Which disease or disorder is the DTx product indicated to treat, manage, or prevent?
• What is the appropriate timing, duration, and frequency of therapy use?
• Should the DTx product be used independently, or with medications, devices, or other therapies?
• Does the product enable greater access to care and align with the patient’s current care?
• Is the product content available in a familiar language for the patient?
• What actionable outcomes are collected by the product and shared with patients, caregivers, and clinicians?

DTx products provide a wide range of valuable information that can be used to optimize patient outcomes, support data-driven care management, and drive clinical decision making such as:

• Patient engagement and adherence to therapy
• Clinical responses and overall therapy progress
• Patient-generated insights
• Real-world outcomes

Data captured by DTx products can be seamlessly integrated into health system practice settings, electronic health records, formularies, and coding systems to evaluate and optimize patient health.