Value of DTx  /  Payors

Digital therapeutics require a fit-for-purpose evidentiary standard due to their agile development processes, mechanisms of action, ability to generate real-time outcomes, ongoing iterative nature, lower potential risk profiles, and place in clinical therapy. Although a DTx-specific standard will incorporate aspects of existing drug and medical device frameworks, it must include tailor-made components that enable appropriate and efficient DTx product design, capability, and performance assessments.

DTx products are designed to track and measure adherence and clinical outcomes. Study types conducted by DTx products include Randomized Control Trials (RCT), Real-World Evidence (RWE) trials, and Health Economic and Outcomes Research (HEOR).

Data including how many patients are accessing the technology, how often a products is used, and clinical outcomes are delivered to the treating clinician and the payor in alignment with privacy and security requirements. Well-established industry standards for a particular disease or disorder are used to define all relevant metrics for measuring and assessing meaningful clinical improvements.

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

• 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

Compared to products that track fitness, encourage medication adherence, or monitor patient activity, DTx products deliver medical interventions directly to patients. As such, digital therapeutics undergo rigorous testing and are held to the same standards of evidence and regulatory requirements as traditional medical treatments.

Wellness and fitness apps that consumers download to their smartphones are not typically regulated, nor do they need to prove product claims by scientific testing or clinical evidence.

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

Digital therapeutics complement traditional medicine in the treatment, management, and prevention of a wide range of chronic and mental health conditions. They provide patients with access to clinically proven treatment options outside of traditional office settings, thereby expanding access to needed medical care. By directly delivering medical interventions to patients, tracking progress and reporting outcomes, and increasing clinician capacity through the use of remote technologies, DTx products create substantial value in improving population health.

Additionally, real-world outcomes generated by digital therapeutics may be used to optimize outcomes at the individual patient and population levels. At the individual patient level, DTx products provide clinicians with meaningful, actionable clinical reports. At the population level, data generated by DTx products may be aggregated to track progress or compare aggregate outcomes based upon patient disease state, level of acuity, geographic location, age, gender, etc.

Europe

National coverage frameworks for digital medical devices (DMD) that include DTx products are currently being implemented in Belgium, France, Germany and the United Kingdom.

To learn more visit the DTx Policy Landscape website.

United States

In the United States, DTx products most frequently receive third-party payment through employers, Pharmacy Benefit Managers (PBM), insurers, or other third-party payors. DTx products may be covered under the medical benefit, the pharmacy benefit, or through other forms of contracting.

In some cases, facilities may receive a bundled payment as part of a diagnosis-related group (DRG), while licensed providers prescribing or authorizing DTx products may be reimbursed for their time under professional fees such as CPT codes.

Public programs in the United States, such as Medicare and Medicaid, are still working to determine how to formally recognize and provide patients with access to DTx products.