In early April 2020, the Digital Therapeutics Alliance (DTA) announced an ‘Urgent Access’ campaign to provide individuals covered by publicly funded programs with increased access to clinically evaluated digital therapeutics (DTx) from the safety of their homes. Digital therapeutics, while not intended to treat COVID-19, have the potential to offer tremendous relief to patients and caregivers, strengthen patient-clinician relationships, and provide actionable insights as we collectively rebuild our new normal during and following this pandemic.

The next phase of DTA’s ‘Urgent Access’ campaign expands the spotlight to DTx product quality and appropriate utilization. Our goal is to provide clarity on how patients, clinicians, and payors can identify, access, and appropriately use clinically evaluated digital therapeutics for the purpose of treating, managing, and preventing a broad spectrum of behavioral, mental, and physical diseases and disorders. Our Alliance is committed to increasing available resources for end users and decision makers on how to explore and adopt the potential benefits of DTx products throughout the pandemic and beyond, while minimizing the risk of potential harm from experimental products and not-yet proven therapies.

Product Claims Matter. Is this product a digital therapeutic?
Digital health products have been available to patients for well over a decade. During this time, the types of product claims, purposes, safety, and levels of clinical evidence have diversified significantly. It is therefore becoming increasingly difficult for end users to know how to properly evaluate digital health products prior to use.

General digital health products that capture, store, or transmit health data – such as lifestyle apps, fitness trackers, and consumer health information – do not necessarily require clinical evidence, real world outcomes, or regulatory oversight. In comparison, digital therapeutics – software products that treat, manage, or prevent diseases and disorders – must demonstrate clinical evidence, real world outcomes, patient privacy and security protections, and regulatory oversight as required to support product claims of risk, efficacy, and intended use.

Patients and clinicians must not only understand what a product claims to do, but also what clinical evidence is available, or even necessary, as they face the difficult decision of determining which products will best meet their needs. To assist in this navigation process, DTA members are mobilizing to provide end users and decision makers with the tools they need to make informed decisions.

Product Quality Matters. What can I expect from a digital therapeutic?
Quality extends from the components and processes used to manufacture DTx products, to the quality management systems relied on to ensure patient safety, all the way through to the outcomes achieved by these therapies. Based on industry standards, only those software products that meet the following ten criteria are considered a digital therapeutic:

  1. Prevent, manage, or treat a medical disorder or disease
  2. Produce a medical intervention that is driven by software
  3. Incorporate design, manufacture, and quality best practices
  4. Engage end users in product development and usability processes
  5. Incorporate patient privacy and security protections
  6. Apply product deployment, management, and maintenance best practices
  7. Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals
  8. Be reviewed and cleared or approved by regulatory bodies as required to support product claims of risk, efficacy, and intended use
  9. Make claims appropriate to clinical validation and regulatory status
  10. Collect, analyze, and apply real world evidence and/or product performance data

To protect against the risk of counterfeit, unproven, or potentially harmful products, these criteria provide end users and decision makers with a strong framework to understand and evaluate digital therapeutic products.

Product Access is Necessary. How can payors provide access to DTx products?
To assist public and private payors in providing access to DTx products that meet the criteria outlined above, DTA provides the following considerations (please refer to this worksheet for further detail):

  • What type of screening or clinician authorization process is necessary for appropriate patient access?
  • How is the product delivered to the patient?
  • What type of device does the patient use to access the therapy?
  • Are additional product components necessary?

Payors should also consider product implementation and scalability, clinical appropriateness, patient engagement and sustainability, privacy and security requirements, and the value provided to patients, caregivers, and clinicians — including improved health outcomes, reduced overall healthcare utilization costs, and individual and population health benefits.

National coverage frameworks for digital health products, which include access to DTx products, are currently being implemented in Germany and Belgium, while France and the United Kingdom have been reimbursing the use of DTx products regionally for more than three years.

In the United States, DTx products most frequently receive third-party payment by employers, PBMs, or insurers. Unfortunately, digital therapeutics are not currently reimbursed by Medicare or most state Medicaid programs, although we urge the federal government to take action in line with DTA’s ‘Urgent Access’ campaign.

Appropriate Utilization is Crucial. How can clinicians ensure that DTx products are used appropriately?
DTx products provide evidence-based therapy options for a wide variety of physical, mental, and behavioral conditions. Of primary concern to clinicians is clearly understanding which disease or condition the product has been indicated to treat, manage, or prevent. DTx products may be used independently, in tandem with remote or in-person clinician-delivered therapy, and/or paired with medications, devices (e.g., sensors, glucometers), and other therapies to optimize patient outcomes.

For products requiring clinician authorization, the following “DTx Rights” will help guide appropriate product utilization and ensure that the right care is delivered at the right time (please refer to this worksheet for further detail). Is this DTx product being used for the:

  • Right indication?
  • Right patient?
  • Right therapy?
  • Right timing and frequency?
  • Right cultural references?
  • Right outcomes documentation?
  • Right response to therapy?
  • Right evaluation?

Digital therapeutics are designed to meet specific patient needs at specific times. They align with clinical guidelines, integrate into health systems, and are used in the context of patients’ current care plans. It is therefore crucial that appropriate product utilization is ensured once access to high quality digital therapeutics has been provided.

Moving Forward 

Digital therapeutics create new treatment and self-management options for mental health and chronic disease populations. Building on the ease of product scalability and access through patient-owned devices, DTx products can more easily reach high-risk, rural, and underserved communities that often lack access to healthcare services even during the best of times.

In line with our mission, and in direct response to the quickly evolving global landscape, DTA will continue to develop resources for patients, caregivers, clinicians, payors, and government agencies to ensure the optimal utilization of, and access to, high quality DTx products.

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About

Founded in 2017, the Digital Therapeutics Alliance (DTA) is a non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics (DTx). DTA has over 35 global members, located in 15 countries across four continents.

Whether DTx products are used independently or by clinicians in the course of in-person, remote, or digital care models, DTA stands behind rigorous patient-centered core principles, ethical standards, and product development best practices to ensure product integrity, user-centered designs, patient privacy, and validated clinical outcomes.

DTA does not function as a certification, accreditation, or standard setting body. Nor does DTA endorse specific DTx products.