Digital Therapeutics in the United States

Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or together with medications, devices, or other therapies to optimize patient care and health outcomes. DTx Alliance

Digital Therapeutics in the United States is now a relatively mature industry with significant and growing penetration.

Digital Therapeutics are now used regularly across various elements of diabetes care (NEBGH diabetes therapeutics). They represent several different technology approaches and business models.

  • Regulated digital therapeutics are those that receive clearance from the FDA and generally follow a prescription model similar to Med-Tech and pharmaceutical therapeutics. One example in diabetes are software algorithms that dose insulin. Companies have FDA cleared and commercially available insulin dosing algorithms – (e.g., Tandem, Voluntis, Hygieia, and Welldoc).
  • Digital therapeutics that complement devices and pharma –best example is the work of Livongo to incorporate remote monitoring and coaching with blood glucose monitoring. Other examples include the work of Onduo and Welldoc.
  • Digital therapeutics that map to provider services – the best example in the US is that of the CDC’s National Diabetes Prevention Program CDC’s National DPP. The digital delivery of diabetes prevention services is recognized by the CDC with the same rigor and opportunity as the in-person provision.  Similarly, many health plans are covering digital delivery and putting digital providers in their network.
  • Digital therapeutics are being seen as covered benefits Reviewing U.S. Connected Diabetes Care.  They are (1)  now being supported by the FDA with new approaches to fast-track review and approval  FDA digital health, (2)  included in Pharmacy Benefit Manager’s formularies – e.g., ExpressScripts digital formulary,  and CVS/CIGNA, (3) many companies have insurance coverage for patients with diabetes – examples include: Livongo, Omada, and Welldoc,  and (4) digital therapeutics approved by HHS as covered evidence-based programs.
    HHS-2020-ACL-AOA-CSSG-0366.pdf  page 47/48 including Canary Health’s Better Choices, Better Health®.

Digital Therapeutics has spawned the development of effective advocacy and trade associations. Examples include: Digital Therapeutics Alliance DTx Alliance; DTxAlliance Report; and HealthTech4Medicaid HT4M.

Digital Therapeutics companies have received billions of dollars of financing with more expected in the future.  Is Digital Health for Diabetes in an Investment Bubble?  including several with valuations > $ 1 billion.

Digital Therapeutics are now covered by an increasingly robust variety of publications and journals. Examples include: Mobihealthnews; Closeconcerns ; medcitynews; DiabetesTechnology and Therapeutics; Journal of Diabetes Science and Technology;  Journal of Medical Internet ResearchJournal of Digital Health; ATTD Yearbook chapter edited by Neal Kaufman, MD, MPH.

Digital Therapeutics, from a market perspective, is a rich eco-system with a number of very large companies in the space alongside a growing number of startups digitalhealthstorymap; NEBGH digital therapeutics.  Examples include Livongo’s successful Initial Public Offering, Onduo’s purchased by Verily, MySugr’s purchased by Roche, and Omada having raised over $199.5M.

Digital Therapeutics – What’s next?

  1. Digital therapeutics have clearly passed in a significant number of use cases the required clinical evidence for regulatory approval and payer coverage
  2. They are becoming an increasing part of regular healthcare
  3. Still relatively early but now not just startups
  4. Next phase will be about how Digital Therapeutics can further weave into general care

Digital Therapeutics – Recommendations

  1. Continue to encourage innovation with focus on outcomes that matter for all stakeholders
  2. Create new evaluation approaches to demonstrating value in addition to RCTs
  3. Create collaborations between developers of digital therapeutics and plans, providers, pharma, and employers
  4. Advocate with governmental regulators for improved processes for approval of digital therapeutics
  5. Develop funding approaches which continue to encourage innovators to create digital therapeutic


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