The Age of Digital Therapeutics: A Primer

You’re probably reading this because you’ve heard or seen the term digital therapeutics increasingly pop-up and want to know what exactly it entails. Or, you may be a bit more familiar with the concept but still have questions regarding the depth of what the term actually encompasses. If neither of those apply, you could even be a digital health aficionado who simply cannot get enough of this exciting field.

In any case, this overview aims to address some of those thoughts in an easy to read, concise format. Consider this article a primer on the advent of digital therapeutics in healthcare. Future posts will examine its impact from patient, clinician, payer, and legislator perspectives.

Digital therapeutics (DTx) are evidence-based interventions delivered via software to improve health. In this domain, health can be defined as not only the absence of disease, but an overall state of sustained wellness. These DTx can be used in prevention, management, or treatment of a medical disorder or disease. DTx fall within the realm of digital health in which there has been an explosion of innovation in the past few years. The amount invested in the field has increased year-over-year. There was over $2 billion of funding in digital health and therapeutics in 2020,1 and the number is projected to increase to as much as $56 billion by 20252.

The digital health, digital medicine, and digital therapeutics spectrum.
Figure courtesy of the Digital Medicine Society

Digital health is a broad discipline which encompasses user-facing software, hardware, health IT, telehealth, amongst other technologies to promote health and wellness. Digital medicine further refines the use of those mediums into diagnostics, biomarkers, and patient care.4 Digital therapeutics is a subset of digital health and medicine which leverages software to deliver evidence-based care to treat and mange disease or improve health.

Digital therapeutics (DTx) deliver evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.

— Digital Therapeutics Alliance5

As a result of the increased interest in the area, the Digital Therapeutics Alliance (DTA) was established to help guide safe adoption of these novel interventions. Per the DTA, to qualify as a DTx, a product must adhere to certain foundational principles, including:

Prevent, manage, or treat a medical disorder or disease

Produce a medical intervention that is driven by software

Incorporate design, manufacture and quality best practices

Incorporate patient privacy and security protections

Publish trial results inclusive of clinically-meaningful outcomes in peer-reviewed journals

Be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use

Digital Therapeutics Alliance: Digital Therapeutics Definition and Core Principles6

A Virtual Front Door in Healthcare

If digital health is is the virtual front door, so to speak, then digital therapeutics are the virtual treatment plans prescribed by doctors and other clinicians. They can be in the form of mobile or internet-based apps, software as a medical device (SaMD), virtual reality (VR), and other Internet of Things (IoT) devices.

The aim of DTx is to restructure interventions that would be otherwise delivered in-person into a virtual or app-based medium. Due to the nature of the intervention, DTx have largely been tailored towards the treatment of psychological and neurological disorders. There is often a lack of access to mental health professionals and specialized psychologists in many areas of the world, even in large cities and healthcare systems.

A relevant example can be seen in the management of patients with irritable bowel syndrome (IBS) and other disorders of gut-brain interaction (DGBI). Evidence has shown that gut-directed psychotherapies, including cognitive behavioral therapy and gut hypnotherapy, has good efficacy in the treatment of IBS. Moreover, these therapies often come without significant adverse effects or drug-drug interactions which are often seen with traditional pharmacotherapy. However, a frequent rate-limiting step in providing this low-risk intervention is the lack of availability of specialized psychologists, even in large institutions and tertiary care centers. To address these shortcomings, companies have already developed app-based CBT to treat patients with IBS, with clinical trial data showing positive results.

Regulatory Approval of DTx

Security Regulation

In the United States, DTx are generally reviewed and approved by the U.S. Food and Drug Administration (FDA). The FDA has already approved DTx in areas such as type II diabetes management and treatment of substance use disorders.

Notably, during the COVID-19 pandemic, the FDA relaxed certain regulations on digital remote monitoring devices7 including blood pressure and cardiac monitors, EKGs, pulse oximeters, and spirometers. This was done to expand availability and facilitate patient care while decreasing patient and provider exposure to SARS-CoV-2.

The FDA grants approval for digital therapeutics through the de novo or 510(k) pathways for medical devices after clinical trial results show superiority of the intervention. The regulatory pathway for SaMD is a bit more nuanced and a replicable framework is currently being established. 

The Digital Therapeutic Difference

So, what separates DTx from any wellness or fitness app you can find in the app store? The evidence behind their efficacy. They are required to prove their efficacy through scientific evidence or trials in peer-reviewed medical literature. DTx are also more strictly regulated and can be reimbursed by payers including employers or insurance plans.

What also makes DTx unique from traditional prescriptions or interventions is the ability of the software to be revised and improved rapidly, even without additional cost to the consumer or payer. This is generally positive, however we should also consider that a new iteration may depart from the FDA approved initial version, and in rare instances diminish its efficacy or compromise its once favorable adverse effect profile. The FDA has released papers to address these concerns in SaMD using AI and machine learning.

Considerations and Future Directions

One of the underlying issues with DTx products is the lack of prevalent and established payment models for reimbursement. There is still significant variability in how they are reimbursed. Benefits to payers include reducing overall cost of care, enhancing or optimizing current standard medical treatments, increasing patient engagement, and improving provider efficiency. They aim to expand coverage and access to care by circumventing traditional clinic-based treatment. Ultimately, this may also support value-based and outcomes-based care initiatives.

Increased education and awareness is imperative to get buy in from payers, including insurers, pharmacy benefit managers, employers, and clinicians. Patients should also be willing to accept the use of DTx as part of their care plans. Given the technology-based nature, adoption may be more difficult in older patients who are also the ones more likely to utilize healthcare resources. 

The potential benefits of DTx are numerous and their adoption is rapidly increasing, spurred by the recent pandemic. We can envision a reality in the near future where a digital pharmacy supplements, but does not replace, a traditional one. DTx can also provide us with rapidly updated data to aid in refining diagnoses and adjusting treatment plans. The real-time data produced by these products can assist clinicians in improving patient outcomes.

DTx can provide access to alternative treatment options for patients that may not otherwise be available, and do so potentially at lower costs and with a more favorable side effect profile. Future legislation should focus on providing a framework for reimbursement in which payers are incentivized to improve population health and value-based care.

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  1. A defining moment for digital behavioral health: Four market trends.
  2. Insider: Digital Therapeutics Report.
  3. Ideo
  4. Digital Health, Digital Medicine, Digital Therapeutics (DTx): What’s the difference? Digital Medicine Society:
  5. Understanding DTx, Digital Therapeutics Alliance.
  6. Digital Therapeutics Definition and Core Principles, Digital Therapeutics Alliance.
  7. Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
  8. Dang, A., Arora, D., & Rane, P. (2020). Role of digital therapeutics and the changing future of healthcare. Journal of Family Medicine and Primary Care9(5), 2207–2213.

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