Making Sense of DTx, PDT, SaMD, and DMP.

Digital Therapeutics (DTx) encompasses evidence-based software products prescribed by a physician to treat, manage, and prevent diseases. Since 2017, the FDA has approved ~40 digital therapeutics. And, with the success of telehealth and remote monitoring during the pandemic, digital therapeutics are accelerating in investment and adoption. In the first of two insights, we’ll define the space, providing some market sizing and what’s trending now. The second insight will highlight the FDA’s evolving approach, how provider and payer organizations use digital therapeutics, and the clinical areas in the DTx product pipeline.

What is Digital Therapeutics? Making sense of the alphabet soup.

There are a host of terms (and acronyms) emerging in the Digital Therapeutics space. Let’s review them and provide some definitions for context.

Digital Health: Refers to the use of technologies, services, and products to deliver health-related value, including digital medicine, digital therapeutics, and telehealth/telemedicine. Digital health products that aren’t classified as medical devices don’t require regulatory oversight.

Digital Medicine

Digital Medicine: Uses software/technology as a foundation for delivery like pharmaceuticals combining prescription medications, ingestible sensors. These products often require certification by regulatory bodies like the FDA.

Software as a Medical Device

SaMD: Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

Digital Therapeutics

DTx: Digital Therapeutics are most frequently categorized by regulatory jurisdictions as a subset of Software as a Medical Device or Digital Health and include “evidence-based, clinically-evaluated software products that treat, manage, and prevent diseases.”

Prescription Digital Therapeutics

PDT: Prescription Digital Therapeutics is a “new therapeutic class that uses software to treat disease.” PDTs are tested in randomized controlled trials, must demonstrate safety and effectiveness, and are used under the supervision of a prescribing clinician. Unlike other digital health solutions, PDTs receive market authorization from FDA and have a product label that addresses safety and effectiveness.

While some of these terms overlap, the term used seems to differ by industry, with pharma saying “prescription digital therapeutics” and other verticals saying digital therapeutics. Essentially, we’re talking about digital apps and technologies that a physician “prescribes” to a patient that may be covered by insurance.

Digital Therapeutics Market Sizing

Keeping these definitions in mind helps when reviewing market trends and sizing.

Digital health products cover wellness and fitness apps, diagnostic tools, and medication adherence apps. Mercom Capital Group reported that the digital health market shattered all previous funding records in the first half of 2021. While telemedicine and digital wellness companies attracted the most funding, mobile health apps ranked third for top-funded digital health categories in Q1 2021 with $1.6B.

Digital therapeutics, however, uses software to provide a patient with a clinical-grade medical intervention to prevent, treat, or help manage diseases and disorders. According to a Markets and Markets report, the digital therapeutics market is valued at $3.4B, expecting to reach $13.1B by 2026. When viewed through the prescription digital therapeutics lens, the market is expected to witness a CAGR rate of 11.20% from 2021 to 2028.

The most aggressive market sizing comes from Insider Intelligence, which expects DTx to be a $56B global market by 2025. Compared to their 2020 forecast of ~$9B by 2025, their expectations have grown six-fold.

What’s Happening in DTx Now?

There’s a lot coming out of this space and many more opportunities in the pipeline of DTx products.

  • The acceleration of telemedicine during the pandemic has had a significant effect on digital behavioral health companies, attracting $2.4B in venture funding during 2020.
  • In March 2020, the FDA approved the first prescription digital therapeutic that addressed chronic insomnia in adults. A randomized controlled trial of Daylight revealed that 71 percent of users achieved remission of generalized anxiety disorder, compared with 33 percent in a control group.
  • In November 2021, the Massachusetts Medicaid program added two PDTs to their Drug List, covering the apps for addiction treatment. The same company that created these tools has eight putative PDTs with FDA breakthrough designation and dozens more in pipeline development.
  • Many major pharma companies have established in-house digital health teams or partnered with digital health manufacturers to create and integrate DTx, providing an alternative therapeutic intervention.
  • A sampling of diseases and disorders in the manufacturer/producer or FDA pipeline include posttraumatic stress disorder, acute and chronic pain, migraine, irritable bowel syndrome, oncology, ADHD, and Opioid Use Disorder.

“Research has shown that conditions treated by PDTs, including substance abuse disorders, depression, and diabetes, tend to impact patients of lower socioeconomic status as well as racial and ethnic minorities, indicating that PDTs could potentially help close disparity gaps in healthcare.”

NCBI – March 2020

Digital Therapeutics Offer a New Class of Treatment, Greater Access, and Potential for Improved Outcomes

DTx is lauded for the potential to save clinicians time, enhance 24/7 support, expand access, and control costs. The potential for DTx, combined with other blended health tools and technologies, greatly expands physician oversight and influence while melding digital health with real-world relationships and action. Explore how DTx could accelerate your organization’s digital transformation and improve care and experience when combined with online and in-person care.

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