What Are Digital Therapeutics and Their Use Cases?

WHAT ARE DIGITAL THERAPEUTICS?

Digital therapeutics are evidence-based, clinically evaluated software and devices that can be used to treat an array of diseases and disorders, according to the Digital Therapeutics Alliance, the industry's trade association. They can be used independently or with medications, devices, and other therapies to treat physical and behavioral health conditions, including pain, diabetes, anxiety, post-traumatic stress disorder, and asthma.

According to the alliance, all software and devices that claim to be digital therapeutics must adhere to certain foundational principles, including incorporating patient privacy and security protections, publishing trial results in peer-reviewed journals, and receiving clearance or certification by regulatory bodies.

As the digital therapeutics industry has grown over the last decade, the companies developing these products have made a concerted effort to bolster clinical evidence backing their use.

"Five years ago, digital therapeutics were still being tested and validated," Eddie Martucci, co-founder, and CEO of prescription digital medicine company Akili Interactive, previously told mHealthIntelligence. "People had questions about the efficacy of DTx [digital therapeutics], and for many, digital therapeutics felt like science fiction. We've pushed hard for clinical validation in this industry, and in the last five years, we've seen a significant amount of clinical validation for DTx, including compelling real-world data showing how these new approaches can help improve patients' lives."

USE CASES FOR DIGITAL THERAPEUTICS

According to the Digital Therapeutics Alliance, there are three main product categories for digital therapeutics: products to treat a disease, manage a condition, and improve a health function.

Products in all three of these categories must "deliver a therapeutic intervention and use clinical endpoints to support product claims," the alliance states.

One key use case for digital therapeutics is chronic pain. Kaia Health offers a musculoskeletal digital therapeutic that focuses on pain relief. The MSK solution guides patients through physical therapy using an algorithm to evaluate performance and adapt exercises to patient needs. It also connects users to coaches and medical providers when necessary.

In a study published in JMIR Human Factors, researchers conducted a comprehensive assessment of reported adverse events by nearly 140,000 users of the Kaia Health solution. The study showed that fewer than 1 percent of users reported any adverse event.

"Science has evolved significantly in the medical field over time and has enabled people to live longer lives, healthier lives, better lives than they previously could," Nigel Ohrenstein, president of Kaia Health, previously told mHealthIntelligence. "Digital therapeutics is just another frontier in that evolution."

Last November, AppliedVR's EaseVRx became the first virtual reality-based digital therapeutic for pain relief to gain Food and Drug Administration approval. EaseVRx is a virtual reality headset preloaded with software content that guides chronic low back pain patients through an eight-week program. Device users reported, on average, a 42 percent reduction in pain intensity, according to one study.

Another use case is diabetes care. Several companies offer digital therapeutics for diabetes care, including Omada Health and Better Therapeutics.

Omada's solution combines data from continuous glucose monitoring devices with virtual physician visits, peer support, and health coaches to improve diabetics' health metrics. An Omada Health-backed study shows that digitally enabled diabetes self-management education and support can improve hemoglobin A1c levels and medication adherence.

Meanwhile, Better Therapeutics provides a form of cognitive behavioral therapy focused on nutrition that aims to improve outcomes among people with type 2 diabetes. The company recently achieved the primary endpoint in the clinical trial of its BT-001 platform. Nearly 43 percent of the patients receiving standard care and BT-001 achieved A1c reductions of 0.4 percent or more, compared with 25 percent of those who only received standard care.

In addition to chronic conditions, digital therapeutics for mental and behavioral healthcare are rising.

Akili Interactive provides a proprietary prescription video game treatment, EndeavorRx, which aims to improve attention function in children with attention deficit/hyperactivity disorder. The treatment deploys sensory stimuli and motor challenges to target and activate specific networks in the brain related to certain cognitive functions, Martucci previously explained to mHealthIntelligence.

One study, published in The Lancet Digital Health, shows that EndeavorRx improved objective attention in children with ADHD between 8 and 12 years.

Freespira provides a digital therapeutic that incorporates a sensor, physiological feedback display, and coaching to help patients alleviate anxiety attacks and post-traumatic stress disorder symptoms. Research shows that 93 percent of users experienced a clinically significant reduction in panic symptoms one-year post-treatment.

Finally, there are digital therapeutics focused on substance use disorders. Pear Therapeutics' reset and reset-O products treat substance and opiate use disorders, respectively. They are 12-week programs that provide a specific type of cognitive behavioral therapy called the community reinforcement approach, Corey McCann, president and CEO of Pear Therapeutics, previously told mHealthIntelligence.

Patients who received the community reinforcement approach intervention plus contingency management exhibited, on average, 9.7 total days more of abstinence, according to one study.

REGULATION OF DIGITAL THERAPEUTICS

Digital therapeutics are regulated as medical devices and are usually categorized as a subset of software-as-a-medical-device, according to the Digital Therapeutics Alliance.

The Food and Drug Administration is responsible for approving new digital therapeutics within the software-as-a-medical-device category. When considering approval, the agency assesses several factors, including whether there is a valid clinical association between the software output and the targeted clinical condition.

The FDA created the Digital Health Center of Excellence to provide advice and support for the regulatory review of digital health technology. It also supports various plans to advance digital health technology approvals, including the Software Precertification (Pre-Cert) Pilot Program. The program will inform the development of a future regulatory model that provides more streamlined and efficient oversight of software-based medical devices.

According to healthcare industry leaders, gold-standard evidence needs to drive the approval of digital therapeutics. In an article for Health Affairs, Troyen Brennan, MD, chief medical officer of CVS Health, John Torous, MD, director of the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center, and Colin Espie, PhD, professor of sleep medicine at the University of Oxford in the UK, argued that regulatory standards for digital therapeutics need to guard against treatments that merely provide a placebo effect.

They recommended specific criteria that should be applied to digital therapeutics, including that the treatment efficacy of digital therapeutics needs to be supported by randomized clinical trials.

"To be clear, we believe that patients can benefit hugely from the bumper digital harvest, but only if we separate the wheat from the chaff," they wrote.