As COVID-19 continues to impact how populations with chronic diseases and mental health conditions across the world are living and receiving healthcare, it is important to consider how the use of a new category of medicine may address some of the emerging challenges – and increasingly growing pressures – introduced by the new realities of life created by COVID-19.

First, what is a digital therapeutic?
Digital therapeutics (DTx) deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of behavioral, mental, and physical diseases and disorders. These products are not intended to directly treat COVID-19.

DTx products may be used independently or in tandem with remote or in-person clinician-delivered therapy to optimize patient outcomes. They differ from lifestyle and wellness apps, adherence, diagnostic, and telehealth products.

Digital therapeutics undergo clinical trials, collect real world outcomes, and are based on patient-centered core principles and product development best practices, including product design, usability, data security, and privacy standards.

How could DTx products address prevailing concerns resulting from COVID-19?

Patients with chronic diseases are facing new challenges in the midst of the COVID-19 pandemic. These individuals still need to manage their conditions, but no longer have as much flexibility in seeing their healthcare providers, picking up and managing their medications, exercising, and eating well-balanced meals, among many other things. The current burden of COVID-19 exacerbates how patients are able to self manage their conditions due to social distancing, isolation, and complications in accessing healthcare services.

What value could DTx products bring to this situation?

  • Increase remote access to therapies that are clinically demonstrated as safe and effective.
  • Provide care independent of a patient’s schedule and in the safety of their home environment.
  • Are easily scalable and often accessible through patient-owned devices (e.g., smartphones, tablets).
  • Generate actionable, real world insights that enable intelligent data-driven care management and clinical decision making.
  • Have the potential to measure the use of medications and consumables (e.g. glucose test strips), and use this information for automatic home-delivery refills, thus avoiding additional trips to the store.
  • DTx product examples include:
    • DarioHealth’s product for type 1 and type 2 diabetes has shown that patients experienced reduced hypoglycemic events by 50% and high glycemic events by 40% over a 2-year period.
    • BlueStar, Welldoc’s product for type 1 and type 2 diabetes, aids patients in diabetes self-management in the home and clinical settings, in addition to delivering 1.7 – 2.0 A1c reductions in clinical and real-world studies.
    • Kaia Health’s DTx product enables chronic pain sufferers to self-manage their condition and associated psychosocial aspects at home using only a smartphone – increasing healthcare access during this transitionary period for many workforces. Users showed a 43% pain level decrease compared to controls in its latest randomized controlled trial (RCT).

Patients with anxiety, depression, cognitive impairments, and other mental health conditions are also facing new challenges in the midst of the COVID-19 pandemic. With an increased focus on social distancing, people are facing long periods of quarantine, social isolation, and uncertainty. These conditions are often significantly impacted by stress, and children and adults will likely not receive the stimulation they normally would for long periods of time. Healthcare systems do not currently have the capacity to provide evidence-based therapies to all of the individuals dealing with mental health conditions and disorders. This represents a high degree of unmet medical need.

What value could DTx products bring to this situation?

  • Enable the expansion of care outside of a traditional clinic setting and offer treatments for non-communicable diseases without requiring physical patient contact.
  • Provide ubiquitous access to treatment options for conditions that previously have been untreated or undertreated by traditional medications and therapies.
  • Provide patients, caregivers, and clinicians with secure progress updates.
  • DTx product examples include:
    • SilverCloud Health’s studies have shown in university students a 25-45% improvement in depression, anxiety and stress scores at 3 months, and an RCT in a routine care setting showing lasting positive effects on depression, anxiety, and functional impairment up to 12 months after start of treatment.
    • Big Health’s product, Sleepio, demonstrated in a placebo-controlled RCT and 11 additional studies that 76% of users achieved healthy sleep levels. Health economic data also suggest that Sleepio is associated with reductions in health care costs.
    • Happify’s RCT found a 25% reduction in both the symptoms of anxiety and depression for patients when compared with an active comparison condition, pyschoeducation, and used as directed by this study.
    • Palo Alto Health Sciences’ product, Freespira, has demonstrated success with these patient populations, showing that after 4 weeks of at-home treatment, more than 80% of patients were panic attack free. Further, 88% of patients with PTSD had a statistically significant reduction in the CAPS 5 score (validated PTSD assessment) at 2 months post-treatment.
    • Akili Interactive’s candidate DTx product is designed to improve attention in children using video game-based experiential medicine, showing a statistically significant improvement in objective measures of attention in a randomized, controlled trial of 348 children with ADHD (Attention-Deficit/Hyperactivity Disorder).
    • reSET and reSET-O from Pear Therapeutics increase access for patients to Substance Use Disorder and Opioid Use Disorder treatments. Without therapeutic interventions, these patients risk feeling isolated and may revert to using addictive substances.

Healthcare systems are searching for ways to reduce unnecessary clinic visits and hospitalizations for non-acute conditions. If the environmental conditions necessitated by COVID-19 push patients with mental health and chronic disorders into uncontrolled states, these individuals are more likely to require immediate care, thus delivering an additional strain on the healthcare system. Additionally, for patients over the age of 70, this presents an increased likelihood of them being exposed to the virus, infecting others, or demonstrating worse clinical outcomes.

What value could DTx products bring to this situation?

Patient Access
In order to address growing mental health needs, provide remote care for patients with chronic conditions, limit viral exposure for aging populations, and reduce unnecessary burdens on clinicians and health systems, it is crucial for patients to be given access to evidence-based digital therapies from the safety of their home environment.

National coverage frameworks for digital health that include DTx products are currently being implemented in Germany and Belgium, while France and the United Kingdom have been financing 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 currently are not reimbursed by Medicare or most state Medicaid programs.

Conclusion
This is a challenging and disruptive time for everyone. As we all take the steps necessary to keep our loved ones and ourselves healthy, safe, and cared for, it is important to consider technologies that are available to provide accessible treatments wherever a patient is located, without creating an additional burden on medical professionals.

Patient access to and utilization of digital therapeutics could improve health outcomes, thereby reducing chronic disease-related hospitalizations, mitigating additional pressures on healthcare providers during the COVID-19 outbreak, and reducing vulnerable populations’ potential coronavirus exposure.

 

About DTA
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. DTA has over 35 global members, located in 15 countries across four continents.

DTA does not function as a certification, accreditation, or standard setting body. DTA does not endorse specific digital therapeutic (DTx) products, nor does information provided through DTA intend to serve as patient-specific medical advice.