​ Health Information Technology

Digital Therapeutics

An emerging field

By Megan Coder, PharmD, MBA, and Christina Nyquist

s COVID-19 continues to impact health systems, lessons learned to date can assist in determining how to navigate ongoing challenges, and could lead to improvements in addressing ever-increasing levels of chronic disease, mental health, and opioid abuse. To build a stronger and more holistic health ecosystem, it is critical that technologies such as telehealth and remote monitoring become foundational components—along with the emerging field of digital therapeutics.

Defining DTx

Still in a relatively early stage of formation, digital therapeutics (DTx) are a subcategory of digital health technologies that deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a disease or disorder. DTx provide patients, caregivers, and clinicians with access to new models of remote and on-demand care, with evidence-based treatment delivered through personal devices such as smartphones and tablets.

DTx products must comply with ten rigorous patient-centered core principles and best practices (https://tinyurl.com/mp-dtx-best-practices) to ensure product integrity, user-centered designs, patient privacy, and validated clinical outcomes via randomized controlled trials and real-world evidence.

All products claiming to be a digital therapeutic must:

• 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.
• Engage end users in product development and usability processes.
• Incorporate patient privacy and security protections.
• Apply product deployment, management, and maintenance best practices.
• 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.

• Make claims appropriate to clinical evaluation and regulatory status.
• Collect, analyze, and apply real world evidence and/or product performance data.

​DTx products must comply with ten rigorous patient-centered core principles.

Many DTx products are used in concert with other devices, medications, or therapies to optimize patient care and health outcomes, while others may be used independently. Collectively these treatment options yield distinct, additive benefits to patients’ physical, mental, and behavioral health.  In the United States, private insurers, pharmacy benefits managers, and employers are increasingly embracing digital therapeutic technologies to improve patient outcomes.  As a result of observations from the COVID pandemic, three important things  present expanded opportunities for digital therapeutics.

Underlying health disparities have resulted in unequal impacts.

Minority populations in the United States have suffered from the COVID-19 pandemic disproportionately. The Black community has the highest age-adjusted mortality rate in the United States from COVID, estimated at 3.8 times the rate for White populations. Native American and Hispanic populations experience similar disparities with estimated mortality rates 3.2 times and 2.5 times, respectively, that of White populations.

The unacceptable impacts of COVID-19 on minorities parallels longstanding, well-documented health disparities within these communities. Using diabetes as an example, the rate of disease in Black adults is 60% higher than White adults, with Hispanics being 1.4 times more likely than White adults to die from diabetes. In the U.S., Native Americans account for the highest rate of diabetes, with one in six individuals receiving this diagnosis, and in some tribes as many as 60% of adults having Type 2 diabetes.

Mental health shortages have long persisted and may worsen through and following this national emergency.

Prior to COVID-19, 115 million Americans lived in a mental health care shortage area. This number is expected to increase as Americans continue adjusting to unfamiliar “new normals,” while already overburdened health care providers face new demands on their time and address outstanding patient backlogs. Research by the Well Being Trust indicates the aftermath of the COVID-19 pandemic is likely to trigger another 75,000 deaths of despair from drug abuse, alcohol misuse, or suicide. The United States will be unable to meet this heightened need for mental health services if we rely solely on traditional sources of counseling and treatment.

​

Technology adoption is essential to a health care system under duress.

During coronavirus isolation periods, Americans of all ages and backgrounds quickly adopted the use of a wide range of technologies to continue working, maintain connections to friends and family, and connect with health care services. Many clinicians embraced telehealth and other technologies for the first time to meet with and serve patients, to the extent that telehealth visits in the United States increased 4,347% in March 2020 compared to March 2019.

Overall, patient and clinician experiences have been favorable, with 74% of patients reporting high satisfaction with telehealth usage and 57% of clinicians viewing it more favorably than before COVID-19. While the immediate scaling of telehealth has been very successful, further benefits could result with additional technologies such as remote monitoring tools and digital therapeutics being layered into the broader care ecosystem. With these integrations, clinicians will be able to treat patients across existing language barriers (e.g., Spanish and other non-English speaking populations), in addition to having access to objective physical measurements and clinical outcomes to better assess and optimize therapy, thus moving beyond patient recollection and perception of health status as sole sources of clinical evidence.

Immediate value of digital therapeutics

Building on the ease of product scalability and access through patient-owned devices, the lessons learned during COVID-19 demonstrated that DTx products can more easily reach high-risk, rural, and underserved communities that often lack access to health care services even during the best of times. Among numerous other patient benefits (see https://tinyurl.com/mp-dtx-benefits), these products provide patients and clinicians with actionable real-world insights, introduce a new degree of flexibility for patients who may have difficulty leaving work or school for medical appointments during traditional office hours, and increase the number of languages in which active treatment may be delivered.

​DTx products are used in concert with other devices.

Chronic Diseases. Clinical research has demonstrated that digital therapeutics are highly effective for health conditions such as asthma and diabetes, where prominent disparities exist. Propeller, a digital therapeutic developed for asthma, has demonstrated a 50% reduction in emergency room hospitalizations and a 63% increase in asthma control. Several effective digital therapeutics are available for patients with diabetes. BlueStar, Welldoc’s DTx product for Type 1 and Type 2 diabetes, lowers A1c levels on average between 1.7 to 2.0 points. DarioHealth’s DTx product showed a 50% reduction in hypoglycemic events over 24 months, plus a 60% drop in hyperglycemic events over a year. Voluntis’ Insulia, a DTx product that generates personalized insulin titration recommendations, showed at four months that twice as many patients with Type 2 diabetes achieved an A1c <7 versus a control group (29.8% vs 12.5%).

Behavioral & Mental Health. Digital therapeutics may also dramatically improve access to mental health treatment. Since they are often provided in the context of traditional or novel clinician-delivered care models, DTx products can expand clinicians’ ability to care for patients in and beyond traditional settings by providing clinical grade, personalized therapies to patients in their home environments. This has enabled health systems to begin filling critical gaps in patient care.

Clinical research has demonstrated the success of numerous DTx products in treating mental health conditions. For example:

SilverCloud Health’s DTx product, Space from Depression, demonstrated that 60% of patients with a diagnosis of depression achieved recovery criteria after three months of usage.

Big Health’s Sleepio showed that sustained sleep health can be achieved in 76% of users with sleep problems.

A randomized controlled trial with Vorvida demonstrated significant improvements in patients with alcohol use disorder, increasing those with “low risk drinking patterns” from 7.5% at inception to 38.9% by the six- month mark.

ReSET, a DTx product for substance use disorder, is able to double abstinence rates among individuals with opioid and other substance use disorders.

Freespira demonstrated that approximately 88% of patients with Post Traumatic Stress Disorder (PTSD) experienced an alleviation of symptoms. Additionally, PTSD patients had a statistically significant reduction in CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) at two months post-treatment, with 50% in remission at six months.

​

What’s next?

As with any new category of medicine, the rewards and risks must be intensely studied to appropriately guide patients, clinicians, and health systems through the development and adoption phases to ensure quality outcomes. Stakeholders across the digital therapeutics spectrum have made significant steps in terms of product design, evaluation, and meaningfulness in the context of patient care. There is still much to be done across the broader health care industry to ensure that these products are appropriately represented in clinical guidelines, covered alongside other medical treatments, and delivered at scale to patients across the world.

Advances made within other sectors of the digital health technology landscape, such as telehealth, need to be expanded to include DTx products. Interoperable platforms must be further developed to enable greater fluidity between monitoring, diagnostic, and therapeutic tools, while providing an increased ability to reach target populations.

Digital therapeutics can produce significant personal and public health benefits. Product quality, efficacy, usability, and appropriateness are of paramount importance. The Digital Therapeutics Alliance (DTA) is committed to advancing these principles and working with health care decision-makers to ensure that industry education and convening efforts directly support patients, caregivers, and clinicians as they face critical changes in how health care is delivered during and beyond this pandemic era.

Megan Coder, PharmD, MBA, is executive director of the Digital Therapeutics Alliance (DTA). Dr. Coder graduated from the University of Wisconsin—Madison School of Pharmacy and completed an Executive Residency in Association Management & Leadership with the American Pharmacists Association.

Christina Nyquist, is chief strategy officer at the Digital Therapeutics Alliance. Previously, she spent eight years as vice president, regulatory affairs with Aetna and 18 years with the Blue Cross Blue Shield Association.