DTA Applauds CURES 2.0 Leadership

Arlington, VA: In June, the Digital Therapeutics Alliance (DTA) lauded the vision of Representatives DeGette (D-CO) and Upton (R-MI) on their CURES 2.0 Initiative and their leadership “in eliminating barriers to innovation in the healthcare system.” DTA provided a letter with recommendations that align with our Alliance’s ongoing 2020 global initiative to break down patient access obstacles to clinically-evaluated digital healthcare.

Our comments highlighted how major healthcare payors in the United States, such as Express Scripts, CVS Health, Cigna, and individual BlueCross and BlueShield plans, offer digital therapeutic options to their commercial customers. However, since traditional Medicare and Medicaid plans do not currently have systems in place to recognize and offer access to digital therapeutics, aging and low-income populations are denied access to these remotely delivered, evidenced-based treatment options.

Digital therapeutics are critical to patient care, particularly in their ability to address the following issues:

• The growing mental health epidemic likely to follow the lockdown: Prior to Covid-19, 115 million Americans lived in mental healthcare shortage areas. This number is expected to increase as Americans continue adjusting to unfamiliar new normals, while already overburdened healthcare providers face new demands on their time and work to address outstanding patient backlogs. DTx products offer significant opportunities to address new and ongoing behavioral and mental health concerns. Examples include DTx products that lead to remission for 50% of PTSD patients, the ability to double drug abstinence rates for those in substance abuse recovery, and result in remission for 71% of users with generalized anxiety disorder.
• Extended isolation requirements for older individuals and the chronically ill: Since DTx interventions are delivered to patients from the safety of their homes, vulnerable populations may receive active therapy during extended isolation periods. Research demonstrates that DTx products can significantly improve chronic disease health outcomes. Sample outcomes include DTx products’ ability to significantly reduce A1c levels in diabetes, increase control of asthma and COPD symptoms, and improve patients’ ability to manage chronic back pain symptoms.
• Underlying health inequities of underserved populations: DTx products may be used to deliver high quality therapies to underserved populations. This is particularly important when Blacks are 60% more likely to have diabetes and 20% more likely to have asthma. Similarly, Native Americans and Latinx populations have higher rates of multiple chronic diseases and face numerous barriers to receiving consistent, high quality care. It is critical that these individuals receive equitable access to healthcare services and treatments that are provided in-person and digitally.

“The impacts of Covid-19 on patients and clinicians continue to grow as quarantines are extended, as vulnerable populations are increasingly at risk of viral exposure, and healthcare resources are further restricted to those requiring acute care,” said Megan Coder, DTA Executive Director. “While digital therapeutics do not treat Covid-19, they directly impact critical consequences of this pandemic. Yet today, patients covered by publicly funded programs rarely have access to this category of medicine.”

Digital therapeutics 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 differ from health and wellness apps, telehealth platforms, or tools solely designed for monitoring, diagnostic, and adherence purposes. DTx products comply with rigorous patient-centered core principles and best practices to ensure product integrity, user-centered designs, patient privacy through HIPAA (in the US), and validated clinical outcomes via randomized controlled trials (RCT) and real world evidence (RWE).

“Product quality, patient access, and appropriate utilization are critical for all digital therapeutics,” emphasized Coder. “We support quality standards to ensure that patients and clinicians can be assured they are accessing a trustworthy treatment that has undergone rigorous clinical research. Building on the ease of product scalability and access through patient-owned devices, DTx products can more easily reach high-risk, rural, and underserved communities that often lack access to healthcare services even during the best of times.”

About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more please visit: www.dtxalliance.org.