Arlington, VA: Over the past two months, the Digital Therapeutics Alliance (DTA) has petitioned governmental bodies across the world to provide their citizens with access to clinically-validated digital therapeutic (DTx) products. DTA has communicated with governments in Australia, Finland, France, Germany, Saudi Arabia, Scotland, Spain, United Arab Emirates, United Kingdom, United States, and the European Union. Communications have been provided in the appropriate languages, including Arabic, English, French, German, and Spanish.

DTA advised governments on how DTx products should play a critical role both during and after the Covid-19 pandemic. Digital therapeutics benefit clinicians and patients by expanding access in the following ways:

  • Provide remote access to evidence-based therapies that are clinically demonstrated as safe and effective.
  • Align with clinical guidelines, current medical care practices, and concurrent therapies.
  • Provide targeted care for patients per their schedule and in the safety of their home environment.
  • Offer scalable therapy options, with treatments being made available on patient-owned devices (e.g., smartphone, tablet).
  • Deliver actionable, real world insights to patients, caregivers, General Practitioners, and other clinicians.

DTA Executive Director Megan Coder notes, “patient utilisation of digital therapeutics has the ability to improve health outcomes following the Covid-19 outbreak, optimize concurrent therapies, and minimize co-morbidities. This may help reduce otherwise unnecessary hospitalisations, assist healthcare professionals in triaging critical patient needs, and reduce vulnerable populations’ potential coronavirus exposure.”

As part of this campaign, the Digital Therapeutics Alliance highlighted to policymakers ways that specific DTx products could impact individual and population-level needs. While product availability varies between countries, health conditions and disease states addressed by digital therapeutics include alcohol use disorder, anxiety, asthma, chronic pain, chronic obstructive pulmonary disease (COPD), depression, diabetes (type 1 and 2), insomnia, and other mental and behavioral health disorders.

“We are committed to expanding patient access to high quality digital therapeutics across the world,” shares Jessica Shull, DTA European Lead. “In many countries, the lack of governmental recognition and reimbursement of DTx products has become a major healthcare barrier. We are particularly encouraged however by efforts taking place in countries such as Germany, where the first national financing framework for digital products has been created.”

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 GDPR (in the EU), and validated clinical outcomes via randomized controlled trials (RCT) and real world evidence (RWE).

“Quality, access, and appropriate utilization are critical for all DTx products,” 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.