“Urgent Access” campaign aims to provide individuals covered by publicly funded programs with increased access to clinically evaluated digital therapeutics from the safety of their homes during this critical time.

ARLINGTON, VA – April 7, 2020 – During this uniquely challenging time, patients with chronic diseases and mental health conditions are struggling to receive consistent medical care due to travel restrictions and isolation measures resulting from the COVID-19 crisis.

In response, the Digital Therapeutics Alliance (DTA) is announcing an industry-wide “Urgent Access” initiative to further expand patient access to clinically evaluated digital therapeutics (DTx). DTx products deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a spectrum of medical conditions. DTA’s legislative and regulatory proposals intend to provide new therapeutic options for patients with critical unmet needs during this pandemic.

“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 hospital care,” said Dr. 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.”

Campaign to Provide Patient Access
DTA’s urgent, multi-pronged effort for immediate legislative and regulatory changes will benefit patients through increased access to clinically evaluated DTx products during this critical time:

  1. In the United States, a public policy campaign to accelerate access to digital therapeutics for vulnerable populations. DTA calls for Health & Human Services (HHS) to use their emergency power to clarify that Medicare and Medicaid will provide access to digital therapeutics in this time of crisis. If HHS fails to do so, and in line with DTA’s current legislative efforts, we ask Congress to intervene to provide this access.
  2. In Europe, a campaign to reduce the challenges patients face in accessing digital therapeutics. DTA calls for European Ministries of Health to authorize and expand use of CE-marked DTx products within their healthcare systems. For countries where authorization and financing pathways are already available, we call on medical professionals to authorize DTx products for appropriate populations.

Additionally, DTA is highlighting the efforts member companies are undertaking to directly engage in the pandemic response. DTA members are not only making DTx products available to patients in need, but companies are also donating medical supplies, manufacturing respirators, and producing medications that directly aid patients affected by COVID-19.

Risk of Overlooking Critical Benefits
Populations with chronic medical conditions such as diabetes, lung disease, and heart disease, in addition to those facing existing disparities and inequities in healthcare access, are at an increased risk of being hospitalized with COVID-19. When vulnerable populations do not have access from the safety of their homes to clinically-validated therapies that align with clinical guidelines and current care, they are at greater risk of worsening, relapsing, or requiring in-person care.

“The usual burdens faced by patients with chronic conditions are compounded during this challenging period,” shares Dr. Anand K. Iyer, Vice Chair, DTA Board of Directors. “The goal of digital therapeutics is to provide patients with safe and secure self-management and treatment mechanisms that align with their current care, while simultaneously improving health outcomes, reducing unnecessary costs, and significantly reducing emergency room visits and other in-person healthcare encounters.”

Specific to behavioral and mental health disorders, digital therapeutics address patient needs arising from standalone conditions, underlying mental health issues stemming from co-morbid chronic diseases, in addition to acute burdens resulting from COVID-19. As individuals under stay at home orders seek ways to treat and manage their conditions, the solitude of confinement may further add to their burden of disease.

“Even during the best of times, access to effective mental healthcare is a challenge for many. At a time like this, when many are isolated and suffering extraordinary stress, with healthcare systems being under enormous strain, this challenge is exacerbated. Digital therapeutics can play a critical role in rapidly meeting this need by providing safe and effective care that is deliverable remotely,” explains Peter Hames, Chair, DTA Board of Directors. “The ‘Urgent Access’ initiative mobilizes the whole digital therapeutics industry to provide help to millions in this time of need.”

A United Vision
Since DTA’s inception in 2017, we continue to unite the diverse digital therapeutics industry. What unites us, and differentiates us, is a commitment to representing the wide spectrum of digital therapeutics that have undergone rigorous clinical research to demonstrate the safety and efficacy of products’ ability to treat, manage, or prevent a broad spectrum of behavioral, mental, and physical diseases and disorders.

Whether DTx products are used by patients and clinicians to treat, manage, or prevent a disease; whether they are made available directly on a patient’s phone or are complemented by additional wearables and devices; and whether they are provided as a prescription or non-prescription product, there is tremendous value that digital therapeutics are able to offer to patients, caregivers, and clinicians during this critical period.

Looking ahead
Digital therapeutics offer solutions to country leaders as they search for new ways to: address the ever-increasing mental health burdens caused or exacerbated by COVID-19, enable patients with chronic diseases to have greater control of their conditions, and reduce unnecessary burdens placed on over-taxed clinicians and healthcare systems.

We are confident that digital therapeutics can bring tremendous personal and public health benefits to patients, caregivers, clinicians, and health systems. As an Alliance, we are committed to working alongside government and healthcare leaders who are looking to provide patients with access to this critical category of medicine.

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

Whether DTx products are used independently or by clinicians in the course of in-person, remote, or digital care models, DTA stands behind rigorous patient-centered core principles, ethical standards, and product development best practices to ensure product integrity, user-centered designs, patient privacy, and validated clinical outcomes.

DTA does not function as a certification, accreditation, or standard setting body. Nor does DTA endorse specific DTx products.