DTA Announces 2021 Board of Directors and Work Group Leaders

Thursday, January 28 – Arlington, VA – The Digital Therapeutics Alliance (DTA) is pleased to welcome member company leaders to the DTA Board of Directors and Work Group leadership. In our effort to transform global healthcare by advancing digital therapeutics, we are grateful to work with each of the following individuals.

Board of Directors
The DTA Board of Directors provides critical guidance related to the strategy and direction of the organization. The newest member of DTA’s Board is Scott Kollins, Ph.D, Professor within the Department of Psychiatry and Behavioral Science at the Duke University School of Medicine, and Co-Lead Digital Health Solutions with Duke Clinical Research Institute.

DTA’s 2021 Executive Committee includes: Debra Reisenthel (Chair), Eddie Martucci (Vice-Chair), Pierre Leurent (Secretary), and Scott Kollins (Treasurer).

Board Chair, Debra Reisenthel shares: “I am honored to assume the role of Board Chair of DTA during this exciting time for the Alliance. We accomplished much on behalf of our members in 2020 and we look forward to continuing this momentum in 2021. Our focus this year will be on the following global initiatives: expanding payor reimbursement opportunities, educating healthcare providers on the efficacy and value of digital therapeutics, and building confidence in the application of digital therapeutics within the healthcare ecosystem.”

DTA Member Work Groups
In line with DTA’s growing global work, this year we are proud to launch three regionally-based work groups led by industry experts:

As DTA leads the digital therapeutic industry in 2021, our collective efforts will be instrumental in providing patients and caregivers, clinicians, policy and healthcare decision makers with reliable resources to meaningfully integrate DTx products into practice and transform global healthcare.

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.

DTA Member Milestones in 2020

Wednesday, December 16 – Arlington, VAPatients, caregivers, and clinicians have faced unprecedented challenges in 2020. Given the global need to address growing mental health concerns, provide remote care for patients with chronic conditions, and enhance healthcare delivery processes, it is crucial to address increasing gaps in care by providing patients with access to appropriate evidence-based digital therapies in their home environments.

Digital therapeutics (DTx) can easily reach high-risk, rural, and underserved populations who often lack access to healthcare services even during the best of times. In order to encourage the integration of these technologies into current healthcare models, the Digital Therapeutics Alliance (DTA) undertook the following initiatives in 2020:

Central to these industry efforts are companies dedicated to providing high-quality care to patients and their caregivers. DTA is therefore incredibly proud to highlight the many ways that DTA members have worked tirelessly in 2020 to serve the needs of patients, caregivers, and clinicians globally.    

DTA Member Highlights, 2020:

The Association of Diabetes Care & Education Specialists (ADCES) won the 2020 ClearMark Award for best brochure in partnership with Lilly Diabetes. This award recognizes their patient first approach to communicating complex diabetes information with individuals and their families. Link

Akili Interactive‘s EndeavorRx became the first prescription treatment delivered through a video game after obtaining U.S. FDA clearance in June. EndeavorRx improves attention function in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Link

Astellas advanced activities under collaboration with Welldoc and continued evaluation of further collaborative efforts to provide patients with access to digital therapeutics in multiple markets.

Bayer organized its first “Virtual Digital Health Forum: Agents of Change” to discuss the three pillars of how we change the experience of healthcare: Equity, Access and Sustainability. Link

BehaVR partnered with Sumitomo Dainippon Pharma to expand on virtual reality’s capability to personalize the patient experience and address critical unmet needs in social anxiety disorder (SAD) using real-time biometrics and machine learning. Link

Better Therapeutics announced key findings from their clinical trial demonstrating that a software-only product configuration delivering behavioral therapy can produce meaningful outcomes in patients with type 2 diabetes. Link

Big Health demonstrated that patients who use Sleepio for sleep improvement yielded 28% lower healthcare costs than those who did not during an 18-month health economic evaluation. Link

Boehringer Ingelheim entered into a collaboration with Click Therapeutics to develop and commercialize a prescription-based digital therapeutic with the goal of helping schizophrenia patients achieve certain positive clinical outcomes. Link

Cognoa was named to the 2020 Global Digital Health 100 list by The Journal of mHealth recognizing their innovative work in autism spectrum disorder diagnosis and treatment. Link

Curelator prepared a submission for FDA clearance of N1-Headache, enabling them to shift from clinical research platform to a more interventional, commercial version of N1-Headache which will be launched early in 2021. Link

DarioHealth released key findings in two studies showing that the use of Dario’s platform promotes behavioral modification, enhanced individual engagement, and improved clinical outcomes for patients with diabetes and hypertension. Link

Dreem published a study on the Dreem headband’s clinical validation against polysomnography, published in SLEEP, and new findings showing that their multimodal sleep improvement solution demonstrates significant efficacy and engagement in a real world study. Link

Duke DCRI published a groundbreaking study in The Lancet: Digital Health proving the efficacy of a video game by Akili Interactive Labs to treat inattention associated with ADHD. DCRI team has also continued to work with a number of DTA member companies to design and execute their clinical evidence strategies. Link

Freespira, Inc (formerly Palo Alto Health Sciences) raised $10 million to continue commercialization of the Freespira digital therapeutic for treating Panic Disorder, panic attacks, and PTSD with health plans, employers, and the VA. Link

Global Kinetics developed an enhanced care model that combines the Parkinson’s KinetiGraph system (PKG) with Remote Physiologic Monitoring (RPM) reimbursement codes in the U.S., leading to greater opportunity for clinician adoption.

Happify Health launched Kopa to support people with chronic conditions by driving engagement with tools and support to navigate the clinical, social, psychological, and physical challenges of their condition. Link

Headspace expanded access to its mindfulness content to help people manage anxious thought, build mental resilience, and navigate through the uncertainty faced during the Covid-19 pandemic. Link

Health Catalyst was able to expand and meet the urgent needs of health care systems and technology platforms across the U.S. in direct response to the Covid-19 pandemic.

Hello Sunday Morning demonstrated the effectiveness of Daybreak to drive alcohol behaviour change following a study that showed large reductions in alcohol consumption and psychological distress among Australians who downloaded the product in Spring 2020. Link

HERINGS collaborated with Korea’s National Evidence-based Healthcare Collaborating Agency (NECA) on HDT-204, a product with a focus on early detection of recurrence of lung cancer.

JOGO Health partnered with Harvard Medical School to study the efficacy of their digital therapeutic product for chronic lower back pain.

Kaia Health closed a $26 million series B financing round allowing them to launch more therapies and double down on their rigorous clinical approach. Link

Kaiku Health was acquired by Elekta, furthering the development of personalized digital interventions in order to help improve the lives of cancer patients globally. Link

Lucine closed a €5.5 million seed funding round to develop a digital therapeutic to relieve and treat patients with chronic pain. Link

Mahana Therapeutics obtained U.S. FDA de Novo authorization for Parallel, the first DTx to receive this authorization in the gastrointestinal space. Link

MedRhythms received U.S. FDA Breakthrough Device designation for its product to treat chronic stroke walking deficits. Link

Novartis acquired DTx company Amblyotech, expanding their refractive disorder pipeline in ophthalmology. Link

Orexo accelerated the launch of Deprexis and Vorvida in the U.S. market to meet the patient need for access to low-risk clinically-validated digital health devices during the ongoing Covid-19 pandemic and employ the recent U.S. FDA “Enforcement Policy” providing an accelerated pathway to market for digital therapies focused on psychiatric conditions. Link

Pear Therapeutics launched via an end-to-end virtual care experience their product Somryst™, the only FDA-authorized prescription digital therapeutic for patients with chronic insomnia. Link  Somryst was awarded Best Digital Health Product by the Prix Galien USA. Link

Propeller Health launched the first co-packaged asthma medication and digital health solution in collaboration with Novartis in the EU. Link 

Roche successfully communicated with the U.S. FDA on a development program for a digital therapeutic product for people with autism spectrum disorder.

S3 Connected Health created and rolled out Enodatis, a clinical support tool for respiratory care of Covid-19 patients, in a record ten-days across Ireland and the UK to support clinicians with triage, monitoring, and treatment of patients in-hospital. Link

S-Alpha Therapeutics closed a $2.7M seed funding round to develop a digital therapeutic in the area of ophthalmology. Link

Sanofi partnered with Health2Sync to improve diabetes care and management in Taiwan, as well as to accelerate digital adoption and transformation for clinics and hospitals. Link

SilverCloud Health developed “Challenging Times,” a Covid-19 specific program to support mental health and increased access to its mental health services for frontline workers and their families in response to the pandemic.  Link 

Sumitomo Dainippon Pharma collaborated with BehaVR in the U.S. aimed at leveraging virtual reality experiences to address social anxiety; and with Save Medical Corporation in Japan, to co-develop a product for patients with diabetes. Link

Voluntis partnered with Bristol-Myers Squibb to co-develop a product to support cancer patients by providing real-time recommendations for self-management of symptoms related to their therapy. Link

Welldoc received FDA clearance for an additional feature on their product BlueStar, allowing real-time adjustments to insulin. Link

Welt established DTx guidelines with the South Korean Ministry of Food and Drug Safety (MFDS), translated it into English for DTA members, and signed an MOU with the National Center for Mental Health (NCMH) to define DTx for the Korean government.

As we collectively look ahead to 2021, this community of companies will be instrumental in offering tremendous relief to patients and caregivers, using technology to strengthen patient-clinician relationships and provide actionable insights to healthcare decision makers. Together, our goal is to transform global healthcare by building a stronger system that is designed around patient needs and improves outcomes through the delivery of evidence-based therapies.

 

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.

DTA Releases Paper, “Digital Therapeutics: Reducing Rural Health Inequalities”

Wednesday, October 28 – Arlington, VA – Individuals living in rural and underserved settings encounter challenges that others may not regularly experience. Barriers to healthcare include factors such as mismatched clinician supply and demand, long distances between patient homes and sites of care, and isolation measures during Covid-19 that prevent ongoing in-person visits.

Traditional therapies in the United States may not be able to sufficiently address the increase in unmet medical needs that are emerging during this pandemic. DTA’s report “Digital Therapeutics: Reducing Rural Health Inequalities,” calls for Medicare and Medicaid to leverage evidence-based digital therapeutics (DTx) to address critical gaps in care for underserved populations, regardless of whether disparities are based on patient age, language, culture, income, disease state, or geography.

Value of DTx Products in Providing Care to Underserved Populations
Building on the ease of DTx product scalability and access through patient-owned devices, digital therapeutics create new treatment and self-management options for a broad range of chronic and mental health conditions. DTx products can easily reach high-risk, rural, and underserved populations who often lack access to healthcare services even during the best of times. This include digital therapeutics’ ability to:

Unbalanced DTx Access Across Underserved Populations
While numerous patients who receive their insurance coverage through private payors and employers in the U.S. have access to DTx products, low income and aging populations covered by Medicare, Medicaid, and other publicly funded programs generally do not have access to these important therapies. Until Medicare and Medicaid begin providing patients with access to remotely delivered therapies and enable the formal reimbursement of DTx products, there will continue to be an unbalanced ecosystem.

Policy Solutions for Underserved Populations
Comprehensive, multi-faceted solutions are necessary to achieve healthcare parity for rural residents. It is crucially important that a key component of these plans include the expansion of digital therapeutic coverage and patient access. We encourage legislators to direct CMS to expand access to DTx products as follows:

Digital therapeutics offer a new ability to provide interventions to patients in rural and underserved settings. These opportunities — among others — can only be capitalized on if Medicare and other publicly funded programs create an adequate clinical payment mechanism and patient access pathway for high quality, clinically-validated DTx products.

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.

Evolution of the digital health spectrum of care

A post written by Jessica Shull (Digital Therapeutics Alliance), Dr. Keith Grimes (Babylon Health), and Alexandra Yembele (Withings) 

The evolution of health systems is speeding up

Physicians in Europe have been devoting 100% of their time and effort to caring for patients for decades; their grueling schedules leave them with little bandwidth for anything other than direct patient care activities. With this as the backdrop, Covid-19 introduced a whole new category of patient concerns and access problems.

Health systems are increasingly overburdened, and the majority of national healthcare budgets cannot be expanded. This is not ideal as countries aim to maintain current standards of care for their aging populations while needing to develop novel ways to treat patients with acute and mental health conditions in the midst of a continuously shifting pandemic.

However, healthcare processes and treatments continue to evolve — as they always have — from penicillin and the X-ray to gene therapy and digital health technologies (DHT). This evolution of healthcare has sped up in the last 20 years. In particular, innovations in digital health now provide invaluable assistance to clinicians and nursing staff, easing their ability to triage patients, rely on actionable insights, and extend care beyond the office setting. These advances offer integrated care for whole populations in countries across the globe, providing the tools so that potentially, no one is left behind.

New solutions for new challenges

Recognizing the immense need, healthcare systems are adopting innovative pathways for DHTs. Three examples include:

This did not replace or reduce the value of the physicians. Instead, it was quite the opposite. These examples highlight countries’ need to find new ways to interact with patients and provide care within existing healthcare systems.

The best-case scenario is when these three resources — digital therapeutics, remote patient monitoring, and telemedicine platforms — work together. This trio of digital health technologies can be used to assist a wide variety of patients.

A concrete potential

In the example of patient Maria, who was diagnosed with Chronic Obstructive Pulmonary Disease (COPD) in 2015, she consistently visits Dr. Becker every 6 months for a routine check-up. The European Respiratory Society estimates 15–20% of adults over 40 in Europe suffer from this disease. In 2019, Maria learned that she could begin accessing digital care products to manage her disease. She now has a Withings ScanWatch to monitor her oxygen saturation and daily walking distance. The backend integration of Withings’ open API allows Babylon, a telemedicine platform, to automatically and safely receive data that Maria has authorized to be sent. Now, Dr. Becker has on-demand access to the data she needs and can adjust Maria’s medication accordingly, while also monitoring the long-term effectiveness of Maria’s treatment.

Additionally, Maria uses a companion digital therapeutics (DTx) for COPD, which works with her medications, tracks her triggers, and helps her adjust key behaviors to optimize her overall condition. Due to the insights provided via the DTx, she now avoids taking walks on days with high levels of air pollution, has lowered her use of rescue inhalers, understands how to best exercise, and appreciates reduced dyspnoea episodes.

Through this suite of technologies, Maria and Dr. Becker have co-created a care plan that helps identify goals and well-defined actions to help improve her health and change key behaviors. While Maria still checks in every 6 months with Dr. Becker, she hasn’t been admitted to the hospital and each of her health indicators is better. During the COVID-19 quarantine months, in-person visits have been performed virtually on the Babylon digital platform. If Maria’s condition changed, Dr. Becker could enable a series of alerts that would initiate a clinician review. Through these configurations, defined by triggers based on Maria’s condition and history, Dr. Becker only sees the information that is needed, not daily dumps of data.

This scenario is real and these collaborations could provide additional access to people who need care when systems are stressed.

More about the digital health spectrum contributors:

Babylon Health

Babylon Health is a globally leading technology company with the ambitious mission to put an accessible and affordable health service in the hands of every person on Earth. We combine technology and medical expertise to bring doctors and people closer together, with digital health tools designed to empower people with knowledge about their health. Through a range of digital health services — such as an AI-backed app and video doctor appointments — we provide around-the-clock access to affordable, holistic healthcare services and information. We work with governments, health providers and insurers across the globe, and healthcare facilities from small local practices to large hospitals. With a $2Bn valuation, Babylon covers 20 million people across the globe, and has delivered more than 8m virtual consultations and AI interactions. We have teamed up with 170 impactful worldwide partners — including Mount Sinai Health Partners, the NHS, Telus Health, the Bill & Melinda Gates Foundation and the Government of Rwanda — to fulfil our vision of accessible and affordable healthcare, for all. For more information, visit https://www.babylonhealth.com.

Digital Therapeutics Alliance

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 maintains an international industry focus and is headquartered in the United States. DTA exists to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics into healthcare through education, advocacy, and research. In Europe, digital therapeutics offer regulated, CE marked digital therapies to patients with a diagnosed condition or disease. Most DTx products in Europe require third-party authorization or a prescription from a qualified clinician. 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.

Withings

Withings produces medical grade devices for at-home monitoring so that patients can understand with precision their symptoms and trends in indicators. Withings’ mission is to continuously and effortlessly provide healthcare professionals with medical-grade data generated by patients from an ecosystem of connected devices. For more than a decade, Withings has built a range of award-winning products including activity trackers, connected scales, a wireless blood pressure monitor, a smart temporal thermometer, and an advanced sleep system. From remote patient monitoring to clinical research to chronic disease management, Withings has dedicated solutions that provide the richest array of accurate real-world data thanks to a complete ecosystem of connected devices, data connectivity options, and a remote patient monitoring platform. Visit our website here.

DTA Recognizes Senate HELP Efforts on Pandemic Preparedness

Arlington, VA: In June, the Digital Therapeutics Alliance (DTA) submitted formal comments in response to the United States Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander’s call for recommendations on pandemic preparedness. These recommendations are part of DTA’s ongoing global 2020 initiative to break down obstacles to patient access to digital therapeutics (DTx).

As part of our comments, the Digital Therapeutics Alliance highlighted how in the United States private insurers and employers are increasingly embracing digital therapeutic technologies to improve patient outcomes. Unfortunately, traditional Medicare and most Medicaid programs do not currently recognize and reimburse for these clinically validated therapies. Due to their flexible delivery platforms and ability to treat underserved populations, DTx products offer critical solutions for the three following lessons that we’ve learned during the Covid-19 pandemic:

The Digital Therapeutics Alliance recommends that policymakers take this opportunity to curate a cohesive, efficient healthcare system that includes the necessary spectrum of available digital technologies, including telehealth platforms, remote patient monitoring, and digital therapeutics. In particular, DTx products can begin helping the nation break down some of the health disparities that are experienced by minority populations, rural residents, and patients with chronic and mental health conditions, while additionally addressing other significant policy issues.

Digital therapeutics have clinically demonstrated reliable patient outcomes for numerous health conditions. DTx products for chronic diseases have demonstrated a 63% increase in asthma control, increased symptom free days for COPD patients by 35%, and decreased A1c levels in patients with diabetes by 1.7 to 2.0 points. DTx products have also demonstrated that 60% of patients with a depression-only diagnosis can achieve recovery criteria, 50% of PTSD patients can achieve remission, and the abstinence rate of substance abusers can double. This represents a fraction of the clinical outcomes that are being demonstrated by DTx products for physical, mental, and behavioral health conditions.

“We will have an unbalanced ecosystem in the United States until Medicare and Medicaid begin providing patients with access to remotely delivered digital therapies and enable the formal reimbursement of DTx products,” shared Megan Coder, DTA Executive Director. “While many patients who receive insurance coverage through private payors and employers have access to DTx products, low income and aging populations covered by Medicare, Medicaid, and other publicly funded programs are generally prevented from accessing these important therapies. Given that DTx products may be accessible via patient-owned devices, they can become important treatment options for many underserved and rural populations who require care but may not always have access to it.”

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).

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.

DTA Petitions Countries For Digital Therapeutic Coverage

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:

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.

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 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.

Crucial Components of DTx ‘Urgent Access’: Product Quality and Appropriate Utilization

In early April 2020, the Digital Therapeutics Alliance (DTA) announced an ‘Urgent Access’ campaign to provide individuals covered by publicly funded programs with increased access to clinically evaluated digital therapeutics (DTx) from the safety of their homes. Digital therapeutics, while not intended to treat COVID-19, have the potential to offer tremendous relief to patients and caregivers, strengthen patient-clinician relationships, and provide actionable insights as we collectively rebuild our new normal during and following this pandemic.

The next phase of DTA’s ‘Urgent Access’ campaign expands the spotlight to DTx product quality and appropriate utilization. Our goal is to provide clarity on how patients, clinicians, and payors can identify, access, and appropriately use clinically evaluated digital therapeutics for the purpose of treating, managing, and preventing a broad spectrum of behavioral, mental, and physical diseases and disorders. Our Alliance is committed to increasing available resources for end users and decision makers on how to explore and adopt the potential benefits of DTx products throughout the pandemic and beyond, while minimizing the risk of potential harm from experimental products and not-yet proven therapies.

Product Claims Matter. Is this product a digital therapeutic?
Digital health products have been available to patients for well over a decade. During this time, the types of product claims, purposes, safety, and levels of clinical evidence have diversified significantly. It is therefore becoming increasingly difficult for end users to know how to properly evaluate digital health products prior to use.

General digital health products that capture, store, or transmit health data – such as lifestyle apps, fitness trackers, and consumer health information – do not necessarily require clinical evidence, real world outcomes, or regulatory oversight. In comparison, digital therapeutics – software products that treat, manage, or prevent diseases and disorders – must demonstrate clinical evidence, real world outcomes, patient privacy and security protections, and regulatory oversight as required to support product claims of risk, efficacy, and intended use.

Patients and clinicians must not only understand what a product claims to do, but also what clinical evidence is available, or even necessary, as they face the difficult decision of determining which products will best meet their needs. To assist in this navigation process, DTA members are mobilizing to provide end users and decision makers with the tools they need to make informed decisions.

Product Quality Matters. What can I expect from a digital therapeutic?
Quality extends from the components and processes used to manufacture DTx products, to the quality management systems relied on to ensure patient safety, all the way through to the outcomes achieved by these therapies. Based on industry standards, only those software products that meet the following ten criteria are considered a digital therapeutic:

  1. Prevent, manage, or treat a medical disorder or disease
  2. Produce a medical intervention that is driven by software
  3. Incorporate design, manufacture, and quality best practices
  4. Engage end users in product development and usability processes
  5. Incorporate patient privacy and security protections
  6. Apply product deployment, management, and maintenance best practices
  7. Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals
  8. Be reviewed and cleared or approved by regulatory bodies as required to support product claims of risk, efficacy, and intended use
  9. Make claims appropriate to clinical validation and regulatory status
  10. Collect, analyze, and apply real world evidence and/or product performance data

To protect against the risk of counterfeit, unproven, or potentially harmful products, these criteria provide end users and decision makers with a strong framework to understand and evaluate digital therapeutic products.

Product Access is Necessary. How can payors provide access to DTx products?
To assist public and private payors in providing access to DTx products that meet the criteria outlined above, DTA provides the following considerations (please refer to this worksheet for further detail):

Payors should also consider product implementation and scalability, clinical appropriateness, patient engagement and sustainability, privacy and security requirements, and the value provided to patients, caregivers, and clinicians — including improved health outcomes, reduced overall healthcare utilization costs, and individual and population health benefits.

National coverage frameworks for digital health products, which include access to DTx products, are currently being implemented in Germany and Belgium, while France and the United Kingdom have been reimbursing the use of 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 are not currently reimbursed by Medicare or most state Medicaid programs, although we urge the federal government to take action in line with DTA’s ‘Urgent Access’ campaign.

Appropriate Utilization is Crucial. How can clinicians ensure that DTx products are used appropriately?
DTx products provide evidence-based therapy options for a wide variety of physical, mental, and behavioral conditions. Of primary concern to clinicians is clearly understanding which disease or condition the product has been indicated to treat, manage, or prevent. DTx products may be used independently, in tandem with remote or in-person clinician-delivered therapy, and/or paired with medications, devices (e.g., sensors, glucometers), and other therapies to optimize patient outcomes.

For products requiring clinician authorization, the following “DTx Rights” will help guide appropriate product utilization and ensure that the right care is delivered at the right time (please refer to this worksheet for further detail). Is this DTx product being used for the:

Digital therapeutics are designed to meet specific patient needs at specific times. They align with clinical guidelines, integrate into health systems, and are used in the context of patients’ current care plans. It is therefore crucial that appropriate product utilization is ensured once access to high quality digital therapeutics has been provided.

Moving Forward 

Digital therapeutics create new treatment and self-management options for mental health and chronic disease populations. 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.

In line with our mission, and in direct response to the quickly evolving global landscape, DTA will continue to develop resources for patients, caregivers, clinicians, payors, and government agencies to ensure the optimal utilization of, and access to, high quality DTx products.

Learn More

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.

DTA announces “Urgent Access” pandemic campaign to provide essential healthcare to millions

“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.

Learn More

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.

DTA Member Companies Are Providing Direct Support to Patients, Caregivers, and Clinicians During COVID-19

During the COVID-19 crisis, members of the Digital Therapeutics Alliance (DTA) have answered the call to serve their communities. While each contribution differs, all reflect the unifying DTA mission “to enhance healthcare quality, outcomes, and value for patients, providers, and payors.”

DTA member companies are not only dedicated to ensuring the manufacture and support of high quality digital therapeutics. Many of our members are also engaged in the development of pharmaceuticals, medical devices, technology platforms, and general digital health products. We are proud to represent each of these companies as they serve their communities in a variety of ways.

In relation to the broader healthcare industry:

Fighting on the front lines: DTA member companies are contributing resources critical to the front lines of this fight. Health Catalyst developed a tool to aid healthcare systems in forecasting the hospital impact of COVID-19, while other members are stepping up production to meet these predicted needs. Philips and ResMed have both significantly increased their manufacturing of ventilators and other critical medical equipment. These companies are collaborating with global leaders to overcome capacity and logistical challenges, with their employees working long hours to meet these heightened production goals. Additionally, Bayer, Novo Nordisk, Sanofi, Orexo, and other members are donating critical medical supplies, money, and other resources to assist governments, health workers, and patients in need of assistance.

S3 Connected Health developed ACORRD (Assessment Of COVID-19 Risk of Respiratory Deterioration), a web-based clinical support tool designed to help hospitals optimise and scale acute respiratory care amid the rising number of coronavirus cases. This will help specialists identify patients most in need of their attention, while providing decision-making support for clinicians less experienced in respiratory care so health workers can be drafted in from other departments to help bolster respiratory teams.

Developing potential treatments: DTA member companies are actively engaged in research to develop potential treatments and vaccines for COVID-19. Sanofi is undertaking the development of vaccine candidates, as well as research for potential treatment options. Bayer is undertaking a search for new active substances that may treat COVID-19, while Boehringer Ingelheim is screening their molecule library to identify potential candidates that could fight the virus. Similarly, Novartis is contributing to global research efforts, supporting communities, and ensuring a stable supply of essential medicines.

Informational research: Members are also compiling useful resources on their websites related to COVID-19. The Association of Diabetes Care and Education Specialists provides targeted resources for diabetes care and education specialists since these individuals are on the front line of care for patients affected by diabetes, prediabetes, and other cardiometabolic conditions. Additionally, Propeller Health, DarioHealth, Welldoc, Better Therapeutics, Kaiku Health, and Global Kinetics Corporation provide educational content and resources for patients, caregivers, and clinicians amid the COVID-19 outbreak.

Specific to mental health-focused products:

The core contribution of our members remains their ability to deliver high quality, clinically validated digital therapeutics that enable patients to treat or manage their health conditions in the safety of their home during this precarious time. With large percentages of the global population under “stay at home” orders, many individuals are experiencing heightened mental health and behavioral concerns. Additionally, doctors, nurses, pharmacists, and fellow frontline workers are under tremendous strain during this time. DTA members are therefore stepping up to offer services to these quarantined populations and frontline workers.

Big Health, a digital therapeutics company, has extended no-cost community access to their mental health solutions: Sleepio for poor sleep, and Daylight for worry and anxiety. In response to COVID-19, their team created quick-access versions of their solutions and in the first two weeks, over 70 employers across the US and the UK have made the mental health solutions available. A few of the companies include Nike, H-E-B, Compass Group, AdventHealth, TTEC, Target, BJC Healthcare, UCSF, the UK Department of Health & Social Care, and the NHS staff of England, which covers 1.2 million individuals.

SilverCloud Health’s digital therapeutic is being provided by Express Scripts to members during the COVID-19 pandemic to clients and their members at no cost. This product is based on principles of cognitive behavioral therapy (CBT), mindfulness, and positive psychology. These action-oriented products help members build self-awareness and self-management skills to improve emotional health.

In addition, Shoppers Drug Mart is making peace of mind a little more accessible to Canadians as they struggle with increased stress in the face of COVID-19. In partnership with SilverCloud Health, the company has opened a virtual stress management program, accessible anywhere from their phones, tablets, or computer. The company will cover all associated costs.

Hello Sunday Morning’s Daybreak program has achieved expanded reimbursement from the Australian Government. This will support an additional 10,000 people in managing alcohol-use-disorder, during the COVID-19 pandemic. As a digital program that combines a supportive online community with access to trained health coaches, Daybreak provides a unique alternative to face-to-face support during this time.

And featuring the wellness products from member companies, Happify is providing specially curated content including webinars and live weekly yoga, while Headspace has a free “Weathering the Storm” program of meditations, sleep, and movement exercises.

Looking forward:

Before, during, and after this pandemic, one thing remains the same: DTA members are committed to the delivery of innovative regimens to enhance patient healthcare outcomes. We will continue to update this list to feature steps our members are taking to be a part of the global fight against COVID-19.

Version: 6 April 2020

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