Monday, January 24, 2022– Arlington, VA– The Digital Therapeutics Alliance (DTA) is leading the next phase of industry growth and impact by convening leaders and stakeholders to establish consistent and scalable frameworks for the assessment, integration, and adoption of digital therapeutic (DTx) products.
As a part of this work, DTA published overviews for DTx regulatory and reimbursement pathways in eight countries: Australia, China, France, Germany, Japan, South Korea, United Kingdom, and United States. These publications provide a snapshot of currently available pathways within each market. Recognizing the significant progress these countries have made to develop DTx frameworks, DTA looks forward to the continued maturation of these pathways and will regularly update each document to reflect ongoing changes within national systems.
“Digital therapeutics are increasingly being recognized and adopted into national frameworks around the world to improve patient care. Yet, there is still much to be done to ensure consistency in how these products are defined, regulated, evaluated, and funded,” explains Megan Coder, DTA Chief Policy Officer. “Understanding the current landscape is a first step towards establishing clear and consistent patient access pathways. This year, DTA is taking critical steps to build on this important foundation.”
These resources will help policymakers and DTx manufacturers understand commonalities and differences across jurisdictions, identify potential obstacles to overcome, and inform strategic approaches to ensure appropriate patient access to clinically-validated therapies. These pathways add to DTA’s collection of resources that broaden the understanding of DTx products across global regions, including a set of country-specific briefs that introduce digital therapeutics to patients, clinicians, payors, and policymakers in each country’s official language.
DTA Resource Partners, Health Advances and Eversana, were instrumental in developing these pathways, alongside DTA members, ANDHealth, and FlyingHealth. Through this and forthcoming initiatives, DTA looks forward to developing resources that enable patients, caregivers, clinicians, and policymakers to integrate, use, and benefit from DTx 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, adoption, and integration 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 or follow us on LinkedIn and Twitter.
The 2021 China National Symposium on DTx was recently organized by GlobalMD Organization (GlobalMD), a DTA member. The Symposium was attended by hundreds of participants from local Chinese DTx start-ups, digital health chronic disease management firms, and other members of DTA. The Symposium convened international DTx champions to present their successful cases followed by panel discussions between both local and international DTx firm executives. They shared their experiences with DTx implementation in different health care systems and diverse regulatory environments.
Digital therapeutics are new in China. These solutions offer a unique and emerging technology to improve health, but there is also uncertainty regarding how DTx should fit into standard care of practice. The Symposium purposefully highlighted issues with successful DTx solutions, such as Alzheimer disease, diabetes management and mental health illnesses, including depression. These areas have demonstrated tremendous DTx progress over the past few years. Meanwhile there are also big, ongoing challenges in China. Ultimately, there is a huge potential market for DTx to benefit billions of patients’ lives in China.
Wellness-focused therapies (non-prescription apps) and prescription DTx products are currently utilized in the Chinese health care system. However, these solutions face critical challenges with gaining the general public’s trust and obtaining official approval from the China National Medical Products Administration (NMPA). As a positive sign of Chinese DTx industry progress, the local government has teamed up with leading DTx companies with a joint commitment of ￥20 billion RMB ($32 billion USD) in funding support to formalize a giant DTx Industrial Park project. The details of the project and funding application has not yet been released, but the presence of a newly established DTx Industrial Park in Hangzhou, Zhejiang Province will soon be the DTx industrial flagship in China.
Dr. Tim Shi, the Chief Director of GlobalMD Org China office and the leading medical advisor for the DTx Industry Park, has a positive view on the Chinese digital health strategy and development. Firstly, China has the largest population using fast-speed internet and mobile tools. This is a critical component of digital care for patients. Secondly, approximately 80% of people are using cellular phone and social media daily——wechat and tiktok to communicate with each other, enjoy entertainment, and access health care. Education is crucial to accelerating the adoption of digital health therapies, as it will help inform market strategies and the design of affordable solutions.
Dr. Shi has also raised a question that is critical for the DTx industry and digital health community in China – where do companies want DTx products to be utilized, at the hospital and in clinical environments, where, impossibly, doctors would have to spend extra time with patients coaching the use of the DTx apps, or should companies focus on promoting DTx solutions towards a combination with wearable devices and telemedicine, as proactive digital solutions to prevent people becoming sick and to improve access to quality care from their mobile phone, tablet, or PC.
As long as DTx apps and digital solutions demonstrate outcomes as safe and efficacious compared with standard of care therapeutics, users will be inclined to pick up the bill and sooner or later this will be taken up by payers (insurances and employers). As the first international Symposium focusing on DTx in China, it is clear that there are multiple opportunities for international strategic collaborations, such as licensing DTx products and jointly conducting clinical trials in local Chinese communities. To that end, GlobalMD is ready to provide the largest DTx social community—wechat with over 5000 participants helping to accelerate the development of digital therapies and supporting collaboration in the coming years.
GlobalMD Organization Network Corp (GlobalMD) is a not-for-profit international medical professional organization based in Maryland and has a physician network spanning 165 countries. GlobalMD’s mission is to improve global healthcare through its professional network, translational research, and collaboration without borders. GlobalMD functions as an “adaptor” to facilitate communications and collaborative projects between medical practitioners and public health professionals, especially in developing countries. It will allow them to access the latest medical knowledge and advanced technology from developed countries. In recent years, we are focusing on digital health including telehealth and digital therapeutics, particularly in conducting sound research and clinical implementation. The goal is to bring these advanced skills into the online/offline examining room, resulting in a benefit for patients.
Email contact： Chinaoffice@GlobalMD.org