| While the term ‘digital therapeutic’ is still largely unknown, it represents a new category of medical interventions that will significantly influence the way healthcare is delivered and consumed across the world.
Today, the Digital Therapeutics Alliance released a comprehensive report that provides an overview of the industry, defines the term digital therapeutic, and establishes formal product categories. Core principles and best practices related to the design, manufacture, clinical validation, and regulatory oversight of these products are also featured. |
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| What is a Digital Therapeutic? |
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Digital therapeutics (DTx) combine patient-centric technologies with evidence-based medicine to deliver highly personalized care.
DTx products deliver direct therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They incorporate advanced technology best practices and are validated by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
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The integration of digital therapeutics into patient care is no longer a theoretical conversation. As these products continue to be utilized across the healthcare ecosystem, digital therapeutics will increasingly influence the way healthcare is delivered and consumed across the world.
Digital therapeutics present patients, healthcare providers, and payers with evidence-based technologies that have the ability to elevate medical best practices, address unmet medical needs, expand healthcare access, and improve clinical and health economic outcomes.
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| How Do They Benefit Patients? |
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Digital therapeutics are demonstrating meaningful benefits for stakeholders across the spectrum of healthcare delivery, including:
- Increased access to novel treatment options for conditions that previously have been untreated or undertreated by traditional medications and therapies
- Personalized care delivered to a patient independent of schedule constraints and in the privacy of their own environment
- Reduced stigma associated with the delivery of certain traditional therapies
- Ability to prescribe DTx products to patients as monotherapy or in concert with other therapies
- Intelligent data-driven care management and clinical decision making capabilities
- Improved clinical and health economic outcomes at the patient and population levels for a large range of physical, behavioral, and mental disorders and diseases
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The delivery of personalized treatment interventions to patients places digital therapeutics in a unique position, one full of additional responsibility and promise. Given the diversity of interventions being delivered and the types of disease states addressed, it is important for all products to adhere to industry-adopted core principles and best practices.
Access this report to learn more about the quickly evolving industry, DTx product categories, and industry best practices.
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Over the coming months, DTA will further develop best practices and frameworks that directly support the design, validation, utilization, and regulatory oversight of digital therapeutics across multiple cultures, languages, and national borders.
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The Digital Therapeutics Alliance convenes thought leaders from across the industry – including DTx companies, industry partners, patients, healthcare providers, and payers – to establish foundational best practices and frameworks related to DTx product validation, operations, value, and regulatory oversight.
DTA is a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. DTA envisions enabling broad access to high quality, evidence-based digital therapeutics for patients, healthcare providers, and payers in order to improve clinical and health economic outcomes.
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Grand Rapids, Mich. – October 3, 2018: Today Priority Health announced it will offer a new digital prevention tool to help members manage their diabetes. Through its partnership with Omada Health, Priority Health will provide clinically-eligible members access to Omada, the country’s leading digital Diabetes Prevention Program (DPP), beginning this month. Priority Health is the first health plan in Michigan to add the Centers for Disease Control and Prevention (CDC) fully recognized digital Diabetes Prevention Program as a preventive benefit.
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Highmark Inc. Adds Coverage For Medical Innovations In Treatment Of Panic Attacks
PITTSBURGH, Pa. (Sept. 17, 2018) — A new, non-pharmaceutical treatment, Freespira, and non-invasive diagnostic technology, Heartflow FFRct (fractional flow reserve), were added to Highmark’s medical policy in 2018 following positive results from a program that fast-tracks medical innovations to the marketplace.
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Use of Digital Health Technology to Enable Drug Development
This pilot study developed and evaluated the feasibility, usability, and perceived satisfaction with an end-user mobile medical application and provider web portal. The two interfaces allowed for remote monitoring, provided daily guidance in the management of hypertension and diarrhea, and allowed for rapid management of adverse events during a clinical trial of olaparib and cediranib.
Quest, Omada Health Collaboration Shows One-Third in Workforce Study Reduced Risk for Diabetes
A study presented Monday at the American Diabetes Association (ADA) Scientific Sessions found that one-third of those who initially screened positive for prediabetes or diabetes were able to bring their blood sugar down to normal levels after taking part in a workforce-based intervention. The study by Quest Diagnostics, which involved a collaboration with the digital health provider Omada Health, shows promise for employer-based wellness programs that involve a 2-step process: screening for those at risk, and then offering an evidence-based program of lifestyle change and support for those whose health risks are revealed during screening. […]
WellDoc Presents Economic Analysis Demonstrating Opportunity for Significant Healthcare Cost Savings with the Use of BlueStar
WellDoc®, a leading digital health company revolutionizing chronic disease management to help transform lives through the use of its digital therapeutics, today announced results from an innovative economic analysis that demonstrated the potential for significant healthcare cost savings with the use of BlueStar®. BlueStar is powered by WellDoc and is a 510K-cleared digital therapeutic designed to coach adults with type 2 diabetes. […]
Digital Therapeutics Alliance and USP Announce Collaboration
WASHINGTON, June 4, 2018 /PRNewswire-USNewswire/ – The Digital Therapeutics Alliance (DTA) and USP announced a collaboration to explore the development of appropriate standards and guidelines for digital therapeutics at a roundtable discussion co-hosted by the two organizations today at USP headquarters in Rockville, MD.
“Innovative digital therapies have the potential to dramatically affect the way healthcare is delivered,” said Megan Coder, PharmD, DTA executive director. “Without quality as a priority in delivering these therapies, patients face a challenging landscape in determining which products to trust when it comes to technology in their health care. Working with USP enables us to promote the development of quality standards that allow patients and clinicians to have even greater confidence using digital therapeutics.”
Digital therapeutics deliver medical interventions via clinically-validated technologies to prevent, manage, and treat medical conditions and may be used standalone or in conjunction with therapeutic pathways to optimize patient care and health outcomes. From device and medication sensors to patient-focused applications and software, digital therapeutics create opportunities to strengthen current clinical interventions and disease management options for patients with diabetes, asthma, heart disease, substance abuse, pain, sleep disturbances, and other conditions.
“DTA’s commitment to ensuring quality aligns well with USP’s nearly 200-year mission of ensuring quality through standards,” explained USP CEO Ronald Piervincenzi, Ph.D. “Digital therapeutics represent an emerging industry, and this collaboration is an opportunity for USP to demonstrate how public standards can help ensure quality for patients even on the cutting edge of technology.”
The roundtable included stakeholders who shared their perspectives on the future of digital therapeutics and the collaboration with USP, as well as their concerns with quality in this area.
“Digital therapeutics offer new treatment options and completely change our definition of medicine,” said Eddie Martucci, Ph.D., Akili Interactive’s co-founder and CEO. “We envision a future where medical treatments continue to be quality-focused and effective but can also be highly engaging and interactive. Working with USP, we can deliver on both the promise of this field and the assurance of quality we’ve come to expect in medicine.”
“Mapping between the rigor of USP’s approach and the digital therapeutics landscape is a key opportunity for all of us,” offered Anand Iyer, Ph.D., MBA, WellDoc’s Chief Strategy Officer. “We have to find ways to match the accelerated evolution of the digital therapeutics industry with the commitment to quality standards at USP to capture the future of technology in health care each of us desires.”
This collaboration will explore ways to safeguard product quality and integrity for digital therapeutics, with input from relevant stakeholders. If areas of need are identified, any development of standards or guidelines will follow USP’s usual, rigorous public processes.
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About USP
USP is an independent non-profit organization that collaborates with the world’s top health and science experts to develop high-quality standards that set the bar for manufacturing and distributing safe and effective medicines, supplements and food around the globe. Two billion people world-wide have access to quality medicines, dietary supplements and food as a result of USP’s standards, advocacy and education.
About DTA
The Digital Therapeutics Alliance is a global nonprofit trade association with the mission of broadening the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. To learn more please visit: www.dtxalliance.org.
Voluntis signs contract with US payer, WellDyneRx for coverage of a digital therapeutic
Voluntis, a company specialized in digital therapeutics, and WellDyneRx, a full-service, independent pharmacy benefit manager (PBM), announced today that Voluntis’ Insulia® will be incorporated into the recently-launched WellManaged-Diabetes program. This innovative, patient-centered program uses a high touch model often seen in traditional specialty pharmacy for high cost medications and expands its application to better serve WellDyneRx members with diabetes.
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