DTA Announces DTx Accreditation Program

Collaboration to expand existing DirectTrust programs by establishing a new accreditation program for efficacy and data privacy and security for digital therapeutics applications and platforms 

WASHINGTON, DC – June 6, 2024 – DirectTrust®, a non-profit healthcare industry alliance focused on furthering trust in healthcare data exchange through standards, accreditation, and other services, and Digital Therapeutics Alliance (DTA) today announced a collaborative partnership that will provide accreditation for efficacy, data privacy and security for digital therapeutics applications and platforms (DTx).

Through this strategic partnership, DTA and DirectTrust will develop a program set to expand existing DirectTrust programs that provide independent assessment of health apps for privacy, security, and transparency, as well as interoperability compliance with regulations and best practices. DirectTrust will administer the program, while DTA will lead the criteria development.

“This collaboration will add to DirectTrust’s growing suite of programs designed to assess the diverse digital health app and platform market,” said Scott Stuewe, DirectTrust President and CEO. “Our Health App program evaluates privacy and security, while the CARIN Code of Conduct for Consumer-Facing Applications assesses transparency and data use outside of HIPAA. Additionally, our UDAP programs validate effective, scalable connections to national health networks using the FHIR® standard. With the creation of this new accreditation to assess clinical efficacy for Digital Therapeutics, organizations will be able to select the program(s) that are appropriate for their business models.” 

Over the past six years, DTA has produced collaborative and validated assets to define and assess DTx products, which will serve as the foundation for program assessment criteria. These assets include a Product Library that incorporates the industry core principles; DTx Value Assessment and Integration Guide; along with the clinical evidence paper “Setting the Stage for a Fit-for-Purpose DTx Evidentiary Standard.” 

“As the digital therapeutics industry grows, an increasing number of U.S. clinicians, provider systems, health plans, employers, and patients are evaluating how to best incorporate DTx products into their care plans to provide the highest quality of care,” said Andy Molnar, CEO, DTA. “With an overwhelming number of products touting a wide range of clinical rigor, it is critical that we set a high bar to build trust. In order to achieve this, DTA and DirectTrust are partnering to establish a rigorous accreditation program  specific to DTx products that will build upon DirectTrust’s established, and widely adopted, Privacy and Security accreditation program.”

The new program is slated to launch later this year following DirectTrust’s standard procedures of developing proposed criteria and publishing those criteria for a 60-day public comment period.

Call for DirectTrust Criteria Council Sub-Group Members 

To establish and codify the criteria to be used for this new program, a focus group comprised of key stakeholders with expertise and interest in clinical efficacy will be established as a subgroup of the DirectTrust Criteria Council. Any interested constituent is welcome to apply to the Criteria Council. Because this group will convene to collaborate on criteria related to Digital Therapeutics accreditation, representation from health care organizations, condition-specific advocacy groups, and digital therapeutics companies is highly encouraged. Already committed to participate in the effort are active participants in the Digital Therapeutics Alliance community including payer representatives Mark Rakowski of Children’s Community Health Plan, Nick Dougerty from Mass General Brigham Health Plan, Jon Vecchiet from OscarHealth, and Jeff Dunn representing Cooperative Benefits Group.  

Stakeholders with an interest in participating as a beta organization for accreditation, or in joining the Criteria Council subgroup can complete the form on the DirectTrust website at bit.ly/DTDTx, or email Admin@DirectTrust.org.

DirectTrust’s accreditation and certification programs are governed by the organization’s Electronic Healthcare Network Accreditation Commission (EHNAC). DirectTrust criteria for each of its accreditation programs sets the stakeholder and program specific foundational requirements for assessing an organization’s ability to meet/align with federal and state healthcare reform mandates such as HIPAA/HITECH, 21st Century Cures Act, TEFCA and other mandates and best practices like NIST SP 800-53 800-171, and 800-63, for healthcare organizations focusing on the areas of trust, privacy, security, cybersecurity, breach handling, confidentiality, best practices, procedures, and assets.

About DirectTrust®
DirectTrust® is a non-profit, vendor-neutral alliance dedicated to instilling trust in the exchange of health data. The organization serves as a forum for a consensus-driven community focused on health communication, an American National Standards Institute (ANSI) standards development organization, an accreditation and certification body through EHNAC (the Electronic Healthcare Network Accreditation Commission), and a developer of trust frameworks and supportive services for secure information exchange like Direct Secure Messaging and trusted, compliant document submission.

The goal of DirectTrust is to develop, promote, and, as necessary, help enforce the rules and best practices necessary to maintain privacy, security, and trust for stakeholders across and beyond healthcare. In addition, DirectTrust is committed to fostering widespread public confidence in the interoperable exchange of health information while promoting quality service, innovation, cooperation, and open competition in healthcare. To learn more, visit: DirectTrust.org.


About Digital Therapeutics Alliance (DTA)
As the leading global authority on the evolution of digital health technology, Digital Therapeutics Alliance (DTA) is a 501(c)(6) non-profit trade association of industry leaders and stakeholders dedicated to 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 to improve clinical and health economic outcomes. As the leading international organization on digital therapeutic thought leadership and education, DTA provides the digital health ecosystem with the necessary tools to define, evaluate, and utilize DTx products.

Letter from the CEO: Breaking Bureaucratic Barriers and Navigating the Next Phase of DTx

DTA Members and DTx Stakeholders,

Despite the efforts of entrenched healthcare executives to stifle innovation and prioritize revenue over patient care, we continue to make advancements in providing clinically validated digital healthcare.

I’ve had a unique opportunity to sit down with global organizations, policymakers, investors, and thought leaders over the past three years. As we come out of an incredibly difficult period, I want to share what I have learned as we are clearly moving into the next phase of Digital Therapeutics. 

 

  1. Why I’m Writing This

I have been swimming through a sea of people saying what is and isn’t possible with DTx, and I have watched the impossible happen and the obvious get shut down. In the U.S., seasoned policy experts with extensive experience on Capitol Hill have said that certain DTx endeavors were unattainable or futile. Initially, I took that as fact, yet, a few months later, they were proven wrong. 

 

I have heard some of our seasoned DTx partners on stage at conferences say “the prescription model will never work”only to be contradicted offstage by a top-ten health system, which exclusively engages with prescription products. (this was 6 months ago). For years now, many have been trying to choose the right business model for the industry, but in digital it is about choosing the right business model for your product. It’s not about jumping on the next buzz word, it’s about being realistic in your approach to the market. For example, Venture capitalists are only hesitant about the prescription DTx model because of inflated projections (seen particularly from Pear Therapeutics) rather than an inherent flaw in the model itself.

 

  1. International DTx Landscape

While we have hit speed bumps and roadblocks in the U.S., the global perspective on Digital Therapeutics is strong. In December I sat down with the Korean FDA, and when I asked how I could help, they said the U.S. FDA is visiting to learn from the progress that has been made in South Korea. . Since then, we have seen AIMMED launch Somzz in South Korea, and the Korean FDA said they want to see more DTx come to South Korea as quickly as possible. As U.S. Pharma companies start to embrace PDURS (Prescription Drug Use-Related Software), South Korea is moving quickly with their version, and without the same reimbursement issues faced in the  U.S. (South Korea: Digital Medical Products Act Enacted | Library of Congress)

 

Germany has also demonstrated adoption of PDTs through DiGA. Although not perfect, DiGA has established a revenue pathway that allows for DTx expansion and growth. There are over 60 products covered in Germany (DiGA-Verzeichnis). Germany is demonstrating the viability of the DTx promise: we can build products fast, bring them to market faster than pharmaceuticals, and adapt them faster. That promise was just a dream, until now.

 

We forget that biologics found their foothold in Europe well before they were adopted in the U.S. Do we also forget how many biologics companies went out of business before the industry took off? Here is a List of bankrupt biotech, pharma & medical device companies in Europe. For products that aren’t FDA regulated, or fall under enforcement discretion, think about the issues with supplements making claims: Label Claims for Conventional Foods and Dietary Supplements | FDA

 

  1. Let’s gain perspective

The (DTx) industry is still young, and the initial excitement felt the real pains of healthcare. But now is THE TIME to pick ourselves up and take this industry to the next level as various initiatives and programs are aligning to drive real change. With CMS’s recent RFI in the Physician Fee Schedule and the increasing utilization of remote therapeutic and remote physiologic monitoring (RTM & RPM), alongside legislative pressures like the Access to Prescription Digital Therapeutics Act, policymakers are compelled to respond. Moreover, the FDA’s breakthrough and TAP programs, alongside PDURS, signify evolving market opportunities and exert ongoing pressure on CMS and commercial payors.

 

VC, pharma, payors, manufacturers and policymakers are looking for people to be realistic and grounded. We’re entering the slope of enlightenment in the Gartner Hype Cycle…Embrace it. (Gartner Hype Cycle Research Methodology

 

And last but not least, Fierce Healthcare showed $2.7 Billion across 133 deals in Q1 2024, so we’re still seeing major investments in digital Q1 2024 digital health funding: Great (reset) expectations. With many DTx products already incorporating AI capabilities, I want to point out that AI interventions are DTx. While there is a new hype around AI, every roadblock to coverage of SaMD and DTx exists for AI interventions. DTA’s work on Capitol Hill applies to all software as a medical device delivering clinical validated therapeutics interventions

 

So let’s focus on what is working and look towards the next phase of DTx. Let’s rally around the success stories and use the pressure that we have put on policymakers to pave our way for success. 

 

  1. Success Stories

Business models: Let’s look at what is working. 6 years ago this landscape didn’t exist. But the collective WE made THIS happen:

 

PDT in the EU: Board member Hannes Klöpper, CEO of HelloBetter, has 6 prescription products on DiGA. I also sat down for dinner in April with other DiGA companies. Their rate of bringing new products to market because of DiGA is that of the promises we heard in 2018 in the US. The phrase “We can bring products to market much faster than drugs” was heard around the clock in 2018, and Germany is showing that that is truly possible. France is following suit (watch the French Ministry of Health’s overview of PeCAN here)

 

Question: Would you consider launching in Germany and France first based on actual reimbursement models for PDTs?

 

DME: I can’t tell you how many times I have heard “DME will be the end of us”. Companies and associations were asserting to CMS that software as a medical device should be recognized as a medical device (imagine a drug company having to assert that a drug is indeed a drug). However, CMS’s stance was clear: they don’t reimburse for software alone. Interestingly, a company that initially sought parallel review was denied eligibility on the basis that CMS doesn’t reimburse for software. Yet, this same company is now classified as a medical device, demonstrating the importance of understanding and navigating CMS regulations in securing reimbursement.

 

Our most public example of a product getting DME classification is Applied VR. They now have a code from CMS and a reimbursement rate. Let’s strike through the statement that “DME will be the end of us”, because there is a big difference between coverage under DME or a reimbursement rate of $0. If this is the right pathway for your product then, just like PDTs in Germany, you have a viable business model and are able to demonstrate revenue and RWE to scale.

 

Chronic Care Management and SaaS models: “Care at home” is the next buzzy topic with policymakers as we look at our aging population. Well it isn’t a new topic for DTx companies. These platform models have been around for almost a decade now and have shown to be embraced by patients, particularly in diabetes. These models absolutely work. We have seen them transition into care platforms that include telehealth, coaching, medicine titration, etc. These have shown up now in diabetes, COPD, at home pulmonary rehab, and many more. 

 

Pharma Partnerships: Pharma is starting to show enticing business models for DTx. This includes a therapeutic offering to build market awareness instead of an “unbranded campaign”, a lift to utilization, extensions to branded products, chronic care management to offer a higher touch approach to patient care, and the ability to have the sales force carry more products in their “bag”.

 

These models find stability due to recent PDURS regulatory considerations, signaling a future where prescription drugs, alongside DTx, can play a more significant role in patient care.

 

Provider Reimbursement: JOGO is demonstrating success by being paid as a provider. (Watch the JOGO Webinar here) We see RTM companies doing this to accompany their DTx, and we see software diagnostics companies like Digital Diagnostics using this model.

 

Last year, the idea that DTx could be reimbursed under the “incident to” benefit category started gaining traction. DTA submitted an RFI to CMS so that we could gain reimbursement via supply codes when providers’ offices procure the digital products. We have collectively put pressure on CMS to move reimbursement out of legislation. The next Physician Fee Schedule will be open for comment in early July. Regardless of what happens, you will see DTA continue to put pressure on CMS to move this reimbursement pathway forward.  

 

Medicaid: In 2022, Massachusetts covered Reset and Reset-O in a value based agreement, Florida covered those products on the pharmacy benefit, and Oklahoma covered the product through a bulk purchase agreement. These are all opportunities for you if Medicaid is your market. IF you can show cost savings, you can also gain coverage in Managed Medicaid programs via “in lieu of services” Brief Leveraging In Lieu of Services in Medicaid Managed Care. You can also gain coverage through EPSDT programs. DTA put forth legislation in 2022 to help move this forward. If you want to see this move again, please contact us S.5238 – Medicaid and CHIP Access to Prescription Digital Therapeutics Act 117th Congress (2021-2022) .

 

Employer: There are many success stories in the employer space, but BE CAREFUL WITH EMPLOYERS! They are not a fail safe when other business models aren’t working. They have a very specific value prop. And people that work in HR benefits departments are not doctors looking at clinical evidence. BigHealth, for example, offers a very clear value proposition to employers: if you don’t sleep at night you won’t be productive during the day (my words, not the words of the BigHealth marketing department). Employers look at benefits around weight management like weight watchers and Noom, general health and wellness like gym memberships, family care, and areas that focus on productivity and employee retention. Landing these contracts are then followed by massive marketing campaigns to ensure that employees use your product. Employers are a great option if you have the right product.

 

PDTs in the US: OK, so we still have a major gap in reimbursement. If you don’t qualify as DME, then you will be told that SaMD isn’t covered by Medicare. Wait, but isn’t RPM and RTM covered by Medicare? Aren’t some services covered under the “incident to” benefit category?  And weren’t we all told that it was impossible to get a HCPCS code if there is no benefit category right before the creation of A9291? (CMS officially separated coding from benefit categories and it turns out that the best way to get an answer from CMS is to do the obvious and just apply). 

 

The PDT bill is stuck in the Congressional Budget Office because nobody knows how much the bill will cost, but the PDT bill has created an incredible amount of positive momentum for the industry regardless of its current status. While many got caught up in the details and worried about the harm of the PDT bill, this bill gave congress and policymakers a platform to drive education around DTx, point out issues with our healthcare system, and to put pressure on CMS. This pressure on CMS is compounded by programs in the FDA like the breakthrough program and TAP and policy like TCET. These programs are demonstrating a massive gap in Medicare coverage for innovative technologies.

 

And in the middle of all of this federal work, Highmark puts out a medical policy covering PDTs. highmark commercial medical policy – pennsylvania 

 

PDTs are covered by a wide variety of purchasers, including the Veterans Administration, at risk health systems, and commercial payors. Scale in the US isn’t there yet, but we are certainly seeing advancements across the spectrum of payors.

 

FSA/HSA: And last but not least I guess: yes, DTx do qualify for the FSA/HSA. You just need to apply. Are you an OTC product? Great…allow your patients to pay using pre-tax dollars or company match programs.

 

These models and partnerships are exciting to VC, Pharma, Employers, at risk health systems, and purchasers in general. Let’s work together to drive these forward and change healthcare.

 

For next steps, come to our conference to hear DTA’s key initiatives and where you’ll get to talk to the FDA, the head of CPT, commercial payors, the VA, VC, pharma, and more: DTA Summit

 

And join our mission to make DTx available to all patients: Engage – Digital Therapeutics Alliance  

 

Non-Prescription Digital Therapeutics: A Manufacturer and Employer Perspective

In the rapidly evolving landscape of healthcare, digital therapeutics (DTx) have emerged as a promising solution for improving patient outcomes and augmenting traditional medical interventions. In the recent webinar, Non-Prescription DTx Integration Workflows, the Digital Therapeutics Alliance (DTA) welcomed member companies, Sanofi and Woebot Health, along with an employer representative from WalkMe, to discuss how stakeholders come together to offer non-prescription DTx to employees.

Understanding Digital Therapeutics
Digital therapeutics are health softwares intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health. Digital therapeutics have the potential to benefit employees by providing accessible treatment for a wide variety of conditions.

Bringing Digital Therapeutics to Life: Workflows and Distribution Models

Bringing digital therapeutics into the healthcare ecosystem involves navigating complex workflows and distribution models. From the manufacturer’s perspective, it requires a comprehensive understanding of the needs of both patients and employers, as well as collaboration with various stakeholders to ensure successful adoption.

Distribution Models for Non-Prescription Products

The distribution of non-prescription digital therapeutics involves multiple stakeholders, including initiators, recommenders, receivers, and end-users. Initiators (health plans, employers, patients, or providers) play a pivotal role in recommending and facilitating access to these products.

Recommenders (health plans) employ various methods, such as text message campaigns or including digital therapeutics recommendations in after-visit summaries, to provide access to patients. Receivers (the provider) must ensure data exchange agreements are in place to safeguard patient privacy and security.

Ultimately, the end-user (the patient) stands to benefit from the accessibility and quality offered by non-prescription digital therapeutics.

Employer Perspective: A Case Study
Let’s delve into a real-world scenario to understand how employers play a crucial role in facilitating the adoption of DTx and other digital health technologies (DHTs). Consider Jeremy, an employer representative, tasked with identifying and implementing digital solutions to address the health needs of his organization’s employees.

Jeremy’s journey begins with identifying the specific health needs of employees through direct outreach and engagement. Once the needs are identified, Jeremy collaborates with a broker to vet solutions that align with these needs. Demos and presentations from manufacturers play a pivotal role in the decision-making process, providing valuable insights into the functionality and efficacy of the products.

Multiple teams within the organization, including finance, information security, and legal, are involved in evaluating and implementing solutions to close gaps in healthcare delivery and improving outcomes for their employees. Understanding the needs and priorities of employers, such as data exchange, privacy, and security, is crucial during the contracting process.

Key Performance Indicators (KPIs) should be established early on to measure engagement and outcomes. This enables both parties to track progress and make data-driven decisions to optimize the effectiveness of digital therapeutics solutions.

Successful implementation of DTx requires a collaborative effort between manufacturers and employers with roles and responsibilities clearly mapped out. Manufacturers must provide clear and compelling promotional materials, including demos, to showcase the value of their products. 

Conclusion
Digital therapeutics represent a paradigm shift in healthcare delivery, offering innovative solutions to address the evolving needs of patients and employers alike. By understanding the workflows and distribution models involved, manufacturers and employers can collaborate effectively to drive the adoption and utilization of digital therapeutics, ultimately improving patient outcomes and transforming the future of healthcare.

Learn more about DTA’s 2024 DTx Integration and Workflow Report.

DTA Responds to the Peterson Health Technology Institute’s Evaluation of Digital Diabetes Products

Digital Therapeutics Alliance appreciates the effort put forth by PHTI  to evaluate digital health technologies. DTA acknowledges the importance of evaluating evidence and health economics, as these principles are integral to our core values. Unfortunately, the framing of this report detracts from the evidence based approach that they are attempting to promote.

DTA was established with a commitment to incorporating clinical rigor into all healthcare solutions. In the digital health and mobile health sphere, numerous products fail to adhere to our industry core principles, as outlined in our documentation. However, DTA’s member companies, including DarioHealth whose product is included in this report, align with these principles, sharing common goals with PHTI, such as striving for clinically meaningful outcomes for diverse patient populations, adhering to best practices in quality, ensuring patient privacy and security, and prioritizing real-world outcomes and product performance, among others.

When organizations join our alliance we expect the utmost respect for the delivery of healthcare and the data to support cost and interventions. We were founded in an effort to bring clinically validated products to patients, and ensure that non-validated products do not hurt patients and caregivers.

PHTI’s “transparent evidence-based approach” follows the ideas and philosophy that DTA and its members embrace. While we support their overarching methodology, it’s essential to address specific oversights in the approach to evaluate the products and suggest areas for improvement in future reports. We would like to further promote transparency and inclusivity in future reports. The following is a demonstration of areas of improvement:

    1. The limited selection of solutions included overlooks a significant portion of the diabetes related digital health products on the market today, some of which can be found on DTA’s product library. The low sample size of this report’s study does not accurately reflect the products on the market, making its generalized conclusions somewhat misleading. How do we take a small sample size and make a sweeping conclusion for all diabetes products? We were fully expecting a framing of a spectrum of solutions that have both positive and negative healthcare implications, and there are a number of products that provide positive clinical and economic outcomes.
    2. While a predictive model makes sense when RWE doesn’t exist, we must include RWE when it’s available. The report’s reliance on predictive models rather than actual cost savings studies for health economics overlooks real-world evidence, particularly concerning products like Dario, included in the report,  for which there are independently published comparative studies demonstrating substantial healthcare cost reductions and reductions in hospitalizations.(Link to Studies) Comparative studies using actual HCRU data are generally considered more rigorous than the budget impact models using putative cost models. Comparative studies using actual HCRU data across the US are highly generalizable and scientifically rigorous. These types of comparative studies based on actual utilization reduction are preferred by health plans and other payors over predictive models. It is concerning that PHTI intentionally excluded published real-world economic studies in favor of lower performing predictive figures.
    3. PHTI’s approach to analyzing digital health technologies by disease state presented an opportunity to include scientific and economic experts specific to the condition, in this case, diabetes. We would like, again, to request further transparency, and include as many key stakeholders and clinical advisors as possible. For example, we did not see any of the 9,000 endocrinologists (diabetes experts) listed as advisors. Had there been expertise in this evaluation, they may have considered the broader scope of diabetes management like reductions in hypo- and hyperglycemic events, in addition to the reduction of A1C levels. 

DTA respectfully disagrees with the conclusions drawn, particularly in the case of DarioHealth as we can only speak to the evidence and performance of DTA member companies.

PHTI has the opportunity to support the future of healthcare by developing an advanced approach evaluation to match advancements in treatments and the new expectations of today. The expectations include positive, real-world health and economic outcomes, addressing the whole person, and accessibility to diverse patients. We recommend PHTI include experts that are specific to the condition they are studying,  invite more stakeholders to provide input into their analysis via public forums like we see with ICER and CMS, expand the cohort before making generalizations, and be more transparent on inclusion and exclusion of evaluation criteria. DTA looks forward to supporting PHTI in its future efforts to evolve the evaluation of modern medicine.

Digital Therapeutics Alliance Responds to Better Therapeutics Winding Down Operations

Response from DTA’s Chief Operating Officer, Jessica Hauflaire:

In the ever-evolving landscape of healthcare innovation, we often witness the rise and
fall of pioneering companies. Today, we acknowledge that Better Therapeutics has
decided to wind down operations and delist from the Nasdaq. While the company’s
journey has come to an end, it’s crucial to recognize and appreciate their contributions
to the DTx industry and support the longevity of their products for people with type 2
diabetes.

The bankruptcy of Better serves as a sobering reminder of the inherent risks associated
with healthcare startups. The road to success in this industry is fraught with challenges,
including regulatory hurdles, funding uncertainties, market adoption barriers, and clinical
validation requirements. Leaving many people wondering, where did Better go wrong?
We are witnessing a systemic problem within the U.S. healthcare system. Patient
access to digital health technologies is a crucial aspect of modern healthcare, yet CMS
and private health plans fail to provide coverage for these FDA cleared products. While
countries like Germany, France, UK, South Korea, and Japan have implemented
initiatives to facilitate patient access to digital therapeutics, the U.S. lags behind. It is
disheartening that in a country as advanced as the United States, our governing bodies,
agencies, and representatives will not take the steps to ensure that patients receive the
care they need. This is yet another stark example of the shortcomings of the U.S.
healthcare system and the bureaucracy that plagues it, leaving patients at a
disadvantage.

Digital health represents the future of healthcare. With advancements in technology,
data analytics, and artificial intelligence, digital solutions have the potential to
revolutionize patient care, improve outcomes, and enhance the efficiency of healthcare
delivery. From remote patient monitoring and personalized interventions to virtual care
platforms and predictive analytics, the possibilities are endless.

The story of Better Therapeutics is not an industry signal – there are many examples of
financial successes in digital health. Let us express our gratitude for their contributions
and commit ourselves to advancing the field of digital therapeutics with renewed
determination and optimism. With perseverance, collaboration, and a shared vision for
the future of healthcare, we can overcome challenges and realize the full potential of
digital health to transform lives

DTA Releases Updated ‘DTx Integration & Workflow Report’

Digital therapeutics (DTx) have potential to fill gaps in care for people and their families across the world. As a new category of medicine, one of the first barriers is the challenge of integration into the traditional healthcare system so patients can receive access in a way that is convenient and consistent for them. This effort takes significant collaboration amongst diverse stakeholders across the complex healthcare system in the United States.

In January 2023, DTA released the DTx Integration & Workflow Report to identify gaps and pain points in integrating digital therapeutic products into workflows across the U.S. healthcare system and outline necessary next steps to optimize the patient and clinician experience. The report identified pain points, considerations to solve for, and next steps in solving for those pain points. DTA continued to work with collaborators across the healthcare ecosystem and with NCPDP Task Groups to publish a Progress Report in August 2023.

A critical barrier identified is understanding the payment pathways as it impacts each stakeholder downstream. Through the generous support of the NCPDP Foundation, DTA was awarded a grant to research how DTx products would be reimbursed. The research is included in this updated report. We are proud of the efforts of our member task groups and other engaged stakeholders as we present this third DTx Integration & Workflow Report.

View full report (March 2024): DTx Integration & Workflow Report

Navigating the Intersection of Health and Technology: A Patient’s Perspective, Part 2

In part 1 of this interview, posted here in December, we spoke with one of DTA’s patient advisors about their patient journey, how digital therapeutics impacted their patient experience, and how to educate patients so they can adopt DTx solutions into their own care plans. In part 2, we discuss what actionable steps the Digital Therapeutics Alliance can take to increase awareness among patients, clinicians, and payors.

Interview

1- What can DTA do to promote awareness among patients, clinicians and payers?

Patient Advisor: 

Among patients:

Send DTA and digital therapeutic company representatives to regional and local community events where at-risk and medically needy patients, and their loved ones, will be present.

Among healthcare providers and payees:

Similar to the above, consider having an actual patient who has direct experience with the therapeutic who can speak to its efficacy and quality from personal long-term experience.

The target demographic should be medical conferences, continuing education seminars, med schools and/or teaching hospitals and research events, insurance events, etc.

In all groups:

2- What insights would you like to provide that we haven’t covered?

Patient advisor: I recently learned that early DTx solutions were being floated as early as the late 90s/early 00s! I think that, although the specialized nature of my needs would have put me on the map as a good candidate for some of these interventions, a lot of what was available to me had to do with income, budgeting, medicaid, and generational and cultural divide. My parents are boomers, and while my mom enthusiastically embraced the internet, she has a strong conservative religious leaning that makes her resistant to emerging technology as it relates to medicine. This is definitely a demographic that is at high risk with all kinds of odds stacked against reaching them.

Conclusion:

As we navigate the intersection of health and technology, this interview offers a profound perspective on the transformative power of digital therapeutics. From a complex patient journey to the potential of bridging healthcare gaps, the story resonates with hope, resilience, and a vision for a more inclusive and connected future in healthcare.

 

Year in Review: Digital Therapeutics in 2023 and Beyond

2023 was a rollercoaster for the Digital Therapeutics (DTx) industry. It began with an ominous undertone, hinting at challenges ahead, and true to the script, the sector experienced rapid and unpredictable shifts. Despite the turbulence, DTA held tight, weathering the ups, downs, and sideways swings, emerging on the other side with valuable insights.

Pioneering companies showcased resilience through strategic pivots, exemplifying adaptability in the face of adversity. Akili’s shift to direct-to-consumer (DTC) models and JOGO’s innovative commercialization strategies demonstrated that nimbleness could work around barriers to find revenue generating pathways. Meanwhile, Pear products witnessed a revival, changing hands and being brought back to life. Germany’s DiGA pricing strategies further highlighted the commitment to getting DTx into the hands of providers and patients. 

What truly stood out in 2023 was the heightened interest and action from healthcare stakeholders. Provider systems, health plans, pricing compendias, distributors, and public health insurance programs in countries like France (PECAN), and South Korea demonstrated an increased willingness to embrace digital therapeutics, paving the way for reimbursement pathways.

Despite the industry’s growth, investment funding remained a challenge, with innovation outpacing adoption. In spite of these challenges, new companies entered the market through NIH’s non dilutive funding opportunities and strong seed funding. For later stage companies, investment is still possible with expectations of substantial revenue, widespread adoption, and robust evidence supporting its efficacy.

As we step into 2024, the landscape for digital therapeutics continues to evolve. Demands for quality and performance in all types of care—digital, pharmaceutical, and in-person—are on the rise. The industry is witnessing a shift towards real value-based arrangements, attracting interest from large employers looking to invest in the well-being of their workforce.

Digital Therapeutics emerges as a promising solution to alleviate the challenges posed by clinician and staffing shortages. By leveraging technology to deliver evidence-based interventions and support, DTx not only enhances the efficiency of healthcare delivery but also empowers patients to actively manage their health. This innovative approach has the potential to fill gaps in care, optimize resource utilization, and contribute significantly to the transformation of the healthcare landscape in the coming years.

Read DTA’s Comment Letter regarding the FDA’s draft guidance on prescription drug use-related software (“PDURS”)

Addressing Concerns Raised in Health Affairs Vol 42. No. 11 Studies of Prescription Digital Therapeutics Often Lack Rigor and Inclusivity

The Digital Therapeutics Alliance (DTA) is a global non-profit organization that advocates for the adoption and integration of digital therapeutics into mainstream healthcare. DTA provides a platform for collaboration among industry stakeholders, including healthcare providers, technology developers, and regulatory bodies. DTA focuses on establishing industry standards, promoting research, and advancing the understanding of digital therapeutics’ efficacy and value in treating various medical conditions. Digital Therapeutics Alliance aims to drive awareness, credibility, and accessibility of digital therapeutics. DTA seeks to ensure the responsible and effective use of digital therapeutics in improving patient outcomes.

We recently read your publication in Health Affairs  Studies of Prescription Digital Therapeutics Often Lack Rigor and Inclusivity.  While we appreciate the effort put into the study, DTA would like to offer some clarifications and considerations that may contribute to a deeper understanding of the DTx landscape.

For background, a digital therapeutic is health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health (ISO/TR 11147).  Digital Therapeutics may be stand-alone software or may be combined with wearables and devices. Accessing digital therapeutics encompasses various avenues, with prescription serving as merely one. 

  1. Premarket Approval and Risk Assessment

The study begins by discussing premarket approval (PMA) for high-risk devices, asserting that no DTx has undergone the “FDA’s most rigorous review pathway.”  It is crucial to note that none of the DTx products are inherently high risk, and in fact, FDA would certainly reject the PMA pathway for a DTx. The PMA pathway, as defined by the FDA, is only used for Class III products, which are devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury,  like pacemakers.  The study indicates that 65% were authorized through the 510(k) pathway and 35% through Denovo, suggesting a predominantly low-risk profile. Therefore, the absence of pre-market approval (PMA pathway) does not imply a lack of rigor for DTx products. 

  1. Blinding

Conducting a sham (or placebo) study with Cognitive Behavioral Therapy (CBT) or digital therapeutic products poses inherent challenges. Unlike drug trials where a placebo product can be administered effectively, creating a credible placebo for psychological interventions like CBT is complex due to the nature of the therapy. Additionally, replicating the therapeutic effect without the active elements of CBT makes blinding difficult. 

In the case of many digital therapeutic products, designing a sham group that mimics the user experience without delivering the intended therapeutic content is not possible since the clinical outcomes often rely on specific, tailored interventions.  Comparisons to treatment as usual (TAU) can provide robust evidence, and the FDA’s clinical guidelines for DTx recognize the unique nature of these interventions.

  1. Study Design 

Innovations like decentralized and virtual trials address logistical challenges while ensuring diverse samples, which is crucial, especially with nationwide recruitment.  The emphasis should be on the appropriateness of the chosen study design for the research question.

In your article, the authors mention that these DTx companies are well-funded and could easily fund large-scale clinical trials. But we want to highlight that the vast majority of DTx companies are independent startups.  Many are in their seed – Series A rounds of funding and have generally raised between $5-7MM.  DTx companies do not have the money nor the resources of pharmaceutical or medical device companies.  As the adoption and revenue of prescription digital therapeutics continue to rise, we anticipate an accompanying enhancement in study designs, reflecting a commitment to robust and rigorous research methodologies.

  1. Digital Therapeutics Alliance’s Product Library

While we appreciate the use of DTA’s Product library, the limitations of the Product Library in listing all trials from manufacturers should be acknowledged. DTA has more than 100 member companies, listing products in the DTA library is voluntary and there is a restriction to listing only 3 clinical trials for each company. The current library includes just 16 companies and 22 products. Of these products, 7 are not available in the United States.  These restrictions can skew the perception of the breadth of evidence supporting DTx.

  1. Language Proficiency and Global Adoption:

English proficiency as a baseline requirement is common among US-based startups. However, it’s essential to recognize that adoption into more languages will likely grow in tandem with increased US adoption and increased funding by investors based on the early results of clinical trials. Limited language availability at this stage should be understood in the context of evolving market dynamics.

  1. Strength of Evidence in PDT Studies

The strength of evidence is clearly shown in Exhibit 4, but your interpretation implies this is negative. In fact, this table shows:

We find this to be a positive for the PDTs reviewed since it demonstrates the robustness of the evidence supporting DTx.

  1. Long-Term Follow-Up Data and Real-World Evidence:

The study expresses concern about the lack of long-term follow-up data for DTx, impacting payer hesitancy. Many PDTs incorporate built-in mechanisms within their apps to provide real-world patient reported outcome data, which can address this concern and contribute to ongoing evidence generation. This feature addresses concerns about the lack of long-term data and should be recognized as a strength rather than a limitation. Further, many DTx companies follow patients in their clinical trials out to at least one year to demonstrate long term benefits, and often payers that incorporate DTx products require the manufacturer to follow the clinical outcomes of patients as well as costs for at least one year.  Lastly, the primary purpose of long term follow-up data is to determine safety and measure adverse events over a longer period of time, given the non-invasive nature of  DTx products the need to measure this over the long term is not as relevant. 

  1. Diversity in Clinical Trials

Limited diversity and inclusion in clinical trials are acknowledged issues across the healthcare industry. It’s crucial to recognize that this challenge is not unique to DTx trials and is a broader concern within the field of clinical research including pharmaceuticals and medical devices.  (Turner et al., 2022, Khan et al., 2020; Lolic et al., 2021). When conducting clinical trials with payers, it is often the case that they will not provide access to their Medicare population, and access to Medicaid patients is even more difficult, thus follow-on studies and real-world data collection is required. This is achieved in the real-world utilization of DTx as they are often adopted across a diverse population and measured using the robust data gathering platforms most DTx products have designed. Furthermore, DTx products have the ability to demonstrate clinical outcomes and adherence rates broken out by Line of business for a payer on a monthly basis, which is unique to healthcare. 

  1. Industry Advocacy for Strong Clinical Data: 

While there is room for research improvement, the DTx industry has openly advocated for strong clinical data, emphasizing the commitment to rigorous research standards (e.g., Espie, Torous & Brennan., 2022 Espie et al., 2018) DTA Value Guide  Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard

  1. Study Limitations and Dialogue Invitation:

The authors mention that one study limitation is that they may not have identified all PDT products or studies due to the absence of a uniform review pathway. We are keen to engage in a constructive dialogue about the data and would appreciate the opportunity to discuss the specific list of PDTs reviewed in your study.  Furthermore, we would like to highlight some PDTs with extensive data published in peer-reviewed journals. 

While continuous improvement is essential, it’s equally important to strike a balance that does not stifle innovation in a field that has the potential to transform healthcare. It is equally crucial to acknowledge the robust evidence supporting Digital Therapeutics. The objective is not to diminish the evidentiary requirements but rather to ensure that the evaluation process aligns appropriately with the unique nature of DTx. This study underscores crucial considerations, yet a more profound comprehension of the DTx landscape is essential for accurate interpretation.

We look forward to the opportunity for further discussion and collaboration to advance the field of digital therapeutics.

 

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