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.
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:
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Andy’s blog
In the heart of Rome, the 2023 edition of Frontiers Health unfolded as a dynamic and transformative event, offering diverse and insightful content. The event left attendees with a renewed commitment to placing the patient at the core of healthcare efforts.
The conference kicked off with a profoundly moving moment, as a courageous mother took the stage to share her journey. This poignant reminder set the tone for the entire event, reinforcing that the essence of our industry lies in the lives and stories of the patients we aim to serve. It emphasized the need for a patient-centric approach in every facet of healthcare, from research and development to policy-making and implementation.
One session that resonated deeply with the attendees was the discussion on health equity. The stark reality that there is still a long way to go to achieve fair access to healthcare resources and the elimination of disparities hit home. The conversation revolved around the imperative to ensure that everyone, regardless of their background or socioeconomic status, has the opportunity to attain their highest level of health. This session acted as a powerful call to action, urging the industry to work collaboratively towards a more equitable and inclusive healthcare landscape.
As the conference unfolded, the Healthware Group team and the Digital Therapeutics Alliance took a proactive step towards shaping the future of digital medicine. On the last day, they organized a morning session that brought together policymakers and thought leaders from seven countries across Europe, Asia, and America. The objective was clear – to foster a deeper understanding of digital medicine and digital therapeutics policies and, more importantly, to harmonize evaluation criteria.
The collaboration aimed to create a standardized framework that would enable a quicker scale-up for companies in the digital therapeutics sector. By aligning policies and evaluation criteria, the goal is to facilitate a more efficient and streamlined process, ensuring that innovative solutions can reach patients faster and more effectively. This collaborative effort is crucial in addressing the core needs of patients and enhancing the impact of digital therapeutics on healthcare outcomes.
The diverse representation of policymakers from different regions added a global perspective to the discussion. It became evident that, while healthcare systems may vary across borders, the challenges and opportunities presented by digital medicine are universal. The need for a common ground, a shared understanding, and a cohesive approach in policy-making became increasingly apparent.
The session acted as a catalyst for meaningful conversations and collaborations that extend beyond borders. It showcased the power of collective intelligence and the potential for global collaboration in shaping the future of healthcare. By bridging the gaps in policies and fostering international cooperation, the industry is better positioned to address the complexities of digital medicine and deliver impactful solutions to those who need it the most – the patients.
As we reflect on the Frontiers Health 2023 conference, it is clear that the future of healthcare is intricately linked with our ability to collaborate, innovate, and prioritize the patient experience. The pivotal moments, impassioned discussions on health equity, and the collaborative efforts to shape digital therapeutics policies underscored the industry’s commitment to transformative change.
Frontiers Health 2023 was not just a conference; it was a collective journey towards a future where healthcare is not just a service but a holistic and inclusive experience. The challenges ahead are substantial, but the shared vision, insights, and collaborations forged at this event have illuminated a path forward – a path that places the patient at the center and charts a course toward a more equitable, accessible, and patient-centric healthcare future.
Andy Molnar, CEO, Digital Therapeutics Alliance
Digital Therapeutics Alliance is thrilled to announce the release of our latest white paper in collaboration with Clearview Healthcare Partners!
Building upon the success of the Commercial Launch Playbook, our new white paper delves into a captivating case study with Freespira, exploring the critical success factors that drive a successful launch in the Digital Therapeutics (DTx) landscape.
This white paper is a must-read for: