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.
1- What can DTA do to promote awareness among patients, clinicians and payers?
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.
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.
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:
Washington, DC – The Digital Therapeutics Alliance is excited to announce the 2024 Digital Therapeutics Alliance Summit, taking place from June 5-7, 2024, at the Washington Marriott Metro Center in Washington, DC. This annual event is poised to be a groundbreaking gathering, setting new standards for thought leadership, innovation, and addressing and clarifying the commercialization challenges in the digital therapeutics industry.
The 2024 DTA Summit distinguishes itself through its unique combination of interactive workshops, cutting-edge thought leadership, and a concerted focus on tackling commercialization challenges in the field of digital therapeutics. By convening experts, industry leaders, and innovators, the summit aims to foster collaboration and innovation for the advancement of this rapidly evolving sector.
The 2024 Digital Therapeutics Alliance Summit will feature:
Interactive Workshops: Gain hands-on experience in the latest digital therapeutics tools, methodologies, and best practices, providing valuable insights for implementation.
Thought Leadership: Engage in stimulating discussions and presentations from industry leaders and visionaries, exploring the most pressing topics in the field.
Commercialization Challenges: Understand the strategies, opportunities, and obstacles in bringing digital therapeutics to market, with insights from experts who have successfully navigated these waters.
Networking: Connect with like-minded professionals, foster collaborations, and build relationships that will drive the industry forward.
Mandy Harvey, a remarkable autistic, and deaf jazz singer, will be the keynote speaker at the summit. Her story of overcoming barriers and achieving incredible success in the world of music is nothing short of inspiring. Attendees will have the unique opportunity to hear her speak about resilience, determination, and the power of human potential. Her compelling story and soul-stirring performance promise to be a highlight of the summit, leaving attendees with a profound sense of empowerment.
Speakers: The full agenda and speaker list will be published in 2024 with the following confirmed to speak at the Summit:
The Summit is made possible thanks to the generous support of Curavit Clinical Research, a leading research and development company in the field of digital therapeutics. Their commitment to advancing healthcare through research and innovation aligns perfectly with the mission of the DTA Summit. We are proud to have them as our sponsor.
We are also pleased to announce our media partnership with Healio, a trusted source of healthcare news and information. Healio’s support will help ensure that the insights and knowledge shared at the summit reach a wide and engaged audience.
The 2024 DTA Summit promises to be an unparalleled event, providing a unique blend of learning, inspiration, and networking opportunities. With a focus on interactive workshops, thought leadership, and addressing commercialization challenges, this summit is set to play a pivotal role in shaping the future of digital therapeutics.
Don’t miss the opportunity to be a part of this transformative event and join the conversation on the future of digital therapeutics. Register now to secure your place at the 2024 Digital Therapeutics Alliance Summit.
Registration opens November 1st, and early-bird pricing is available until December 31st. To secure your spot at this premier event, visit 2024 DTA Summit
Join us at the 2024 DTA Summit, where innovation, collaboration, and inspiration converge to redefine the future of healthcare. For sponsorship opportunities, speaking inquiries, or media partnerships, please contact us at Hazel@DTxAlliance.org
For more information, please visit our official website: 2024 DTA Summit
About Digital Therapeutics Alliance:
The Digital Therapeutics Alliance is a global non-profit organization with the mission to drive the adoption of high-quality digital therapeutics into mainstream healthcare. The organization promotes collaboration between industry, healthcare providers, and regulators to advance the field and improve patient outcomes. The annual DTA Summit is one of the organization’s flagship events, bringing together industry leaders, researchers, and stakeholders to explore the latest developments in digital therapeutics.
A Letter from Andy Molnar, DTA CEO
I am thrilled to share exciting news from the Digital Therapeutics Alliance.This week, three DTA member companies unveiled groundbreaking products that are set to revolutionize the field of digital therapeutics. These launches not only underscore the relentless pursuit of excellence within our community but also reaffirm the ever-growing potential of digital therapeutics to reshape the future of healthcare.
These launches from Better Therapeutics, MedRhythms, and Poppins are a testament to the transformative potential of digital therapeutics and the dedication of our member companies. DTA is committed to continuing its mission of supporting, advocating for, and advancing the digital therapeutics industry. We look forward to witnessing the positive impact of these innovative solutions on healthcare and the lives of individuals who will benefit from them.
Better Therapeutics – AspyreRx for Type II Diabetes:
Our first highlight is Better Therapeutics and their product ‘AspyreRx.’ Better Therapeutics has tirelessly worked to create a solution that empowers patients with effective, data-driven tools to manage their condition. Their launch marks a significant step forward in the ongoing battle against diabetes, highlighting the power of digital therapeutics in preventive care and disease management.
MedRhythms – InTandem:
Next on the list is MedRhythms. Their latest product, ‘InTandem,’ is a clinically-validated digital therapeutic system designed to improve walking and ambulation in adults with chronic stroke. We are deeply impressed by MedRhythms’ commitment to delivering science-backed interventions that genuinely enhance the quality of life for stroke survivors. Their work is a testament to the critical role that digital therapeutics can play in addressing complex medical conditions.
Poppins (Formerly Mila) – Poppins for Dyslexia (OTC):
Finally, we highlight Poppins, formerly known as Mila, who have introduced a transformative digital therapeutic solution for dyslexia,’Poppins. Poppins leverages cutting-edge technology to provide personalized, accessible, and evidence-based interventions. We are proud to have Poppins as a DTA Member as their work is truly commendable and will undoubtedly pave the way for a brighter future in dyslexia treatment.
DTA’s Journey with These Companies:
DTA is proud to have these 3 DTx companies as members. We have been inspired by the dedication of these members to uphold the highest standards of quality, safety, and efficacy. The relationships we foster within our alliance are pivotal in nurturing the innovative spirit that drives the digital therapeutics industry forward.
The State of the DTx Industry:
As these product launches demonstrate, the state of the digital therapeutics industry is in a constant state of evolution and progress. We are witnessing an unprecedented surge in innovation, with digital therapeutics emerging as a powerful complement to traditional healthcare. The industry’s potential to deliver personalized, effective, and scalable interventions is undeniable.
This also highlights the need for “one voice”, during these critical inflection points in the industry. While DTA works to establish more comprehensive coding and defined benefit categories, we need all of the key stakeholders to come together to continue to pave the path forward for the patients we serve.
Healthcare and Digital Therapeutics:
The impact of digital therapeutics on healthcare is profound. These products enable patients to take a more active role in managing their health conditions, reduce the burden on healthcare systems, and offer clinicians invaluable tools for monitoring and treatment. As the demand for accessible, evidence-based solutions grows, our member companies are at the forefront of driving meaningful change in healthcare delivery.
Together, we can shape the future of healthcare.
CEO, Digital Therapeutics Alliance
Board Nominations Now Open: Digital Therapeutics Alliance Seeks Visionary Leaders to Represent the Diverse Membership and Global Ecosystem”
Digital Therapeutics Alliance (DTA), the leading global non-profit trade association for digital therapeutics (DTx), today announced plans to expand its Board of Directors in 2024 and 2025 to support the organization’s continued growth and evolution.
In 2024, the DTA Board will expand from its current 7 members to 10 members, plus the CEO. In 2025, the Board will further increase to 12 members, plus the CEO as a voting ex-officio member of the board. These additions will broaden the Board’s expertise and perspectives, enhancing governance and strategic leadership as the digital therapeutics industry matures.
“As digital therapeutics gain mainstream adoption, it is crucial that DTA’s leadership represents the diversity of our member organizations driving this healthcare revolution,” said Andy Molnar, DTA CEO. “Expanding our Board will allow greater representation to inform DTA’s mission of enabling patient access to high-quality, evidence-based digital therapeutics.”
DTA is seeking nominations from current members for the 2024 Board of Directors through October 13, 2023. Nominees should be senior executives with demonstrated strategy, board, and governance experience in digital health and commitment to DTA’s vision. Ideal candidates will contribute complementary knowledge across healthcare, technology and policy.
A Nomination Committee will review applications and propose candidates in November based on criteria such as leadership experience, subject matter expertise, and ability to fulfill Board member responsibilities. DTA’s industry membership will vote on final Board member selections in December.
New Board members will serve 3-year terms beginning in 2024. They will help shape DTA’s strategic direction, provide financial oversight, and drive the adoption of clinically-validated digital therapeutics worldwide.
For details on DTA’s Board nomination process, criteria, and application questions may be directed to Andy Molnar.
June 14, 2023 – Arlington, VA – Digital Therapeutics Alliance (DTA) is announcing the launch of the Policymaker & Payor DTx Evaluation Toolkit, a comprehensive set of resources to enable global healthcare and digital technology leaders to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics (DTx) into healthcare.
According to ISO, digital therapeutics “generate and deliver software-based medical interventions to patients to treat or alleviate a disease or disorder”. DTx products additionally provide clinicians and payors with robust opportunities to enhance clinical and health economic outcomes for patients and populations.
As part of its core mission, DTA continues to convene healthcare decision makers, end users, and industry leaders to develop a strong foundation for how patients and caregivers access and utilize digital therapeutics. This Toolkit originated through the work of the DTx Policy Coalition, which launched in June 2022, and provides clarity for healthcare decision makers responsible for evaluating and implementing DTx in real-world settings.
Components included in this Toolkit include:
In an increasingly fragmented landscape of differing product requirements and expectations within and across national jurisdictions, this Toolkit represents a first step toward enabling policymakers, payors, and manufacturers to harmonize baseline requirements and scale therapies across populations.
To that end, the Toolkit is equipped with an explanation of the benefits and challenges associated with developing and implementing DTx in clinical care, and provides education on the evaluation processes and metrics for assessing clinical benefits, risks, and patient preferences.
Through advocacy, education, and cross-industry collaboration, the Policymaker & Payor DTx Evaluation Toolkit will provide greater insight on the development and integration of DTx into healthcare, in an effort to ultimately improve patient outcomes and benefit global healthcare.
“Digital therapeutics will undoubtedly become a critical part of patient care. With the appropriate frameworks and pathways, this is the first treatment modality that can equitably scale across global healthcare settings to deliver personalized, high quality, impactful healthcare,” said Megan Coder, Chief Policy Officer of DTA. “The Policymaker & Payor DTx Evaluation Toolkit offers decision makers a full spectrum approach to understanding the complexities of DTx value assessment, legal and regulatory guidelines, and implementation, in addition to optimizing the impact of DTx therapies on patient care.”
These tools are free and open access, available to all: DTx Evaluation Toolkit – Digital Therapeutics Alliance.
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.