Excited and inspired for the future of the DTx industry
The DTx East conference in Boston was a whirlwind of three content-packed days and a hotbed of activity. An FDA-regulated offshoot of digital health, digital therapeutics (DTx) is a relatively new market gaining a lot of interest—and this event had no shortage of technology, fresh ideas, and takeaways.
The fifth annual event was touted as a one-stop shop of all things digital therapeutics. It didn’t disappoint, as there were many engaging keynotes, panel presentations, and fireside chats (no real fires or S’mores though) by cross industry participation from DTx companies, biotech, pharma, providers, contract research organizations (CROs), consulting firms, and the FDA.
A lot of my time was spent meeting and engaging with some of the most passionate and committed business and industry thought leaders. From the sessions I attended, and vendor booths visited, here are my four observations—plus a fifth opportunity that could be a game changer for patients and providers alike.
The first type of solution from DTx companies is an independent app. These often focus on a single clinical indication or sub-indication, such as Calmsie who is working to alleviate pediatric (ages 8-12) anxiety and depression. Calmsie is accomplishing this focus through gamification, AI, and cognitive behavioral therapy (CBT) to help children understand their emotions and learn coping mechanisms—as explained by co-founder and CMO, Brian Wallace MD, PhD.
Companies developing these types of apps are typically independent DTx startups, which also include Pear Therapeutics and Twill. From their panel discussion, Astellas identified themselves as one of a select group of biopharma companies also taking this approach of building unique DTx as independent modalities—not connected to any of their pharmaceutical brands.
A major challenge for independent apps is reimbursement, where companies chiefly depend on employer contracts or payer plans. This is a big challenge, due to the need to demonstrate benefit—often over the standard of care—through randomized clinical trials and peer-reviewed clinical evidence. Generating this level of clinical evidence requires several years and millions of dollars.
Real-world evidence (RWE) often falls short of meeting these expectations. Also, regulatory approval in every country requires clinical trials to be repeated in the local population. This represents the second biggest challenge faced by this segment.
Companion apps are the DTx industry’s second major segment. These apps accompany and support a branded drug. Ideally, the use of the app helps improve upon a drug’s efficacy or contributes to improving the brand experience—by providing helpful training, informational content, support of medication adherence, access to patient support services, and more.
A chief benefit of this approach is that it offers the opportunity for remote patient monitoring, thereby enabling the care team to access the patient between visits to monitor progress. Also, by collecting and integrating user data for RWE generation, companion apps offer the drug manufacturer a unique window into the patient’s treatment journey. This provides some measurement of patient behavior that can impact clinical outcomes such as medication adherence and/or proper self- administration. Companion apps also offer a channel to capture patient reported outcomes, and quality of life parameters in real time.
Product development of this type of DTx app often is aligned to a drug’s go-to-market strategy and many panelists during the conference recommended that potential companion app planning is best explored during phase 2 clinical development. Most large biopharma companies are engaging in developing companion apps today.
A third industry segment is a variant of companion apps, known as a combination drug, consisting of a drug and its companion app as one therapeutic entity. For combination drugs, the drug trials and filing necessitate that both the DTx app and drug are linked into one new drug application (NDA) filing and product.
Many of the conference sessions explored other challenges that most DTx solutions face: long-term patient engagement, driving physician awareness, and getting their buy-in to write prescriptions. Even with FDA approval, prescriptive behavior is often hard to increase and sustain.
Decimal.health CEO, Kamal Jethwani, MD MPH, shared that in 2022, only 3.8% of physicians are using digital health tools. Providers cite many factors for the low adoption rate, including time constraints with app training, capacity challenges in clinical workflow integration, and a majority of DTx solutions that lack FHIR integration.
A major area of friction is the lack of trust physicians share in DTx evidence and effectiveness. In his presentation, Jethwani cited McKinsey report sharing that in a three-year window of research, “less than 1% of DTx research are peer-reviewed scientific publications utilizing data.”
However, this appears to be changing, as Jethwani notes the last five years have seen a 240% rise in the number of clinical research studies, as well as an increase in the average number of patients being enrolled in each study. Time will tell how this improvement will translate into physicians’ adoption of, and prescriptive practices involving DTx.
One of the event’s notable speakers was Dr. Amir Lahav, Head of Digital R&D for Mitsubishi Tanabe Pharma. In addition to presenting day two’s opening and closing remarks, he also gave a rousing presentation on combining DTx apps with traditional drug therapies. One of the biggest takeaways from his talk was the importance of a care provider's recommendation for patients to download and use a companion the DTx app—creating the necessary “stickiness” for the drug by providing patients a more holistic solution to manage their disease. This will help improve the patient’s experience, optimize the quality of care, and generate clinical insights that can have a positive impact on patient outcomes that is greater than what could be achieved by either the drug or the app alone.
Dr. Lahav calls this a “1+1=3” effect.
An example of this math would be a drug brand pill pack with QR code, recommended by a prescribing physician or pharmacist at the time of picking up the prescription. Their endorsement creates trust and subsequent stickiness on patient adoption and use. For the clinician, it creates a reason to look at the data the next time the patient comes in to visit—adding benefit and creating a complete experience for each stakeholder.
The current business models around both flavors of DTx remain experimental. Biopharma is largely focused on how to best utilize the trends toward digital, patient engagement, and patient empowerment—to deliver greater value overall to the healthcare ecosystem. Reimbursement challenges, from employers and payers, revolve around the need for a better quantity and quality of RWE.
Many sessions at this year’s conference focused on plan and provider expectations around RWE through controlled clinical trials—demonstrating clear benefit over the current standard of care. This high burden of evidence has been and remains a challenge for startup DTx firms. There were deep discussions between provider organizations and the DTx community on this topic; and this will continue to be an evolving area of collaboration for the industry.
Many sessions at the conference outlined the necessity to connect digital patient apps better to providers’ workflows for improved adoption, and greater trust. However, one attendee asked the question:
Is DTx integration to providers and EHRs really necessary? Could this perhaps be replaced with a strategy embracing a direct DTx-to-patient model?
While it certainly depends on the specific app and its clinical indication, in general—and in my view—nothing could be worse for DTx’s impact on patients and commercial success than to cut out the trusted practitioners. While a patient faces a consumer health app explosion in their daily lives, they typically have very few care providers they trust with their healthcare.
This trust, which is the foundation that all treatment decisions are made on, should include DTx. The industry’s biggest challenges—including regulation, reimbursement, patient adoption, earning physician trust, and influencing prescriptive behavior—require more, not less, interaction with providers and integration with their existing workflows. And yes, this is hard to achieve but just as important to get right.
Many provider organizations at the conference, such as Advocate Aurora Health and Banner Health, were active participants in the conference. During their sessions, they laid out some of their strategies in evaluating DTx—demonstrating mutual interest in the use of this new treatment modality.
At Innovaccer, we are determined to encourage and facilitate healthcare industry collaboration across ecosystem partners such as life sciences, health plans and health systems. The bedrock of our technology enables the creation of the single unified patient record derived from multiple health data sources (including digital devices and apps), surfacing patient contextualized insights into the clinician, and care team workflows—then enabling action on those insights within the workflow.
We believe this approach is foundational for driving the digital transformation needed to improve care quality and outcomes. And it’s why we recently announced our Connected Digital Health solution—to help biopharma and MedTech organizations build companion apps and other digital solutions, which connect better to existing clinician and care team workflows. This makes insights more actionable, and ultimately improves clinical outcomes, as well as patient and provider experiences with their brands.
Inspired by the show and the road ahead for DTx
DTx East brought together some incredible companies, technologies, and thought leaders. The runway for success and growth in digital therapeutics is wide and long. The challenges, though significant, are expected to lessen as healthcare’s stakeholders—including patients and their care providers—embrace digital treatment modalities as a non-invasive and viable option to improve their condition, and also as the clinical evidence in favor of DTx mounts.
Despite some challenges, investors, life science, and digital health companies are investing heavily in the DTx space. Visionary leaders and talented professionals recognize the power of patient data—through the inclusion of providers—to drive better outcomes through insights, interoperability, and unified patient record.
Innovaccer entered this space to help patients and healthcare organizations in our network improve care management, medication adherence, population health, and help build learning health ecosystems through partnerships across multiple healthcare ecosystem stakeholders. It’s simply the right thing to do.