San Francisco, CA — At this year’s Digital Medicine & MedTech Showcase (part of Biotech Showcase), a panel of digital therapeutics (DTx) experts illuminated the status and future of their work, moderated by Syneos Health Commercial Solutions Chief Strategy Officer, Baba Shetty. The progress announced by this panel makes it hard to believe that—less than a year ago—a digital therapeutics report from McKinsey suggested that, “…there’s a huge morass of solutions with incredible variance in quality—and there isn’t yet an established set of criteria.” The experts at Biotech Showcase conveyed how much this space has grown and evolved in just the past year—as demonstrated by the more than 150 companies developing DTx solutions, the billions of dollars in investments it’s attracting, and the big partnerships emerging, all indicators of the groundbreaking developments we can expect in the very-near future.

Shetty started the panel by asking where we are in the development of digital therapeutics as a category. According to panelists, DTx is now recognized as a viable category of products, sharply distinct from telehealth, clinical decision support, or trial digitization. As explained by Megan Coder, Executive Director of the Digital Therapeutics Alliance (DTA), “We are talking about products that are using digital algorithms and are software-based, to prevent, manage, or treat a medical disorder…We’re looking at something that’s actually delivering an intervention to a patient.”

Susan Cantrell, CEO of the Academy of Managed Care Pharmacy, crystallized what distinguishes DTx from other digital-health inventions. “In the past, we thought of DTx as tech that augments existing interventions.” But, she says, there was an aha moment in 2018: “Now, digital therapeutics are the innovations.” [You can read more about what Cantrell has to say on the topic in her own LinkedIn post, “Applications for Value: The Digital Therapeutics Revolution.”]

As for ensuring quality and establishing regulatory criteria, the foremost considerations of any health endeavor, Coder reported that, “We have 20-some member companies working on this together, all from different indications and ways to deliver an intervention, but there’s pretty impressive cohesion.” DTA is already at work establishing consensus around “what it should do, and what are the principles it should adhere to in order to ensure that patients are getting a safe, effective, high-quality treatment.”

Yuri Maricich, Chief Medical Officer and Head of Clinical Development of Pear Therapeutics, re-affirmed the degree to which this space has solidified. “This is not just one or two companies but a whole sector emerging,” he said. “We’re seeing the work that the DTA’s doing—setting standards on what good looks like and what’s needed to make sure these products can be used effectively, safely, and how to get them to patients.” Pear’s lead product, the app reSET, is authorized by the FDA to treat substance abuse disorder.

Akili Interactive’s VP of Strategy, Vincent Hennemand, highlighted the unique value proposition of digital therapeutics, explaining that they can often address the cognitive effects of a condition that traditional symptomatic treatments don’t. “Drugs and medical devices have not done a good job treating cognitive events,” said Hennemand. “The mechanisms of action of drugs are not optimized for coordination of brain functions—they actually shut down pathways.” This is where a company like Akili Interactive comes in. According to Hennemand, “Our product was able to hit and improve cognitive performance.”

Our Perspective

Stakeholder engagement and education is critical for this emerging new treatment category, and a consistent definition of DTx is integral. The DTA defines DTx as providing “evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease.” So, it’s not to be confused with the plethora of health and wellness solutions that have not always had the same rigor applied. Working early with stakeholders across the continuum, from patients, caregivers and healthcare professions, to pharmacists and payers, in order to understand how these solutions embed within care pathways and workflows, is important. This early engagement also provides an opportunity to understand the educational and support requirements needed to support adoption and an appreciation of the differentiated value proposition.

Check back here in the coming weeks for more perspectives about digital therapeutics: what they look like and what’s needed to make them available to the public. You can read an executive summary of our upcoming report by clicking here.

About the Author:

Ben helps spark innovative healthcare thinking as Associate Director of Innovation. Previously on the editorial staff of Vanity Fair, he brings experience in engaging, rigorous storytelling to the healthcare world. Ben’s goals are to move brands to rethink their roles, own their evolving narratives, and maintain vital and vigorous consumer relationships.