Assessing the Growth of Digital Therapeutics: Latest News and Views

In late 2019, I interviewed Corey McCann, president and CEO of Pear Therapeutics, about his company, its products, and the digital therapeutics space. In September 2017, Pear’s lead product, reSET, for substance use disorder, was the first prescription digital therapeutic (PDT) granted FDA Class II medical device approval to treat disease. The company’s second product, reSET-O, for the treatment of opioid use disorder, received FDA marketing approval in December 2018. McCann said at the time, “We’ve gone effectively from zero understanding in 2015, 2016, to the point where this is a hot new modality in 2019.”

Keeping in mind that COVID-19 was just around the corner, developments in digital medicine and digital therapeutics to date may have been missed. To wit, the 2019 establishment of the Digital Medicine Society, or DiMe; the late September 2020 launch of FDA’s Digital Health Center of Excellence; the early 2021 final FDA guidance issuance for the “Safer Technologies Program,” or “SteP,” which is modeled on the principles and features of FDA’s Breakthrough Devices Program; and the February 2022 establishment of a new Centers for Medicare & Medicaid Services (CMS) Level II HCPCS code for prescription digital behavioral therapy, FDA-cleared, per course of treatment.

Digital distinctions and directions

All digital therapeutics, as defined by the Digital Therapeutics Alliance, share core principles, some of which are as follows: publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals; be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use; make claims appropriate to clinical evaluation and regulatory status; and collect, analyze, and apply real-world evidence and/or product performance data.

Other digital therapeutics include Noom Health’s weight management product. It was registered on ClinicalTrials.gov for its clinical trial, but listed under not studied as an FDA regulated product or device. NovoNordisk partnered with Noom in 2019 to offer it as a 12-month patient service for its product Saxenda. Alkili Interactive is also in the PDT space, targeting ADHD, delivering its FDA-cleared medicine through a video game experience. Happify Health currently offers its mental health digital therapeutic, known as Ensemble, not yet FDA-approved and available only by prescription or through an investigational study. Happify is expected to file for FDA review with this data in a little over a year.

While digital therapeutics may be a place where there is significant momentum and growth, there remains the fact that bills must be paid. Mostly, costs have been absorbed through partnerships with insurers, pharmacy benefit managers (PBMs), and employers. Pursuing pathways to progress are choices that digital therapeutics players must decide on early on, an issue explored at the recent the DTx West summit in February. And while many might continue down the road with healthcare reimbursement, others look to pharma.

Many consultants and external observers of this space view pharma as the problem—that it hasn’t embraced “digital transformation enough.” But in actuality, pharma views digital much the way as any investment. At DTx West, an expert from Bayer said during a panel, “We aren’t a software company or a tech company. We look at these ecosystems where we can facilitate on top of that.” He continued: “What does a pharma company really do? We create value that’s measurable. We have rigor, in terms of measurable results that measure the value that we’ve created. Demonstration is the whole measurable part.”

Another expert from Pfizer commented, “We run the risk of investing in the interesting instead of the possible. How do I assess the value and effectiveness and safety to the patients and system at large? We have a singular purpose—deliver breakthroughs that change patient lives. We are hopefully on the cusp of digital health becoming health, but how do you demonstrate value in an intervention with data?” He added that what industry will see is “akin to how we source world-class science, some is internally. Then we have a very robust sourcing mechanism for external science and assets. This will not be any different in the DTx space. You need to be the partner of choice.”

Finally, a Roche representative urged DTx companies to “be driven and follow the science. In the long run, having digital products being science-based will make healthcare providers, payers, and pharma have greater buy-in.”

Julian Upton is Pharm Exec’s former European and Online Editor, and currently Editor-in-Chief of sister publication Pharmaceutical Commerce. He can be reached at jupton@mjhlifesciences.com.