Arwen Podesta, MD, provides an overview of how PDTs have evolved over the past 6 years since their introduction into the medical world.
Arwen Podesta, MD: Prescription digital therapeutics have evolved over the past decade. Starting in 2015, there have been massive clinical trials in all different fields of medicine—psychiatry, cardiovascular, addiction, endocrinology—and there are thousands of health therapeutics. There are hundreds of digital therapeutics, and there are tens of authorized prescription digital therapeutics. The landscape is vast when we start with our device and preparing a cognitive behavioral therapy tool, or a monitoring, or a number of steps that your fitness device monitors. Those are all advances that we've had in the past 10 or so years. When we start getting the evidence and applying it to what we know in medicine, then we start getting the ability to authorize through the FDA—some very specific, very effective tools. Right now, there are something like 11 or 12different FDA-authorized digital therapeutics—many in the bio-behavioral space, mental health, but also in pulmonary cardiovascular and diabetes. Those are the areas where it looks good if they're not already FDA authorized, that they're attempting authorization.
There's been an interest in prescription digital therapeutics for multiple reasons. First, we're not a healthy nation, and we have a lot of things against us right now, between the COVID-19 pandemic, lack of resources, and lack of access. Insurance wants to pay for that. Payers want to help with health, patients want health, but we don't have all of the resources. We have something like 600 sleep specialists that can bill appropriately under their specialty heading for cognitive behavioral therapy for insomnia, which we know works. We know insomnia is a huge problem, more so now [because of] the pandemic. Yet, we only have a handful of providers that are billable by most entities. There is a prescription digital therapeutic that does cognitive behavioral therapy for insomnia. With the lack of access and very specialized knowledge base, as well as the availability to capacity build to get this treatment out to many more people, that's where we're pushing the barrier points using prescription digital therapeutics.
Why now? We know that smartphone apps and all sorts of health therapeutics have been on the rise because people are on their phone 4–6 hours a day. Why not use something health-forward? That coincided with the 21st-century CURES Act in 2016, whichI'm going to quote, “…facilitates innovation. The CURES act and the FDA breakthrough device programsoffer PDT manufacturers the opportunity to hold pre-market certification meetings with the FDA.” We've seen the progress—FDA authorization through the same regulatory pathways as medical devices, payers getting involved, patients getting involved. We’re just at the beginning of the wave.
This transcript has been edited for clarity.