What Are PDTs?

Two experts define prescription digital therapeutics (PDTs) and their role in behavioral care therapy.

Arwen Podesta, MD: What are prescription digital therapeutics, also known as PDTs? Digital health technology is a burgeoning field. We have digital media, smartphones, emails, websites, virtual webinars. What we're doing now is digital media, digital health. We also have mobile technology and artificial intelligence, virtual reality, that have been incorporated into digital therapeutics—things that monitor blood pressure, blood sugar, different levels in your blood, and different vital signs. That's digital health overall. It's a huge umbrella. Then there's digital therapeutics, which is a tighter umbrella, and digital therapeutics have to be deemed therapeutic. Then there's prescription digital therapeutics, which gets down into a much smaller part of the umbrella. Prescription digital therapeutics are the subset that has to be prescribed by a physician or prescriber. They've been FDA authorized through the same sort of rigor that the FDA does to authorize devices and medications. They've been FDA authorized with evidence and systemic lack of adverse events. This is where we have this small subset of prescription FDA authorized digital therapeutics under the larger umbrella of digital therapeutics under the large umbrella of digital health products. Why and how is it regulated by the FDA? In 2017, the FDA wanted to get development of AMD software as a medical device so prescription digital therapeutics could start seeking FDA authorization through the same regulatory pathway as a medical device would be. That would be with randomized control trials, with confirmation of efficacy and lack of adverse events. This is the key differentiating factor between prescription and digital therapeutics and other digital therapeutics or health tools.

Diana Brixner, RPh, PhD: Well, PDTs are an interesting, evolving therapeutic option for our members. We're trying to evaluate them as any other therapeutic and understand how they would benefit the member and what their value is to the health plan and to the member. As we've learned during COVID, there's been a decrease of available providers in many areas and a shift from one-on-one visits to telehealth visits. I think one of the areas we see that the most is in behavioral treatment and behavioral health—from depression and sleep disorders to looking at opioid abuse and substance abuse disorders. A lot of these mental health aspects have a new option now for looking at treatment.

This transcript has been edited for clarity.

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