Understanding DTx and PDTs

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EP: 1.Understanding DTx and PDTs

EP: 2.Considering DTx and PDTs as Part of Treatment

EP: 3.Monitoring Patients Through DTx and PDTs

EP: 4.Using PDTs Evidence to Explain the FDA Approval Process

EP: 5.Comparing PDTs With More Conventional Therapies

EP: 6.Durability of DTx and PDTs

EP: 7.DTx, PDTs, and Cost Savings for Payers

EP: 8.Using Real-World Evidence to Advocate for DTx and PDTs

EP: 9.DTx and PDT Access

EP: 10.PDT Coverage: Pharmacy or Medical Benefit?

EP: 11.Closing Thoughts on DTx and PDTs

John Fox, MD: Hello, and welcome to this Managed Healthcare Executive® and Psychiatric Times® Payer Provider Perspectives. Our topic today is around prescription digital therapeutics and behavior-driven conditions. My name is John Fox. I'm a physician and former health care medical director, serving as the moderator today. Joining me today for this virtual discussion are Dr. Arwen Podesta of Podesta Wellness in New Orleans; Dr. Timothy Aungst, associate professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences in Worcester, Massachusetts; and Dr. Scott Whittle, a physician and psychiatrist at Intermountain Healthcare in Salt Lake City, Utah, and a former medical director at SelectHealth. Since our topics today are primarily psychiatric applications and prescription digital therapeutics, it might be helpful to start from each of your perspectives: how would you describe a digital therapeutic to a colleague who's not familiar with this space?

Arwen Podesta, MD: I want to make sure that the audience knows what PDTs and DTX stand for. PDTs are prescription digital therapeutics, those that are FDA authorized, whereas DTX is kind of the larger umbrella of just digital health technologies. I want to include in digital therapeutics that there's an evidence component of it—that there's an evidence-based software and/or hardware that's using tools to advance patients’ health and to improve the betterment of patients’ health in whatever capacity, whether it's insomnia, addiction, any of the tools that we're using it for.

John Fox, MD: What level of evidence is important since these are evidence-based tools? Is FDA approval a critical element? Is that a distinguishing feature?

Arwen Podesta, MD: [It is a] distinguishing feature for those that are FDA authorized. However, there are digital therapeutics that are not FDA authorized but still host a decent amount of evidence. Patients seem to like them, and the customers like them, but that's not something that's a prescription.

Timothy Aungst, PharmD: That's a key thing because if you [take] your smart phone and look up something in there in the app store, you're going to get hit with a lot. There's 300,000 plus health and medical apps out there, and there's no curation by and large. Looking at how things have evolved—even in 2013 when the FDA came out with their suggestions on how look at a mobile health app—we think on recent balance beyond that, where people are like, “How do we know this stuff actually works?” How do we go from a business to consumer model where we [tell them to] sign up for a subscription, download this thing, and it’ll do something for you? We've gotten to the point where we want evidence. In what patients do you use this for? In how much time do you achieve the set outcome? For me, looking at digital therapeutics and PDTs, what stands out is that it's standing alone. It could work with a medication. It could work with hardware. It could even be a VR headset. It could be a device, for instance, but it's going to achieve some kind of therapeutic outcome. It's going to manage or diagnose, treat that thing. There is a battle going on for whether you need FDA clearance to achieve that. Is evidence alone enough to account for payers saying, “Yeah, we want to cover it” or are they going to come back and say, “We want a regulator to give the stamp of approval for that?” Worldwide, we see that is an issue. Whether you look at Germany with NHS [National Health Service] or in the United States with the FDA, it's still an area that's developing.

John Fox, MD: It's a wonderful point you make about this being a standalone and therapeutic. Increasingly, as a pediatrician, I knew that there were a lot of parents who didn't want to treat their kids’ ADHD symptoms with a medication. They were averse to that. Yet, we didn't have good, easily implementable strategies. The fact that this is a therapeutic without being a medication has appeal for some patients, either as a standalone or as a part of an ancillary approach. Scott, how about you? As a psychiatrist and a former payer, how do you describe a digital therapeutic or prescription digital therapeutic to your colleagues?

Scott Whittle, MD: The points we've made thus far are absolutely on point. I would add that it doesn't change a lot when you go up the chain of who your customer is. From a payer's point of view, your customers are large employers. When I'm addressing a benefit or network design to a large employer, the point I have to communicate is that this is a well thought out digital strategy that has evidence behind it, that it’s consistent with the rest of the benefit design I'm proposing to them as a health care solution. One of the challenges you face with that kind of scrutiny is that a wellness app is going to fall outside of that. It can be a positive thing. It's going to fall out of that level of scrutiny. If you have large employers, if you have health care systems, if you have the providers within health care systems—feeling that kind of comfort, that the evidence is there and the focus of the therapeutic is appropriate on the condition with demonstrated efficacy, you have to say the return on investment because health care is increasingly value-based. If the therapeutic is also demonstrating good outcomes at a cost that continues to allow a health care system to deliver without increasing the burden of increasing policy cost, then they're able to deliver a value-based health care product. We all know, as clinicians, these aren't products really; these are vehicles for wellness, but if they're vehicles for wellness that deliver in a value-based environment, their value is much higher.

Transcript edited for clarity.