Using PDTs Evidence to Explain the FDA Approval Process

EP: 1.Understanding DTx and PDTs

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

EP: 3.Monitoring Patients Through DTx and PDTs

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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: Scott, as a payer, how important is that evidence? Some prescription digital therapeutics are FDA authorized as a class 2 medical device. All of them are required to have clinical trials as part of the FDA authorization, yet there are many payers who are covering digital therapeutics that haven't gone through that approval process. From your vantage point, having assessed these technologies, how important is that FDA approval?

Scott Whittle, MD: It depends on the organization's commitment to the quality of its digital strategy. In my case, I interface with community-based health plans nationwide. It's important from a perspective of branding and credibility. It's okay to have something that may not fit the paradigm, but it can't be the only tool in your toolbox. The idea would be having all these different digital offerings. The table stakes of being in the digital strategy space is to have the credible tools for when you speak to your real audience, and your real audience are the larger stakeholders, the state you work within, the Medicaid system you work within. It's the health care systems that you're interfacing with, and their questions are always the same. Many times, it’s, “How does your digital strategy stack up to what is available out there?” Tim, your representation of the marketplace is entirely accurate. It's beyond chaotic out there. With something like FDA approval, I shorten that conversation. I brand the offering in a way that supports my brand, in a way that supports the providers who I'll be asking to adopt a strategy and the stakeholders who are reviewing the benefit design I'm building. It's absolutely essential. That doesn't mean you can't have others, but if you don't have the ones that are credible, the ones that really position you within your brand and your marketplace, you can't speak to the stakeholders you're speaking to in the way you would really like to.

John Fox, MD: It's helpful to say that you're using the same evidentiary requirements, including FDA authorization, for a digital therapeutic as you would for a drug. These digital therapeutics are often an alternative to the drugs.

Scott Whittle, MD: If I could, I would just add that one of the most challenging conversations is when you sit down with a group of providers and explain to them what you're wanting to roll out. The realistic questions that they ask you is, “Explain to me, why this? Why not the other?” When you have a credible answer to that, it doesn't tarnish your credibility trying to ask them to do something that's meant to improve the patient population they're trying to serve.

Arwen Podesta, MD: Authorization has been rigorously evidenced. To your point of doing cognitive behavioral therapy as an outpatient, most insurances, even Medicaid or Medicare, cover a certain number of cognitive behavioral therapies, or not even cognitive behavior therapy, just therapy sessions. That could be anything. We can go into a lot of therapies that aren't evidence-based that people are getting insurance coverage for. Why not apply that to something that's FDA authorized, with consistent algorithms and evidence in combination—in conjunction, if possible, or in lieu of?

Timothy Aungst, PharmD: If we talk about examples, sleep, for instance. I have trouble sleeping. We know the FDA [does not look at wellness products] because of the 21st Century Cures Act. You can say this DTX [digital therapeutic] helps you out with sleep, and the FDA can say we won't look at that vs this product that helps with insomnia. Once you say that I'm going to treat depression, once you say, I'm going to treat insomnia, that's where the FDA clearance and everything else comes into play. Instead of going for your Ambien, they reach for that melatonin. You're going to have this split between a lot of digital therapies that are going to go under, not needing FDA clearance, because of what they're going to treat vs some of them having made medical claims on actual medical conditions, and the FDA is going to look at that. They're going to say you need to have evidence that this does that kind of thing. The question is, if you do that, does it need to be prescribed and become a PDT [prescription digital therapeutic]? Can it be something else? Nonetheless, once you’ve made that medical claim, that's a big differentiating factor right now in DTX.

Transcript edited for clarity.