Access to Prescription Digital Therapeutics Act of 2023


The panel provides an overview of the benefits surrounding the Access to Prescription Digital Therapeutics Act of 2023.

Megan Coder, Pharm.D., M.B.A.: In terms of the broader idea of access, there is a bill that’s being circulated and has been introduced on Capitol Hill, called the Access to Prescription Digital Therapeutics Act of 2023. It was introduced last year and was introduced again this year. There’s definitely momentum building behind it, which is incredible given some of the questions and curiosities we faced in early 2020 when we first introduced this on the Hill. I’m curious to hear your thoughts, if you are familiar with this bill, know what it could do to help with Medicare and help expand access, and enable that inequity that exists in the United States to start to dissipate.

Arwen Podesta, M.D.: I’ll jump in quickly. I’m super excited about it. I was aware of it because of my interest in this particular case. I was aware of it at the beginning, and I’m glad that it’s back on the Hill. I think it could improve treatment for the things we are at capacity for using, as prescribers, and what we have out there already. I think this could be great.

Megan Coder, PharmD, M.B.A.: Thank you.

Paul L Jeffrey, Pharm.D.: I’m very familiar with it, I just finished a term on the Academy of Managed Care Pharmacy [AMCP] board of directors. You would know well, Megan, that that organization, AMCP, has adopted prescription digital therapeutics [PDT] access as one of its strategic initiatives. So AMCP strongly supports the Access to Prescription Digital Therapeutics bill that is before Congress. We will be lobbying actively to see that that gets adopted. It will compel CMS [Centers for Medicare & Medicaid Services] to do some of the things that I mentioned in my previous comments about acknowledging that these items exist and to help provide a way for them to be paid for so we have more universal access to them, other than pockets of access we have today, primarily stimulated by champions of the products.

Megan Coder, PharmD, M.B.A.: It’s been encouraging to see groups like AMCP working alongside the DTA [Digital Therapeutics Alliance] and others on the same issue, so thank you for explaining that. When we’re looking at this then, how do we even start to approach this from that payer perspective and start to understand where digital therapeutics fit? We know there are 350,000 health apps [applications] out there. We know that digital therapeutics is a very small subset of that larger ecosystem. We also are aware that the FDA [Food and Drug Administration] is able to clear nonprescription and prescription products, but prescription products is the area we’re focusing on today and has been the main focus of a lot of these different types of discussions. When we’re looking at this from either the payer or health care decision-maker perspective, I’m interested to see, Eric, from your perspective first, how these different entities are starting to navigate the differences between these FDA types of clearances or approvals, some of the evidence they come to the market with, and some of the real-world evidence that needs to be developed to ensure the applicability to patient care.

Eric Cannon, Pharm.D., FAMCP: Thanks, Megan. I think that’s a great question. I think there are a lot of people using cleared and approved interchangeably. Pear Therapeutics, I think, provides a good case study in terms of that. If you look at reSET, reSET-O [PDT treatment] when that was approved in 2017, they went through the de novo pathway where they had sham-controlled clinical trials rigorously designed to demonstrate the outcomes and the benefits of that treatment. Now, that ended up being approved by the FDA. Pear Therapeutics went on, and we’ve heard Arwen talk about Somryst. Well, Somryst went through the 510(k) pathway, which really was intended to demonstrate similarity to an already approved product. There are subtle differences that are happening there. Somryst didn’t come to market with the same rigor in terms of the level of clinical trials and everything that’s out there. I think there’s a notion that exists within people’s minds that everything approved through the FDA has gone through this rigorous review. For those of us who have been involved in pharmacy for a long time, you’ve got prescription pharmaceuticals, and then you’ve got herbal medications. Both can be approved by the FDA or cleared by the FDA, yet some carry a higher level of evidence than others.

As we have this conversation, I think we’re looking at it internally as a plan to say, whether it has a prescription or doesn’t, some of that goes back to the process of going through the FDA, and what did the manufacturer submit on that application to say this is prescription or this is not. That ends up sometimes in a discussion with the FDA, but I think what’s the evidence behind its use? Having those more rigorous sham-controlled trials, or even trials that are more real world, is really helpful. I think the other thing we have a lot of times with pharmaceuticals is, we go to phase 3 [trials], we get approved, but every manufacturer continues into phase 4 with supplemental trials, supplemental data, and so the data continue to come and continue to drive that adoption. As we look at whether we’re going to cover them or not, I don’t know that it matters if it’s cleared or approved. I don’t think it matters if it has a prescription or it doesn’t have a prescription. Ultimate adoption is going to be driven by the level of evidence and the level of data that came out with that product when it was put on the market.

Megan Coder, Pharm.D., M.B.A.: Arwen, when we’re talking about evidence, that must mean a lot to you. We’ve already spoken a bit about the clinical evidence coming into this. We spoke about real-world data already, and the data that are generated from a patient and come back to you as a clinician. In real-world evidence, how much does that impact your decision-making process, in terms of the types of evidence being generated in a real-world setting, but undergoing a robust trial package, to make sure that evidence is seen as the legitimate source that it is?

Arwen Podesta, M.D.: I do that with medications. I’m not going to put something in my patient’s mouth that has side effects, that might be a very big risk, unless it’s authorized and approved and has rigorous safety, efficacy, and side effect studies, and I know about them. We do have some great new medications that are coming through the pipeline for psychiatry and mental health, which is fantastic. Luckily, we also have that same rigor applied to these PDTs regarding safety and efficacy, and risk and benefit, and side effects. That’s what I’m looking for. I know I can tell a patient to go download a cognitive behavioral therapy app from their app store, and they can do it. I don’t see data, and I don’t know that the data exist for it. Whereas with these PDTs, I see the data, I get to augment the treatment plan using these tools and using my dashboard, and the patient using their device and their PDT. I hope that answered the question.

Transcript edited for clarity.

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