Managing PDTs Amidst Other Therapeutics

EP: 1.What Are PDTs?

EP: 2.Evolution of PDT

EP: 3.Successes and Challenges With Using PDTs

EP: 4.PDT Patient Selection

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EP: 5.Managing PDTs Amidst Other Therapeutics

EP: 6.PDT Coverage Decisions

EP: 7.Improving the Payer-Provider Relationship Influencing PDT Use

EP: 8.Increasing Access to PDTs For All Parties

EP: 9.Value-Based Pilot Programs for PDTs

EP: 10.Educating Peers About PDTs

Diana Brixner, RPh, PhD: There is not a lot of evidence out there as far as how these PDTs [prescription digital therapeutics] impact overall economics outcomes and costs because it is a new type of technology. Part of a follow-up to going through the full FDA process is they have developed the real-world evidence to demonstrate exactly that, what the impact is on cost and outcomes, but even those studies are usually in a specific population; as they look to cover it for their own population, many health plans need to translate that data to understand what the potential impact could be for their individual plan.

There are ways to measure outcomes and costs because they really aren't any different than looking at a more traditional drug therapy. What is the baseline of care today? What is the scope of your population that could be impacted by a particular treatment? What are the costs and outcomes of the current therapies that are being used, and how could a new treatment impact the current cost outcomes for treating a particular disease? A PDT would undergo those same assessment opportunities. You would look at treatment pattern, standard of care prior to a PDT intervention, and then look at treatment costs and outcomes post-PDT treatment intervention to understand what the impact is on that overall health care cost, as well as the patient satisfaction and outcomes.

Because of the status, the “P” prescription in PDT, the PDTs have undergone the same development processes as drug therapeutics. Therefore, they also undergo the same review process as any drug therapy would on a formulary committee—if there's a coverage decision, if there's a benefit design, all the same influencers that would be there for a drug therapeutic. With the digital support patient support programs, those often come with no or very little cost. Those are more the realm of the provider: being aware of those types of support programs, offering them to patients, having patients decide whether they want to do uptake or not. They don’t have data that looks at the impact of outcomes for those types of tools. The way I view it is they're more part of the patient education component of health care, whereas the PDTs are really considered as a therapeutic and are therefore reviewed and considered as any prescription therapy would be.

Arwen Podesta, MD: The questions regarding patient satisfaction and patient outcomes always comes up. Very good outcomes have been reported for patient satisfaction when they use these apps, and they're very satisfied as evidenced by not just practices using and adopting them, but also as evidenced by the FDA authorization process itself. The questions that went with the authorization included a satisfaction survey, and it was very high. As far as my gathering absolute data, I personally have not been doing that in my private practice, but certainly, that has occurred in some of the IOPS, the intensive outpatient programs that I'm affiliated with. Those with reSET & reSET-O do have fewer relapses. The good news is that data is also collectible from the clinician dashboard or from the pharmaceutical company itself. They collect data, knowing when people are working the prescription digital therapeutic and what their outcomes are because you can attach drug screens as well. There's an element where prescription digital therapeutics can fill a lot of the gaps in care that we're seeing, partially because of COVID and also a higher level of anxiety, addiction, depression, and sleeplessness. We can use some PDTs to make it so that my knowledge and my treatment is going to hit many instead of a few.

I also see that there's improvement in access for those in different geographic and socioeconomic areas. If we look at where there are psychiatrists, where there are sleep specialists, or where there are therapists that are available and taking patients covered by insurance, we're going to see that it lines up with the more urban areas and very little in the rural and lower socioeconomic areas. There's a big opportunity with payers adopting PDTs to really bring access to those that are most disenfranchised. Almost everybody that I'm aware of, even some of my homeless patients, have access to a smartphone—whether they have access to internet, that's a question based on region—but even some entities in the state have been giving those that don't have any devices the inexpensive smartphone devices. There's not a question of whether it's technology that is the barrier. It's prescribability, geographic location, and access to a prescriber.

There's a question about comparing PDTs vs traditional prescriptions. I don't see them as mutually exclusive. What we know from reSET & reSET-O regarding addiction treatment is that these are not standalone therapies. They're to be used in conjunction with medication-assisted treatment and with other individual or group therapy. They really augment each other. It's a synergistic effect, and it's capturing some contingency management in addiction treatment that will make people stick with the treatment more, as well as reiterating and taking home a lot of the behavioral techniques and therapies. I don't see PDTs as mutually exclusive to medications in any light regarding chronic insomnia. What we know is that for all acute diseases that turn into chronic diseases, we should treat the acute symptoms. Sometimes medication needs to be the heavy hammer that we treat that with initially. As we're getting the medication stabilized and maybe starting to think of pulling away the medication, we are doing other behavioral techniques. Think about diabetes. If we are suddenly with type-2 diabetes after aging through many years of chronic diet issues with high glycemic diet, we use a medication to help treat the symptoms. While we're using that medication, we then start making behavioral changes—perhaps losing weight, getting a nutritionist, doing some cognitive behavioral therapy for nutrition and diet. You might not need the medication anymore. That's how I see prescription digital therapeutics really influencing health and long-term durability of wellness.

This transcript has been edited for clarity.