Prescription Digital Therapeutics for Mental Health: Effectiveness, Challenges, and Future Trends

In an interview with Pharmacy Times, Kari Franson, PharmD, PhD, BCPP, Senior Associate Dean for Academic and Student Affairs & Professor of Clinical Pharmacy, USC Mann discussed her presentation at the 2024 American Association of Psychiatric (AAPP) Conference. Franson examined evidence for the effectiveness of prescription digital therapeutics in treating mental health conditions like sleep disorders, ADHD, and substance use disorders. However, she highlighted challenges around integrating these tools into personalized treatment plans due to financial barriers and issues with patient persistence in using apps long-term. Franson emphasized emerging trends with these digital therapeutics, that include utilizing artificial intelligence for cognitive behavioral therapy and real-time monitoring of symptoms to provide faster feedback to patients. However, she noted that further research is still needed to evaluate their long-term effectiveness and safety.

Pharmacy Times

How effective are prescription digital therapeutics (PDTs) for treating mental health issues like sleep disorders, schizophrenia, ADHD, and substance use disorders?

Kari Franson

What's interesting is prescription digital therapeutics (PDTs) have really blown up in the last couple of years. What's been happening is there's actually been over 5000 different studies out there that look at the effectiveness, the outcomes associated with these different types of products. When you look at them, by and large, you're going to find some positive studies. But the problem is, by and large, they have a very small number of patients that are involved with them. They're almost exclusively here in the United States and in English language. You can't find something that would be appropriate, let's say for the population in Mexico, that would be speaking Spanish, for example. They're short term and because they're short term, that means that although we can see an initial response for the patients using these products, the question is, these are chronic diseases — what happens in the long term? We do see good effectiveness studies and that's why they're FDA approved, because low risk but there is a benefit. But I think the issue that really has come to the forefront is where are their real place in therapy. Sure, they're effective, but for how long? How much do they cost? What's the benefit cost benefit ratio of that?

Pharmacy Times

What evidence supports the effectiveness of PDTs compared to non-prescription digital apps?

Kari Franson

The FDA doesn't have a formalized process yet. They've adopted this loose international protocol that many countries are using. What they do is they look at each individual prescription therapeutic for its efficacy, as well as safety. Then when it's looking at safety, it's looking at a multitude of things. Obviously, the safety in the patient, but the safety of the data that is being gathered. Who has access to it, are there any kind of adverse effects? With some of the apps there was a complaint that a patient had seizures, because they were utilizing the app. So, they are looking at that type of safety, but they're also looking at the efficacy. Typically, in head-to-head trials, some of them are looking at patient populations that have over 100 patients been randomized in these trials. Now, it doesn't necessarily mean their power to really show good outcomes, but they seem to be doing and putting forth their best effort to really try and demonstrate effectiveness in these studies.

Pharmacy Times

What practical tips can pharmacists offer for integrating PDTs into personalized treatment plans for patients with mental health disorders?

Kari Franson

This is the interesting thing— it's a prescription digital therapeutic. But the reality is that prescription pretty much bypasses pharmacists. So, the provider will provide the patient the prescription, and then that is essentially a key that unlocks some sort of website for the patient to be able to access the application or the software. Sometimes the prescription digital therapeutic is actually almost a medical device that the patient could use in the clinic setting. In many ways, pharmacists might be bypassed in the traditional looking at what the therapeutic is, what it's for, and making sure it's appropriate for the patient. Therefore, I think the pharmacist really needs to be aware of what is the place of these digital therapeutics in the entire therapy plan for the patient. Because most often these are being used in conjunction with pharmaceutical agents that are trying to treat the disorder. So, they often can be helpful in monitoring improvement in that disease state so that pharmacists having access to that information can be very, very helpful. Then you see the patients doing better with real data because you have something that's monitoring symptom improvement. Pharmacists need to be aware of these digital therapeutics as far as what their treatment outcomes can be, and try and help patients navigating, am I getting a benefit from it or am I not over the long term?

Pharmacy Times

What challenges might arise when using PDTs in clinical practice, and how can they be overcome?

Kari Franson

Some of the challenges with these PDTs is 100% financial, unfortunately. The situation is you have this explosion of different devices, whether it's for mental health disorders, neurological disorders, you name it, optimal, logical. There are so many different types of prescription therapeutics that are being utilized. I would say first and foremost, we could say that diabetes agents are becoming pretty well integrated into our health care system. It's easy for a pharmacist to say, okay, here's some data and I'm going to provide you the insulin that's going to help you navigate you what's happening here. When it comes to the mental health apps, I think what the biggest issues are, is many of them are based on cognitive behavioral therapy. That means training through a series of modules, the person to look at their situation, to look at their symptoms from a different frame of mind. Other apps are cool where they actually provide feedback to the patient. So, somebody might be having a nightmare from a post-traumatic stress disorder, and their Apple Watch that's part of the app will be tapping on them saying wake up, so you don't feel this. The problem is that that while these can be helpful, not many providers or health system providers are paying for them. What we find is typically a lot of the patients who are going to try this are pretty resistant to therapy — nothing else has worked. They're willing to spend money on this, on their own. The other problem is because it could be a series of modules for cognitive behavioral therapy, they might not complete all the modules. They might give up because they're not seeing the instantaneous response that they might from, let's say, a benzodiazepine, which feels good right after you take it. I think that pharmacists really need to help patients navigate persistence in using the product, making sure that they get through all the trainings that are necessary, and try to help in any way possible to advocate that the different health plans are covering these agents. It seems to be right now, which is kind of unfortunate, there was a recent study that looked at all the different health plans. They just called them up and said, are you going to be covering this, and everybody pretty much said, we're going to take a wait and see on that. I think everybody's waiting for somebody else to jump into that pond and make a commitment to utilize these as a regular part of therapy.

Pharmacy Times

What new trends are emerging in prescription digital therapeutics for mental health, and how might they impact future care?

Kari Franson

To touch on some of the apps that I think are really interesting with cognitive behavioral therapy, what do they need? They need that language processing from AI that really can help a patient feel that that they're getting and being responded to for their specific needs. I think AI is very helpful for the cognitive behavioral therapy apps, but also just the fact that we're getting that up to the moment monitoring of a patient's symptoms. It is just the best thing because everybody wants to get better faster. They don't want to wait to the next time that they go to the clinician to find out am I getting better? But getting that instantaneous feedback can be really, really satisfying for some people, particularly if they're getting better. Now, on the flip side of that, if their symptomatology is increasing, then they might require more care because they're getting feedback that I'm not doing so well. But I really think that that combination of utilizing AI plus the therapeutic monitoring that they're getting better will only make sure that our patients are getting better and they're getting better faster. I think that can really be a game changer for us moving forward.