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Nationally recognized psychiatrist, internist, and addiction medicine specialist Muhamad Aly Rifai discusses his article, “The rise of digital therapeutics in medicine.” Muhamad explains what prescription digital therapeutics (PDTs) are, emphasizing they are not wellness apps but Food and Drug Administration (FDA)-cleared, evidence-based software prescribed by clinicians to treat specific diagnoses. He explores the groundbreaking examples already authorized by the FDA, including software for substance use disorder, a video game for pediatric attention-deficit/hyperactivity disorder (ADHD), and a new adjunct treatment for major depressive disorder. Muhamad breaks down how these digital therapeutics are designed to work alongside (not replace) human clinicians, offering continuous, skill-building support for mental health conditions. Learn how this new category of medicine is moving care from the exam room into the patient’s daily life and what it means for the future of treatment.

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today, we welcome back Muhamad Aly Rifai. He is a psychiatrist, internist, and addiction medicine specialist. Today’s KevinMD article is “The rise of digital therapeutics in medicine.” Muhamad, welcome back to the show.

Muhamad Aly Rifai: Thank you very much for having me to talk about this very important and timely topic. Prescription digital therapeutics and digital therapeutics in medicine have come to help a lot of patients in my field of psychiatry and neurology, as well as other fields. This is going to become the wave of the future for patients by employing basically their phones to help them with the management of their illness.

Kevin Pho: For those who did not get a chance to read your article, tell us what it is about.

Muhamad Aly Rifai: Basically, with the advancement of handheld devices, we have seen that handheld devices have been utilized more and more in daily life. Most people have a health app on their phone, whether it is an Apple-based phone or an Android, that measures how much they are walking. It can also connect to other health care equipment such as blood pressure cuffs and thermometers, and it can connect to their electronic watch that could check for their sleep and pulse.

Digital therapeutics and prescription digital therapeutics go a step further. They are not just a wellness tracker, and they are not just a medication app. They are medical treatments. If they are digital therapeutics, they undergo significant and rigorous testing. If they are prescription digital therapeutics, they actually undergo approval by the Food and Drug Administration that is rigorous. They undergo trials to understand and prove that they actually are effective in terms of treating the condition that they claim to treat.

We are seeing that there has been a plethora of new apps that have come out in the last 10 years, and we have seen the number accelerate. Specifically in my field of psychiatry, we have about three or four apps that are FDA-approved now as prescription digital therapeutics. That is why I wrote this article to draw attention to this coming phenomenon. It is something that a lot of our patients are going to be seeing and physicians are going to be dealing with on a regular basis.

Kevin Pho: Give us an overview of some of these conditions that they treat. In your article, you talk specifically about these digital therapeutics to address substance use disorder, ADHD, and major depressive disorder. Give us a sense of how they work from the end user’s perspective.

Muhamad Aly Rifai: Sure. The first application that was approved was actually for substance use disorders and alcohol use disorder. The app was called reSET, and it was granted FDA approval in 2017. This was one of the first apps. Basically, it had some traction but not a lot of traction. It manages a person’s daily life. It talks about healthy relationship needs, managing thoughts and emotions, and boundaries. It focuses on relapse management for individuals with drug and alcohol issues.

Later on, another app was approved for alcoholism and for opiate use. It did not get a lot of traction because it was very expensive, and insurers did not approve it on a regular basis. However, it is having a comeback. They have restructured the price, and I think people are going to be utilizing it. It is going to be modified a little bit. That software extends evidence-based therapy, such as abstinence therapy and relapse prevention for individuals who have drug and alcohol issues.

The next app was actually for attention deficit disorder, or ADHD. Because it was targeted toward adolescents, children, and adolescents, it was actually a game. It was a game-based app that targets attention and concentration. The child or the adolescent engages in this game in a pattern that would help them extend their concentration and focus. It does have a cognitive behavioral approach also to help with their concentration and focus. It is probably one of the most utilized apps because it was marketed and FDA-cleared for children and adolescents. Parents actually really advocated for their children to get that. Insurers were approving the app, and it does have very robust data. One of the apps that has the best robust data is the one for ADHD. There may be additional apps that would target different domains of the ADHD condition.

Kevin Pho: Now, these particular apps have to be prescribed. These aren’t simply apps that patients can download and pay for in the app store. These apps have to be prescribed by a physician.

Muhamad Aly Rifai: It will ask for a physician prescription. The way that is done is once the physician signs up in a portal, they are able to generate a code for the patient to utilize the app. In terms of payment for some of the newer apps, they are allowing the patient to pay for it but with a prescription from the physician. When the physician prescribes this app, that generates a code that will link the app of the patient to the physician. The physician would get feedback on the utilization of the app.

One additional point is very important. These apps are actually not dependent on the internet or broadband, so they could be utilized in underserved areas. The app could be downloaded when there is a Wi-Fi connection, but if there is not a robust Wi-Fi connection, the app can operate independently. The person could use the app. It does not need internet access. Only when it gains internet access again does it transmit the data of the utilization of the app and the patient’s progress to the physician.

It does have an emergency component as well, especially for the ones with ADHD, drug and alcohol issues, and depression. If the person is experiencing thoughts about harming themselves or harming others, it will dial 911. It does have a safety feature for the app. Basically, it is pretty straightforward for the physician to be able to prescribe that, but the insurance adoption is still pretty spotty.

Kevin Pho: Why does it have to be gatekept like that? Why can’t it just be released to the public in the app store? Are there any risks to the patients that require these apps to be prescribed?

Muhamad Aly Rifai: The app is actually on the app store, and you can download it, but you cannot get it activated without a code that gets generated by the physician. The apps are on the app store. The thought of why it requires a prescription is because it has an FDA component and it is a treatment. The thought is that if you have it available without physician supervision, individuals who have severe conditions may think that they could manage their condition just with an app and do not need to consult with a physician or need further treatment.

The FDA wants to make sure that the physician is involved in ensuring that the app is an adjunct treatment because it is not the main treatment. In the case of the app for depression, which is called Rejoyn, it is basically an adjunct treatment for individuals who are already on medications, such as antidepressant medications, or who are receiving other treatments such as transcranial magnetic stimulation. We want to make sure that the individual is well cared for. It is not just that you download the app and think that is it and your depression is treated. Individuals may have untoward issues related to the fact that their condition is pretty severe, and they just thought that they could download an app and have their condition treated.

Kevin Pho: What are some of the indications where physicians can consider prescribing an app like this? For patients who are already being treated for say, ADHD and depression, what are some of the indications where prescribing an app may be in that patient’s best interest?

Muhamad Aly Rifai: Sure. Let’s talk a little bit about the app that is actually FDA-approved for depression. It is called Rejoyn. It is an adjunct app that employs a cognitive behavioral therapy approach for individuals who have depression. It is an add-on to medications. As you know, it is very difficult to find therapists. There is a lack of access to therapists, and there is very little access to psychiatrists. Primary care doctors could start their patients on antidepressant medications and add on the app, which would be a component of cognitive behavioral therapy.

It is a prescribed course of cognitive behavioral therapy for six weeks. It has modules where a person does a task every day focusing on their behavior, their concentration, their thought perception, and cognitive distortion. It does have a prescribed course of cognitive behavioral therapy that is FDA-approved. That is how it works as an adjunct to medications.

When it is prescribed by a physician, the physician is involved in that app and receives periodic reporting about how their patient’s progress is. Especially if the patient basically has significant adverse effects or develops suicidal ideation, the physician is notified and there is access to help if the patient’s condition deteriorates.

For example, the app for depression, Rejoyn, is available. The person could pay for the app. The price that I saw on their website is $200. You could download it and get a prescription from your physician if you are battling with a condition of depression or anxiety. Then you could pay for the app and get it activated. I think that they are becoming more and more available and more and more affordable for individuals as opposed to seeing a therapist.

Kevin Pho: Have you had personal experience prescribing these apps or heard about your colleagues prescribing these apps? What have their experiences or experiences that you have heard been like?

Muhamad Aly Rifai: When I got introduced to this app, I actually asked to see the app. The company that developed the app will give physicians a trial copy of the app so you can test it. I have it on my iPad, and I see the Rejoyn digital therapeutic. Basically, it has classes. You interact with the app on a daily basis for a few minutes with cognitive behavioral components. The app seems to be very helpful.

I tried it myself just to see what the patient’s experience with this app is. I have prescribed it for a few patients. They were very satisfied and have had good success in terms of it being an adjunct treatment for their depression. For example, if they are a busy professional who cannot go see a therapist, it helps. In addition to medications, it does boost the rates of response to medications in individuals who have depression.

There is very little adoption with a lot of my colleagues, and this is why I am trying to raise attention to it. It is a new topic. However, our patients are faster than us physicians. Our patients are on their phone all the time. They have all these apps. Why not use a prescription digital therapeutic to improve their condition? There are other digital therapeutics, for example, for managing migraine headaches that are prescription digital therapeutics. They are working on developing multiple other prescription digital therapeutics for other conditions.

I think that is the future. As physicians, we have to be able to get on that wave to basically be able to help our patients because our patients are there. They are going to come to us and ask if we can prescribe this for them. You cannot just tell your patients that you do not know what they are talking about. We have to be very well-educated about these things.

Kevin Pho: Logistically, how do physicians prescribe these apps?

Muhamad Aly Rifai: The physician will sign up on a portal specifically for the apps that are for that condition. In terms of depression, the physician signs up, gets verified through their NPI, and is able to prescribe. Basically, that generates a code that the physician would give to the patient who would download the app because the app will ask if you have a prescription. The prescription is that code that the physician provides to the patient once they prescribe this app.

When the patient utilizes the app, there is feedback that comes back to the physician. I see the wave of the future where a lot of health apps will send reports to your physician about your steps, about your sleep, and about other things that you could choose to share with your physicians. Now it is going to be depression screening, PHQ-9, MADRS scales, and anxiety scales. Physicians will get a lot of feedback from their patients when they are at home to see if they can improve the management of their condition.

Kevin Pho: In terms of costs, you threw out that number of $200 for one of those apps. Is that something that the patients would pay, and how often would insurers cover this?

Muhamad Aly Rifai: Insurance adoption is still difficult. But for example, ADHD is the one where parents were able to get a lot of insurers to pay because it is a game and it is for kids. The prices have come down significantly, but I think we are going to see a lot of adoption from insurers because they realize the value, especially once there is more data. A lot of insurers are data-driven, and they want to see that they are going to get a return on their investment. I think it is coming, and they are seeing that on a regular basis with other apps. Prescription digital therapeutics, I think, is the wave of the future.

Kevin Pho: We are talking to Muhamad Aly Rifai. He is a psychiatrist, internist, and addiction medicine specialist. Today’s KevinMD article is “The rise of digital therapeutics in medicine.” Muhamad, let’s end with some take-home messages that you want to leave with the KevinMD audience.

Muhamad Aly Rifai: I see that digital therapeutics are moving parts of the care from the exam room into the routine of our patients where their life happens. We are being involved in their life, and we get reports on that with digital therapeutics as we are able to manage difficult conditions such as depression and ADHD. There are digital therapeutics for migraine headaches, and I think that is the wave of the future. Each condition will have an app, a digital therapeutic that helps management of this condition. We are going to see much more of these FDA-approved prescription digital therapeutics in the future. We have to be prepared when our patients propose those treatments for us.

Kevin Pho: Muhamad, thank you so much for sharing your perspective and insight. Thanks again for coming back on the show.

Muhamad Aly Rifai: My pleasure.