Brent I. Fox, Pharm.D., Ph.D and Joshua C. Hollingsworth, Pharm.D., Ph.D.

Our nation currently faces several epidemics, including the opioid epidemic, the obesity epidemic, and the epidemic of chronic illness. In 2015–2016, drug overdose deaths in the United States increased by more than 20% (from 16.3 to 19.8 per 100,000 people). According to the CDC’s most recent National Vital Statistics Report (Volume 67, Number 9), which examined drug mentions on death certificates from 2011 to 2016, fentanyl topped the list in 2016 in terms of the drug most implicated in overdose deaths. In 2011, it was oxycodone, and from 2012 to 2015, it was heroin. In total, opioids were responsible for two-thirds of the overdose deaths in 2016. As for the obesity epidemic, nearly 40% of adults and 20% of children had obesity in 2015–2016. These are the highest percentages ever documented, and there are few, if any, signs of the issue shrinking anytime soon. In fact, no states saw a decrease in obesity rates in 2016–2017, and the prevalence increased in six states during this time. Closely linked to the obesity epidemic, chronic illness has also reached epidemic proportions. Sixty percent of U.S. adults have at least one chronic disease, such as heart disease, chronic lung disease, or diabetes, and 40% have two or more chronic diseases. More than 100 million U.S. adults have diabetes or prediabetes. In addition to wreaking havoc on those individuals and families directly affected, these epidemics are leading drivers of healthcare costs. Something must be done, and it will likely take multiple concerted efforts across the continuum of care. One such approach that is becoming more and more available is the use of prescription-only mobile medical applications.

What Are They?

Prescription-only mobile medical apps are mHealth (mobile health) apps that have been tested, usually in randomized clinical trials, and subsequently cleared by the FDA to be used in the treatment of disease. These apps are sometimes referred to as “prescription digital therapeutics.” However, since the term digital therapeutics also includes technologies such as wearable devices, telemedicine platforms, and digital pills, let’s call them Rx apps. Rx apps, often prescribed alongside drug therapy, aim to help patients better manage their illness. To do so, they employ clinically proven treatments, such as cognitive behavioral therapy, self-monitoring, and other evidence-based approaches. As with the distinction between a drug and a dietary supplement, FDA clearance is required before any claims are made that an mHealth app treats or manages a disease. Rx apps often include a desktop application in addition to the mobile app, as well as a dashboard to be used by healthcare providers to monitor patients’ progress. They are adjudicated as a pharmacy benefit like other prescription products. After downloading an Rx app, the patient must first enter a prescription access code before he or she can actually use it.

In addition to providing some assurance of safety and efficacy, FDA clearance also helps Rx apps stand out in the marketplace. While there are more than 318,000 mHealth apps available today in the mobile app stores, there are currently only a handful of FDA-cleared Rx apps. However, this number is likely to grow quickly in the coming years. Since they are prescription-only, and pharmacists fill prescriptions, you can anticipate patients inquiring about their use. Let’s take a look at some of the Rx apps that are available now and that could play a role in addressing the epidemics mentioned above, as well as some Rx apps that are currently in development, undergoing clinical study, or awaiting FDA clearance.

BlueStar

BlueStar, an Rx app by WellDoc that received FDA clearance in June of 2013, is touted as a digital diabetes management platform. In addition to collecting patient data, such as blood glucose readings and food and physical activity logs, and sharing this data with the patient’s healthcare team, the app also provides automated and personalized behavioral coaching, motivational messages and challenges, access to diabetes educators, and educational content. The app can also be used to keep track of medications and set dose reminders. In multiple clinical trials, use of the platform resulted in clinically significant reductions in A1C, above and beyond usual care alone. In March of 2017, a nonprescription version of the BlueStar app was FDA cleared, and in July of 2018, WellDoc expanded the platform to include focus on weight loss and hypertension in patients with diabetes. The company is currently working on a stand-alone product for hypertension.

reSET

reSET, developed by Sandoz (a division of Novartis) and Pear Therapeutics, is the first Rx app that aims to help treat substance-use disorder, including use and abuse of cocaine, alcohol, marijuana, and stimulants. It was cleared by the FDA in September 2018 for use in conjunction with outpatient therapy. The app is derived from a web-based addiction therapy program, which was based on established in-person cognitive behavioral therapy for substance-use disorder. The app contains over 60 therapy lessons that include quizzes and exercises on particular topics. The recommended dose is four lessons per week. The aim is to modify patient behavior by facilitating the development of the skills needed to maintain abstinence, such as recognizing and avoiding triggers and coping with thoughts about using. Patients receive encouraging feedback and rewards, such as gift cards, after completing a lesson and after testing negative for substance abuse. In terms of efficacy, clinical trial results showed that abstinence rates at 12 weeks were higher for patients who used the reSET system versus those who did not. However, at six months, abstinence rates were about the same across the two groups.

reSET-O

In December of 2018, the FDA cleared reSET-O. Also produced by Sandoz and Pear Therapeutics, reSET-O is the first Rx app developed specifically to treat opioid use disorder. Similar to reSET, reSET-O uses cognitive behavioral therapy and a compliance reward system, and it is intended to be used in conjunction with outpatient therapy and pharmacotherapy, such as buprenorphine. In the 12-week, multisite, unblinded clinical trial reviewed by the FDA, retention rates in the behavior program were 82.6% for those participants who used the reSET-O system in addition to buprenorphine, versus 68.4% for those who did not.

More Rx Apps on the Way

There are several Rx apps that are currently being developed, studied clinically, or awaiting FDA clearance. Novartis announced in March of 2018 that they plan to collaborate with Pear Therapeutics on Rx apps to treat patients with schizophrenia and multiple sclerosis (MS). Novartis says that the Rx app for multiple sclerosis, which is presumably under development, will “address underserved mental health burden in patients with multiple sclerosis.” Early clinical trials with THRIVE, their Rx app for schizophrenia, has shown some promise in terms of usability, retention, and preliminary efficacy. The digital medicine start-up Akili Interactive Labs is currently developing Rx apps that use mobile games to treat cognitive deficits associated with several disease states, including childhood attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder (ASD), major depressive disorder (MDD), multiple sclerosis, and others. Akili says that, although they look like typical high-end video games, its products “target cognitive deficits at the specific sources in the brain to improve cognitive function.” Akili has submitted AKL-T01, its prescription video game for childhood ADHD, to the FDA and is currently awaiting the agency’s decision on clearance.

It is early days for Rx apps, and we believe pharmacy integration is a key component of the future adoption and utility of these apps. The long-term impact that these technologies can have in terms of disease management, improved quality of life, and cost containment is largely yet to be seen. Time will tell. And despite the seemingly obvious innovation, there are some who argue that Rx apps are simply repackaging of existing treatments. However, we feel that this view does not take into account the increased accessibility of a proven treatment, once repackaged in an Rx app. Smartphones, which are almost never out of arm’s reach, are now used more widely than desktop or laptop computers. As more Rx apps are developed, tested, FDA cleared, and brought to market, we hope to see more integration with pharmacies and pharmacy management systems. As we’re all well aware, pharmacists are an integral part of the healthcare team, across which coordination of care is key. To this end, Rx apps could play an integral role, facilitating communication and planning between patients and providers. Pharmacists, empowered by the data Rx apps provide, could help address medication adherence and other medication-related concerns, thereby improving the overall quality of care.

So what are your thoughts? Do you have any experience with Rx apps? Have patients asked you about them? We welcome your comments and suggestions. CT

Joshua C. Hollingsworth, Pharm.D., Ph.D., is an assistant professor, Pharmacology and Biomedical Sciences, Edward Via College of Osteopathic Medicine, Auburn Campus, Auburn University, and Brent I. Fox, Pharm.D., Ph.D., is an associate professor in the Department of Health Outcomes Research and Policy, Harrison School of Pharmacy. The authors can be reached at jhollingsworth@auburn.com.edu and foxbren@auburn.edu.

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