In the last several years, a new class of diagnostic and behavioral therapy options for select neuropsychiatric indications has emerged in the form of Prescription Digital Therapeutics (PDT, sometimes abbreviated DTx). These therapies are typically rooted in the psycho-social intervention technique known as cognitive behavioral therapy (CBT). From Attention Deficit Hyperactivity Disorder (ADHD) to irritable bowel syndrome (IBS), many unique, new digital therapy options have already received the FDA’s stamp of approval, with even more in the development pipeline. Here, we have compiled some prominent examples of these pioneering new therapies currently paving the way for this intriguing treatment modality.

Non-pharmacologic therapy has always been an essential tool for the management of conditions with limited treatment options, as well as those with incomplete response to traditional pharmacologic therapies. The arrival of DTx to the scene brings with it new questions and challenges for patients, prescribers, and 3rd party payers. Though answers and solutions will become clearer with time, it will be important to ask the right questions about these innovative new therapies to foster stewardship and ensure the healthcare dollars spent on them yield meaningful improvements in patient care. From the payer perspective, among the first of these questions will be: should there be a formulary for digital therapy? The following is a brief review of currently available digital therapies and diagnostics for 3 important disease states. Part 2 of this blog will contain information associated with 3 additional disease states, along with a summary of pharmacy benefit considerations.

Autism Spectrum Disorder (ASD)
In 2021, the FDA approved the use of the first digital diagnostic software, Canvas Dx™ by Cognoa, to aid in the diagnosis of autism spectrum disorder. Cognoa received Breakthrough Device Designation by the FDA for its two lead products, the second of which is still in development, and is intended to treat ASD by improving socialization in pediatric patients. In clinical trials, Canvas Dx™ demonstrated the ability to correctly diagnose 81% of patients with ASD, and correctly rule out an ASD diagnosis in an impressive 98% of patients. This software is now available in the US and is being marketed as the first of its kind. This tool will almost certainly find an invaluable place in the diagnostic toolkit, one that may allow for earlier detection and treatment of a condition that can require months of waiting on specialists and referrals.

Attention Deficit Hyperactivity Disorder (ADHD)
In 2020, another digital therapy in the form of a children’s video game was approved by the FDA for use in 8 to 12-year-olds with ADHD. EndeavorRx® by Akili, is a game-based digital therapeutic option which has yielded improvements in attention function as demonstrated by multiple clinical studies carried out in over 600 pediatric patients. No serious adverse events have been reported, and though mild adverse effects like frustration, headache, dizziness, and aggression were documented, these are common screen-related side-effects that are temporary in nature. While patient and caregiver education are key in guiding an ADHD patient’s treatment plan, EndeavorRx® presents a new option for non-medication-based therapy, which may be of particular significance for patients who are intolerant to typical ADHD medications, and to parents who are interested in more conservative treatment options for their children.

Substance Use Disorder (SUD)
A less-recent FDA-approval in 2018, reSET®, and reSET-O® are medical mobile phone applications for use in SUD and opioid use disorder (OUD) patients, respectively. The latter of which was the first PDT to receive Breakthrough Designation from the FDA. These apps utilize mobile cognitive behavioral therapy which is indicated for use in conjunction with other therapy options. The apps focus on improving patients’ commitment to recovery and offer various options for positive reinforcement to help motivate patients in the right direction. The research done on both the SUD and OUD options of this application have shown that use of the program improves retention to treatment plans and can improve overall motivation to recover with a very limited side effect profile compared to medication-based therapy plans.

Part 2 of this blog will cover Insomnia, Nightmare Disorder and Irritable Bowel Syndrome, along with some perspectives regarding the manner in which DTx fits into the pharmacy benefit.