Digital Therapeutics and the Pharmacy Benefit: Part 2


In Part 1 of this blog on Digital Therapeutics and the Pharmacy Benefit we discussed the emergence of a new class of diagnostic and behavioral therapy options for select neuropsychiatric indications, Prescription Digital Therapeutics (PDT, sometimes abbreviated DTx).  We shared an abridged summary of DTx associated with Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder and Substance Use Disorder. In Part 2, below, we tackle Insomnia, Nightmare Disorder and Irritable Bowel Syndrome, along with a brief summary of pharmacy benefit considerations.


Insomnia: The first FDA-approved PDT for insomnia was launched in 2020. Somryst®, by Pear Therapeutics, is a cognitive behavioral therapy application for patients 22 years of age and older with chronic insomnia. This is a particularly interesting approval because it is one of the only options that is technically guideline-recommended for its clinical indication. Current insomnia treatment guidelines recommend cognitive behavioral therapy for insomnia (CBT-I) as first-line for chronic insomnia. And, this new digital therapeutic option allows patients to receive CBT-I virtually, without the need for an in-person office visit. The clinical data for this new therapy are quite compelling, with two clinical trials on the web-based platform which show both efficacy and improved safety compared to some alternative options, specifically in the form of sleep-aid medications.


Nightmare Disorder: Also approved in 2020, another sleep-related digital therapy worth mentioning is the eponymous smart-watch app by NightWare, Inc., which is indicated for the treatment of nightmare disorder, and was granted Breakthrough Designation for nightmares secondary to PTSD. NightWare™ tracks heart rate and body movement to detect when a patient is experiencing a nightmare. It then uses subtle vibrations to interrupt the nightmare, all without even waking the patient, or inducing any discernible adverse effects. In clinical trials, NightWare™ demonstrated greater improvements in sleep quality compared to control subjects wearing watches without the app’s AI and vibratory stimulation.


Irritable Bowel Syndrome (IBS): Another CBT-based PDT, Parallel™ by Mahana Therapeutics, is a three-month digital therapy which was approved by the FDA in 2021 to reduce the severity of IBS symptoms in adults. This CBT-based program has been shown to improve symptomatic presentation in patients diagnosed with IBS, with benefits continuing after a full year of therapy. 


Pharmacy Benefit Considerations for DTx: These products have demonstrated efficacy, but where do they belong in therapy? And should they be included on your formulary? One of the most important questions that will need answering regarding the new field of prescription digital therapeutics is whether clinical trial efficacy can be supported by real-world effectiveness, and whether these devices should be covered under the pharmacy benefit. Right now, for many of these digital therapies, the available primary literature, and clinical trials, though promising, are limited to small patient populations. To ensure appropriate utilization of these new treatments and contain unnecessary pharmacy benefit costs, thorough evaluation will be required to establish their place in therapy and identify appropriate candidates who will benefit the most.


The Profero Team specializes in prior authorization and utilization management for pharmacy benefits and analyzes available data to determine how innovations like digital therapy can be integrated into an existing formulary in a way that controls cost and enhances quality of care. If your organization is seeking more information about implementing these therapies under your health plan, we are available for consultation. Reach out to us, and learn more about our organization through our website,