Digital Therapeutics: Another Arrow in a Physician and Pharmacist’s Quiver

March 29, 2018

By: Matthew Rubin, Advisor, Faegre Baker Daniels Consulting

In a time when an estimated 22.7 million Americans struggle with substance use disorders and only 11% of these individuals receive appropriate health care-related services, efforts are underway throughout the pharmaceutical and biotechnology industries to improve access and outcomes. Specifically, a handful of companies throughout the United States have undertaken the field of prescription digital therapeutics in an effort to further facilitate the health care provider-patient dialogue and advance opportunities to leverage a multifaceted approach in the treatment of diseases and illnesses, often with high unmet needs.

Prescription digital therapeutics includes software and electronic application-based services that are used standalone or in conjunction with traditional standards of care. Unlike traditional wellness apps, these products have been reviewed and cleared by the US Food and Drug Administration (FDA) using randomized clinical trial data. These products have demonstrated their roles as safe and effective medical intervention when used appropriately. Alongside the growth in the field of digital therapeutics is the rise in clinical data and peer-reviewed journal publications that highlight the effectiveness of these products to improve therapeutic outcomes and reduce comorbidities and related health care costs.

Innovative companies have begun to develop and submit for approval prescription digital therapeutics focused on areas such as diabetes, substance use or opioid use disorder, schizophrenia, Alzheimer’s disease, attention deficit/hyperactivity disorder, and post-traumatic stress disorder, among others.

In September 2017, Pear Therapeutics became the first company in the prescription digital therapeutics market to receive clearance from FDA to market a product for the clinical treatment of a disease. The product, known as reSET®, is indicated for the treatment of substance use disorder in conjunction with the standard of care, being face-to-face therapy. Clinical trials conducted as part of the clearance process indicated a statistically significant doubling of abstinence rates and program retention in utilizing reSET as compared to the standard of care. Shortly after receiving clearance for reSET, Pear Therapeutics received an Expedited Access Pathway (“breakthrough”) designation for an additional product in their pipeline: reSET-OTM, with an indication specifically for the treatment of opioid use disorders.

In a press statement from FDA on the clearance for reSET, Carlos Peña, MS, PhD, director of the Division of Neurological and Physical Medicine Devices within the Center for Devices and Radiological Health, said: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment. More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

While Dr Peña’s remarks were geared toward FDA clearance of reSET for substance use disorder, his statement rings true around the implications and impact of this technology across a wide array of therapeutic indications. As technology advances, prescription digital therapeutics stand to serve an integral part of facilitating a more comprehensive and impactful dialogue and treatment plan between a patient and care team – including pharmacists and physicians. Utilization of this burgeoning technology will help improve medication adherence – critical in the management of many diseases of interest in this field – as well as giving health care providers the opportunity to track and engage in patient care through novel digital health-based technologies.