For years, Big Pharma has flirted with digital apps as a value-added proposition: a virtual route into patients’ homes and daily lives to help encourage engagement and drug adherence, with the end goal of maximizing both profits and outcomes.
Pear Therapeutics makes the app the drug, so to speak; its prescription digital therapeutics for substance abuse are designed to not only complement medication-assisted treatments but also reproduce the effects of cognitive behavioral therapy (CBT) traditionally administered through face-to-face psychology sessions.
In CBT, the therapist works to help a patient find effective strategies for dealing with various disorders, harmful behaviors and triggers. So do Pear’s reSET and reSET-O smartphone apps—with the latter receiving FDA approval late last year as a way to help people maintain treatment programs for opioid abuse.
Pear’s opioid abuse program approval was predicated on its first reSET app, which the FDA cleared de novo in September 2017 for substance abuse treatments not related to opioids. reSET rewards patients for completing modules covering craving management, life skills and other fields. reSET-O also allows patients to self-report cravings and triggers to their physician, as well as their buprenorphine use, while their doctor or addictionologist can track progress via a dashboard.
And to continue proving that it all works—and, in part, the broader feasibility of prescription digital therapeutics and software-as-a-drug (or in this case, a medical device)—the 2018 FierceMedTech Fierce 15 company has been working to validate its standalone programs using gold-standard clinical testing methods and single-variable studies, with the same endpoints you’d see for an injection or a pill.
The commercialization of reSET-O launched this January through a profit-sharing deal with Novartis’ Sandoz unit that includes a dedicated sales force, representing the first time that a Big Pharma has directly sold a piece of software, according to Pear.
According to national surveys by the U.S. government, more than 80% of patients do not receive or seek out care for opioid abuse, while only 13% of outpatient facilities offer treatments such as buprenorphine. With reSET-O, Pear and Novartis aim to cut down that treatment gap as part of a multimodal therapy, as well as help standardize care across regions.
At the J.P. Morgan Healthcare Conference in January, Pear CEO Corey McCann, M.D., Ph.D., told FierceMedTech that he believes the use of software as a therapeutic has reached a tipping point.
“I joke a little that we've seen this evolution—where in the first year or two, people had no idea what we were talking about. After that, people acknowledged the idea but thought it was ridiculous,” McCann said. “And then they knew what it was, but not what the business model looked like. But now last year and this year, I think that they think it was all their idea—which is exactly where we want to be.”