Pear Therapeutics, Novartis announce commercial launch of reSET | MobiHealthNews
reSET — a substance use disorder treatment that was the first software-only therapeutic cleared by the FDA — is now commercially available for clinicians to prescribe to their patients, according to a release from Pear Therapeutics and Sandoz, a division of Novartis with which Pear partnered back in April.
But while physical prescription drugs are usually handled through a pharmacy, the process is a bit different for the digital therapeutic, Dr. Yuri Maricich, Pear’s chief medical officer and head of clinical development, told MobiHealthNews. Prescribing physicians will write a script that is sent to Pear’s reSET Connect Patient Service Center, which staffs specialists who guide the patient through downloading and using the app.
Outside of that wrinkle, though, Maricich said that disseminating the treatment to care centers has been “very similar” to how a pharmaceutical company might put a novel treatment into the wild.
“We have a team of salespeople who are going out and educating clinicians about the product, its data, how to use it; and we also have a set of services that support dispensing, but they aren’t selling to the clinicians,” he said. “Also, that dispensing and fulfillment process allows the physician to access the dashboard and the therapeutic for their patient as well. And in the background we [Pear and Sandoz] work with payers around coverage and contracts. So, really, what we’re focusing on now is getting the therapeutic in the hands of patients who need it and helping clinicians understand how to use it, who’s the right patient for it, how do I prescribe it and interact with it as part of standard care.”
Still, Pear and Sandoz seem to be playing it safe with the new treatment modality — beyond general distribution and sales, the Patient Service Center is also equipped talk patients and providers through any questions or troubles they might be having.
“How a patient gets access to [reSET] and how it’s prescribed is new, so we really wanted to try to provide bespoke services to the clinician and the patient,” Maricich explained. “The Patient Service Center is available to help with troubleshooting, they have clinical staff available if there’s clinical questions, and then they also are available if there are complaints or adverse events. So they are, basically, the central node for all of those activities to help clinicians and patients get access to therapeutic and to use it.”
reSET is a 12-week digital cognitive behavioral therapy program accessed through an app and designed to accompany outpatient care delivered by a physician. According to Maricich, it is the only treatment authorized by the FDA for patients aged 18 years and older experiencing addiction to and dependency on stimulants, cannabis and cocaine (as well as alcohol).