What You Should Know:
– PreferredOne teams with Pear to provide its members with covered access to two prescription digital therapeutics (PDTs) for the treatment of substance use disorder (SUD) and opioid use disorder (OUD)
– PDTs are a new therapeutic class that uses software to directly treat disease. Like traditional medicines, PDTs are tested in randomized controlled trials demonstrating safety and effectiveness, evaluated and authorized by regulators like FDA, and used under the supervision of a prescribing clinician.
Pear Therapeutics, Inc. and PreferredOne announced today that reSET® and reSET-O®, the first two prescription digital therapeutics (PDTs) to receive authorization to treat disease from the U.S. Food and Drug Administration (FDA), have been added to PreferredOne’s medical benefits as covered products for its members. PreferredOne is a wholly-owned subsidiary of Fairview Health Services, leads the market with products and services that conserve employer health plan dollars while helping more than 364,000 members achieve their best health.
reSET was the first PDT to receive authorization from FDA. reSET-O was the second PDT to receive authorization from FDA and was granted Breakthrough Designation. Both products have been tested in real-world cases and randomized controlled trials, the latter results have been published in peer-reviewed medical journals. Both products, which are adjunctive to outpatient counseling, provide patients with algorithm-driven cognitive behavioral therapy, fluency training, and contingency management, while clinicians receive access to clinical dashboards to inform in-office and tele visits. reSET is used as a monotherapy and reSET-O is used in combination with transmucosal buprenorphine.
Defining Prescription Digital Therapeutics
PDTs are a new therapeutic class that uses software to directly treat disease. Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, evaluated and authorized by regulators like FDA, and used under the supervision of a prescribing clinician1,2. Unlike traditional medicines, PDTs are designed to collect real-world data for use by prescribing clinicians and for population health management by payors and health systems.
Why It Matters
This announcement comes on the heels of Pear’s announcement last week that The Hartford, a leader in property and casualty insurance, group benefits, and mutual funds, became the first company to offer its employees and their beneficiaries with benefit coverage of PDTs. Both announcements represent major milestones for PDTs that expand the access of these life-saving medications to patients.
“The Pear team is proud to work with PreferredOne to continue to expand patient access to reSET and reSET-O in Minnesota and across the nation,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “We won’t rest until everyone who is suffering from addiction has covered access to our PDTs.”