Pear Therapeutics, Inc. and RemedyOne today announced that RemedyOne will offer and administer benefit coverage to its customer base of 2.5 million lives for reSET® and reSET-O®, the first two prescription digital therapeutics (PDTs) to receive authorization from the U.S. Food and Drug Administration (FDA) to treat disease. This marks an important milestone for PDTs and for the pharmacy benefit management (PBM) industry to implement coverage within existing benefits, formulary design, and standard pharmacy claims processing.
“RemedyOne was born out of dissatisfaction with the status quo. Our deep experience and unique relationships, combined with an in depth understanding of the complex systems that touch the lives we serve, allows us to put patients over profit. RemedyOne is leading the charge for the better and we see prescription digital therapeutics as an opportunity for our customers and their members,” said Ralph Pisano, Chief Pharmacy Officer of RemedyOne.
RemedyOne will engage its growing customer base to implement formulary addition of reSET and reSET-O, offering their members with software-based, FDA market authorized addiction recovery support and treatment when they need it.
“This marks an important milestone in increasing access to two products that address the biggest healthcare crisis in America before the pandemic – a crisis that has gotten worse because of the pandemic. We commend RemedyOne for supporting patients on their recovery journey as they are also grappling with isolation, social distancing and increased stress brought on by COVID-19,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “This coverage decision also marks an important milestone in increasing access to PDTs by adding them to a standard formulary so that they can be optimally utilized. Our goal is to ensure that the more than 20 million people in the U.S. living with SUD and OUD have access to reSET and reSET-O.”
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PDTs are a new therapeutic class that uses software to treat disease. Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, authorized by FDA, and used under the supervision of a prescribing physician1,2. Unlike other digital health solutions, PDTs receive market authorization from FDA and have a product label that addresses safety and effectiveness.
Source: Pear Therapeutics
