BOSTON, SAN FRANCISCO, & COLLINSVILLE, Conn.--(BUSINESS WIRE)--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.”
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.
reSET Important Safety Information
Indications for Use
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program.
Important Safety Information:
Warnings: reSET is intended for patients whose primary language is English and whose reading level is at the 7th grade level or above and who have access to an Android/iOS tablet or smartphone. reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET is not intended to be used as a stand- alone therapy for Substance Use Disorder (SUD). reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
reSET should not be used by individuals outside active enrollment in a SUD treatment program. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET is not intended to reduce the amount of face-to-face clinician time.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.
The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.
This Press Release does not include all the information needed to use reSET safely and effectively. Please see the full Clinician Brief Summary for reSET for more information.
reSET-O Important Safety Information
Indications for Use
reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only prescription digital therapeutic.
Important Safety Information:
Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
reSET-O should not be used by individuals outside active OUD treatment. It is not intended to replace treatment by you, the patient’s medical provider. It should be used as an adjunct to clinician treatment, buprenorphine treatment and contingency management.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the full Clinician Brief Summary Instructions for reSET-O for more information.
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™ for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.
RemedyOne is a fast-growing healthcare industry change agent, focused on leveraging the experience of its healthcare professionals to improve outcomes for health plans, employers, pharmaceutical manufacturers, PBMs, and ultimately patients. For more information visit, www.remedy-one.com.
- Campbell ANC, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.
- Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.