BOSTON & MILWAUKEE--(BUSINESS WIRE)-- Pear Therapeutics, Inc. and Serve You Rx 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 Serve You Rx’s standard formularies and are being administered as standard pharmacy benefits for its members.

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“We’re excited to team with Pear to provide our clients and their members with access to FDA-authorized prescription digital therapeutics complemented by our comprehensive clinical program for people battling the complex disease of addiction, especially at a time when face-to-face treatment is difficult,” said Sharon Murillo, President and CEO of Serve You Rx. “Our coverage of reSET and reSET-O aligns with our goals of fighting this epidemic holistically, ending the stigma associated with addiction and leading the supply chain in new ways to augment and optimally support treatment and recovery.”

As part of Serve You Rx’s commitment to help combat the public health crisis associated with addiction and prescription opiates, Serve You Rx will provide prescription benefit coverage of reSET and reSET-O to their members as adjunct therapy to substance use disorder and opioid use disorder treatment, respectively. It will also expand its core clinical offerings within its Opioid Risk Management Program to help improve addiction treatment outcomes.

“Pharmacy benefit managers (PBMs) have a responsibility to do their part in fighting against the substance use disorder crisis,” added Mike Pace, Vice President of Market Access at Pear Therapeutics. “PBMs can provide plan sponsors and their members with access to safe and effective products like prescription digital therapeutics via their standard national formularies, while taking a programmatic approach to addiction treatment augmentation through programs like the ones Serve You Rx is implementing.”

“We are pleased to expand access to prescription digital therapeutics for participating clients and members of Serve You Rx, and we applaud Serve You Rx for including reSET and reSET-O on formulary,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Our goal is to ensure that all people living with substance and opioid use disorders have every opportunity for favorable outcomes for recovery.”

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 clinician^1,2. Unlike other digital health solutions, PDTs receive market authorization from FDA and have a product label that addresses safety and effectiveness.

About Serve You Rx

Serve You Rx is a national pharmacy solutions provider based in Milwaukee, Wisconsin that specializes in pharmacy benefit management, mail order services, and specialty medication management. For more than 30 years, Serve You Rx has been collaborating with benefit advisors, third-party administrators, and employer groups to design and deliver strategies that reduce prescription drug costs and improve consumer access to affordable and clinically appropriate medication therapies. Learn more about Serve You Rx at serveyourx.com.

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 7^th 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.

References:
1. 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.
2. 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.

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