BOSTON & SAN FRANCISCO & REDMOND, Wash.--(BUSINESS WIRE)-- Pear Therapeutics, Inc. and Prescryptive Health today announced that Prescryptive, the first health intelligence platform, will offer and administer benefit coverage 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. reSET and reSET-O have been added to Prescryptive’s formularies and are being administered as standard pharmacy benefits for its members.

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“Prescryptive has launched the world’s first health intelligence platform powered by blockchain that delivers patients the necessary prescription information they need in real-time to their mobile device while they are engaged with their healthcare provider,” said Chris Blackley, CEO of Prescryptive Health. “Teaming with Pear to make reSET and reSET-O available to our members is a natural extension of our aim to deliver empowering benefit plan solutions that inspire better health.”

“With an aligned mission to engage patients and redefine the delivery of care, we are pleased to team with Prescryptive to provide people in recovery with covered access to innovative FDA-authorized treatments through their mobile devices when and where they need it most,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “With this coverage decision, Pear continues to expand access to PDTs by adding reSET and reSET-O to a standard formulary.”

As Prescryptive Health and Pear both have a commitment to delivering digital solutions at the point-of-care, in a mobile-enabled environment that’s patient-centric, the collaboration drives transparency and control for members when they need care most.

Prescryptive will include reSET and reSET-O on its platform, making a seamless experience for members who will benefit from PDTs. Both reSET and reSET-O have been tested in real-world use and randomized controlled trials, with results published in peer-reviewed medical journals. Both products, which are adjunctive to outpatient counselling, 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 for patients 18 years of age or older with substance use disorder and reSET-O is used in combination with transmucosal buprenorphine for patients 18 years of age or older with opioid use disorder.

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 clinician^1,2. 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. Pear recently released publications showing the potential for improved health outcomes and decreased treatment costs for patients using reSET-O^3-7.

About Prescryptive Health

Prescryptive is putting an end to the U.S. drug debacle with the world’s first health intelligence platform, eliminating middlemen from the drug market to let consumers take charge of their medication costs. By delivering a simple, mobile experience that integrates in real-time with their benefit plan and provider, Prescryptive Health is transforming the prescription drug market and the pharmacy experience by empowering consumers, cutting costs, and inspiring better health. To learn more about how we’re rewriting the script, visit www.prescryptive.com.

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.

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 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 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 Clinician Brief Summary Instructions for reSET-O for more information.

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.

3. Yuri A. Maricich, MD, Xiaorui Xiong, PhD^, Robert Gerwien, PhD, Alice Kuo, BA Fulton Velez, MD MBA, Bruce Imbert, MD PhD, Keely Boyer, MBA, Hilary F. Luderer, PhD, Stephen Braun, BA, Karren Williams, PhD (2020): Real-World evidence for a prescription digital therapeutic to treat Opioid Use Disorder, Journal of Current Medical Research and Opinion, DOI:10.1080/03007995.2020.1846023.

4. Fulton F. Velez , Sam Colman , Laura Kauffman , Charles Ruetsch & Kathryn Anastassopoulos (2020): Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1840357.

5. Weijia Wang, Nicole Gellings Lowe, Ali Jalali & Sean M. Murphy (2021) Economic modeling of reSET-O, a prescription digital therapeutic for patients with opioid use disorder, Journal of Medical Economics, 24:1, 61-68, DOI: 10.1080/13696998.2020.1858581

6. Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder, Current Medical Research and Opinion, DOI: 10.1080/03007995.2020.1846022.

7. Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin Parcher, Dylan Mezzio & Daniel C. Malone (2021) Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder, Postgraduate Medicine, DOI: 10.1080/00325481.2021.1884471

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