Pear Therapeutics, Inc. and Health Transformation Alliance (HTA) 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 HTA’s custom formulary as a standard pharmacy benefit. HTA will offer its 56 Member organizations the opportunity to add reSET and reSET-O to their formularies.
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“Substance use disorders are chronic, treatable diseases, and it is even more important now than ever before that we come together to increase accessibility to care for those who struggle with addiction,” said Nadina Rosier, PharmD, Chief Product Officer of Health Transformation Alliance. “The HTA and its Member Companies believe patients should have access to affordable, high-quality healthcare. We are excited to work with Pear to offer coverage of this innovative prescription digital therapeutic option to help improve addiction treatment outcomes for employees, retirees and their families.”
“With millions of people across the county struggling with addiction, and with the addiction crisis getting worse due to the pandemic, all of us at Pear are grateful to HTA for providing access to reSET and reSET-O to HTA’s Member organizations,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Representing many of the most influential and significant employers in the country, HTA is uniquely positioned to disrupt the healthcare status quo and fight the public health crisis of addiction.”
Staying in treatment is critical for people on their recovery journey. reSET and reSET-O can be used to enhance and support treatment anytime and anywhere. Both products 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, which is intended to increase abstinence from a patient’s substances of abuse during treatment and to increase retention in the outpatient treatment program, is used as a monotherapy for patients with substance use disorder. reSET-O, which is intended to increase retention of patients in outpatient treatment, is used in combination with transmucosal buprenorphine for patients with opioid use disorder.
“Pear and HTA share a common mission of access and health outcomes improvement with similar views on mobilizing change in healthcare,” said Mike Pace, Vice President of Market Access, Value & Evidence at Pear Therapeutics. “With chronic, systemic issues in behavioral health increasingly challenging health plans’ quality and cost management efforts, HTA’s integration of our PDTs into its member offering stands to help.”
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.
Health Transformation Alliance
The Health Transformation Alliance (HTA) is a cooperative of more than 50 of America’s leading employers that have come together to fix our broken healthcare system. With responsibility for more than 7 million covered lives and a collective annual health care spend of $27 billion, the member companies of the HTA have combined their resources, knowledge and experience to transform the way health care is delivered. To that end, the HTA has developed value-driven solutions in Data & Analytics, Pharmacy, Medical and Consumer Engagement specifically designed to improve patient care and economic value.
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 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.
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.