Pear Therapeutics has announced a collaboration with Wellpath Community Care Centers to bring its FDA-authorized digital therapeutics (DTx) to elevate the nation’s battle against the substance and opioid use crisis. Wellpath Community Care Centers can now offer Pear’s reSET® and reSET-O® products to provide same day, single centered comprehensive medical and behavioral services with 24/7 access to optimize clinician delivered medication-assisted treatment (MAT) for optimal outcomes.
This is the second announcement in three days for Pear Therapeutics. Earlier this week Pear announced reSET and reSET-O are being added to PreferredOne’s list of covered standard healthcare benefits for all its members (more than 364,000).
reSET was the first DTx to receive authorization from FDA. reSET-O was the second DTx to receive authorization from FDA and was granted Breakthrough Designation. Both products have been tested in real world cases and randomized controlled trials, the latter results have been published in peer-reviewed medical journals. Unlike traditional medicines, DTx’s are designed to collect real world data for use by prescribing clinicians and for population health management by payers and health systems.
Through Pear’s reSET and reSET-O patients have access to algorithm-driven behavioral therapy, activities and self-reporting applications that are designed to drive engagement and improve long term outcomes. Using the Pear platform, clinicians can track patient treatment compliance and progress. Pear’s reSET and reSET-O for treatment of substance use disorder and opioid use disorder, respectively, which are adjunctive to outpatient counseling, may be used in conjunction with Wellpath’s outpatient clinician delivered care, including buprenorphine based MAT for opioid use disorder patients 18 years and older.
After 25 years as an emergency room physician where I saw firsthand people die from drug overdose and families suffer due to this treatable disease, I joined Wellpath to save lives and make an impact on the millions who are affected by opioid addiction. One of the most impactful tools we all use, every day is our smartphone, and now, through a new generation of DTx, we are able to elevate patient care by promoting deeper levels of engagement, accountability, communication, and education.Dr. Neil Schamban, President of Wellpath Community Care Centers
What is reSET?
reSET, the first Prescription Digital Therapeutic (DTx) to receive authorization from FDA to improve disease outcomes, is a 90-day DTx for Substance Use Disorder (SUD) intended to provide cognitive behavioral therapy (CBT), 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.
What is reSET-O?
reSET-O, the first PDT to receive Breakthrough Designation and authorized by FDA in December 2018, is an 84-day DTx for Opioid Use Disorder (OUD) intended to increase retention of patients in outpatient treatment by providing cognitive behavioral therapy (CBT), 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.
For a brief summary of prescribing information on reSET or reSET-O please see links below:
This article refers to Digital Therapeutics as DTx. However, Pear Therapeutics refers to Digital Therapeutics as Prescription Digital Therapeutics as PDTs. DTx, or PDTs, are a new therapeutic class.
Similar to traditional biologics or drugs, PDTs:
- Directly treat serious diseases
- Are built under current Good Manufacturing Practices
- Demonstrate safety and efficacy in randomized clinical trials
- Receive labeled claims from the FDA
- Are used by physician prescription
- Are reimbursed as products, via Pharmacy and Medical benefits
- Have barriers to entry that span regulatory exclusivity and intellectual property
About Pear Therapeutics
Pear Therapeutics, Inc. is the leader in prescription digital therapeutics. We aim 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 severe psychiatric and neurological conditions. Our lead product, reSET®, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, received marketing authorization from the FDA in December 2018. For more information, visit www.peartherapeutics.com.
About Wellpath Community Care Centers
Wellpath Community Care Centers is a division of Wellpath. Wellpath holds patients at the center of everything we do. Our company promotes rigorous standards of care, nurtures innovation, and values compassionate service. With more than 15,000 clinicians and professionals in 33 states across the U.S. and Australia, Wellpath focuses on delivering high-quality medical and mental healthcare. Every day, Wellpath provides care for nearly 300,000 patients located in state hospitals, forensic treatment and civil commitment centers, Community Care Centers, as well as, local, state and federal correctional facilities. For more information about Wellpath, visit www.wellpathcare.com.
PreferredOne, a wholly-owned subsidiary of Fairview Health Services, leads the market with products and services that conserve employer health plan dollars while helping more than 364,000 members achieve their best health. Comprehensive local and national provider networks together with an emphasis on health care cost and quality maximize the value of employee health benefits. For more information, visit www.preferredone.com.