Pear Therapeutics and SelectHealth Announce Coverage to Provide Access to FDA-Authorized Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder

• SelectHealth teams with Pear to provide its members with covered access to Pear’s innovative prescription digital therapeutic (PDT), reSET-O®, for the treatment of opioid use disorder (OUD) as adjunct to outpatient treatment that includes transmucosal buprenorphine Medication-Assisted Treatment (MAT).

• SelectHealth intends to offer and administer Pear’s reSET-O as a covered benefit for fully-insured commercial members with OUD on transmucosal buprenorphine being treated on an outpatient basis.

BOSTON & SALT LAKE CITY--(BUSINESS WIRE)--Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), and SelectHealth, a Utah based not-for-profit health plan and wholly owned subsidiary of Intermountain Healthcare, announced today that reSET-O®, the only FDA- authorized PDT to treat opioid use disorder (OUD), has been added as a covered benefit for SelectHealth’s members. SelectHealth serves more than one million members across Utah, Idaho, and Nevada.

“Both organizations are focused on keeping people healthy and providing high-value care that is accessible throughout the communities that we serve,” said H. Eric Cannon, Chief Pharmacy Benefits Officer at SelectHealth. “This move to provide access is vital to the treatment of opioid use disorder and highlights another example of our commitment to clinical programs that improve outcomes and embrace innovation.”

reSET-O is an innovative response to the ongoing opioid crisis in America. In Utah specifically, ten adults die each week from drug overdose, eight of which are a result of opioids, with Utahns particularly affected by prescription opioids¹. The White House recently released its National Drug Control Strategy that outlines the administration’s comprehensive path forward to address the addiction crisis, noting that, for the first time in our Nation’s history we have passed the tragic milestone of 100,000 deaths resulting from drug overdoses in a 12-month period². The strategy outlines ways to expand access to evidence-based prevention, harm reduction, treatment, and recovery services, including evidence-based motivational incentives such as contingency management and FDA-cleared digital tools that enable treatment.

“With the opioid epidemic impacting more people than ever across the country, we applaud SelectHealth for its leadership in being the first in the state of Utah to provide patients seeking recovery coverage of innovative FDA-authorized treatment delivered through their mobile devices when and where they need it most,” said Julia Strandberg, Chief Commercial Officer at Pear Therapeutics. “Together, we can help improve access to safe and effective treatment options for those suffering from addiction.”

PDTs are an innovative therapeutic class that uses software to directly treat disease. reSET-O has been measured in real-world use and its therapeutic content studied in a randomized controlled trial, with results published in a peer-reviewed medical journal³. Pear recently released publications showing the potential for improved real-world health outcomes and decreased healthcare resource utilization for patients using reSET-O^4-13. Used in combination with transmucosal buprenorphine, reSET-O is adjunctive to outpatient care, provide patients with cognitive behavioral therapy, fluency training, and contingency management, while clinicians receive access to clinical dashboards to inform in-office and tele visits.

About Pear Therapeutics
Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of 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 the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the 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.

About SelectHealth
SelectHealth is a not-for-profit health plan serving more than 1 million members. Through a shared mission with Intermountain Healthcare of Helping People Live the Healthiest Lives Possible, SelectHealth is committed to ensuring access to high-value care, providing superior service, and supporting the health of our members and the communities they serve. In addition to commercial and government medical plans, SelectHealth offers dental, vision, and pharmacy benefit management. SelectHealth plans are available for Medicare Advantage and Medicaid enrollees, and SelectHealth is a carrier for the Children’s Health Insurance Plan (CHIP) and the Federal Employee Health Benefits (FEHB) Plan. Year-after-year, SelectHealth is rated as Utah’s top HMO plan by state and national organizations, receiving top scores in both member satisfaction and clinical performance. For details, visit selecthealth.org.

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 digital therapeutic.

Important Safety Information:
Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, 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). 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.

reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner and is not intended to reduce the frequency or duration of in-person therapy. 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.

Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.

The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.

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. https://ibis.health.utah.gov
2. https://www.whitehouse.gov/wp-content/uploads/2022/04/National-Drug-Control-2022Strategy.pdf
3. 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.
4. 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.
5. 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.
6. 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: 1080/13696998.2020.1858581.
7. 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: 1080/03007995.2020.1846022.
8. 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: 1080/00325481.2021.1884471.
9. Fulton F. Velez, Charles Ruetsch & Yuri Maricich (2021) Evidence of long-term 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: 1080/14737167.2021.193968.
10. Fulton F. Velez & Daniel C. Malone (2021) Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, Journal of Market Access & Health Policy, 9:1, DOI: 1080/20016689.2021.1966187.
11. Yuri A. Maricich, Robert Gerwien, Alice Kuo, Daniel C. Malone & Fulton F. Velez (2021) Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder, Hospital Practice, DOI: 1080/21548331.2021.1974243.
12. Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K, Maricich YA. Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. Clinicoecon Outcomes Res. 2021;13:909-916
    https://doi.org/10.2147/CEOR.S334274.
13. Fulton F. Velez, Kathryn Anastassopoulos, Sam Colman, Neel Shah, Laura Kauffman, Sean M. Murphy, Charles Ruetsch & Yuri Maricich (2022). Reduced healthcare resource utilization in patients with opioid use disorder in the 12 months after initiation of a prescription digital therapeutic. Advances in Therapy. 2022; https://doi.org/10.6084/m9.figshare.20013323.v1.