• reSET-O® is the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for patients with opioid use disorder (OUD).

• New publication evaluated 351 patients to compare real-world claims data from 321 OUD patients who utilized a single 84-day course of reSET-O plus buprenorphine plus counseling versus 30 OUD patients who utilized buprenorphine plus counseling alone.

• For patients who engaged¹ with reSET-O and utilized buprenorphine plus counseling, real-world healthcare resource utilization (HCRU) analysis showed an average -$2,385 reduction per patient in medical costs for the 6-month period following initial engagement with reSET-O, compared to the 6-months prior.

• In contrast, for patients who utilized buprenorphine plus counseling alone but did not engage with reSET-O, real-world healthcare resource utilization (HCRU) analysis showed an average $353.80 per patient increase in medical costs for a similar 6-month period compared to the 6-months prior.

• This new analysis continues to support reSET-O as a tool that may aid in reducing healthcare spending.

Pear Therapeutics, Inc., today announced publication of a new analysis demonstrating the real-world cost impact of reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD). The real-world retrospective analysis, published in the peer-reviewed journal Hospital Practice, showed a substantial reduction in medical costs of -$2,385 per patient over 6 months in patients who engaged with reSET-O¹. In comparison, patients who did not redeem/engage with reSET-O beyond week 1 had a net cost increase of $353.80 per patient during the same time period.

“Prior to the pandemic, the cost of OUD to the US healthcare system was already an estimated $70 – 90 billion annually, largely driven by excess hospital and emergency department encounters,” said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. “This analysis showed that reSET-O is a cost-effective solution that provides effective treatment for patients as an adjunct to outpatient therapy. Prescribed by physicians, reSET-O can safely expand use of the behavioral component of treatment by giving patients 24/7 access to therapeutic content. This may help address the issues of limited access to clinicians, either because of geographical variations, lack of viable appointment time slots for individual patients, or as a result of restrictions on face-to-face interactions due to the COVID-19 pandemic.”

In this analysis, real-world health care resource utilization and associated costs among 321 patients with OUD who were treated with buprenorphine and engaged with reSET-O were evaluated for up to 6 months before and 6 months after the initiation of a reSET-O prescription. The analysis adjusted for differences in the duration of medical enrolment between the 6 months post-treatment vs. the 6 months pre-treatment baseline period.

• The 321 patients who engaged with reSET-O were identified in a large medical and pharmacy database representing over 150 Commercial, Medicaid, and Medicare Advantage Payers, with most patients being covered by Medicaid.
• More than 80% were covered by Medicaid, and more than 70% were adherent to buprenorphine in the 6 months prior to the initiation of reSET-O.

The full paper, Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder, is available online by clicking here.

reSET-O delivers a form of neurobehavioral therapy based on the community reinforcement approach (CRA), an intensive OUD-specific form of cognitive behavioral therapy (CBT) validated in multiple clinical trials for OUD^2-5. The CRA approach is based on the observation that drugs compete with more delayed positive reinforcers, hence treatment teaches patients to increase satisfaction with drug-free sources of reinforcement⁶. reSET-O content consists of a series of 67 interactive, on-demand audio, text, and video CRA modules (also called therapy lessons), which are sequentially unlocked as patients progress through the therapeutic. Modules are designed to deliver approximately 30 minutes of treatment, and it is recommended that patients complete 4 modules per week.

These results are further supported by recently published real-world clinical and economic data showing the potential for improved health outcomes and decreased treatment costs for patients using reSET-O^7-13.

About OUD

In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD)^14-16. The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives¹⁷. However, the latest SAMHSA report showed that only 18.1% of adults with OUD in 2019 received treatment for opioid use in the past year, highlighting the need for expanded access to comprehensive OUD treatment¹⁸.

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 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.

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. References to patient engagement mean the patient continued on reSET-O for more than 1 week.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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
7. Jalal H, Buchanich JM, Roberts MS, et al. Changing dynamics of the drug overdose epidemic in the United States from 1979 through 2016. Science. 2018 Sep 21;361(6408).
8. Florence CS, Zhou C, Luo F, et al. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Medical care. 2016;54(10):901-906.
9. The Council of Economic Advisers. The underestimated cost of the opioid crisis 2017. Available from: https://static.politico.com/1d/33/4822776641cfbac67f9bc7dbd9c8/the-underestimated-cost-of-the-opioid-crisis-embargoed.pdf
10. Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018;178(6):764-773.
11. Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. https://www.samhsa.gov/data/sites/default/files/reports/rpt29393/2019NSDUHFFRPDFWHTML/2019NSDUHFFR1PDFW090120.pdf
12. Maricich YA, Xiong X, Gerwien R, et al. Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. Curr Med Res Opin. 2020:1-9.
13. Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K. Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. Expert Rev Pharmacoecon Outcomes Res. 2020;Epub ahead of print. PMID: 33146558.
14. Marsch LA, Guarino H, Acosta M, et al. Web-based behavioral treatment for substance use disorders as a partial replacement of standard methadone maintenance treatment. J Subst Abuse Treat. 2014;46(1):43-51.
15. Bickel WK, Marsch LA, Buchhalter AR, Badger GJ. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. 2008;16(2):132-143.
16. 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.
17. Maricich YA, Bickel WK, Marsch LA, Gatchalian K, Botbyl J, Luderer HF. Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Curr Med Res Opin. 2020:1-7.
18. Budney AJ, Higgins ST. Therapy manuals for drug addiction, a community reinforcement plus vouchers approach: treating cocaine addiction. Rockville, MD: National Institute on Drug Abuse; 1998.

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