- reSET-O® is the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for patients with opioid use disorder (OUD).
- New economic analysis showed reSET-O to be cost-effective compared to treatment-as-usual alone over 12 weeks, and to have economic dominance when contingency management (CM) was included as part of treatment as usual.
BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc., today announced publication of a new economic analysis describing the cost-effectiveness of reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD). The analysis, “Economic modeling of reSET-O, a prescription digital therapeutic for patients with opioid use disorder”, published in the peer-reviewed Journal of Medical Economics, concluded that reSET-O plus treatment-as-usual (TAU) was cost effective versus TAU alone, and economically dominant when TAU included contingency management (CM), with both scenarios producing a 16.3% absolute increase in retention in therapy vs TAU.
“OUD is one of the costliest health conditions in the United States, generating an estimated 40 to 70 billion dollars in annual medical costs, and relapse rates due to the ongoing pandemic are expected to further increase the use of emergency department visits and inpatient stays, which are the main cost drivers in OUD,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “This analysis describes the potential value of adding reSET-O to current treatment and the need to expand access for patients living with OUD.”
In the study, adult patients with OUD diagnosis and treated with buprenorphine were identified from commercial and Medicare databases. The 12-week healthcare resource utilization (HCRU) costs for patients categorized as adherent and nonadherent to buprenorphine treatment were estimated and total 12-week costs included OUD treatment and other HCRU costs. The 12-week budget impact of reSET-O was modeled for a 1 million-member healthcare plan.
These results are further supported by recently published real-world clinical and economic data demonstrating reSET-O is positively associated with retention in treatment, fewer inpatient, intensive care unit, emergency department and other clinical encounters .1,2 In an additional real-world analysis of data from more than 3,000 patients prescribed and using reSET-O from 30 different states and representing a wide range of demographics, showed real-world therapeutic engagement is positively associated with retention in treatment and other meaningful outcomes data and that reSET-O is a potentially valuable adjunct to buprenorphine MAT for patients with OUD.1
In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD).3 According to recent estimates, the cost of OUD to the U.S. healthcare system alone is estimated at approximately $40-70 billion per year, and is largely driven by excess hospital and emergency department encounters.4,5 The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives.6 However, less than 35% of adults with OUD in 2019 received treatment for opioid use in the past year, highlighting the need for expanded access to comprehensive OUD treatment.7
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.
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.
- 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.
- 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.
- 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).
- 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.
- The Council of Economic Advisers. The underestimated cost of the opioid crisis 2017. Available from: https://www.whitehouse.gov/briefings-statements/cea-report-underestimated-cost-opioid-crisis/.
- 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.
- Food & Drug Administration. Opioid use disorder: endpoints for demonstrating effectiveness of drugs for medication‐assisted treatment guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/opioid-use-disorder-endpoints-demonstrating-effectiveness-drugs-medication-assisted-treatment. Accessed September 29, 2020.
Director, Corporate Communications