- reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD), is intended for patients in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management.
- Data from a retrospective claims study shows real-world reduction in healthcare resource utilization over six months following reSET-O.
- reSET-O use was associated with fewer inpatient, intensive care unit, emergency department, and other clinical encounters, lowering net healthcare costs by $2,150 per patient over six months.
- Near-term reductions in medical costs after prescription of reSET-O exceeded the amount needed to offset the cost of the product.
BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc. today announced publication of real-world data analyzing healthcare resource utilization for reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD), in the peer-reviewed journal Expert Review of Pharmacoeconomics & Outcomes Research. The study provides real-world evidence of the economic value of reSET-O. The new real-world data showed a robust decrease in costly healthcare utilization categories in patients with OUD. These results indicate a strong potential for the cost effectiveness of reSET-O in real-world care settings.
“These newly shared data reinforce how reSET-O can improve total quality of care while reducing the main healthcare cost drivers in OUD,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Real-world patient outcomes support the cost-impact of reSET-O. Payers who are not providing access to the product are sacrificing better outcomes and healthcare savings.”
In the study, retrospective real-world claims analysis evaluated healthcare resource utilization up to six months after reSET-O initiation. reSET-O use was associated with fewer inpatient, intensive care unit, emergency department, and other clinical encounters, lowering net healthcare costs over six months. Decreased healthcare utilization reduced overall healthcare spend by $2,150 per patient.
Study results for Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic:
- Among 351 patients (mean age 37; 59.5% female; 82.6% Medicaid), there were 228 pre-index (i.e., six months pre-reSET-O initiation) and 153 post-index (i.e., six months post-reSET-O initiation) unique hospital-related visits in this population (pre-index medication possession ratio = 0.76).
- This reduction represents a total of 75 unique facility encounters avoided in this cohort (i.e., ~one event was avoided per five treated patients), including 45 inpatient hospital stays (four of which included ICU stays), and 27 emergency department visits.
- Overall, there were approximately 1,181 fewer claims post-index across the 351 patients, with a corresponding $2,150 projected reduction in healthcare spending for each patient treated with reSET-O (using 2020 CMS fee schedule).
The full paper is available online by clicking here.
In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD).1 The cost of OUD to the U.S. healthcare system alone is estimated at approximately $30 billion per year, and is largely driven by excess hospital and emergency department encounters.2,3 The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives.4 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.5
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.
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.
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. reSET®, for the treatment of substance use disorder, was the first digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s reSET-O® is indicated for the treatment of opioid use disorder and Somryst® is indicated for the treatment of chronic insomnia. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurologic conditions. For more information, visit us at www.peartherapeutics.com.
- 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.
Meara Murphy, Director of Corporate Communications