BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc., today announced publication of new analysis demonstrating 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, published in the peer-reviewed journal Postgraduate Medicine, showed that reSET-O plus treatment-as-usual (TAU) (i.e., transmucosal buprenorphine, face-to-face counseling and contingency management) decreased total health care costs and resulted in improved post-treatment quality-adjusted life year (QALY) gains.
“OUD is one of the deadliest and costliest health conditions in the United States, generating close to 50,000 deaths and costing an estimated 40 to 70 billion dollars in annual medical costs each year, mostly from the more than 80% of untreated patients. Already high OUD-related deaths jumped after the start of the COVID-19 pandemic, and relapse rates due to the ongoing pandemic are expected to further increase the use of emergency department visits and inpatient stays, which are primary direct cost drivers in OUD,” said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. “This analysis showed that reSET-O has the potential to improve population health while reducing costs, further highlighting the importance of providing holistic, low-barrier care to one of our most vulnerable populations.”
In the study, a decision analytic model evaluated the cost-effectiveness of reSET-O relative to TAU alone over 12 weeks. Clinical effectiveness data (abstinence and health utility) were obtained from a clinical trial, and a resource utilization and cost data were utilized from a recent claims data analysis to reflect less frequent face-to-face counseling with reSET-O. Results of this model showed population-level gains in quality-adjusted life years at a lower cost with reSET-O treatment vs TAU alone. In addition to clinical value, these results emphasize the limited economic risk of reSET-O as an adjunct to TAU.
The full paper, Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, is available online by clicking here.
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-O1-4.
In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD)5. 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 encounters6,7. The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives8. 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 treatment9.
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 you, 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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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).
6. 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. Retrieved from https://www.samhsa.gov/data/
7. 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/.
8. 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.
9. 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.