BOSTON & SAN FRANCISCO--(BUSINESS WIRE)-- Pear Therapeutics Inc., today announced results of two new analyses 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 data showed that reSET-O plus treatment-as-usual (TAU) (i.e., transmucosal buprenorphine, face-to-face counseling and contingency management) vs TAU alone resulted in a projected cost savings of $765,321 per million covered lives over five years. In a separate analysis, any level of engagement with reSET-O was associated with an approximate 60% reduction in the proportion of patients with inpatient (IP) stays and emergency department (ED) visits vs a 21% increase in the proportion of patients with IP and ED utilization among non-engaged patients. The results were presented at Virtual ISPOR 2021, the virtual annual meeting of The Professional Society for Health Economics and Outcomes Research.

The first analysis estimated the budget impact of reSET-O on the market over a five-year period using real-world healthcare resource utilization data, retreatment rates, and cost scenarios from a US third-party payer. The model structure for this analysis included adult patients with OUD who received transmucosal buprenorphine and contingency management under clinical supervision. Results from the base-case analysis showed that, though the cost of treating OUD increased over five years, introduction of reSET-O into the market consistently reduced yearly costs compared to the current market, with an estimated cumulative reduction in cost by $765,321 over five years.

“The pandemic has exacerbated the already epidemic prevalence and associated costs of OUD in this country,” said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. “According to the Center for Disease Control and Prevention, 64,472 Americans lost their lives due to an accidental opioid overdose in the 12-month period ending in September 2020, with countless more requiring treatment emergency room or inpatient care following an overdose. The results of these health economic analyses are consistent with the literature that show that providing ongoing long-term treatment for patients is associated with substantial reductions in expensive episodes of care, such as emergency room visits and hospital stays, and add to our growing data set demonstrating the potential for reSET-O, when used with MOUD, to help reduce OUD-related healthcare utilization and total costs.”

In the second analysis, researchers used machine-learning to assess the real-world relationship between a patient’s engagement with clinician-prescribed reSET-O and their frequency of IP or ED visits as recorded in health care claims data. Patients were stratified into four engagement subgroups: zero lessons completed vs. k-means clustering-defined categories (low, medium, and high). Results showed that while the proportion of patients with at least one IP or ED visit increased by 21% in the non-engaged group, all engagement categories saw a 60% decrease in the proportion of patients with IP or ED healthcare utilization. Considering the impact on healthcare utilization, any engagement with reSET-O was projected to decrease cost reduction by 1.8-2.7 times compared to non-engagement (cost reduction range: $1,749 - $2,654) over a six-month period.

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^1-5.

About OUD

In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD)⁶. The cost of OUD to the U.S. healthcare system alone is estimated at approximately $90 billion per year and is largely driven by excess hospital and emergency department encounters^7,8. The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives⁹. 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 treatment¹⁰.

reSET-O Important Safety Information

Indications for Use:

reSET-O prescription digital therapeutic is a 12-week (84 day) software application 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 for Clinicians:

Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7^th 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. 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. 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.

6. 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).

7. 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/.

8. Murphy SM. The cost of opioid use disorder and the value of aversion. Drug Alcohol Depend. 2020 Dec 1;217:108382. doi: 10.1016/j.drugalcdep.2020.108382. Epub 2020 Oct 26. PMID: 33183909; PMCID: PMC7737485. https://pubmed.ncbi.nlm.nih.gov/33183909/.

9. 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.

10. 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.

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