• reSET-O® is the only FDA-authorized prescription digital therapeutic (PDT) for the treatment of opioid use disorder (OUD)
• Results support the real-world value of reSET-O, demonstrating durable treatment outcomes and reductions in healthcare resource utilization
• 12-month analysis builds on prior publications of population-level improvements in health care resource utilization for reSET-O at 6 and 9 months, as data demonstrated >$3,800 per patient cost savings for the Medicaid population¹

Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs), today announced a manuscript accepted for publication and available via pre-print of a real-world study demonstrating reduced health care resource utilization and associated costs for reSET-O®, the only FDA-authorized PDT for the treatment of opioid use disorder (OUD).

Results from a 12-month real-world data study of reSET-O showed a reduction in healthcare utilization, particularly inpatient (IP) stays (which also include ICU stays and readmissions) and emergency department (ED) visits, contributing to a net cost reduction of $3,832 per patient for the Medicaid population, and an increase in buprenorphine adherence in patients with OUD treated with reSET-O compared to controls, based on a linear model of the medication possession ratio.

This health economic study was accepted for publication and made available via pre-print by the international peer-reviewed journal Advances in Therapy.¹

“The data show our health economic outcomes for reSET-O now go out to 12 months, demonstrating durability of the clinical effect for opioid use disorder patients, which is an often difficult to treat patient group as shown in part by the record number of overdose deaths over the last year,” said Yuri Maricich, M.D., Chief Medical Officer and Head of Development at Pear Therapeutics. “To overcome the opioid crisis, we must increase access to treatment options that may improve outcomes. The results of this analysis demonstrated that patients who were treated with reSET-O showed lower incidence of inpatient stays and emergency department visits, compared to control patients.”

The study used claims data to evaluate 901 adult patients who were prescribed and treated with reSET-O compared to 978 controls. Compared to the control group, the 12-month period post-initiation of reSET-O showed reductions in:

• IP stays (28% reduction; IRR: 0.72; 95% CI: 0.55-0.96; P=0.026) which included a 30% reduction in ICU stays and a 56% reduction in readmissions).
• ED visits (7% reduction; IRR: 0.93; 95% CI: 0.79-1.09; P=0.386).
• Per-patient costs across all-payer mix by an estimated $2,791 and per-patient costs for the Medicaid population, specifically by an estimated $3,832 reduction.¹

Results also showed that among those patients on buprenorphine therapy, adherence significantly increased among those treated with reSET-O vs controls, based on a linear model of the medication possession ratio, despite both groups having similar buprenorphine adherence at baseline.¹ Additionally, this study adds to a larger body of evidence for reSET-O that now spans 6, 9 and 12 months both pre-post and vs. controls.

The full paper is available online by clicking here.

reSET-O has been evaluated in randomized controlled trials, in real-world clinical, and real-world health economic studies.^1-13

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, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of 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 the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the 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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws that are subject to risks and uncertainties and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements generally relate to future events involving, or future performance of, Pear. For example, statements about the real-world value of reSET-O or statements concerning reSET-O’s durable treatment effect and/or associated reductions in healthcare resource utilization are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “can” or variations of them or similar terminology.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Pear and its management are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) delay or reluctance by patients and/or providers to adopt, request or use Pear’s products, (ii) the possibility that Pear may be adversely affected by other economic, business, regulatory, and/or competitive factors; (iii) the evolution of the markets in which Pear competes; (iv) the impact of the COVID-19 pandemic on Pear’s business; (v) changes in applicable laws or regulations; and (vi) other risks and uncertainties set forth in Pear’s filings with the SEC (including those described in the Risk Factors section). These filings will identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Readers are cautioned not to put undue reliance on forward-looking statements, and Pear assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

References:

1. Fulton F. Velez, Kathryn Anastassopoulos, Sam Colman, Neel Shah, Laura Kauffman, Sean M. Murphy, Charles Ruetsch & Yuri Maricich (2022). Reduced healthcare resource utilization in patients with opioid use disorder in the 12 months after initiation of a prescription digital therapeutic. Advances in Therapy. 2022; https://doi.org/10.6084/m9.figshare.20013323.v1.
2. Fulton F. Velez, Charles Ruetsch & Yuri Maricich (2021). Evidence of long-term 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: 10.1080/14737167.2021.1939687.
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. 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. doi:10.1037/a0037496.
5. 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.
6. 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.
7. 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: 1080/13696998.2020.1858581.
8. 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: 1080/03007995.2020.1846022.
9. 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: 1080/00325481.2021.1884471.
10. Fulton F. Velez, Charles Ruetsch & Yuri Maricich (2021) Evidence of long-term 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: 1080/14737167.2021.193968.
11. Fulton F. Velez & Daniel C. Malone (2021) Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, Journal of Market Access & Health Policy, 9:1, DOI: 1080/20016689.2021.1966187.
12. Yuri A. Maricich, Robert Gerwien, Alice Kuo, Daniel C. Malone & Fulton F. Velez (2021) Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder, Hospital Practice, DOI: 1080/21548331.2021.1974243.
13. Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K, Maricich YA. Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. Clinicoecon Outcomes Res. 2021;13:909-916
    
    https://doi.org/10.2147/CEOR.S334274.

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