Pear Therapeutics, Inc.

News Release

Pear Therapeutics Announces Publication Showing Cost Savings and Decreased Hospital Encounters For Opioid Use Disorder Patients Treated With reSET-O® Compared to Control Patients During Nine-Month Period Following Prescription

November 3, 2021

  • reSET-O® is the first and only FDA-authorized prescription digital therapeutic (PDT) for patients with opioid use disorder (OUD)
  • Real-world patients who engaged with reSET-O had a 46% lower incidence of hospital-related stays over 9 months following the first prescription of reSET-O compared to control patients
  • Total hospital facility and clinician services costs on a net basis were reduced by $2,708 per patient over 9 months following the first prescription of reSET-O compared to control patients

BOSTON, November 3, 2021 – Pear Therapeutics, Inc., today announced results from an analysis of real-world data evaluating healthcare resource utilization (HCRU) for reSET-O®, the first and only FDA-authorized prescription digital therapeutic (PDT) for the treatment of opioid use disorder (OUD). In the study, HCRU was measured during the nine-month period following a patients’ first prescription of reSET-O. Results from the analysis, published in ClinicoEconomics and Outcomes Researchfound that total hospital facility and clinician services costs for patients treated with an 84-day prescription of reSET-O (n=444) were $8,733 compared to $11,441 for patients who were prescribed but did not use or engage with reSET-O (n=64). The resulting net cost savings over the 9-month period of $2,708 per treated patient was largely driven by a 46% lower incidence of hospital-related stays. These results support the real-world value of reSET-O in the treatment of a patient population in need of more comprehensive support with recovery.

“The severity of the opioid epidemic continues to increase due to the widespread availability of synthetic opioids, and due to the pandemic, which has increased social isolation and has shifted care patterns to a range of remote or virtual modes,” said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. “The results of this analysis showed that patients who were treated with reSET-O showed substantially lower incidence of hospital encounters, particularly inpatient stays and ICU stays, compared to control patients. The data further show the value of behavioral interventions like reSET-O that can be delivered remotely to help patients.”

The analysis evaluated HCRU patterns among adults receiving a reSET-O prescription and analyzed health claims for the 9 months post initiation of an 84-day prescription of reSET-O. All patients in the analysis were treated with buprenorphine.

Total cost of hospital facility encounters was lower for treated patients versus control patients ($2,693 versus $6,130, respectively), while total per-patient cost for clinical services was $6,040 for treated patients versus $5,311 for control patients. The lower facility encounter costs among treated patients outweighed their slightly greater clinician services costs versus control patients, resulting in lower overall costs of $8,733 for treated versus $11,441 for control patients, or an overall cost reduction of $2,708 per patient over 9 months following the first reSET-O prescription for treated patients.

The full paper 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-O1-7.

About OUD
In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD)8. 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 encounters9,10. The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives11. However, less than 20% of adults with OUD in 2019 received treatment for opioid use in the past year, highlighting the need for expanded access to comprehensive OUD treatment12.

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 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.

Contacts:
Meara Murphy
Senior Director, Corporate Communications
meara.murphy@peartherapeutics.com

References:

  1. Yuri A. Maricich, MD, Xiaorui Xiong, PhDRobert 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. 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
  7. 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: 10.1080/20016689.2021.1966187
  8. 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).
  9. 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/
  10. 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.
  11. 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.
  12. 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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