Pear Therapeutics Announces Publication of Cost-Utility Data Showing Quality of Life and Cost Reduction with reSET-O® for the Treatment of Opioid Use Disorder

• reSET-O® is the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for patients with opioid use disorder (OUD).
• Consistent with prior analyses, new analysis shows reSET-O in conjunction with treatment-as-usual (TAU: buprenorphine + clinician) to be more effective and less costly compared to TAU alone over 12 weeks, underscoring the advantages of providing access to reSET-O as part of an overall OUD treatment plan for patients with OUD.
• Analysis reveals that the clinical benefit of retention in treatment from reSET-O + TAU results in economic benefit compared to TAU alone.
• Findings of the third-party payer-perspective cost-utility model showed a reduction in total healthcare costs net of product cost, increased retention, and improved quality-adjusted life year (QALY) gains.
• Results of this model are supported by recently published real-world clinical and economic data showing improved health outcomes and decreased treatment costs for patients followed up for 12 weeks, 6 months, and 9 months after the initiation of reSET-O therapy.

BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc., today announced publication of a cost-utility model evaluating the cost impact and treatment retention effectiveness of reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD). This early analysis, published in the Journal of Market Access & Health Policy, the official journal of the Market Access Society, showed that reSET-O plus treatment-as-usual (TAU – transmucosal buprenorphine, face-to-face counseling and contingency management) decreased total healthcare costs net of product cost over a 12-week period, increased retention in therapy, and resulted in improved post-treatment quality-adjusted life year (QALY) gains, as compared to TAU alone.

“OUD continues to be one of the deadliest and costliest health conditions in the United States, made worse by COVID-19, where continued isolation, depression, and increased barriers to care due to social distancing measures have contributed to an increase of nearly 20,000 deaths during the calendar year ending in January 2021, compared to the year ending January 2020 – highlighting that current prevention and treatment approaches are not working,” said Yuri Maricich, M.D., Chief Medical Officer of Pear Therapeutics. “This economic model, which builds on our commitment to measure short, medium and long-term real-world data, reinforces that reSET-O has the potential to not only increase therapy retention for more patients in treatment, but has the potential to reduce healthcare costs, consistent with findings in other recent publications.”

In the study, a third-party payer-perspective decision analytic model evaluated the cost-effectiveness of reSET-O relative to TAU alone over 12 weeks. Clinical effectiveness data (retention 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 show the limited economic risk of reSET-O as an adjunct to TAU.

These results are further supported by other recently published real-world clinical and economic data showing the potential for improved health outcomes and decreased treatment costs for patients followed up for 12 weeks, 6 months, and 9 months after the initiation of reSET-O therapy.^1-6

The full paper, Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, is available online by clicking here.

About OUD

In recent years, OUD has been responsible for approximately two out of every three deaths related to substance use disorder (SUD).⁷ 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.^8,9 The ultimate treatment goal of patients with OUD is sustained abstinence and recovery of their lives.¹⁰ 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.¹¹

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. 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. 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).

8. 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.

9. The Council of Economic Advisers. The underestimated cost of the opioid crisis 2017. Available from: https://static.politico.com/1d/33/4822776641cfbac67f9bc7dbd9c8/the-underestimated-cost-of-the-opioid-crisis-embargoed.pdf

10. 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.

11. 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.

 

Contacts

Meara Murphy

Senior Director, Corporate Communications

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