23 February 2021 13:00 UTC
BOSTON & SAN FRANCISCO – (COMMERCIAL THREAD) – Therapeutic Pear, Inc., today announced the publication of a new analysis demonstrating the profitability of reSET-OÂ®, the first and only digital prescription therapeutic drug (PDT) approved by the FDA for the treatment of opioid use disorder (OUD). The analysis, published in the peer-reviewed journal Postgraduate medicine, showed that reSET-O plus usual processing (TAU) (v.) wins.
âOUD is one of the deadliest and costliest health problems in the United States, causing nearly 50,000 deaths and costing an estimated $ 40-70 billion in annual medical costs each year, mostly for over 80% of untreated patients. Already high number of OUD-related deaths jumped after the onset of the COVID-19 pandemic, and relapse rates from the ongoing pandemic are expected to further increase the uptake of emergency department visits and stays in hospitalizations, which are the main direct cost drivers in OUD, âsaid Yuri Maricich, MD, medical director of Pear Therapeutics. “This analysis has shown 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 analysis model evaluated the cost-effectiveness of reSET-O compared to TAU alone over 12 weeks. Data on clinical efficacy (abstinence and health utility) were obtained from a clinical trial, and data on resource use and cost were used from an analysis of data from recent complaints to reflect less frequent face-to-face counseling with reSET-O. The results of this model showed population-level gains in quality-adjusted life years at a lower cost with reSET-O treatment compared to TAU alone. In addition to the clinical value, these results underscore the limited economic risk of reSET-O as an adjunct to TAU.
The complete paper, Cost-effectiveness analysis of digital prescription therapy for the treatment of opioid use disorders, is available online by clicking here.
These results are also supported by recently published real-world clinical and economic data showing the potential for improved health outcomes and reduced treatment costs for patients using reSET-O.1-4.
About the OUD
In recent years, OUD has been responsible for about two in three deaths related to substance use disorders (SUD)5. The cost of OUD to the U.S. healthcare system alone is estimated to be around $ 40 billion to $ 70 billion per year and is largely due to excessive visits to hospitals and emergency departments.6.7. The ultimate goal of treating patients with OCD is sustained abstinence and life recovery8. However, less than 35% of adults with TOU in 2019 received treatment for opioid use in the past year, underscoring the need to expand access to comprehensive treatment for TOU.9.
reSET-O Important Safety Information
Indications for use
reSET-O is intended to increase the retention of patients with opioid use disorder (ODD) in outpatient treatment by providing cognitive behavioral therapy, in addition to outpatient treatment which includes transmucosal buprenorphine and contingency management, for patients 18 years of age or older who are currently under the supervision of a clinician. reSET-O is indicated as a digital prescription therapy only.
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 have a smartphone and are familiar with the use of smartphone applications (apps).
reSET-O should not be used by people outside of active OUD treatment. It is not intended to be a substitute for treatment by you, the patient’s caregiver. It should be used in addition to clinician therapy, buprenorphine therapy and contingency management.
reSET-O is not intended to be used as a stand-alone therapy for opioid use disorder (OUD). reSET-O is not a substitution for a patient’s drug. Patients should continue to take their medications as directed by their healthcare provider. The ability of reSET-O to prevent a potential relapse after discontinuation of treatment has not been studied.
Clinicians should not use reSET-O to communicate with their patients about emergency medical problems. Patients should be clearly instructed not to use reSET-O to communicate any urgent or emerging information to their clinician. In an emergency, patients should dial 911 or go to the nearest emergency room.
This press release does not include all the information necessary to use reSET-O safely and efficiently. Please see the Brief summary of clinician instructions for reSET-O for more information.
About Pear Therapeutics
Pear Therapeutics is the leader in digital prescription therapies, or PDTs. Pear aims to redefine medicine by discovering, developing and delivering clinically validated software therapies to deliver better patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of product and product candidates across all therapeutic areas, including the top three PDTs with FDA disease treatment claims. Pear lead product, reSETÂ®, for the treatment of substance use disorders, was the first PDT to receive market authorization from the FDA to treat the disease. Pear’s second product, reSET-OÂ®, for the treatment of opioid use disorders, was the first PDT to receive the breakthrough designation. Third pear product, SomrystÂ® for the treatment of chronic insomnia, was the first PDT submitted via the FDA’s traditional 510 (k) pathway while under consideration under the FDA’s pilot software pre-certification program. For more information, visit Poire Ã 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 digital prescription therapy 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 health resource use after treatment for opioid use disorder with reSET-O , a new digital prescription therapy, expert review on Pharmacoeconomics Research and Outcomes, DOI: 10.1080 / 14737167.2021.1840357.
3. Weijia Wang, Nicole Gellings Lowe, Ali Jalali and Sean M. Murphy (2021) Economic Modeling of reSET-O, a Digital Prescription Therapeutics for Patients with Opioid Use Disorders, Journal of Medical Economics , 24: 1, 61-68, IS THAT I: 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 Effectiveness of Prescription Digital Therapy as an Adjuvant to Buprenorphine for Treatment of Opioid Use Disorders, 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 to 2016. Science. September 21, 2018; 361 (6408).
6. Administration of addiction and mental health services. (2020). Key Indicators of Substance Use and Mental Health in the United States: Results of 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 Quality and Statistics, Addiction and Mental Health Services Administration. Recovered from https://www.samhsa.gov/data/
7. The Council of Economic Advisers. The underestimated cost of the 2017 opioid crisis.Available at: 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 depot formulations of buprenorphine versus daily sublingual buprenorphine with naloxone for the treatment of opioid use disorders: a randomized clinical trial. JAMA Med intern. 2018; 178 (6): 764-773.
9. Food & Drug Administration. Opioid Use Disorder: Endpoint to Demonstrate Effectiveness of Drugs in Drug-Assisted Therapy 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.