Pear Therapeutics presents the results of two analyses, these results show that the use of reSET-O® for the treatment of opioid use disorders in patients with reduced medical resource utilization and related costs

• reSET-O® is the first and only FDA-authorized prescription digital therapy (PDT) for patients with opioid use disorder (OUD).

• A five-year budget impact assessment conducted from the perspectives of business and Medicare third-party payers in the United States shows that the use of reSET-O can reduce the total medical cost, and the use of higher technology can reduce costs, and it is estimated that each cost will be saved at $765,321. Millions of people cover five years of life.

• A machine learning analysis of real-world patients grouped by clusters with increasing therapist participation showed that inpatient and emergency department utilization rates in all clusters were reduced by 60%, and related costs are expected to be reduced by 1.8 compared with non-participants. -2.7 times (cost reduction range $1,749-$2,654).

Pear therapy co., Today announced the results of two new analyses that demonstrate the cost-effectiveness of reSET-O®, which is the first and only FDA-authorized prescription digital therapy for the treatment of opioid use disorder (OUD) ( PDT). Data shows that compared with TAU alone, reSET-O plus conventional treatment (TAU) (ie, transmucosal buprenorphine, face-to-face consultation and emergency management) is expected to save life costs per million people within five years US$765,321. In a separate analysis, any level of participation in reSET-O would reduce the proportion of inpatient (IP) inpatient and emergency (ED) visits by approximately 60%, while the proportion of patients with RESET-O increased by 21% of non-participating patients. IP and ED utilization. The results were published on Virtual ISPOR 2021, the virtual annual conference of the Professional Association of Health Economics and Outcomes Research.

This is the first analysis using real medical resource utilization data from third-party payers in the United States, retreatment rate and cost scenarios, and estimates the budgetary impact of RESET-O on the market during the five-year period. The model structure of this analysis includes adult OUD patients who have received mucosal buprenorphine treatment and emergency management under clinical supervision. The results of the basic case analysis show that despite the increase in the cost of treating OUD within five years, the introduction of reSET-O into the market continued to reduce the annual cost compared with the current market. It is estimated that the cumulative cost reduction in five years was 765,321 US dollars. year.

Dr. Yuri Maricich, chief medical officer of Pear Therapeutics, said: “The pandemic has exacerbated the already prevalent OUD in the country and increased related costs.” “According to the data from the Centers for Disease Control and Prevention, as of In the 12 months of September 2020, 64,472 Americans died due to accidental opioid overdose. After the overdose, countless people needed emergency room or hospital treatment. These health economic analyses are consistent with the literature, which shows Providing patients with continuous long-term treatment is associated with a substantial reduction in costly care (e.g. emergency room visits and hospitalizations) and adding to our growing data set, proving its potential when used with MOUD, which can be used in reSET-O, To help reduce healthcare utilization and total costs associated with OUD.”

In the second analysis, the researchers used machine learning to evaluate the true relationship between the patient’s interaction with clinicians’ prescription of reSET-O and their IP or ED access frequency recorded in the healthcare requirements data. Divide patients into four participating groups: completed zero lessons and categories defined by vs. k-means clustering (low, medium, and high). The results showed that although the proportion of patients in the non-participating group who had at least one IP or ED visit increased by 21%, the proportion of IP or ED healthcare patients in all participating categories decreased by 60%. Taking into account the impact on health care utilization, it is expected that within six months compared with reeng-o, any contact with reSET-O will be reduced by 1.8-2.7 times (cost reduction range: $1,749-$2,654).

These results are further supported by recently published real-world clinical and economic data, showing the potential of using reSET-O to improve health and reduce patient treatment costs^1-5.

About OUD

In recent years, OUD has caused two-thirds of deaths related to drug use disorder (SUD)⁶.The OUD cost of the U.S. medical system alone is estimated to be approximately US$90 billion per year, mainly driven by excessive encounters in hospitals and emergency departments^7,8. The ultimate goal of treatment for OUD patients is to continue abstinence and return to life⁹.However, in the past year, less than 35% of OUD adults received opioid therapy in 2019, which highlights the need to expand access to comprehensive OUD treatment¹⁰.

reSET-O important safety information

Indications for use:

The reSET-O prescription digital therapy software is a 12-week (84-day) software application designed to increase the retention rate of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy. Including transmucosal buprenorphine and emergency management, for patients 18 years of age or older who are currently under the supervision of clinicians. reSET-O is indicated as a prescription-only digital therapeutic agent.

Important safety information for clinicians:

caveat: reSET-O is suitable for patients whose primary language is English and whose reading level is 7^day Grade or above, and have the right to use an Android/iOS tablet or smartphone. reSET-O is only applicable to patients who have a smartphone and are familiar with the use of smartphone applications (apps). Clinicians should not use reSET-O to communicate with patients about urgent medical issues. Patients should be clearly instructed not to use reSET-O to communicate any urgent or urgent information to their clinicians. In an emergency, patients should call 911 or go to the nearest emergency room.

reSET-O cannot be used as a stand-alone treatment for opioid use disorder (OUD). reSET-O does not replace the care of a licensed medical practitioner, nor does it aim to reduce the frequency or duration of in-person treatment. reSET-O cannot replace the patient’s medication. The patient should continue to take the medicine according to the instructions of the medical staff.

The incidence of mental health diseases and comorbid medical problems in patients with opioid use disorder is higher than that of the general population. The suicidal ideation, suicide attempt and suicide completion rate of patients with opioid use disorder are higher. Clinicians should take standard care measures to monitor patients for medical problems and mental health conditions, including the risk of harm to others and/or themselves.

In the OUD population, studies lasting more than 12 weeks (84 days) did not evaluate the long-term benefits of reSET-O. The ability of reSET-O to prevent potential recurrence after interruption of treatment has not been studied.

This press release does not contain all the information required for use Reset Safely and effectively.See Clinician’s summary note for reSET-O Want more information.

About Pear Therapy

Pear Therapy is the leader in Prescription Digital Therapy (PDT). Pear aims to redefine medicine by discovering, developing and delivering clinically validated software-based therapies to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effectiveness for payers Effective solutions. Pear has a series of products and candidate products in the therapeutic field, including the first three PDTs with FDA disease treatment requirements. Pear’s main product, reSET® (for the treatment of substance abuse disorders), is the first PDT approved by the FDA for the treatment of diseases. Pear’s second product, reSET-O®, is used to treat opioid use disorders and is the first PDT to receive a breakthrough designation. Pear’s third product, Somryst® for the treatment of chronic insomnia, is the first PDT submitted through the FDA’s traditional 510(k) route and has also passed the FDA’s software pre-certification pilot program for review. For more information, please visit Pear at: www.peartherapeutics.com.

reference:

1. Dr. Yuri A. Maricich, Xiong Xiaorui, Ph.D.^, Dr. Robert Gerwien, Alice Kuo, Bachelor of Arts Fulton Velez, Master of Medicine MBA, Bruce Imbert (Ph.D.), Keely Boyer (Keely Boyer), MBA, Hilary F. Method of prescription digital therapy for the treatment of 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, and Kathryn Anastassopoulos (2020): The actual decline in the utilization of medical resources after the new prescription digital therapy reSET-O treats opioid use disorders, experts comment on pharmacoeconomics Research with results, DOI: 10.1080 / 14737167.2021.1840357.

3. Wang Weijia, Nicole Gellings Lowe, Ali Jalali and Sean M. Murphy (2021) The economic model of reSET-O, which is a prescription digital therapy 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, and Hilary F. Luderer (2020) as a prescription digital therapeutic for buprenorphine to treat opioid use disorders: safety and Effectiveness, DOI’s current medical research and opinions: 10.1080 / 03007995.2020.1846022.

5. Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin Parcher, Dylan Mezzio, and Daniel C. Malone (2021) Evaluation of the cost-effectiveness of prescription digital therapies for the treatment of opioid use disorders, graduate medicine, DOI: 10.1080 / 00325481.2021.1884471.

6. Jalal H, Buchanich JM, Roberts MS, etc. From 1979 to 2016, the trend of overdose prevalence in the United States. science. September 21, 2018; 361 (6408).

7. Administration of Substance Abuse and Mental Health Services. (2020). Key substance use and mental health indicators in the United States: Results of the 2019 National Drug Use and Health Survey (HHS publication number PEP20-07-01-001, NSDUH series H-55). Rockville, Maryland: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.Get from https://www.samhsa.gov/data/.

8. Murphy SM. The cost of opioid use disorder and the value of aversion. Drug and alcohol dependence. 2020 Dec 1; 217: 108382. doi: 10.1016/j.drugalcdep.2020.108382. Epub 2020 Oct26. PMID: 33183909; PMCID: PMC7737485. https://pubmed.ncbi.nlm.nih.gov/33183909/.

9. Lofwall MR, Walsh SL, Nunes EV, etc. Randomized clinical trials of weekly and monthly subcutaneous buprenorphine depot preparations and daily sublingual buprenorphine combined with naloxone in the treatment of opioid use disorder. JAMA intern doctor. 2018;178(6):764-773.

10. Food and Drug Administration. Opioid use disorder: an endpoint used to prove the effectiveness of the drug in the industry’s drug adjuvant treatment guidelines. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/opioid-use-disorder-endpoints-demonstrating-efficiency-drugs-medication-assisted-treatment. Visited on September 29, 2020.

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