Pear Therapeutics and SelectHealth Announce Coverage to Provide Access to FDA-Authorized Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder
August 8, 2022
SelectHealthteams with Pear to provide its members with covered access to Pear’s innovative prescription digital therapeutic (PDT), reSET-O®, for the treatment of opioid use disorder (OUD) as adjunct to outpatient treatment that includes transmucosal buprenorphine Medication-Assisted Treatment (MAT).
SelectHealthintends to offer and administer Pear’s reSET-O as a covered benefit for fully-insured commercial members with OUD on transmucosal buprenorphine being treated on an outpatient basis.
“Both organizations are focused on keeping people healthy and providing high-value care that is accessible throughout the communities that we serve,” said
reSET-O is an innovative response to the ongoing opioid crisis in America. In
“With the opioid epidemic impacting more people than ever across the country, we applaud
PDTs are an innovative therapeutic class that uses software to directly treat disease. reSET-O has been measured in real-world use and its therapeutic content studied in a randomized controlled trial, with results published in a peer-reviewed medical journal3. Pear recently released publications showing the potential for improved real-world health outcomes and decreased healthcare resource utilization for patients using reSET-O4-13. Used in combination with transmucosal buprenorphine, reSET-O is adjunctive to outpatient care, provide patients with cognitive behavioral therapy, fluency training, and contingency management, while clinicians receive access to clinical dashboards to inform in-office and tele visits.
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
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
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.
- 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.
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.
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.
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.
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 Researchand Opinion, DOI: 1080/03007995.2020.1846022.
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.
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.
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.
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.
Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K, Maricich YA. Comparison of Healthcare Resource Utilization Between Patients
WhoEngaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. Clinicoecon Outcomes Res. 2021;13:909-916
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.
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