reSET and reSET-O, the only FDA-authorized PDTs for the treatment of substance use disorder and opioid use disorder, respectively, have been added to the Florida Medicaid PDL, effective
In
Pear applauds
Florida Medicaid has approximately five million
Both reSET and reSET-O have been measured in real-world use and their therapeutic content studied in randomized controlled trials, with results published in peer-reviewed medical journals.3,4 Pear recently released publications showing the potential for improved real-world health outcomes and decreased treatment costs for patients using reSET and reSET-O.5-16 Clinicians receive access to clinical dashboards to inform visits with patients. reSET is used as a monotherapy for patients 18 years of age or older with substance use disorder related to alcohol, cannabis, cocaine, and methamphetamine, and reSET-O is used in combination with buprenorphine-based medication- assisted treatment for patients 18 years of age or older with opioid use disorder.
reSET Important Safety Information
Indications for Use: reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older,
It is intended to: Increase abstinence from a patient's substances of abuse during treatment, and Increase retention in the outpatient treatment program.
Important Safety Information: Warnings: reSET is intended for patients whose primary language is English or Spanish with a reading level of 7th grade or above, and
Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET 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 is not intended to be used as a stand-alone therapy for substance use disorder (SUD). reSET does not replace care by a licensed medical practitioner and is not intended to reduce the amount of face-to-face clinician time. reSET 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 substance use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with substance use disorder also have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should engage in their normal care practices to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.
The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.
This Press Release does not include all the information needed to use reSET safely and effectively.
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
Important Safety Information: Warnings/precautions: reSET-O is intended for patients whose primary language is English or Spanish with a reading level of 7th grade or above, and
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.
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Email: meara.murphy@peartherapeutics.com
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