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

KEYWORDS:

• Digital therapeutic
• prescription digital therapeutic
• PDT
• opioid use disorder
• opioid epidemic
• reSET-O
• neurobehavioral therapy

Evidence-based behavioral approaches for Opioid Use Disorder (OUD) are resource-intensive and challenging to implement, resulting in the majority of patients not receiving adequate care [1,2]. Medications for OUD (MOUD), primarily buprenorphine and methadone are critical to reduce cravings, but behavioral therapy, such as the evidence-based community reinforcement approach (CRA) for the treatment of substance use disorders (SUDs), is essential for durably reinforcing behaviors that support recovery [3]. Prescription digital therapeutics (PDTs) like reSET and reSET-O, are software-based disease treatments that deliver evidence-based therapeutic content and are authorized by the U.S. Food and Drug Administration (FDA) to treat adult patients with SUD and OUD, respectively. In addition to the therapeutic component these PDTs also provide patient support services with algorithmically driven outbound calls to foster engagement with therapy, and feature a dedicated clinician dashboard which allows clinicians to monitor patients’ progress in real time. Prescribed and initiated by treating clinicians, and delivered on mobile devices, reSET and reSET-O have the potential to safely expand access to evidence-based therapies, which is highly relevant in the context of limited access to clinicians [4–6].

In November 2020, we published in this journal a retrospective claims study evaluating changes in healthcare resource utilization following the initiation of reSET-O among 351 predominantly Medicaid-covered (82.6%) patients with OUD [7]. That analysis showed a net reduction in medical costs of 2,150 USD per patient 6 months post initiation of reSET-O, driven in large part by a reduction in inpatient (IP) stays and emergency department (ED) visits, but also by a reduced utilization of presumptive and definitive drug testing for a variety of substances, and through the substitution of face-to-face counseling sessions (CPT codes for individual and group psychotherapy: 90,785–90,876). Conversely, an increased utilization of case management and behavioral/mental health rehabilitative services was observed, which together with a significant increase in buprenorphine adherence indicates a greater engagement with services supportive of long-term recovery.

Here, we report an extended analysis in a larger OUD patient population (N = 444) with 9-month pre/post initiation claims data identified in the HealthVerity PrivateSource20 (PS20) database between 1 January 2019 and 8 December 2021, which supports the trends we observed in the 6-month analysis, suggesting additional durability of key outcomes. As with our previous report, this study received a waiver of authorization for the use and disclosure of protected health information (PHI) and a determination of exempt status under 45 CFR § 46.104(d)(4) from Western Institutional Review Board on 2 April 2020. IP and ED utilization remained relatively low during months 6 to 9 following reSET-O initiation, with 18 IP stays and 79 ED visits during this period (versus 32 IP stays and 97 ED visits in months 3–6), continuing the trend of reduced quarterly utilization of these services observed during the first 6 months after reSET-O treatment initiation. Consistent with our prior analysis, the period 9-months following reSET-O prescription showed a significant decrease in IP stays (66 fewer – 50% decrease) and ED visits (91 fewer – 27%) versus the 9 months prior to prescription of the product. We also observed decreases in the use of a variety of high-cost clinical services 9 months after reSET-O initiation, including inpatient observation visits, physical medicine/rehabilitation, cardiovascular procedures, inpatient detoxification for alcohol and substance use disorders, and surgery.

In addition to reducing IP and ED visits, we observed multiple reductions in healthcare utilization suggesting a stabilization of patient outcomes. A further reduction in the quarterly trend of drug testing and additional substitution of individual and group counseling sessions was observed during months 6–9 (drug tests: 1,905; counseling sessions: 1,309) compared to the quarterly average during the first 6 months after reSET-O treatment initiation (drug tests: 2,028; counseling sessions: 1,373), and the 6 months prior to reSET-O initiation (drug tests: 2,192; counseling sessions: 1,421). Compared to our previous analysis, we observed a slight reduction in the quarterly trend of case management, behavioral health, and mental health rehabilitative services consultations (months 6–9: case management: 1,544; mental health: 116; behavioral health: 185), compared to the first 6 months after reSET-O initiation (case management: 1,685; 138 behavioral and 188 mental health visits per quarter), and compared to the 6 months prior to reSET-O initiation (case management: 1,756; 124 behavioral and 171 mental health visits per quarter).

As in the previous analysis, a 10% increase in buprenorphine adherence was observed in this new analysis, from 74% to 82%. This finding is significant because it suggests that even in this population with relatively high use of buprenorphine, using the PDT’s neurobehavioral treatment led to increased medication use, a key goal of treatment [8].

Together, these findings of a continued trend toward lower utilization of the main cost drivers in OUD (IP and ED) coupled with a reduced demand for drug testing, face-to-face counseling visits, and a plateauing of the frequency of case management and rehabilitative services, in a broader population followed up over a longer period of time compared to our first analysis, support the durability of the reSET-O treatment effect and a long-term stabilization of the clinical trajectory for patients in recovery. These 9-month data support a durability of effect of digitally delivered neurobehavioral support beyond 6 months and will require ongoing monitoring and analysis over longer periods of time and in larger patient populations as the data become available. We continue to analyze real-world outcomes following patients’ and their care team’s real-world interaction with reSET-O, and we hope to report 1-year pre- and 1-year post comparisons in the future. We felt that it was important to briefly report 9-month post-initiation data due to the urgent need for durable evidence-based behavioral interventions to decrease avoidable use of expensive healthcare resources (IP and ED), and increase use of recovery support services in this highly vulnerable population. Patients also need more flexible approaches to treatment that can be delivered remotely, and that can seamlessly scale-up during times of increased demand for behavioral health and substance use recovery services, which are currently increasing, and which are projected to remain high for years to come [9].

Declaration of interest

FFV and YM are employees of Pear Therapeutics, Inc. CR provided consulting services to Pear Therapeutics, Inc. for the conduct of the study. No author received an honorarium related to the development of this manuscript. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This work was supported by Pear Therapeutics, Inc.