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

Velez, Fulton; Ruetsch, Charles; Maricich, Yuri

doi:10.1080/14737167.2021.1939687

Cited by 10 publications

(10 citation statements)

References 7 publications

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“…Also, consistent with previous analyses [ 26 ], reductions in healthcare utilization and costs over the 12-month period were greater in the reSET-O cohort vs. controls (− $2791). A subgroup analysis of Medicaid patients vs. controls showed an even greater difference in favor of reSET-O treated patients (− $3832/patient over 12 months), which carries important financial implications for states as they disproportionately bear the burden of the OUD epidemic and its ever-increasing costs.…”

Section: Discussionsupporting

confidence: 89%

Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic

et al. 2022

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Background and Aims: reSET-O, an FDA-authorized prescription digital therapeutic (PDT) delivering cognitive behavioral therapy and contingency management to patients with opioid u Ò se disorder (OUD), may help improve clinical outcomes. One-year differences in healthcare resource utilization (HCRU) and costs post-PDT initiation were evaluated. Methods: Retrospective analysis of healthcare claims data compared all-cause HCRU (across hospital facility encounters [sum of inpatient stays, treat-and-release emergency department [ED] visits, partial hospitalizations, and hospital outpatient department visits] and clinician services [procedure categories]) after PDT initiation (index) between reSET-O patients and controls. Overall and Medicaid-specific differences in HCRU, costs, and buprenorphine adherence were evaluated. Findings: Cohorts included 901 reSET-O patients (median age 36 years, 62.4% female, 73.9% Medicaid) and 978 controls (median age 38 years, 51.1% female, 65.4% Medicaid). Compared to the control group, the reSET-O group experienced 12% fewer total unique hospital encounters (non-significant), driven by 28% fewer inpatient stays (IRR 0.72; 95% CI 0.55-0.96; P = 0.02), 56% fewer hospital readmissions [IRR 0.44; 95% CI 0.20-0.93; P = 0.033]), and 7% fewer ED visits (IRR 0.93; 95% CI 0.79-1.09; P = 0.386). Total clinician services increased by 1391 events versus controls. Differences were greater among the Medicaid patients. Adjustment for

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Section: Discussionsupporting

confidence: 89%

Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic

et al. 2022

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“…Several cases that utilized retrospective data for the evaluation of DTx have been found. In the case of Pear Therapeutics’ reSET and reSET-O, cost-effectiveness was analyzed in 351 opioid use disorder patients based on post-market insurance claims data [ 25 , 26 ]. Similarly, retrospective cohort data were used to analyze the therapeutic effects [ 27 ] or conduct an economic analysis [ 28 ] of DTx for patients with type 2 diabetes and hypertension.…”

Section: Evaluation Using Real-world Datamentioning

confidence: 99%

Clinical Evaluation of Digital Therapeutics: Present and Future

Huh

Lee

et al. 2022

Healthc Inform Res

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Objectives: Digital therapeutics (DTx) are software-based therapeutic interventions based on clinical evidence. Randomized clinical trials (RCTs) are often the source of clinical evidence, similar to conventional drugs or medical devices. However, novel approaches such as the use of real-world data or digital biomarkers are also utilized. This article aimed to review how DTx products have been clinically evaluated. Methods: DTx products approved by the US Food and Drug Administration as of 2020 were reviewed and products with sufficient published information were selected. Pivotal clinical trials were analyzed according to the elements of the Consolidated Standards of Reporting Trials (CONSORT) guideline. Case reviews were presented for other clinical evaluation strategies, considering the small number of publications. Results: Most approved DTx products used RCTs for clinical evaluations. Similar to conventional RCTs, parallel-group designs with statistical hypothesis testing were adopted. However, DTx trials were often not blinded due to practical issues and involved various comparator groups. In addition, DTx products could be readily evaluated in home-based settings and delivered through the internet. Other evaluation approaches included retrospective analyses using insurance claims data or usage data, which enabled long-term evaluations of effectiveness. Digital biomarkers obtained from real-time and continuous log data were also used to improve the objectiveness of endpoints. Conclusions: RCTs accounted for the majority of DTx evaluations. The designs of DTx trials were comparable to those of drug or device trials, but blinding and comparator elements were often different. Furthermore, the use of real-world data and digital biomarkers are also being tried.

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“…Velez et al report similar findings with a PDT focused only on opioid use disorder (OUD), reSET-O® but on a longer timescale and in comparison to controls. Previous analyses [ 18 – 20 ] have shown that patients treated with reSET-O had net cost reductions at 6 and 9 months post-treatment vs. control driven by reductions in the use of acute care services. The current study corroborates these results and is the first long-term (12-month) real-world analysis demonstrating a robust durability of response to treatment with PDT-delivered CBT among patients with OUD who are being concurrently treated with buprenorphine pharmacotherapy.…”

Section: Commentarymentioning

confidence: 99%

The Rise of Prescription Digital Therapeutics in Behavioral Health

Brezing

Brixner

2022

Adv Ther

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Medicine is evolving to incorporate digital technologies of all kinds—technologies that may improve patient health, reduce clinician workload, lower costs, reduce health disparities, and expand access to needed treatments. Prescription digital therapeutics (PDTs) are an emerging technology with particular potential. These are software-based treatments delivered on mobile devices that address the behavioral dimensions of many diseases and conditions. Unlike health and wellness apps, PDTs are rigorously evaluated for safety and effectiveness and are authorized by the US Food and Drug Administration (FDA). Nine PDTs are currently authorized to treat conditions such as substance use disorders, attention-deficit disorder, and chronic insomnia. The findings reported in two recent research papers published by Advances in Therapy related to use of PDTs for substance use disorder and opioid use disorder provide real-world evidence of clinical and cost effectiveness, strengthening the evidence base for these technologies and suggesting a role for these technologies in the efforts to help patients recover from these often-chronic and deadly conditions.

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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

Abstract: 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,

Cited by 10 publications

References 7 publications

Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic

Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic

Clinical Evaluation of Digital Therapeutics: Present and Future

The Rise of Prescription Digital Therapeutics in Behavioral Health

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