reSET-O® is an FDA-authorized prescription digital therapeutic (PDT) for opioid use disorder (OUD) providing cognitive behavioral therapy as an adjunct to buprenorphine therapy. This analysis describes differences in inpatient hospitalization rates over a 2-year period between patients treated with the PDT and those who were not.

A real-world claims analysis using the HealthVerity Private Source 20 database compared inpatient hospitalization rates (including intensive care unit stays and rehospitalizations) in patients who filled a reSET-O prescription (“cases”) to patients not filling their prescription (“controls”). Index date was date of reSET-O initiation for cases, and prescription date for controls, from January 1, 2019 to June 30, 2020. Pre- and post-index incidence rates of HCRU were compared with the incidence rate ratio (IRR) using a repeated-measures negative binomial model, adjusted for age, sex, region, payer type, Charlson comorbidity index (CCI) score, and number of similar services in the 12 months pre-index with an offset for number of days in the 12-month post-index period. Adjusted differences in inpatient hospitalizations in cases vs. controls were evaluated at 3-month intervals beginning at 12 months pre-index through 12 months post-index, using a difference in differences (DID) approach.

In this analysis, 901 cases (median age 36 years, 62.4% female, 73.9% Medicaid recipients, 95% treated with buprenorphine in the post-index period) were compared with 978 controls (median age 38 years, 55.1% female, 65.4% Medicaid recipients, 95% treated with buprenorphine in the post-index period). Incidence rate ratios of inpatient stays trended lower in later pre-post comparison periods among cases (IRRs 0.80, 0.95, 0.87, and 0.75 at 3-, 6-, 9-, and 12 months pre-post, respectively), and trended higher in later pre-post periods in controls (IRRs 0.93, 0.83, 0.86, 0.88 at 3-, 6-, 9-, and 12-month intervals respectively). The DID for controls vs. cases during the 12-month post interval compared to the 12-month pre-index rates, represented a 44% lower incidence of inpatient hospitalizations vs. controls between the first and last quarters of observation.

This difference in difference analysis showed a lower 12-month pre-post incidence rate ratio of inpatient hospitalizations for patients using reSET-O vs. controls, and a 24-month change in quarterly inpatient hospitalizations in reSET-O patients that was almost half that of controls.

Pear Therapeutics (US), Inc.