This study is the first to assess the efficacy of this drug combination in a real-world setting.
The study, which was sponsored by Alkermes Inc and shared in a poster presentation at Psych Congress 2023, is the first to assess the efficacy of OLZ/SAM—a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, which is marketed as Lybalvi—in a real-world setting.1
In the study, investigators analyzed data from 855 patients with schizophrenia and 691 patients with bipolar I disorder, all of whom were aged >18 years and had >1 pharmacy or medical claim related to an ICD-10 diagnosis of schizophrenia or bipolar I disorder between October 18, 2021, and June 30, 2022; >1 pharmacy or medical claim for OLZ/SAM during the same time period; and > 6 months of continuous enrollment in pharmacy and medical benefits before and after index date.1
The investigators made comparative analyses between baseline and 6 months using paired t-test for normally distributed continuous variables, Wilcoxon signed-rank test for continuous variables free of distribution, and McNemar test for dichotomous variables.1
The results showed that OLZ/SAM was associated with a significant reduction in all-cause health care resource utilization, including inpatient admissions, emergency department visits, and outpatient visits. Average all-cause inpatient length of stay decreased from 3.4 to 2.2 days (P=0.011)—a 36.9% decrease—and average inpatient length of stay related to mental health decreased from 3.3 to 2.0 days (P=0.007)—a 40.2% decrease.1
“A notable finding was that study results were consistent across patients diagnosed with schizophrenia and bipolar I disorder,” Hemangi Panchmatia, director of health economics and outcomes research at Alkermes and a co-author on the study, told Psychiatric Times®. “Study findings highlight similar and significant reductions observed in all-cause and mental health-related hospitalizations and emergency room visits 6 months after initiating Lybalvi regardless of diagnosis compared to the 6-month period prior to initiation.”
The overall findings of this study are significant because they suggest that OLZ/SAM could be an effective treatment option both for patients with schizophrenia and for patients with bipolar I disorder. The reduction in health care resource utilization also could lead to better outcomes for patients and lower costs for health care systems.1
“Results may inform consideration of Lybalvi by payors, other population-based health care decision-makers, and clinicians by helping them understand outcomes associated with the initiation of treatment with Lybalvi in patients with schizophrenia or bipolar I disorder,” Panchmatia told Psychiatric Times.
“This study focused on changes in hospital admissions and emergency department visits after initiating Lybalvi in these patient populations. These health care services are costly and can place a strain on hospitals, payors, patients, and caregivers, making it important to understand how different treatment options may impact these services.”
Panchmatia added that Alkermes plans to continue evaluating the effectiveness of OLZ/SAM in real-world settings. “After conducting this study, we plan to evaluate the real-world effectiveness of Lybalvi in different subgroups of patients diagnosed with schizophrenia and bipolar I disorder. We also plan to document treatment patterns associated with the use of Lybalvi, including adherence and persistence. We are committed to continuing to study the use of Lybalvi in real-world settings and to evaluate long-term outcomes associated with this treatment option.”
Note: ChatPDF was used in the preparation of this article.
1. Jain R, Panchmatia HR, Hughes AG, et al. Healthcare resource utilization following 6 months of treatment with olanzapine/samidorphan: real-world assessment of patients with schizophrenia or bipolar I disorder. Poster presentation, Psych Congress 2023. Alkermes Inc. Accessed October 6, 2023.