Retrospective Indication-Matched Cohort Study of Reference Product and Biosimilar: Bevacizumab Versus Bevacizumab-Awwb.

Introduction: Due to the abbreviated approval pathway and extrapolation to non-studied indications, an increased importance is placed on post-marketing surveillance of biosimilars to supplement existing evidence and enhance patient and provider confidence. Bevacizumab-awwb (ABP 215, Mvasi) was the first biosimilar approved to bevacizumab (Avastin), a recombinant humanized monoclonal IgG1 antibody that inhibits the vascular endothelial growth factor (VEGF). Purpose: To evaluate utilization, safety, and financial outcomes of bevacizumab-awwb compared to bevacizumab at a national cancer institute (NCI)-designated cancer center. Methods: A single center, retrospective, 1:1 indication-matched cohort study of adult patients who received bevacizumab or bevacizumab-awwb between October 1, 2019 and October 1, 2020 was performed. Thirty-four patients received bevacizumab-awwb during the study period and were matched by indication to 34 randomly selected patients who received bevacizumab. Indications for both groups included: colorectal cancer (n = 19), gynecologic cancer (n = 10), glioblastoma (n = 3), hepatocellular carcinoma (n = 1), and lung cancer (n = 1). Results: Baseline and medication utilization characteristics were similar for this indication-matched cohort of 68 patients receiving bevacizumab-awwb or bevacizumab. Patients in the bevacizumab group had a higher proportion of public payer coverage (64.7% vs 38.2%, P = .029). A higher proportion of patients in the bevacizumab-awwb group remained on active treatment at the end of the study period (52.9%) as compared to the bevacizumab group (35.3%); however, differences in final treatment status and reasons for discontinuation were not statistically significant (P = .218). Rates of worsened hypertension (44.1% vs 44.1%) and worsened proteinuria (38.2% vs 23.5%, P = .077) were common in both groups. Grade 3 adverse drug events in the bevacizumab group included: gastrointestinal perforation (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 2), and venous thromboembolism (n = 2). Grade 3 adverse drug events in the bevacizumab-awwb group included: epistaxis (n = 1), gastrointestinal bleed (n = 1), hypertension (n = 1), intracerebral hemorrhage (n = 1), venous thromboembolism (n = 3), and arterial thromboembolism (n = 1). One patient in the bevacizumab-awwb group experienced grade 4 hypertension. Median drug cost per dose and per milligram for bevacizumab-awwb was less than bevacizumab, representing a 15.8% and 12.1% discount, respectively. Conclusion: Utilization and safety outcomes were similar for this indication-matched cohort of 68 patients receiving bevacizumab or bevacizumab-awwb across a wide range of disease states.

The formulary process for biosimilar additions at a comprehensive cancer center.

Biological products may be used to diagnose, prevent, treat, and cure diseases and medical conditions, including cancer. Biosimilar agents, approved under an abbreviated 351(k) pathway, continue to increase in number and market share for biologic agents, especially for cancer care. Although biosimilars offer the potential for improved access to care, their introduction to the marketplace has created significant disruption. It is imperative that health systems providing care to patients with cancer develop a well-defined process to address the challenges associated with biosimilars. This descriptive article outlines pharmacy considerations for biosimilars and describes the current practices at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University. Biosimilars have and will continue to significantly impact oncology care. Organizations must understand the clinical, operational, and financial challenges associated with the use of these products.

The Safety and Efficacy of Verapamil Versus Diltiazem Continuous Infusion for Acute Rate Control of Atrial Fibrillation at an Academic Medical Center.

PURPOSE: Due to critical shortages of intravenous diltiazem in 2018, the Ohio State University Wexner Medical Center (OSUWMC) adopted intravenous verapamil as an alternative. However, there is a paucity of data supporting the use of intravenous verapamil infusions for rate control in the acute treatment of atrial arrhythmias. The purpose of this study was to determine the safety and efficacy of intravenous verapamil as compared with diltiazem for the acute treatment of atrial arrhythmias. METHODS: This retrospective, case-control study compared patients who received verapamil infusions between June 1 and September 30, 2018, with patients who received diltiazem infusions between June 1 and September 30, 2017, at OSUWMC. Patients were matched 1:1 based on age, sex, and the presence of comorbid heart failure with reduced ejection fraction (≤40%). RESULTS: A total of 73 patients who received at least 1 verapamil infusion and 73 patients who received at least 1 diltiazem infusion met inclusion criteria. The composite need for inotrope or vasopressor was similar for both groups (5% with verapamil versus 4% with diltiazem, P = .999). The rate of hypotension was similar between groups (37% versus 33% experiencing a systolic blood pressure <90 mm Hg, P = .603, and 27% versus 23% experiencing a mean arterial pressure <65 mm Hg, P = .704), as was the rate of bradycardia (19% versus 18%, P = .831). The efficacy outcomes of this study were similar for both groups, with 89% of patients in the verapamil group and 90% of patients in the diltiazem group achieving a heart rate less than 110 beats per minute (P = .785). CONCLUSION: Intravenous verapamil and diltiazem infusions had similar safety and efficacy outcomes when used for acute treatment of atrial arrhythmias in the institutional setting.

Use and effects of cannabinoids in military veterans with posttraumatic stress disorder.

PURPOSE: Published evidence regarding the use of cannabis and cannabis derivatives by military veterans with posttraumatic stress disorder (PTSD) is reviewed. SUMMARY: When inhaled or delivered orally or transdermally, cannabinoids (the psychoactive components of unrefined marijuana and various derivative products) activate endogenous cannabinoid receptors, modulating neurotransmitter release and producing a wide range of central nervous system effects, including increased pleasure and alteration of memory processes. Those effects provide a pharmacologic rationale for the use of cannabinoids to manage the three core PTSD symptom clusters: reexperiencing, avoidance and numbing, and hyperarousal. A literature search identified 11 articles pertaining to cannabis use by military veterans who met standard diagnostic criteria for PTSD. Cross-sectional studies have found a direct correlation between more severe PTSD symptomatology and increased motivation to use cannabis for coping purposes, especially among patients with difficulties in emotional regulation or stress tolerance. Data from 4 small studies suggested that cannabinoid use was associated with global improvements in PTSD symptoms or amelioration of specific PTSD symptoms such as insomnia and nightmares. Large well-designed controlled trials are needed in order to better delineate the potential role of cannabinoids as an adjunct or alternative to conventional approaches to PTSD management. CONCLUSION: While further research into cannabinoid treatment effects on PTSD symptoms is required, the evaluated evidence indicates that substantial numbers of military veterans with PTSD use cannabis or derivative products to control PTSD symptoms, with some patients reporting benefits in terms of reduced anxiety and insomnia and improved coping ability.