Abstract
BackgroundDrug coverage policies that incentivize switching patients from originator to biosimilar products may result in significant health care savings. Our study aimed to detect early impacts on health services utilization following a mandated switch from originator to biosimilar etanercept in British Columbia (BC), Canada.MethodsWe conducted a prospective, population-based cohort study using linked administrative health data from BC (2010–2020). The policy cohort consisted of patients with inflammatory arthritis who used originator etanercept in 2019, prior to BC’s Biosimilars Initiative switching policy. Three historical cohorts included patients with inflammatory arthritis who used originator etanercept in the years 2016, 2017, and 2018. We compared the daily cumulative incidences of drug refills and outpatient and inpatient services between the policy and historical cohorts. A likelihood ratio sustained (≥ 31 days) at 7.1 or higher compared with the null hypothesis was chosen a priori as a threshold for a potential impact of the policy.ResultsEach cohort contained between 1694 and 1963 patients. We detected several potential impacts: 1) a transient increase in etanercept refills between months three and eight (cumulative incidence difference of + 3.0%); 2) an anticipated increase in visits to physicians of any specialty between months three and eight (+ 2.6%); and 3) an anticipated increase in visits to a rheumatologist from the end of month three onwards (+ 12.8%). The policy had no impact on incidences of switching to a different biologic antirheumatic drug, visits to emergency departments, or admissions to hospitals.ConclusionsOnly transient and/or anticipated increases in drug refills and physician visits were observed during the study period. Additional research on clinical outcomes is recommended to strengthen the evidence that no long-term unintended negative health impacts are associated with BC’s Biosimilars Initiative [switching policy].
Highlights
Drug coverage policies that incentivize switching patients from originator to biosimilar products may result in significant health care savings
Biosimilar uptake in British Columbia During the six-month transition period, we observed a sharp increase in the percentage of prescriptions for the Eligible prescriptions for originator etanercept during the identification period Exclusion criteria, number of patients excluded (% of patients identified)b
Diagnosis of psoriasis Low compliance/discontinuers Switchers Short follow-up No PharmaCare coverage Final number of etanercept users included in the cohort a 2016 was a leap year b For details on exclusion criteria, please refer to Additional file 1: Table S1
Summary
Drug coverage policies that incentivize switching patients from originator to biosimilar products may result in significant health care savings. Biologic disease-modifying anti-rheumatic drugs (bDMARDs), such as tumor necrosis factor inhibitors, have revolutionized the management of serious health conditions over the last two decades. This therapy has raised health care costs significantly [1]. The biosimilar products Brenzys and Erelzi were approved by Health Canada in August 2016 and April 2017 respectively [7] Both have demonstrated no clinically meaningful differences in quality, efficacy, safety, or immunogenicity compared with originator etanercept in clinical trials [8] or in analyses of real-world data [9]. Even with increasing evidence that switching to biosimilar products is not associated with negative effects on patient health, some patients and physicians have expressed concerns and resisted switching [12,13,14,15]
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