Rapid monitoring of health services use following a policy to switch patients from originator to biosimilar etanercept—a cohort study in British Columbia

Abstract

Background Drug 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. Methods We 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. Results Each 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. Conclusions Only 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].

Treatment pattern trends of medications for type 2 diabetes in British Columbia, Canada

“…We conducted a longitudinal and cross-sectional retrospective study using data obtained between 1996 and 2020 from the BC Ministry of Health Healthideas database that include dispensing data from all community pharmacies in the province 24. This database has been a source for multiple observational studies25 26 and includes information on patient demographics, drug dispensing records, outpatient physician fee-for-service claims, hospital admissions, and laboratory test results (from 2011 onwards). Detailed information on the dispensed medication, dispensing date, quantity and number of dispensed days supply is available in the database.…”

Monitoring a Mandatory Nonmedical Switching Policy from Originator to Biosimilar Infliximab in Patients with Inflammatory Bowel Diseases: A Population-Based Cohort Study

“…as patients experiencing the outcome earlier without an overall change in the number of patients experiencing the outcome. The study method has been previously published [33,34,38,39]. Patients with Crohn's disease and ulcerative colitis were not analysed separately, because this was a signal detection analysis, with the goal of conducting quick and efficient analysis.…”

“…Recent interventional and observational studies and systematic literature reviews found similar benefits and harms related to the biosimilar infliximab compared with the originator in adult [20][21][22][23][24][25][26][27][28][29]30] and pediatric patients [31] with IBD. However, data on the impact of policies for a nonmedical switch are lacking [9,[32][33][34], and in patients with IBDs, the surveillance to date has been limited to switching rates [32].…”

Uptake and Spending on Biosimilar Infliximab and Etanercept After New Start and Switching Policies in Canada: An Interrupted Time Series Analysis

“…Notably, we detected a small but significant downward trend in the post-switch period, potentially indicating treatment failure and switches back to the reference product. Studies examining biosimilar infliximab and etanercept switching in BC found no differences in health care utilization (e.g., emergency department visits or hospitalizations) post policy (27,28). Nevertheless, concerns around the use of biosimilars remain, stemming in part from their regulatory designation as similar but not identical to the reference product in terms of efficacy and safety, their interchangeability and substitutability, and the use of clinical trial data from one disease state to substantiate claims of efficacy and safety in another (i.e., extrapolation of indication), among other factors (13,(29)(30)(31).…”