The high cost of originator biologicals in Canada has created a demand for biosimilars as a way of reining in costs for Canadian public healthcare payers. However, although several biosimilars are now commercially available in the country for a variety of conditions [1]; it has been suggested that the uptake of biosimilars in Canada remains low [2].
In order to investigate the current use and uptake of biosimilars, The Canadian Agency for Drugs and Technologies in Health (CADTH) collaborated with researchers from the Ontario Drug Policy Research Network (ODPRN) to gather information on the utilization of biosimilars for chronic inflammatory diseases, including any potential cost implications relating to the future use of biosimilars.
A study was carried out using linked population-level information from data sets housed at the Canadian Institute for Clinical Evaluative Sciences (ICES) to examine trends in the use and spending on publicly reimbursed originator biologicals and biosimilars indicated for inflammatory rheumatic conditions* and inflammatory bowel disease (IBD). The study also investigated the differences in the uptake of biosimilars by a patient’s medical indication and by the drug type from the perspective of a large, government-sponsored drug programme.
The results of the investigation were published in reports released by CADTH (Utilization of innovator biologics and biosimilars for chronic inflammatory diseases in Canada: a provincial perspective) and ODPRN (Current and prospective utilization of innovator biologics and biosimilars in Ontario) in January 2020. The reports examine the utilization trends of infliximab and etanercept originator biologicals and biosimilars, as well as the innovator biological adalimumab, in rheumatic conditions and IBD in Ontario.
The ODPRN report found that for the use of publicly funded biologicals in Ontario:
• CA$1.1 billion was spent on biologicals via the public drug programme in Ontario in 2018, an ~3-fold increase from CA$352.9 million in 2010. Total annual costs are expected to reach CA$1.4 billion by 2021.
• Users of biologicals has increased by 462.3% over the past nine years, from 21,383 users (Q1-2010) to 120,247 users (Q2-2019). Projected to increase an additional 95.3% to 162,020 users by Q2-2022.
• Users of biosimilars were only 3.6% (n = 4,300 of 120,247 users) of all biologicals users in 2Q-2019.
• The highest cost biologicals in 2018 were aflibercept (CA$290.0 million), ranibizumab (CA$188.3 million) and infliximab (CA$117.5 million), representing 27.9%, 17.4%, and 10.9% of total biologicals spending, respectively.
The take-away messages from the report were that:
• Biosimilar users accounted for a small proportion of overall biological users, even among biologicals with a currently available biosimilar
• The data suggested that traditional formulary-based policies may not have a significant impact on biosimilar uptake
• The effect of policies on the uptake of biosimilars may differ by patient indication
The CADTH report summarizes the major findings from the ODRPN study and discusses possible implications for decision-makers. The report concluded that policymakers may need to consider more complex cost-containment mechanisms or strategies to optimize the benefits of biosimilars, including:
• Controlled substitution of originator biologicals for biosimilars with prescriber assistance
• Reimburse only biosimilars for newly diagnosed patients
• Provide access to originator biologicals or biosimilars using tiered reimbursement
• Use prescribing quotas to incentivize use of biosimilars
• Provide access to biosimilars using tendering procedures
*Rheumatic conditions were defined as rheumatoid arthritis, psoriatic arthritis and psoriasis; and IBD represented Crohn disease and ulcerative colitis in the ODPRN analysis.
Related articles
Biosimilars regulation in Canada: state of play
Canadian report into international policies for biosimilars
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars makers in Canada to launch patient support programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from www.gabionline.net/Biosimilars/General/Biosimilars-makers-in-Canada-to-launch-patient-support-programme
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