1. Projected impact of biosimilar substitution policies on drug use and costs in Ontario, Canada: a cross-sectional time series analysis.
- Author
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Gomes T, McCormack D, Kitchen SA, Paterson JM, Mamdani MM, Proulx L, Bayliss L, and Tadrous M
- Subjects
- Adolescent, Adult, Aged, Cost-Benefit Analysis, Cross-Sectional Studies, Drug Prescriptions economics, Female, Health Care Surveys, Humans, Male, Middle Aged, Ontario, Reimbursement Mechanisms, Young Adult, Biosimilar Pharmaceuticals economics, Biosimilar Pharmaceuticals therapeutic use, Drug Costs statistics & numerical data, Drug Costs trends, Drug Prescriptions statistics & numerical data, Drug and Narcotic Control legislation & jurisprudence
- Abstract
Background: Several Canadian provinces have introduced reimbursement policies mandating substitution of innovator biologics with lower-cost biosimilars. We estimated the number of patients affected and cost implications if such policy changes were to be implemented in Ontario, Canada., Methods: We conducted a cross-sectional time series analysis of Ontarians dispensed publicly funded biologics indicated for inflammatory diseases (rheumatic conditions, inflammatory bowel disease: infliximab, etanercept, adalimumab) between January 2018 and December 2019, and forecasted trends to Dec. 31, 2020. The primary source of data was pharmacy claims data for all biologics reimbursed by the public drug program. We modelled the number of patients affected and government expenditures (in nominal Canadian dollars) of several biosimilar policy options, including mandatory nonmedical biosimilar substitution, substitution in new users, introduction of a biosimilar for adalimumab, and price negotiations. In a secondary analysis, we included insulin glargine., Results: In 2018, 14 089 individuals were prescribed a publicly funded biologic for inflammatory diseases. A mandatory nonmedical biosimilar substitution would potentially have affected 7209 patients and saved $238.6 million from 2018 to 2020. A new-user substitution would have affected 757 patients and saved $34.2 million. If an adalimumab biosimilar were to become available, 12 928 patients would be affected by a mandatory nonmedical substitution and the 3-year savings would increase to $645.9 million (all biosimilars priced at 25% of innovator biologics). Finally, an expanded nonmedical substitution policy including insulin glargine would affect 115 895 patients and save $288.7 million (not including adalimumab)., Interpretation: Policies designed to curb rising costs of biologics can have substantially different effects on patients and government expenditures. Such analyses warrant careful consideration of the balance between cost savings and effects on patients., Competing Interests: Competing interests: Muhammad Mamdani reports receiving honoraria from Neurocrine Biosciences, and reports being a one-time advisory board member for Roche. Laurie Proulx reports membershp of the executive of the Canadian Arthritis Patient Alliance. Tara Gomes reports receiving a grant from the Ontario Ministry of Health. No other competing interests were declared., (© 2021 CMA Joule Inc. or its licensors.)
- Published
- 2021
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