Given Public Concerns, Canadian Policy Makers Should Be Cautious When Making New Biosimilar Policies

Although biosimilar switching policies in Canada have resulted in increased biosimilar uptake, policy makers should address patient and provider concerns moving forward to ensure greater accessibility, competition, and cost savings, according to a recent report.

The report, which was published in the Canadian Medical Association Journal, detailed the impact, or lack thereof, that current policies surrounding biosimilars have had on biosimilar uptake and acceptance as well as offered advice on how to improve biosimilar uptake across Canada.

Despite only accounting for 1.5% of prescriptions, biologic drugs accounted for 27.3% of Canada’s prescription drug spending in 2018. As of April 2022, 31 biosimilars have been approved for marketing by Health Canada but use is relatively low compared to that in the European Union. Historically, spending on biosimilars accounts for 1.9% of the total biologics spend in Canada.

“The focus should not be solely on direct cost because value-added services, such as nursing services and other patient supports, are important aspects of the total value of biologic therapies….With promises of enhanced accessibility, competition and cost savings, now is the time to overcome biosimilars’ failure to launch,” the authors suggested.

Some of the existing policies that have been implemented to encourage biosimilar use included listing biosimilars on formularies, new start policies, and switching policies, where patients already receiving therapy with the reference product are switched after a certain date to a biosimilar. However, all these policies are implemented on a province-by-province, or a territory-by-territory, basis and some policies, including switching policies, are seen as controversial.

At the time of the report being published, all 10 provinces have listed insulin glargine, infliximab, and etanercept biosimilars on their formularies, 5 of which have biosimilar switching policies (British Columbia, Alberta, Quebec, Nova Scotia, and New Brunswick).

Alas, the authors of the report noted that policies need to do more than simply add biosimilars to formularies to ensure utilization, citing sales of insulin glargine biosimilars as an example. New Brunswick, Nova Scotia, and Prince Edward Island added the biosimilar at full benefit and a requirement for special authorization to access the originator drug, which resulted in an evident increase in biosimilar sales. To contrast, when Saskatchewan and Ontario introduced an insulin glargine biosimilar at full benefit, they did not restrict access to the originator, resulting in “no discernable increase in biosimilar uptake” in those provinces.

A policy issue that Canada shares with the United States is that of interchangeability, albeit the countries approach it differently. In both countries, generic drugs are deemed automatically interchangeable with the branded drug once given regulatory approval, but this is not true for biosimilars. Unlike in the United States, where companies must conduct additional switching analyses to get the FDA to approve a biosimilar for interchangeable status, in Canada, individual provincial and territorial governments are tasked with deciding whether to institute an interchangeability policy.

Indication extrapolation is another contentious policy for patients and providers, some of whom have expressed concerns around using data from trials testing a drug for one indication and applying to another. The authors suggested that this could explain some of the divergent uptake trends among etanercept, infliximab, and insulin glargine biosimilars.

The listing of biosimilars on formularies variers across public and private plans, and the authors suggested that policy consistency is key to increase biosimilar use and savings. They also noted that future policies regarding mandated switching, which has shown to make the greatest changes in uptake, should be balanced with educational and support programs for patients and providers.

“To support a healthy biosimilars market, provincial and territorial policy makers should consider implementing a united policy front, continue education and support for patients and providers, and collaborate with manufacturers,” the authors wrote.

Reference

McClean AR, Law MR, Harrison M, Bansback N, Gomes T, Tadrous M. Uptake of biosimilar drugs in Canada: Analysis of provincial policies and usage data. Can Med Assoc J. 2022;194(15):E556-5560. doi:10.1503/cmaj.211478