More Canadian Jurisdictions Implement Mandatory Biosimilar Switching Policies

The entire country of Canada is getting close to having biosimilar switching policies in place in all 13 jurisdictions. Recently, the province of Newfoundland and Labrador¹ and the territory of Yukon² became the latest jurisdictions to add a biosimilar switching policy, making them the ninth and tenth to join Ontario and others. British Columbia (BC) was the first jurisdiction to implement such a policy back in May 2019.

Canadian territories and provinces | Photo credit: Porcupen - adobe.stock.com

The switching policies require that patients enrolled in the public drug program be prescribed a biosimilar over a reference product, although the therapies included varies between the 2 jurisdictions.

The cost of biologics can put an enormous financial strain on drug budgets, Biosimilars Canada explained, and policies to switch patients to biosimilars can enable the public drug programs to expand access to treatments in addition to invest in new and innovative drug therapies. Plus, there is no difference in the safety and efficacy of biosimilars compared with the originator biologic.

In Newfoundland and Labrador, providers have until March 31, 2024, to prepare and educate patients who are on a reference product about the benefits of biosimilars. The originator products that will be affected are Copaxone (glatiramer acetate), Enbrel (etanercept), Humalog (insulin lispro), Humira (adalimumab), Lantus (insuling glargine), Lovenox (enoxaparin sodium), NovoRapid (insulin aspart), Remicade (infliximab), and Rituxan (rituximab).

Patients who do not want to transition to a biosimilar risk losing their coverage in the Newfoundland and Labrador Public Drug Program.

In Yukon, the policy will initially apply to Humira and Lantus. Residents enrolled in Pharmacare and the Chronic Disease and Disability Program will have 6 months starting April 3, 2023, to make the transition and maintain coverage. The policy will eventually expand to include additional biologic drugs.

“Yukon doctors see sustainability of the health care system as a key part of ensuring that Yukoners receive the best health care possible,” Alex Kmet, MD, president of the Yukon Medical Association, said in a statement.³ “Incorporating biosimilars into these publicly administered drug and benefit programs is part of ensuring equitable high-quality health care into the future.”

In 2022, BC published results of the BC Biosimilars Initiative, the province’s mandatory biosimilar switching program.⁴ The prospective, population-based cohort study of the initiative reviewed the mandated switch from Enbrel (etanercept) to a biosimilar.

At the time of the study, there were 2 etanercept biosimilars approved in Canada: Brenzys from Merck (approved in August 2016) and Erelzi from Sandoz (approved in April 2017). Since the study was published in February 2022, a third etanercept biosimilar, Rymti from Lupi, was approved in September 2022.

The study had found prescriptions for etanercept biosimilars increased from 17.3% in May 2019, when the policy was implemented, to 96.9% in December 2019. There was a 6-month transition period and 65.1% of patients had switched to a biosimilar by the end of it, while 88.1% of patients had switched by the end of the 1-year follow-up period.

The policy had no impact on emergency department visits or admissions.

“We did not find permanent unintended changes in health services utilization, which suggests that switching to the biosimilar etanercept had minimal impacts on patient health,” the authors concluded. “Additional research on clinical outcomes is recommended to strengthen the evidence that no long-term unintended negative health impacts are associated with switching from originator etanercept to its biosimilars.”

Reference

1. Newfoundland and Labrador announces transition to cost-saving biosimilar medicines. Biosimilars Canada. News release. March 27, 2023. Accessed March 31, 2023. https://biosimilarscanada.ca/blog/newfoundland-and-labrador-announces-transition-to-cost-saving-biosimilar-medicines/

2. Yukon announces transition to cost-saving biosimilar medicines. Biosimilars Canada. News release. March 30, 2023. Accessed March 31, 2023. https://biosimilarscanada.ca/blog/yukon-announces-transition-to-cost-saving-biosimilar-medicines/

3. Yukon government enhances public drug plan with biosimilars. Yukon. News release. March 29, 2023. Accessed March 31, 2023. https://yukon.ca/en/news/yukon-government-enhances-public-drug-plan-biosimilars

4. Fisher A, Kim JD, Carney G, Dormuth C. Rapid monitoring of health services use following a policy to switch patients from originator to biosimilar etanercept-a cohort study in British Columbia. BMC Rheumatol. Published online January 27, 2022. doi:10.1186/s41927-021-00235-x