he original wave of biosimilar regulatory approvals in Canada several years ago prompted a range of reimbursement policy responses on the part of both public and private payers. Canadian public payers leveraged introduction of the infliximab biosimilar to create policies intended to secure significant cost savings for drug plans as the scope of available biosimilars expanded over time. In April 2016, the pan-Canadian Pharmaceutical Alliance (pCPA) Office released its First Principles for Subsequent Entry Biologics policy to guide more consistent price negotiations for biosimilars and their related reference biologics.

During this time, international reimbursement bodies aggressively pursued substitution and switching policies to leverage biosimilars’ cost-savings opportunities. Canadian payers, however, avoided forced switching of patients to biosimilars.

Despite drug plan policies mandating use of biosimilars for patients new to treatment (e.g., with infliximab or etanercept), uptake of biosimilars in the Canadian market has been very slow and has not generated expected savings. Emerging evidence coupled with significant health system fiscal pressures have now created momentum for government drug plan managers to move forward with efforts that will secure additional savings from the broader use of biosimilars.

Recent developments in the biosimilar approval and reimbursement environment reflect a significant shift by payers to ensure that they are able to leverage biosimilar savings opportunities to create budget space for new innovative products.

Health Canada

Health Canada introduced guidelines governing regulatory review of biosimilar products in 2010, with an update published in November 2016. As of fall 2019, Health Canada has approved 18 biosimilars (oncology and non-oncology) of 11 innovator products.

In August 2019, Health Canada published a fact sheet to address a number of questions regarding biosimilars and their related regulatory processes. Health Canada’s statement on the potential risk of switching from brand biologics to biosimilars is quite clear:

“Patients and healthcare professionals can have confidence that biosimilars are effective and safe for each of their authorized indications. No differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.”

This portion of the update was important because it addressed issues raised when provinces made policy decisions related to mandated substitution (i.e., switching) of innovator with biosimilar products (see below) through 2019.

British Columbia

British Columbia (BC) was the first province to introduce a biosimilar switching policy in May 2019, choosing a staged approach. BC PharmaCare instituted the Biosimilars Initiative for Patients and its first phase involved switching patients using Enbrel, Remicade, and Lantus (for ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and diabetes) to a biosimilar medication over six months.

The BC Minister of Health also noted that Canada is far behind European jurisdictions in its uptake of biosimilars (less than ten percent market penetration) and emphasized that BC was following evidence-based results from international jurisdictions that have more than ten years of biosimilars experience.

The government also cited the need to improve the sustainability of its PharmaCare program by expanding biosimilar use to create opportunities for new drug listings and boost existing patient coverage. Commensurate with the biosimilars policy statement, the government announced the listing of Jardiance (for diabetes) and Taltz (for psoriatic arthritis) as well as expanded coverage for several drugs used for rheumatoid arthritis (i.e., DMARDs, certolizumab, leflunomide, rituximab, tocilizumab, and tofacitinib). Thus, savings from the biosimilar initiative were directly responsible for enabling the reimbursement of new medicines as well as improving patient access to already licensed drugs for new indications.

Extensive consultations were undertaken prior to implementing this policy. The government received support from prescribers as well as caregiver and patient groups, such as rheumatologists, the BC Society of Rheumatologists, endocrinologists, Doctors of BC, Arthritis Consumer Experts, Arthritis Society, BC Pharmacy Association, Neighbourhood Pharmacy Association, regional health authorities, Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH), the Patented Medicine Prices Review Board, and the pan-Canadian Pharmaceutical Alliance.

In September 2019, BC PharmaCare announced details of the second phase of the Biosimilars Initiative. Patients using Remicade to treat gastrointestinal conditions (i.e., ulcerative colitis, Crohn’s disease) will be switched to a biosimilar over a six-month period. Patients must switch to one of two available biosimilar products by March 5, 2020. Remicade will not be covered after the switch period.

Alberta

In December 2019, the new government announced Alberta’s Biosimilar Initiative to expand use of biosimilars by replacing biologic drugs with their biosimilar versions. Adult patients (except for pregnant women) currently taking a biologic (for specific conditions) that has a biosimilar version must switch to the biosimilar drug before July 1, 2020. Etanercept, infliximab, insulin glargine, filgrastim, and pegfilgrastim are the molecules captured in this policy change.

The Initiative’s website provides guidance to patients and clinicians on the process for switching, as well as direction for securing exceptional coverage if a patient is unable to switch to the biosimilar for medical reasons. In the spirit of transparency, a summary of the evidence to support this policy decision is also provided for all stakeholders to examine.

The rationale for Alberta’s decision is clear: The government’s drug plan has experienced 16.2 percent average annual growth in biologics spending, and brand biologic products (i.e., Remicade, Humira, and Enbrel) are three of the top four drug spending drivers in the province. Switching to biosimilars will save between $227M and $380M over the next four years and makes it possible to commit to investing these savings in other healthcare services.

The Alberta government did not appear to hold consultations with stakeholders in advance of announcing this new policy, as had been done in BC. Clinician and patient stakeholders have been quite vocal in their opposition of Alberta’s biosimilar policy changes since this announcement, which could force the government to make some adjustments to their approach.

What’s Next?

Other provinces are closely monitoring implementation of biosimilar switching policies in BC and Alberta and are likely considering their next steps. For instance, a recent report analyzed current and prospective utilization and expenditure patterns of innovator biologics and biosimilars funded by the Ontario government, which hosts Canada’s largest public drug program. This analysis demonstrated very low levels of biosimilar utilization, despite preferential listing status for biosimilars in patients new to biologic therapy. It is clear that traditional formulary-based policies have not facilitated biosimilar uptake and that other approaches must be considered to shift utilization patterns.

In a sister publication to the report above, CADTH identified potential policy options to address this issue:

• Mandate controlled substitution of innovator biologics for biosimilars with prescriber assistance;
• Reimburse biosimilars for newly diagnosed persons only;
• Provide access to either innovator or biosimilar biologics using tiered reimbursement;
• Use prescribing quotes to incentives the use of biosimilars; and/or,
• Provide access to biosimilars using tendering procedures.

It will be interesting to see which approach individual provinces choose as they seek to secure savings from optimal biosimilar uptake.

In Conclusion

To date, two Canadian provinces (British Columbia and Alberta) have made or are in the process of introducing major reimbursement policy changes to increase the use of biosimilar products. It is reasonable to expect other provinces to follow suit within the next three years. Despite extensive European evidence that supports these policy changes, there has been pushback by some stakeholders. It will be important for government drug programs to evaluate the impacts of these switching policies to assuage stakeholder concerns and demonstrate the contribution of biosimilars to healthcare system fiscal sustainability.