Legal & Regulatory > Canada > Biosimilar Policies in Canada: To Switch or Not to Switch?

Biosimilar uptake initiatives are gaining traction across Canada and have already been implemented in several provinces. Dara Jospé and Lina Bensaidane of Fasken examine the impact of these policies on patients, prescribers, and pharmacists thus far, and the implications should non-medical biosimilar switching become a nationwide norm.

In the last few years, several provinces in Canada have decided to introduce a biosimilar policy, through which only the biosimilar version of a given biologic drug is reimbursed by the public insurer.

A biosimilar is a biologic drug that is very similar to a biologic drug that has been authorized for sale by Health Canada.[1] A biosimilar medicine can enter the market once the patent of the reference biological medicine has expired. Health Canada authorizes the sale of biosimilar drugs under the same regulatory standards of quality, efficacy and safety as biologic drugs. According to the latter, there would be no significant clinical difference in terms of efficacy and safety between a biosimilar medicine and the reference biological medicine whose sale is already authorized.

Still, biosimilar drugs are not treated in the same manner as generic drugs in Canada, i.e., an authorization by Health Canada does not constitute a declaration of equivalence to the reference biologic. Rather, the authority to declare two (2) products interchangeable and thus substitutable at the pharmacy level rests with each province and territory according to its own rules and regulations.^[2]

In this context, the provinces have not declared biosimilar drugs interchangeable but have limited reimbursement of biologics once there is a biosimilar on the market. In fact, one approach, termed the “non-medical switch,” which requires that patients be transitioned to the biosimilar once available, is gaining traction across Canada.

Here we take a closer look at the non-medical biosimilar switch policies implemented across Canada and the general trends that can be noted. The policies vary from one province to another in terms of exemptions and their impact on healthcare professionals.

Switching to a Biosimilar

In May 2019, the government of British Columbia was the first government to introduce a biosimilar initiative in which the provincial public drug plan would only cover the biosimilar versions of specific drugs for affected indications for both new and existing patients.^[3] As of 2021, at least 85 percent of BC PharmaCare patients for which a biosimilar drug was available were switched to this biosimilar drug.[4]

Since then, Alberta[5] (December 2019), New-Brunswick[6] (April 2021), Quebec[7] (July 2021), Nova-Scotia[8] (February 2022) and the Northwest Territories[9] (December 2021) announced similar non-medical switch initiatives.

Each of these provinces has allowed for a transition period, (e.g., six months) from the date of the announcement to the implementation of the biosimilar switch. Once the transition period ends, the provincial insurer only covers the biosimilar version of the drug, unless patients are eligible for a discretionary exemption for medical reasons.

While all provinces provide for exemptions regarding the transition to biosimilars, the criteria for the exemptions vary. Some provinces will have specific criteria laid out, whereas others will require the submission of a request form in which the prescriber justifies the necessity to maintain the biologic drug. For example, in Quebec, the people falling in the following categories are all exempt from the switch to biosimilars:

• Pregnant women, who should be transitioned to biosimilars in the 12 months after childbirth;
• Pediatric patients, who should be transitioned to biosimilars in the 12 months after their 18^th birthdays;
• Patients who have experienced two or more therapeutic failures while being treated with a biologic drug for the same chronic disease.[10]

In Alberta, on the other hand, prescribers must submit a Special Authorization request form for exceptional coverage of the originator biologic to the Alberta Blue Cross, the entity responsible for public medical coverage, which will be evaluated on a case-by-case basis.[11]

To implement the non-medical switch policies, the governments remove the biologic drugs from the provincial formularies when the biosimilar versions are listed. An important consequence of doing so is that no part of the cost of the biologic will be covered by the public insurance plan. This is in contrast to the case of standard generic drugs where the provinces will reimburse patients “up to the price of the generic”; so, in that context, if a patient wants to remain on the brand, the patient can simply pay the difference.

In the case of biologic products, patients have no choice but to switch to the biosimilar version, or they will need to cover the full cost of their medications.

Implementing a non-medical switch policy (or removing biologic drugs from the provincial formulary) has no necessary impact on the private insurance regime. While in some provinces there are minimal requirements imposed on private insurers, e.g. maximum financial participation, including limits on premiums and co-pays, and a requirement to cover, at minimum, all the drugs which are included on the formulary, private insurers are permitted to provide additional coverage or benefits to their beneficiaries.

Impact on Prescribers

Before the transition deadline, prescribers are advised to meet with their patients that are on a biologic for which a biosimilar exists and issue a prescription for the biosimilar (unless an exceptional case applies). Most provinces invite prescribers to identify eligible patients by requesting a list of their patients who are using a biologic for which a biosimilar exists from the Ministry of Health.[12]

Some provinces even offer prescribers a patient support fee in recognition of the efforts involved in contacting patients and supporting their switch to a biosimilar. For example, British Columbia offers providers a biosimilar patient support fee in recognition of the effort involved in contacting patients and supporting their switch to a biosimilar.[13]

In certain provinces, namely Nova Scotia, prescribers who switch their patient to a biosimilar version of a biologic drug are required to contact patient support programs to enroll their patient in the new support program.[14]  In fact, prescribers must ensure that the biosimilar prescription includes the name of the patient support program that the patient is enrolled in.

Impact on Pharmacists

The responsibilities afforded to pharmacists in the switch policies vary from province to province. While some provinces provide only for a supporting role for pharmacists, others have extended pharmacists’ scope of practice to allow them to carry out the substitution to a biosimilar drug themselves.

For example, in British Columbia, if a pharmacist notices that a patient is using an originator drug that is subject to a transition, the pharmacist is encouraged to inform the patient that they should consult their prescriber before the switch period ends to maintain coverage.[15] As is the case for prescribers, pharmacists in BC may claim a biosimilar patient support fee of $15 for identifying and providing information to assist with their patient’s switch to a biosimilar drug.[16]

On the other hand, provinces like Quebec have authorized pharmacists to substitute reference biological drugs for the biosimilar version themselves directly. The Guide de substitution de l’Ordre des pharmaciens du Quebec (Order of Pharmacists’ Substitution Guide) was amended in August 2021 to expressly allow pharmacists to carry out a substitution towards a biosimilar drug.[17] The pharmacist must nonetheless ensure that no indication to the contrary has been formulated by the author of the prescription, as well as notify the patient of the substitution.

Provinces in which pharmacists already had prescribing authority can initiate the transition towards biosimilars for their patients themselves. This is the case in Alberta, where pharmacists with additional prescribing authority can independently initiate prescriptions for Schedule 1 drugs.[18] They can therefore follow the process outlined for health professionals to switch patients to biosimilars.[19]

Provinces that have not yet Opted for the Transition

As of the date of publication of this article, Ontario, Manitoba, Saskatchewan, Prince Edward Island, Newfoundland and Labrador, Yukon and Nunavut have not yet announced a transition to a formal biosimilar policy that requires eligible patients to make the switch. Nevertheless, some provinces have introduced a tiered reimbursement policy that requires new patients and patients that were deemed unresponsive to biologic therapy to first try a biosimilar drug, whereas others have decided to maintain the same listing status and reimbursement criteria for biologic and biosimilar drugs.

In Ontario, for example, patients who are treatment naïve to certain biologics are reimbursed only for the biosimilar version.[20] This is also the case in Saskatchewan, where patients that are new to drugs such as adalimumab and etanercept, only receive public coverage for its biosimilars.[21]

Conclusion

While not all Canadian provinces have introduced a biosimilar initiative, such policy is gaining traction across Canada and has already been implemented in several provinces. The impact of these policies on healthcare professionals, patients and the overall population in the next few years will dictate whether biosimilar switch policies will become the norm across the country.

References

[1] See Health Canada’s “Biosimilar biologic drugs in Canada : Fact Sheet”, available here.

[2] Health Canada, Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs, at s. 2.1.3. .

[3] See BC Government’s Biosimilars Initiative for Patients.

[4] See BC Government’s Biosimilars Initiative for Health Professionals.

[5] See Alberta Government’s Biosimilar Policy.

[6] See New Brunswick’s Biosimilars Intitiative.

[7] See Quebec’s policy on Biosimilar drugs.

[8] See Nova Scotia’s Biosimilar Initiative.

[9] See Northwest Territories’ Biosimilar Initiative.

[10] See Quebec’s policy on Biosimilar drugs.

[11] See Alberta’s Biosimilar Initiative : Guide for health professionals.

[12] See, for example, New Brunswick’s Biosimilars Initiative – Information for Prescribers and Health Professionals and Alberta’s Biosimilars Initiative Support : Patient List Request.

[13] See BC Government’s Biosimilars Initiative for Health Professionals, “Patient support fee for prescribers”. BC has also published several guides for specialists, e.g. Biosimilars Initiative: Prescriber Guide, Gastroenterologists & Internal Medicine Specialists; Biosimilars Initiative: Prescriber Guide, Dermatologists.

[14] See Nova Soctia’s Information for Prescribers about the Nova Scotia Biosimilar Initiative.

[15] See, for example, BC Government’s Biosimilars Initiative for Health Professionals, “Procedures for pharmacists.”

[16] See BC Government’s Biosimilars Initiative for Health Professionals, “Patient support fee for pharmacists.” See also BC’s Biosimilars Initiative: Pharmacy Guide.

[17] Ordre des pharmaciens du Québec, La substitution d’un médicament : guide d’exercice.

[18] See Alberta College of Pharmacy’s page on Additional Prescribing Authority.

[19] See Alberta Biosimilar Initiative’s Guide for health professionals.

[20] See Exceptional Access Program Reimbursement Criteria for Frequently Requested Drugs, p. 4.

[21] See Government of Saskatchewan’s Formulary Bulletin: Update to the 62^nd Edition of the Saskatchewan Formulary.