The Biosim•Exchange: Canada’s trusted source for timely information on biosimilar biologics

Biosimilar Biologics Policy

Arthritis Consumer Experts (ACE) has been learning about biosimilars since 2009 and has become a national thought leader, conducting biosimilar workshops and sharing education with multi-stakeholder groups across Canada. The ACE biosimilars dialogue across Canada has included patients, healthcare professionals and policy decision makers in government and private health insurance.

Annual spending on biologics continues to rise dramatically for public and private drug plans in Canada.  At the same time, 33 Health Canada approved biosimilar biologics are now available, including biosimilar options for two of Canada’s biggest selling originator biologics – Remicade and Humira. With a roughly 40%-50% discount on the price of originators (depending on molecule), biosimilars offer significant savings to private and public drug plans. However, Canada ranks well below the OECD median for biosimilars market penetration, meaning most of our private and public drug plans haven’t realized the savings that many other countries have, like Norway, the United Kingdom, Italy, Sweden, France, and Germany, to the benefit of patients and their healthcare systems.[1]

For the past six years, federal, provincial, territorial and private insurance drug plans in Canada have mandated the use first of biosimilar versions ahead of their originators for treatment-naïve patients (patients who have not previously received the biologic in question). Since 2019, public drug plans have also begun implementing biosimilar transition policies that change coverage for specific biologic medicines.

The leading regulators in the world – including the European Medicines Agency, Food & Drug Administration in the U.S and Health Canada – support well-controlled transitions to biosimilars. Patients need to know transition policy has been safely and effectively implemented over the past 12 years with tens of thousands of patients with autoimmune diseases such as inflammatory arthritis in many countries in Europe with no compromise to patient safety, effectiveness or quality of care.

In the context of biosimilar use, Health Canada considers “switching between authorized products to refer to a change from routine use of one specific product to routine use of another specific product. Patients and health care providers 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.”[2]

During the period of transition policy implementation, the drug plans cover both originator and biosimilar medicines for the affected diseases, providing time for patients to understand the biosimilar transition and their treatment options with their specialists. Following the end of a transition period, the drug plans only cover the biosimilar versions for the treatment of diseases affected by the transition policy. Patients unable to transition or who have an adverse response to the biosimilar can seek exceptional “special authority” coverage for the originator.[3] 

In July 2021, Quebec became the fourth province in Canada to implement biosimilars transition policy, following the successful implementation of similar initiatives by New Brunswick, Alberta and British Columbia. Under Quebec’s new policy, coverage for certain originator medications through the Public Prescription Drug Insurance Plan is changing and may require patients to transition from the originator medicine that they are currently on to a biosimilar version of that medicine. [4] 

In April 2021, New Brunswick became the third province in Canada to implement biosimilars transition policy after British Columbia and Alberta. Under New Brunswick’s new policy, coverage for certain originator biologic medicines through the New Brunswick Drug Plans is changing and may require patients to transition from the originator biologic medicine that they are currently on to a biosimilar biologic version of that medicine.

In May 2019, British Columbia was the first province to implement biosimilars transition policy, which moves patients from their current originator biologic to its biosimilar biologic. Since implementation, B.C. has reported that thousands of patients living with inflammatory arthritis, diabetes and inflammatory bowel disease have been safely transitioned.[5] Through the launch of its biosimilars switching policy, British Columbia stated it is improving the sustainability of its PharmaCare program by adding new medicine listings and boosting existing medication coverage for patients.[6]

In December 2019, Alberta announced its Biosimilar Initiative to expand the use of biosimilar medications through transition policy, explaining  “patients will continue receiving the same safe and effective treatment, but at a lower cost.”[7]

A key benefit of transitioning patients is hundreds of millions of dollars in cost savings to the health care system. Biosimilars have the potential to improve access to biologics (both originators and biosimilars) and save public and private healthcare systems billions of dollars now, and over the coming year.

A study commissioned by the Canadian Government's Patented Medicine Prices Review Board (PMPRB) has estimated that private and public drug palns across Canada could save from $332 million CDN to $1.81 billion CDN in the third year following biosimilar entry across a protfolio of products.[8]

According to the Ontario Drug Policy Research Network: “Utilization and public spending on biologic drugs continue to grow in Ontario, with a projected annual spending of nearly $1.4 billion in 2021. In contrast, uptake of biosimilars has been low, with less than 1 in 5 biologic users accessing these less costly medications when they are available. Initiatives should be explored that could increase the utilization of biosimilars, given the large potential for cost savings for the government.”[9]

At the announcement of the third phase expansion of its Biosimilars Initiative program in August 2020, the B.C. government stated this next phase would allow it to put another $30.7 million over the next three years, in addition to the $96.6 million from earlier phases of the Biosimilars Initiative, back into BC’s health care system.[10] When it announced its biosimilars transition policy in December 2019, the Alberta government claimed switching to biosimilars would save between $227 million and $380 million over the next four years once fully implemented.[11] Quebec’s biosimilar policy is expected to generate annual savings of $100 million by 2022, which will be reinvested in Quebec’s healthcare system and will help improve access to innovative drug therapies.[12]

Current Canadian Biosimilar Biologics Policies

Public and private drug plans are adopting biosimilar policies that affect Canadians living with many disabling and life-threatening chronic diseases, such as inflammatory arthritis, cancer, diabetes, inflammatory bowel disease, Crohn’s disease, and psoriasis .

For up-to-date information about biosimilars policies for each public drug plan, please visit the websites below:

British Columbia

Biosimilars Initiative for Patients: https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/drug-coverage/biosimilars-initiative-patients

BC PharmaCare: https://pharmacareformularysearch.gov.bc.ca/faces/Search.xhtml

Alberta

Alberta Biosimilars Initiative

https://www.alberta.ca/biosimilar-drugs.aspx

https://open.alberta.ca/dataset/58a224a2-0fed-4b1e-b8d5-9f6cf70450c6/resource/4f1f52da-4f07-4809-9397-ce500a8de711/download/health-ahcip-bulletin-med-237-updates-to-the-biosimilars-initiative.pdf

Alberta Health Interactive Drug Benefit List Page: https://idbl.ab.bluecross.ca/idbl/load.do

Saskatchewan

eHealth Saskatchewan: https://www.ehealthsask.ca/Pages/default.aspx

Saskatchewan Formulary: http://formulary.drugplan.health.gov.sk.ca/SearchFormulary

Manitoba

Notice – Tiered Biologics Reimbursement Policy: https://www.gov.mb.ca/health/pharmacare/profdocs/notice_tiered_biologics.pdf

Provincial Drug Formulary: https://www.gov.mb.ca/health/mdbif/index.html

Ontario

Ontario Formulary:  https://www.formulary.health.gov.on.ca/formulary/

Exceptional Access Program Reimbursement Criteria for Frequently Requested Drugs: http://www.health.gov.on.ca/en/pro/programs/drugs/docs/frequently_requested_drugs.pdf

Quebec

Biosimilar Drugs: https://www.quebec.ca/en/health/health-system-and-services/biosimilar-drugs

Quebec Health: http://www.ramq.gouv.qc.ca/en/citizens/health-insurance/Pages/health-insurance.aspx

Quebec Prescription Drug Insurance : https://www.ramq.gouv.qc.ca/en/citizens/prescription-drug-insurance/know-conditions-coverage

List of Medications: http://www.ramq.gouv.qc.ca/en/publications/citizens/legal-publications/Pages/list-medications.aspx

Nova Scotia

Nova Scotia Health Authority: http://www.nshealth.ca

Nova Scotia Formulary: https://novascotia.ca/dhw/pharmacare/documents/formulary.pdf

New Brunswick

New Brunswick Biosimilars Initiative: https://www2.gnb.ca/content/gnb/en/departments/health/MedicarePrescriptionDrugPlan/NBDrugPlan/biosimilars.html

New Brunswick Biosimilars Initiative – Information for Patients: https://www2.gnb.ca/content/gnb/en/departments/health/MedicarePrescriptionDrugPlan/NBDrugPlan/biosimilars/patients.html

Newfoundland and Labrador

Newfoundland and Labrador Department of Health and Community Services: https://www.health.gov.nl.ca/health/

Newfoundland and Labrador Formulary: https://www.health.gov.nl.ca/health/prescription/special_auth_drug_products.pdf

Prince Edward Island

Health PEI: https://www.princeedwardisland.ca/en/topic/health-pei

PEI Formulary: https://www.princeedwardisland.ca/sites/default/files/publications/pei_pharmacare_formulary.pdf

Yukon

Yukon Health and Social Services: http://www.hss.gov.yk.ca/

Yukon Formulary: http://apps.gov.yk.ca/drugs 

Non-insured Health Benefits (NIHB)

Indigenous Health: https://www.canada.ca/en/services/health/aboriginal-health.html

Non-Insured Health Benefits Program Updates: https://www.sac-isc.gc.ca/eng/1578079214611/1578079236012

 

[1] Patented Medicine Prices Review Board: Biologics in Canada. Part 1: Market Trends

https://www.canada.ca/en/patented-medicine-prices-review/services/reports-studies/biologics-part1-market-trends.html

[2] Biosimilar biologic drugs in Canada: Fact Sheet 

https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html

[3] BC Biosimilars Initiative for Patients

[6] British Columbia Ministry of Health: Biosimilars Initiative

 https://news.gov.bc.ca/releases/2019HLTH0080-001072

[7] Alberta Health: Biosimilar Drugs

https://www.alberta.ca/biosimilar-drugs.aspx

[8] Tadrous M, McCormack D, Martins D, Kitchen S, Singh S, Gomes T. Current and Prospective Utilization of Innovator Biologics and Biosimilars in Ontario. Toronto: Ontario Drug Policy Research Network; January 2020.

[9] The Patented Medicines Prices Review Board, Government of Canada. Potential Savings from Biosimilar in Canada poster.

 http://www.pmprb-cepmb.gc.ca/CMFiles/NPDUIS/2017_Conference_Posters/post_6_biosim.pdf.

[10] B.C. Government News: B.C. expands biosimilar program

https://news.gov.bc.ca/releases/2020HLTH0257-001569

[11] Alberta Biosimilars Initiative

https://www.alberta.ca/biosimilar-drugs.aspx

[12] Le ministre Christian Dubé annonce un virage vers les médicaments biosimilaires Québec, le 18 mai 2021 (in French only)

https://www.msss.gouv.qc.ca/ministere/salle-de-presse/communique-2864/


 
What are ACE's views on biosimilar biologics policies in Canada?

As biosimilars research is published in peer-reviewed medical journals and policies regulating them evolve, so do ACE’s organizational views. As always, ACE will follow the evidence.

ACE's mandate is to continue to provide the latest research-based education and information on biosimilars to its members, subscribers and the public. Our guiding principle has been, and continues to be, to follow the scientific evidence in our therapeutic area. Based on current biosimilars regulatory approvals, peer-reviewed, well-designed research studies and current meta-analysis, ACE's views are:

  • Treatment of patients living with inflammatory arthritis should ask for and expect the best care possible through shared decision-making between themselves, their rheumatologist and other healthcare providers;
  • Biosimilars may have advantages over their originators due to improvements in manufacturing processes, delivery devices, among others;
  • Similar to legislated generic drug savings in Canada, biologic biosimilars reimbursement policy has the potential to save public and private healthcare systems billions of dollars now and over the coming years;
  • More than 16 years of clinical experience shows that biosimilars approved through European Medicines Agency can be used as safely and effectively in all their approved indications as their originators;
  • Policy development related to biosimilars to treat inflammatory arthritis should include unbiased and credible patient and rheumatologist participation who fully disclose their sources of funding from the manufacturers of the drug products affected by the policy;
  • Patients should be able to assess treatment (or no treatment) risk against benefit, and have tools to enable them to discuss the pros and cons of all treatment options with their healthcare team;
  • Policy transition is appropriate if the prescribing physician and their patient have the education and information tools they need to support the patient in all aspects of accessing their biosimilar, from “care coach” to help with formulary or private insurance paperwork, to infusion clinic and pharmacy orientation, and adherence support;
  • Government should reinvest policy transition savings in a timely manner into new medicines on formularies for unmet patient needs, list biologics and tsDMARDs with revised/relaxed reimbursement criteria to make access more efficient, and implement other important aspects of inflammatory arthritis models of care, such as instituting rheumatology nursing billing codes;
  • Treatment results should be collected on patients in whom multiple transitions are made between biosimilars and originators.

Comparing Biosimilar Biologics Policies: Canada, U.S. and the European Union

Starting with Canada, ACE provides you the following summary of biosimilars policy positions in Canada, the U.S. and the European Union as they continue to evolve.

The key principles Health Canada[1] uses to evaluate biosimilars align with those of other regulators and international organizations such as the:

  • European Medicines Agency (EMA)
  • United States Food and Drug Administration (FDA)
  • World Health Organization (WHO)

Health Canada's position on the use of biosimilars is consistent with the International Coalition of Medicines Regulatory Authorities (ICMRA), a coalition of regulators from 29 regulatory authorities across the world including: Australia, United States, United Kingdom and the European Union (EU).

In July 2019, the ICMRA issued a statement on biosimilars, providing assurance on the regulatory processes for the approval and monitoring of biosimilars medicines and highlighting the benefits they can provide for patients and healthcare systems in terms of increased treatment alternatives, access and cost competitiveness. [2]

Transition experience and policy in Europe has been successfully implemented in many European countries over the past 12 years among tens of thousands of patients living with inflammatory arthritis and inflammatory bowel disease with no compromise to patient safety, effectiveness or quality of care.

European Union member countries generally agree that EU approved biosimilars are considered alternative therapeutic options to their respective originators, under the supervision of a clinical decision maker. The majority of countries, including England, Norway, Denmark, Germany, Netherlands, Belgium, France, and Portugal support physician led switching or transitioning for biosimilars

In the EU, like in Canada, the ruling regulatory body (European Medicines Agency, the European equivalent to Health Canada) leaves the decision on biosimilar transitioning to individual member countries (comparable to federal, provincial and territorial jurisdictions or private drug plans decision making in Canada).

The EU Consortium of Individual Regulators in 2017 concluded that because of the high similarity, there is no reason to believe that the body’s immune system would react differently to the biosimilar compared with the original upon a switch. This view is supported by the current experience with biosimilars on the market and by literature data.[3]


[2] ICMRA statement about confidence in biosimilar products (for healthcare professionals):

 http://www.icmra.info/drupal/sites/default/files/2019-07/ICMRA_statement_about_confidence_in_biosimilar_product_HCP.PDF

[3] Kurki et al. – Interchangeability of biosimilars: A European perspective
http://bit.ly/InterchangeabilityBiosimilars

Have you been affected by new biosimilar biologics policy?

Provincial drug plans and private health insurers are providing reimbursement for an increasing number of Health Canada approved biosimilars. We're interested in learning about your experience gaining reimbursement for a biosimilar prescription with a public or private drug plan.