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Canadians pay higher prices for pharmaceuticals than any other country except the USA and a trade agreement with Europe is likely to inflate drug prices still further. But access to costly drugs like biologics also varies geographically within Canada, as each individual province controls its own formulary and has different funding priorities. As many as 10% of Canadians cannot afford to fill prescriptions and even those with private insurance have no guarantee that a particular product will be covered. In Canada, biosimilars (which were initially known as ‘subsequent entry biologics’ [SEBs]) are approved under regulations established by Health Canada in 2010 and updated in 2017.

 

Current access to originator biologics in Canada   +

  • Canadian drug costs are the second highest in the world after the USA.1  In addition, through extending drug patent terms, the planned Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada is expected to increase Canadian drug costs still further (by 6.2–12.9%) from 2023.1
  • Canada is the only industrialized nation with universal health insurance but no public coverage of prescription drug costs. The patchwork of provincial and territorial healthcare systems means Canadians with life-threatening illnesses are confronted with drug costs that can vary widely from province to province. After Health Canada determines the safety of all medications and approves them for use, each jurisdiction determines if the medication should be included in its formulary of medications and medical supplies covered by its drug plan. Some formulary policies have been found to cause inequalities and delays in access to urgently required therapies.2
  • Even if Canadians have private drug coverage, their insurers may refuse to reimburse them if the medications aren't considered to be offering value for money. Many medications, especially biologics, are exceedingly expensive in Canada.
"The evidence clearly shows that most private drug plans – that provide coverage to 19 million Canadians – are not sustainable in the long term. The biggest threat is the skyrocketing cost of new biologic and specialty drugs." 3
"I can't tell you how many times I'd have to go into the sample drawer, because I knew that if I gave a prescription to someone, they weren't going to fill it because they couldn't afford it." Eric Hoskins MD

Because there are dozens of different purchasers for the same drugs – private employer plans, public plans and hospitals – Canada is not able to pool its purchasing power and buy drugs in bulk, which would allow negotiation of lower prices. In the face of steadily rising drug costs, many agree that the best solution would be the creation of a government-run program of ‘universal pharmacare.'4,5

In the meantime, Canadians pay 20% more for patented drugs compared to France or the UK, amounting to an extra CDN $2.1 billion a year.An estimated 1 in 10 Canadians can't fill prescriptions because of the expense4 and are at the mercy of their provincial or territorial government’s decision to make important medications easily available to those who need them most. Canadians with chronic conditions like rheumatoid arthritis or inflammatory bowel disease have unequal access to biologics which are internationally recognized as ‘standard of care.’7,8 And for the huge numbers of Canadians living with diabetes, the greatest challenge is affordability and access to diabetes medications, devices and supplies, which varies widely across the country.9

"57% of Canadians with diabetes indicate that they do not comply with their prescribed therapy due to the cost of medications, devices and supplies. Only half of Canadians with type 2 diabetes have their blood glucose levels under control, and the majority of patients incur adverse health conditions." 9


Regulatory guidelines in Canada   +

In Canada, biosimilars were originally known as subsequent entry biologics (SEBs). In March 2010, Health Canada issued its first guidelines for SEBs harmonized with the strict regulatory process used by the EMA. In early 2017, Health Canada’s regulatory guidance was updated. In the interests of international alignment, the term ‘biosimilar’ was officially adopted. Other aspects of the revised guidance reflect Canada’s unique approach to biosimilar regulation:

  • While Health Canada – like the FDA – requires all biosimilar labels to states that the drug is a biosimilar and to include key information from the originator’s product label, Canadian labels must also include the comparative data of the biosimilar versus the originator.
  • Health Canada will not authorize a biosimilar for market release until they are assured the originator’s patents have not been infringed.
  • Although Health Canada is not responsible for pricing, their view is that determining how biosimilars will fit into the healthcare system is just as important as regulating them.

As with small molecule generics, policies regarding the substitution of biosimilars are determined by provinces and territories. However, Health Canada has actively cautioned against allowing the substitution of biosimilars and it seems likely that regional governments will follow federal policy.10

 

Biosimilar approvals in Canada   +

An up-to-date record of biosimilars approved in Canada can be found here.

  • The first biosimilar to receive approval in Canada was a biosimilar of the growth hormone somatropin in 2009 (with additional indications approved some years later) but it was not until 2014 that the next biosimilar products – two infliximab biosimilars – were licensed by Health Canada. A filgrastim biosimilar followed in 2016. The infliximab biosimilars are about a third cheaper than the originator Remicade.11 This discount roughly matches the saving traditionally achieved with small-molecule generics in Canada, which, for a number of reasons, are still far more expensive in Canada than in the US or Europe.12 However, the high price of originator drugs in Canada makes these savings highly worthwhile.
  • Policies regarding the substitution of biosimilars are determined by provinces and territories, as is the case for generics. This said, Health Canada has actively cautioned against allowing the substitution of biosimilars and it seems likely that regional governments will follow federal policy.10
The future of biosimilars in Canada   +

A study by the Canadian Society of Nephrology found that switching to a biosimilar of epoetin could save $35–50 million a year in Canada, with cumulative savings of $221 million after 5 years (2015–2019).13

Patent expiries for leading biologics are typically later in Canada than in Europe or the USA and may be delayed further by CETA.1 However, biosimilar development programs are well underway in Canada and, as in the USA, many innovator biologic companies are positioning themselves to benefit either way by creating their own biosimilar portfolio.

References   +

1. Lexchin J & Gagnon M-A. CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs. Global Health (2014) 10:30. http://www.globalizationandhealth.com/content/10/1/30. Accessed 4 March 2015. 
2. LeLorier J, Bell A, Bougher DJ et al. Drug reimbursement policies in Canada—need for improved access to critical therapies. Ann Pharmacother (2008) 42:869–873.
3. National Post, 27 May 2013. Skyrocketing costs make Canada's private drug plans unsustainable, insurance exec tells pharmacare panel. http://news.nationalpost.com/2013/05/27/skyrocketing-costs-make-canadas-private-drug-plans-unsustainable-insurance-exec-tells-pharmacare-panel/. Accessed 4 March 2015. 
4. CBC, 5 October 2014. Pharmacare national prescription drug program gains support. http://www.cbc.ca/m/touch/canada/newbrunswick/story/1.2788351. Accessed 4 March 2015. 
5. Canadian Health Coalition (PharmaCare Now). The case for pharmacare. http://pharmacarenow.ca/learn-more/the-case-for-pharmacare. Accessed 4 March 2015.
6. EvidenceNetwork.ca. Patent protection for brand name drugs should come at a price. CETA may cause inflated drug prices for Canadians. http://umanitoba.ca/outreach/evidencenetwork/archives/8027. Accessed 4 March 2015.
7. Joint Health. Leveling the field: Do we have fairness in Canada yet? http://jointhealth.org/programs-jhmonthly-view.cfm?id=143. Accessed 4 March 2015.
8. GI Society. Biologic coverage for inflammatory bowel disease in Canada. http://www.badgut.org/about-us/newsroom/report-cards/ibd-report-card/. Accessed 4 March 2015. 
9. Canadian Diabetes Foundation. Diabetes: Canada at the tipping point. Charting a new path. http://www.diabetes.ca/CDA/media/documents/publications-and-newsletters/advocacy-reports/canada-at-the-tipping-point-english.pdf. Accessed 4 March 2015. 
10. BIOTECanada. http://www.biotech.ca/uploads/amgenbooklet_en_web.pdf. Accessed 4 March 2015.
11. HealthyDebate.ca, 8 January 2015. Regulators grapple with Canada’s first generic biologic drug. http://healthydebate.ca/2015/01/topic/seb-biosimilar-biologics. Accessed 4 March 2015. 
12. Law MR & Kratzer J. The road to competitive generic drug prices in Canada. Can Med Assoc J (2013) 185:1141–1144. http://www.cmaj.ca/content/185/13/1141.full.pdf+html. Accessed 4 March 2015. 
13. Tsao NW. A budget impact analysis of the introduction of erythropoiesis stimulating agent subsequent entry biologics for the treatment of anemia of chronic kidney disease in Canada. Can J Kidney Health Dis (2014) 1:28.
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Investigator perspective: Extrapolation: Gaining approval for additional indications