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Province of British Columbia
NEWS RELEASE
For Immediate Release
2019HLTH0125-001718
Sept. 5, 2019
Ministry of Health
B.C. expands biosimilars program
This release was updated on Sept. 5, 2019

VANCOUVER – British Columbia continues to lead the way across Canada by expanding its biosimilars program to include another patient group, while using cost savings to introduce new improvements in patient care.

Approximately 1,700 gastroenterology patients on the drug infliximab will have six months to transition their prescription from the biologic version to one of two biosimilar options. Infliximab is a drug that is administered by infusion and treats the inflammatory bowel disease (IBD) conditions Crohn’s disease and ulcerative colitis. The infliximab biologic is known as Remicade, and the infliximab biosimilars are known as Inflectra and Renflexis. After March 5, 2020, PharmaCare will no longer provide coverage for Remicade for these indications.

“The evidence clearly shows that these patients can transition from original biologics to biosimilars safely and effectively, which are key considerations that have always been our top priorities with this change,” said Adrian Dix, Minister of Health. “We know that the use of biosimilars in other countries has worked extremely well in ensuring people get the medication they need and it’s time we caught up. By using biosimilars in B.C., we will be putting about $96.6 million back into health care over the next three years.”

B.C. is reinvesting these savings into more resources for complex IBD patients by providing funding for more nursing support and granting full coverage of a new non-invasive diagnostic test called the fecal calprotectin test. The test assesses intestinal inflammation and will help physicians and patients to better understand and manage their condition.

“I was honoured to offer my expertise as part of government’s consultation process leading up to the biosimilars policy,” said Dr. Brian Bressler, clinical associate professor of medicine, division of gastroenterology, UBC and founder of the IBD Centre of BC. “Given the existing international evidence on biosimilars for the management of IBD, I have confidence in their efficacy and safety. Using biosimilars and reinvesting the substantial cost savings into more comprehensive care for IBD patients is an innovative model that will provide my patients with more resources that they desperately need and will improve their quality of care.”

B.C. is following evidence-based results from a number of international jurisdictions that have more than 10 years of experience with these innovative drugs.

Despite clear evidence to support the use of biosimilars – highly similar versions of biologics that cost anywhere from 25% to 50% less – Canada has a significantly lower use rate for biosimilars compared to other jurisdictions, at approximately 8%. Other nations have upwards of 50% to 95%.

To provide further clarity around biosimilars, Health Canada recently updated its information to confirm that patients and health-care providers can have confidence that they are effective and safe for each of their authorized indications, and no clinical differences are expected following a change between a biosimilar and its reference biologic drug (1). Other federal organizations also support the use of biosimilars.

“Canadian Digestive Health Foundation knowledge translation enables patients and their health-care professionals to have an informed dialogue when making decisions regarding treatment,” said Jeff Suggitt, CEO, Canadian Digestive Health Foundation (CDHF). “It is important to stress with biosimilars that the rigorous standards for authorization set by Heath Canada means that both patients and health-care providers can have the same confidence in the quality, safety and efficacy of a biosimilar that they have with the biologic. Patients and health-care professionals should also know that the money saved through biosimilar policies can be reinvested into the health care system – which is what B.C. is doing. Some patients may not be medically able to transition to a biosimilar, so CDHF recommends that patients speak with their gastroenterologist to determine if it is medically necessary to remain on the biologic drug.”

Bioengineered drugs, known as biologics, collectively are the single biggest expense for public drug plans and their costs continue to climb. In 2018, B.C. spent $84.2 million on Remicade, and in 2017, Canada spent $1.1 billion on the drug. Since Remicade was first approved for sale by the federal government in 2001, British Columbia has spent more than $671 million to fund it.

The initial biosimilars program announcement in May 2019 highlighted that about 20,700 British Columbians living with either ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis would have six months to work with their health-care team to transition their prescription from the biologic to the biosimilar drug by Nov. 25, 2019.

As of Aug. 15, 2019, many patients have already met with their prescriber and switched from the biologic drug to a biosimilar version well in advance of the November deadline. Roughly 355 people, or 18% of PharmaCare-covered patients taking Enbrel, have switched to Brenzys or Erelzi. Seventy people, or 17% of patients, switched from Remicade to Inflectra or Renflexis, and 2,078 people, or 11% of patients, moved from Lantus to Basaglar. As well, infusion centres have been set up for Inflectra and Renflexis and are available throughout the province, and physician use and patient enrolment at these centres is growing rapidly.

“The use of biosimilars allows us to support new drug listings and improve patient care. I am proud of the enhancements that we have made to PharmaCare over the past year, and we will continue to find ways to better support patients by making improvements to the system as a whole,” Dix  added.

With the immediate savings from the increased use of biosimilars, two new drug listings were added to PharmaCare (Jardiance, a diabetes drug and Taltz, a psoriatic arthritis drug) and coverage of several existing rheumatology drugs were enhanced to increase patient access.

Exceptions may be granted for patients whose physicians determine they are medically unable to transition to the biosimilar drug. Exceptional coverage requests will be reviewed by PharmaCare’s Special Authority branch on a case-by-case basis, in consultation with physician-led advisory committees as needed. Patients or health-care providers with questions about transitioning to a biosimilar can access support by emailing Biosimilars.Initiative@gov.bc.ca or calling 1 844 915-5005, Monday to Friday, from 8:30 a.m. to 4:30 p.m.

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

Quick Facts:

  • This announcement continues to work toward improving access to prescription drugs for British Columbians.
  • In January 2019, B.C. made a $105-million investment, over three years, to reduce and/or eliminate deductibles and co-payments for lower-income British Columbians.
  • B.C. also held a leading role in the national Generics 2.0 agreement to lower costs of the most commonly prescribed drugs and actively participates in the pan-Canadian Pharmaceutical Alliance to negotiate for lower drug costs for all Canadians.
  • British Columbia will continue to work to make sure everyone can afford and receive the medication they need.

Learn More:

For more information about biosimilars: www2.gov.bc.ca/biosimilars

Three backgrounders follow.

 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
Province of British Columbia
BACKGROUNDER 1
For Immediate Release
2019HLTH0125-001718
Sept. 5, 2019
Ministry of Health
What are biosimilars?
  • Biosimilars are highly similar versions of bioengineered drugs, known as biologics. Biologics are expensive, injectable drugs made from living organisms (e.g. bacteria or yeast) and are used to treat a growing number of diseases from cancer to chronic conditions including arthritis, diabetes, and Crohn’s and ulcerative colitis.
  • Once patents for biologic drugs expire (20 years after a patent was filed), other manufacturers can bring biosimilars on to the Canadian market, in a similar way to generic drug manufacturers.
  • Since biosimilars are based on work done to develop the original biologic drug, they require less research and development.
  • This means the biosimilar can be priced lower than the biologic – anywhere from 25% to 50% less – providing the same health benefits, for better value.
  • Biosimilars are approved for sale just as any other drug. In fact, Health Canada will not approve a biosimilar for sale unless it is proven to have no clinically meaningful difference to the patient compared to the original biologic drug.
  • Similarity between biologics and biosimilars is demonstrated using a step-wise approach beginning with structural and functional studies, and continuing with human clinical trials, and are evaluated to confirm that there are no clinically meaningful differences in safety and efficacy between them. 
  • There are currently 17 biosimilar products approved for sale in Canada; 23 in the United States and 54 in the European Union.
 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
Province of British Columbia
BACKGROUNDER 2
For Immediate Release
2019HLTH0125-001718
Sept. 5, 2019
Ministry of Health
What other countries are doing with biosimilars

The Patented Medicines Price Review Board has provided the following data on 2018 infliximab biosimilar use rates for Organisation for Economic Co-operation and Development countries. Infliximab treats rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and Crohn’s disease and ulcerative colitis. The legacy or reference biologic is called Remicade and the two biosimilars currently available in Canada are called Inflectra and Renflexis.

  • Norway: 98%
  • Poland: 96%
  • UK: 92% 
  • Austria: 89%
  • Italy: 79%
  • Sweden: 78%
  • Slovenia: 64%
  • Portugal: 63%
  • France: 60%
  • Czech Republic: 59%
  • Spain: 56%
  • Germany: 53%
  • Ireland: 40%
  • Korea: 37%
  • Slovakia: 36%
  • Belgium: 30%
  • Turkey: 23%
  • Switzerland: 22%
  • Mexico: 17%
  • Finland: 17%
  • Australia: 16%
  • Japan: 9%
  • Canada: 8%
  • United States: 7%
  • Chile: 0%
  • Hungary: 0%
  • New Zealand: 0%

Data source: MIDAS Database, prescription retail and hospital markets, Q4-2018, IQVIA.

 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
Province of British Columbia
BACKGROUNDER 3
For Immediate Release
2019HLTH0125-001718
Sept. 5, 2019
Ministry of Health
Rising cost of biologics
  • According to the Patented Medicines Price Review Board, seven of the top-10 selling drugs in Canada in 2016 were biologics. In addition, there are 13 biologics that have expired patents – or patents that will expire – by 2020. This will allow manufacturers to submit biosimilars for market authorization. Since there is a much higher use of biologics in Canada, it means that Canadians have the most to gain from biosimilar savings. Source: https://www.cadth.ca/sites/default/files/symp-2017/presentations/april24-2017/Concurrent-Session-B4-Gary-Warwick.pdf
  • According to 2018 data from the Canadian Institute for Health Information, $14.4 billion of prescribed drug spending (42.7%) was financed by the public sector. Biologics used to treat conditions like rheumatoid arthritis and Crohn’s disease accounted for the highest proportion of public drug spending (8.2%) for the sixth consecutive year. Canadians with drug costs of $10,000 or more represented 2% of beneficiaries but accounted for more than one-third of public drug spending in 2017. Source: https://www.cihi.ca/en/health-spending/2018/prescribed-drug-spending-in-canada
  • In addition, as of September 2018, there are seven biosimilars available in Canada, and their uptake has been modest. For example, infliximab and etanercept biosimilars accounted for 2.4% of claims and 1.4% of spending in 2017. Source: https://www.cihi.ca/sites/default/files/document/pdex-report-2018-en-web.pdf
  • According to the Canadian Agency for Drugs and Technologies in Health, many of the top-selling biologic drugs already have or are expected to have biosimilars enter the market within the next few years. The European experience shows that increased biosimilar competition has not only affected the prices of the directly comparable biosimilars and their reference product, but also of the whole product class. Source: https://cadth.ca/sites/default/files/pdf/ES0317_biosimilars.pdf
 
Contact:
 
Ministry of Health
Communications
250 952-1887 (media line)
 

 
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