JointHealth™ express April 21, 2021
New Brunswick launches Biosimilars Initiative
New Brunswick has become the third Canadian province to implement biosimilars transition (“switch”) policy, which moves patients from certain originator biologics to the biosimilar versions. Between April 21, 2021 and November 30, 2021 in New Brunswick, both the originator biologic and biosimilar versions will be covered to allow time for patients to consult their prescribing physician and initiate the switching process. Coverage of the originator biologics will end on November 30, 2021 or on the renewal date of the patient’s special authorization approval for the originator biologic under the New Brunswick Drug Plan, whichever is sooner.
British Columbia was the first province to implement biosimilars transition policy in May 2019 and has reported that thousands of patients living with inflammatory arthritis, cancer, inflammatory bowel disease, and diabetes have been transitioned with no compromise to patient safety, effectiveness or quality of care.1
“As the leader of Canada’s largest arthritis patient organization, I hear every day about disparities in patient access to reimbursement for treatment and services they and their rheumatologist feel they need. Today’s announcement in New Brunswick ensures continued reimbursement coverage for patients who transition to a biosimilar biologic and potentially greater access to all advanced therapies for patients in need. Based on the experience in B.C. and Alberta where thousands of patients have been successfully transitioned, we encourage the New Brunswick government to work with chronic disease communities to identify where reinvestment of biosimilars savings can improve sustainability by adding new medication listings, boosting existing medicine coverage and modernizing models of care for patients,” said Cheryl Koehn, ACE Founder & President and person living with rheumatoid arthritis.
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 healthcare 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 More than 170 research studies exist looking at patients who have successfully transitioned from an originator biologic to its biosimilar biologic and show no health differences between patients.
“The key for patients transitioning to biosimilars is understanding the rationale for it and the well-established safety and efficacy of Health Canada approved biosimilars during their treatment options conversations with their specialists. To help patients in New Brunswick, ACE has the latest biosimilar information on our Biosim•Exchange.”
New Brunswick patients who have questions about the Biosimilars Initiative can go to the New Brunswick Department of Health website or contact the NB Drug Plans:
Phone: 1-800-332-3691
Monday to Friday, 8am to 5pm
Email: info@nbdrugs-medicamentsnb.ca
About biosimilar biologics
Biologic medicines are made from living organisms, such as living cells that have been modified using biotechnology. Because of their complexity, biologics are expensive and time consuming to develop.
Originator biologic medicines make up some of Canadian public drug plans’ (including New Brunswick’s) largest drug expenditures. A biosimilar biologic can enter the market after an originator patent expires and after a thorough review by Health Canada. Health Canada defines a biosimilar as a biologic medicine that is highly similar to a biologic medicine that was already approved for sale. There are no expected meaningful differences in efficacy and safety in the biosimilar compared to its originator biologic.3
Biosimilar biologics have been approved for use in Canada since 2009, and in arthritis since 2014. Thirty-three biosimilars are currently approved by Health Canada. Since the European Union approved the first biosimilar in 2006, the EU has approved 72 biosimilars.
Underlying Health Canada’s approach to authorizing biosimilars are the benefits to society the use of biosimilars can bring to patients and the health care system. Biosimilars can be used for the same therapeutic aim as their originator and offer an opportunity to reduce spending on more costly originators. Because biosimilars are produced post-patent, biosimilar manufacturers do not have the same costs to bring the product to market and can therefore offer it at a lower price.4 These savings may be reinvested into improving the healthcare system for Canadians.
Even though less expensive, Health Canada-approved biosimilars are proven to be as safe and effective as their originators, the uptake in Canada of biosimilars continues to be very low. The Canadian Government’s Patented Medicine Prices Review Board has estimated that private and public drug plans across Canada could save from $332 million to $1.81 billion in the third year following biosimilar entry across a portfolio of products.5
References - 2nd look:
New Brunswick launches Biosimilars Initiative
New Brunswick has become the third Canadian province to implement biosimilars transition (“switch”) policy, which moves patients from certain originator biologics to the biosimilar versions. Between April 21, 2021 and November 30, 2021 in New Brunswick, both the originator biologic and biosimilar versions will be covered to allow time for patients to consult their prescribing physician and initiate the switching process. Coverage of the originator biologics will end on November 30, 2021 or on the renewal date of the patient’s special authorization approval for the originator biologic under the New Brunswick Drug Plan, whichever is sooner.
British Columbia was the first province to implement biosimilars transition policy in May 2019 and has reported that thousands of patients living with inflammatory arthritis, cancer, inflammatory bowel disease, and diabetes have been transitioned with no compromise to patient safety, effectiveness or quality of care.1
“As the leader of Canada’s largest arthritis patient organization, I hear every day about disparities in patient access to reimbursement for treatment and services they and their rheumatologist feel they need. Today’s announcement in New Brunswick ensures continued reimbursement coverage for patients who transition to a biosimilar biologic and potentially greater access to all advanced therapies for patients in need. Based on the experience in B.C. and Alberta where thousands of patients have been successfully transitioned, we encourage the New Brunswick government to work with chronic disease communities to identify where reinvestment of biosimilars savings can improve sustainability by adding new medication listings, boosting existing medicine coverage and modernizing models of care for patients,” said Cheryl Koehn, ACE Founder & President and person living with rheumatoid arthritis.
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 healthcare 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 More than 170 research studies exist looking at patients who have successfully transitioned from an originator biologic to its biosimilar biologic and show no health differences between patients.
“The key for patients transitioning to biosimilars is understanding the rationale for it and the well-established safety and efficacy of Health Canada approved biosimilars during their treatment options conversations with their specialists. To help patients in New Brunswick, ACE has the latest biosimilar information on our Biosim•Exchange.”
New Brunswick patients who have questions about the Biosimilars Initiative can go to the New Brunswick Department of Health website or contact the NB Drug Plans:
Phone: 1-800-332-3691
Monday to Friday, 8am to 5pm
Email: info@nbdrugs-medicamentsnb.ca
About biosimilar biologics
Biologic medicines are made from living organisms, such as living cells that have been modified using biotechnology. Because of their complexity, biologics are expensive and time consuming to develop.
Originator biologic medicines make up some of Canadian public drug plans’ (including New Brunswick’s) largest drug expenditures. A biosimilar biologic can enter the market after an originator patent expires and after a thorough review by Health Canada. Health Canada defines a biosimilar as a biologic medicine that is highly similar to a biologic medicine that was already approved for sale. There are no expected meaningful differences in efficacy and safety in the biosimilar compared to its originator biologic.3
Biosimilar biologics have been approved for use in Canada since 2009, and in arthritis since 2014. Thirty-three biosimilars are currently approved by Health Canada. Since the European Union approved the first biosimilar in 2006, the EU has approved 72 biosimilars.
Underlying Health Canada’s approach to authorizing biosimilars are the benefits to society the use of biosimilars can bring to patients and the health care system. Biosimilars can be used for the same therapeutic aim as their originator and offer an opportunity to reduce spending on more costly originators. Because biosimilars are produced post-patent, biosimilar manufacturers do not have the same costs to bring the product to market and can therefore offer it at a lower price.4 These savings may be reinvested into improving the healthcare system for Canadians.
Even though less expensive, Health Canada-approved biosimilars are proven to be as safe and effective as their originators, the uptake in Canada of biosimilars continues to be very low. The Canadian Government’s Patented Medicine Prices Review Board has estimated that private and public drug plans across Canada could save from $332 million to $1.81 billion in the third year following biosimilar entry across a portfolio of products.5
References - 2nd look:
| 1 | B.C. Ministry of Health: Biosimilars Initiative Switch Data https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/biosimilars-initiative-prescribers |
| 2 | Health Canada Fact Sheet on Biosimilars: Switching https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html |
| 4 | Canadian Agency for Drugs and Technologies in Health (CADTH): Biosimilar Drugs: Your Questions Answered https://www.cadth.ca/sites/default/files/pdf/biosimilar_drugs_patient_en.pdf |
| 5 | Patented Medicines Prices Review Board. Potential Savings from Biosimilars in Canada. Date modified: 2018-02-05 https://www.pmprb-cepmb.gc.ca/CMFiles/NPDUIS/2017_Conference_Posters/post_6_biosim.pdf |
Arthritis Consumer Experts
ACE thanks Arthritis Research Canada (ARC) for its scientific review of ACE and JointHealth™ information and education programs.