Alberta will become the third province to expand the use of biosimilar medications, following British Columbia and Manitoba’s lead. Ontario recently announced that it will be consulting on biosimilars before the end of the year.
“The biosimilar policy enables government to continue providing Albertans with the best possible treatment options, but at a lower cost. Over the next four years, this initiative will save us between $227 million and $380 million once fully implemented. These savings will go back into the health system to help ensure we can provide the high-quality care Albertans deserve.”
Excluding pregnant women and pediatric patients, people on an Alberta government-sponsored drug plan who are prescribed a biologic drug need to transition to the biosimilar version through their prescriber over the next six months. If there is a medical reason that prevents a patient from switching, a medical exception can be requested by the physician. All exception requests will be peer-reviewed by a team of physician specialists comprised of representatives from the following clinical specialties: rheumatology, gastroenterology, endocrinology and neurology.
“The Canadian Digestive Health Foundation recognizes that both biologics and biosimilars have gone through rigorous standards for authorization by Health Canada, and both have been found safe and effective for use in inflammatory bowel disease. While CDHF believes in patient-physician choice, we acknowledge a policy change decision has been made affecting adult IBD patients. We are pleased the change exempts paediatric patients, a population with very unique needs. Having to change medication can be stressful and CDHF is committed to providing helpful and unbiased information and resources for adult patients who will transition to a biosimilar in the coming months.”
“As a rheumatologist, I want to provide my patients with the most effective treatments. At the same time, as a steward of the health system, I also want to use the most cost-effective approaches whenever possible. Biosimilars meet both patient and health system needs by providing the same high-quality medications at a lower cost. Like a host of other countries around the world, we need to make this important shift and take the next step forward in the evolution of care.”
“Whenever a change of this magnitude is considered, how the change takes place is as important as the change itself. We’ve been pleased to take part in the government’s consultations to help ensure that the plan going forward reflects the needs and best interests of patients, from transition period to education to support programs to exception process. And we will continue to work with the government to explore how to reinvest savings from this change into further improving patient access to care.”
“As a person living with rheumatoid arthritis, a volunteer and a health educator, I hear every day how patients like me are struggling to gain reimbursement for treatment and services they need. Today’s announcement is a direct answer to this problem, clinically and financially. It ensures continued reimbursement coverage for Albertans who transition to a biologic biosimilar, and through reinvestment of savings, improves models of care for patients living with complex chronic diseases.”
- Over the last decade, the cost for biologic drugs has increased from $21 million to $238 million.
- Biologics costs represent 19 per cent of the total drug plan budget despite only being provided to fewer than two per cent of patients.
- Spending on biologics has increased by 16 per cent per year for the past five years.
- Biosimilars are equally safe and effective, yet significantly less expensive. Biologic drugs can exceed $25,000 per patient per year, while biosimilar drugs cost up to 50 per cent less than biologics.
- Biologic drugs are often used to treat conditions such as rheumatoid arthritis, inflammatory bowel disease and diabetes.
- Health Canada has stated definitively that there are no differences in safety or efficacy following a change in routine use between a biosimilar and a biologic drug.
- In Europe, where biosimilar products have been used since 2006, more than 40 biosimilar products have been approved and are on the market, accounting for nearly a billion patient days of experience spanning 12 years.
- A systematic literature review published in 2018 examined switching from a biologic to a biosimilar. This review included 90 studies with 14,225 patients involving seven molecules in the treatment of 14 diseases. The cumulative results of these studies did not show any significant differences in safety, efficacy or immunogenicity after switching compared to patients who were not switched.
Biologics vs Biosimilars
A biologic drug is a medication manufactured in, extracted from or semi-synthesized from living cells through a complex manufacturing process. A biosimilar drug is a highly similar, equally safe and effective version of a biologic drug.
Due to the complexity of biologic drugs and the natural variability that results from using living cells, it is not possible for a biosimilar to be identical to its biologic. It is also not possible for different lots or batches of a biologic drug to be identical. These variations do not affect the drug’s effectiveness.
Safety and effectiveness
“Patients and health care professionals 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.”
“Over the past 10 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable experience in their use and safety. The evidence acquired over 10 years of clinical experience shows that biosimilars approved through EMA can be used safely and effectively in all their approved indications as other biological medicines. Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.”
“The council recommends formulary management policies, including requiring biosimilar substitution that support the use of biosimilars and encourage patients and prescribers to choose the most cost-effective therapies to ensure the sustainability of national pharmacare. Prescribers and patients should be better supported with information reinforcing the safety, efficacy and benefits of biosimilars.”
“More than 100 research studies exist on patients with inflammatory arthritis, gastrointestinal and skin disease who have successfully policy transitioned from a TNF inhibitor biologic originator to its TNF inhibitor biologic biosimilar.”
“Like any medicine approved by Health Canada, biosimilars can be expected to be safe and effective treatment options when they are used appropriately in their approved indications.”
“Are biosimilars safe and effective? Yes. Health Canada reviews and approves all drugs before they can be sold in Canada. Health Canada also has rules about how all drugs are manufactured. All companies selling drugs in Canada must follow the same rules for the manufacturing process and for ensuring the quality of their ingredients.”
“Do biosimilars work as well as reference biologic drugs? Yes, because reference biologic drugs and biosimilars work the same way. If you were taking a reference biologic drug and are now taking a biosimilar drug, you should expect to have the same results and the same side effects.”
“Are biologics/ biosimilars safe? Health Canada is responsible for making sure that all new drugs, including biologics and biosimilars, are safe, effective and of high quality. Health Canada evaluates all the information provided to confirm that the biosimilar and the original biologic drug are similar and that there are no clinically meaningful differences in safety and efficacy between them.”
“Biosimilars are made with the same types of natural sources as the original biologic they were compared to — and provide the same treatment benefits.”
“Biosimilars could offer yearly savings of $1.8 billion.”
“Manitoba and Alberta had the highest levels of biologic-related costs relative to total drug costs in 2016/17.”
“We performed a retrospective analysis of Canadian drug purchases for filgrastim, infliximab and insulin glargine from July 2016 to June 2018…In total $1,048,663,876 Canadian dollars in savings could have been realized with 100% use of biosimilars over the originator products during this 2 year time period.”
"Alberta’s unrealized savings: $138,074,937."