Canadian provinces encounter opposition in their move to implement forced switching of patients from reference products to biosimilars.
Multiple Canadian provinces aim to switch patients to biosimilars, in a sweeping effort to save money for pubic health, and the transition has provoked much comment, not all of it enthusiastic.
At least 4 of Canada’s 10 provinces—Ontario, Alberta, British Columbia, and Manitoba—have now announced intentions to switch patients to biosimilars from reference products.
Critics argue the change to a policy of nonmedical switching will adversely affect patient care and lead to higher long-term healthcare costs, according to a review in The Lancet Gastroenterology & Hepatology.
The cost-savings appeal of switching to biosimilars is evident in Alberta’s projections for reductions in expense: up to US $268 million over the next 4 years. The province will have switched at least 26,000 patients by the summer of 2020.
Cost of Biologics is Soaring in Alberta
Alberta’s government states that the cost of biologic drugs are going up an average of 16.2% each year, and “the originator biologic drugs Remicade [infliximab], Humira [adalimumab] and Enbrel [etanercept] are 3 of the top 4 drivers of drug spending in Alberta.”
In that province, patients will be switched from the reference biologics for etanercept, infliximab, insulin glargine, filgrastim, pegfilgrastim, and glatiramer.
Biologics have been shown to be effective in inducing remission and avoiding surgical interventions, not to mention improving quality of life for patients.
Anti-tumor necrosis factor therapies are the single highest expense for patients in the Canadian healthcare system, at a cost of US $14,132 annually for each patient, the report said. However, the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada contend in a position paper that their evidence review supports a position against nonmedical switching from reference infliximab to biosimilars in patients with stable inflammatory bowel disease (IBD).
Even Reference Product Changes Over Time
That said, the Lancet authors note that even reference biologics differ from batch to batch, but such high standards are applied to the manufacture of these and biosimilars that “they are just as safe and effective.”
The authors cite Mina Mawani, president and chief executive of Crohn’s and Colitis Canada, who contends the nonmedical switch from reference product to biosimilar introduces variability that “is irresponsible and may jeopardize these patients’ health.”
Another issue raised is that some infusion centers in Canada have exclusive contracts with specific pharmaceutical companies and may not be available for infusion of biosimilars. This may require patients to switch centers and travel long distances for treatment, causing infusion centers to become overwhelmed with patients, according to critics.
The Canadian Association of Gastroenterology and Crohn's and Colitis Canada also contend that “1 patient may lose response to infliximab for every 11 patients undergoing nonmedical switching. Applying this data to the Alberta IBD population, this could lead to 63 avoidable surgeries if all Albertans on Remicade [infliximab] are switched to a biosimilar.”
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.