Critics Assail Nonmedical Switching Policy in Canadian Provinces

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.”