Thursday, November 24 2022

In early 2020, Ontario became the third Canadian province to begin replacing patients taking reference drugs (initiators) with biosimilars; however, this decision did not require all patients to switch to biosimilars if they had already started taking reference products. In a recent study, researchers estimated the potential savings from tighter substitution policies.

Using data from drug claims for biologics reimbursed under provincial drug benefit, the researchers modeled patient spending and utilization based on mandatory substitution of non-medical biosimilars and drug use. substitution for new users only. They also examined the availability of the biosimilars adalimumab and insulin glargine based on price discounts as low as 25% of the price of the reference product, which they believed was achievable based on studies of adoption of biosimilars in other regions.

Their analysis covered the 2-year period from January 2018 to December 2019 and also predicted trends up to December 31, 2020.


A policy of mandatory substitution of non-medical biosimilars for inflammatory diseases would have affected 7,209 patients over the 3-year period and saved $ 238.6 million. If the substitution policy had applied only to new users, 757 patients would have been affected and savings would have been limited to $ 34.2 million. With the hypothetical availability of an adalimumab biosimilar, the 3-year savings from a mandatory switch would have increased to $ 645.9 million, and 12,928 patients would have been affected, based on all biosimilars priced at 25% of the price of the reference product.

Besides the savings on adalimumab biosimilars, expanding the non-medical mandatory switch to include an insulin glargine biosimilar would have saved $ 288.7 million, investigators said.

The importance of biosimilars — as effective and safe as the reference drugs — for savings and access to health care has long been recognized, but in Canadian provinces adoption of these agents has been sluggish, and so in recent years in British Columbia and Alberta, and now in Ontario, have started requiring patients to use biosimilars. The growth in the use of biologics, among the more expensive drugs, has also been behind this trend.

In 2018, biologics accounted for 1.5% of claims in Canadian public health programs, but 27.3% of drug costs. In Ontario, the use of organics increased 462% from 2010 to 2019, and public spending on organics in the province is expected to reach $ 1.4 billion by 2021.

“Although biologics improve patient outcomes, their increasing use and high costs threaten the financial sustainability of public drug programs,” the study authors wrote.

The study included publicly funded prescriptions for infliximab, etanercept, and adalimumab for rheumatic conditions or inflammatory bowel disease (IBD). In their analysis of the 2018 complaint information, investigators found that 84.1% of etanercept users and 86.7% of infliximab users had been treated with a reference product compared to a biosimilar.

When it came to starting treatment for patients with rheumatism or IBD, the reference products always retained their traction: 39.5% of patients starting etanercept and 59.8% of patients starting infliximab had started with a reference product rather than a biosimilar.


“Overall, the significant cost savings and the number of patients affected by the biosimilar policy changes examined in this study are within the range of estimates found in other jurisdictions, both nationally and internationally. “, wrote the study authors.

“International research suggests that policies requiring non-medical changes or automatic substitutions with biosimilars generally result in rapid changes in distribution patterns and significant cost reductions for public payers, but potentially increased costs associated with the drug. ‘use of health services,’ they said.

An important factor when considering a change policy is that manufacturers of benchmark products often fund some patient care and drug administration costs, as well as co-payment assistance, investigators said. “Therefore, any policy introducing mandatory changes in treatment must allow the extension of these services for the corresponding biosimilars,” they wrote.

Although Ontario’s public drug programs require new infliximab and etanercept users to start with biosimilars, the reality is that this policy is being overturned by a hospital practice of starting patients with reference products. which are obtained at a relatively low cost.

“As our model indicates, considerable additional savings could be realized if the biosimilar policy intended for new users were fully enforceable,” the authors wrote.

Adalimumab biosimilars became available in Ontario in February 2021.

Further reading

In a recent study, researchers shed light on useful practices and considerations for pharmacists when switching patients to biosimilars in rheumatology.


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