As of February 2021, two Canadian provinces, British Columbia and Alberta, have implemented or partially implemented forced biosimilar non-medical switching policies. The controversial policies drew strong objections from many in the GI patient and physician community.

 

In a 2017 survey, more than 2/3 of Canadian physicians surveyed said they were not comfortable with a third-party switching their patient to a biosimilar for non-medical reasons (i.e., coverage), as occurs under the BC and Alberta policies. 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.

 

Full implementation of the Alberta policy was delayed six months as a result of the COVID-19 pandemic. Other provinces including Ontario and Quebec are still considering whether or not to enact similar policies.

 

Quebec’s National Institute of Excellence in Health and Social Services (INESS) recently released the official English translation of its report “Safety of switching biologics and their interchangeability”. The report found:

 

There is very little clinician opposition to the use of biosimilars in treatment-naive patients…the picture is different and much more nuanced regarding the use of biosimilars in individuals who are already being treated with a reference biologic drug, in particular because of the risks of immunogenicity posed by the use of biologic drugs and the possible loss of efficacy.

 

In this respect, all the learned societies are clearly opposed to non-medical switching of a biologic drug, and instead favour medical switching, by which the decision to switch a patient’s treatment rests with the individual and his or her doctor. This position is shared by all the clinicians consulted for this project, who stress that the physician is the best person to assess the risk of treatment switching in a given patient.

 

The INESSS report also contrasts BC- and Alberta- style forced-substitution policies with those of Western Europe, likening it more to those in Eastern Europe:

 

Most of the jurisdictions examined are in favour of switching patients being treated with a reference biologic drug to a biosimilar, but do not impose this on all patients (via financial penalties or incentives, quotas, etc.)… Only a few European countries (Denmark, Bulgaria, Poland and Serbia) and two Canadian provinces have adopted policies for mandatory non-medical switching for the vast majority of patients (national tendering processes or reimbursement of biosimilars only).”

 

The pro-competition, pro-physician choice policies found in most European biosimilar markets were the subject of a recent whitepaper by ASBM’s Michael Reilly and Philip Schneider; read that paper here. 

 

Also new for 2021, ASBM Member the Gastrointestinal Society has released a series of resources for Canadian patients, including a handout entitled “Good Biosimilars Policy in Canada 2021” which reflects principles of biosimilar substitution policy supported by GI patient advocacy organizations. From the document:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

 

The Gastrointestinal Society also has a list of recommended exemptions  were a province to implement such a policy. These include, pregnant women, the elderly, high-risk patients, those with severe disease, and children.

 

Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.