In the Changing Biosimilar Landscape, Canadian Rheumatology Association Updates Its Position

The Canadian Rheumatology Association (CRA) has issued an update to its position statement on biosimilars. In the document, the CRA says that evidence for the risk/benefit ratio for biosimilars is accruing rapidly, and physicians must demonstrate fiscal responsibility while providing the best care possible to individual patients.

According to the position, for patients who are new to biologic therapy, cost-effectiveness must be considered whenever there is a choice between a reference and a biosimilar product. For patients who are already taking biologics, “a respectful and informed conversation between the rheumatologist and patient” must take place before transitioning to a biosimilar option.

Substitution by anyone other than the prescriber, says the CRA, should involve notification of both the prescriber and patient, and no substitution should occur without an informed consultation of the patient. Six months, says the CRA, would be an appropriate time frame in which to carry out these discussions. Patients who have clinically relevant disease flares in the first 6 months of treatment should be allowed to change back to the reference.

If nonmedical substitution is imposed by a third party, it is imperative that there not be an interruption in patient care; access to the reference product must remain stable until the biosimilar is made available.

CRA also emphasizes that no additional costs should be incurred by the patient as a result of a transition, and it encourages drug makers to provide adequate patient support programs.

The update to the group’s position comes as Canada makes major steps toward adopting biosimilars; earlier this week, British Columbia announced that it would switch patients taking reference biologics of infliximab, etanercept, and insulin glargine for rheumatological diseases and diabetes to biosimilars within 6 months.

Furthermore, officials noted, patients who receive biologics for inflammatory bowel disease will also be switched to biosimilars, and details concerning this patient population’s switching program will be made available shortly.

Additionally, the nation’s health technology assessment body, the Canadian Agency for Drugs and Technologies in Health (CADTH), announced recently that, as of June 1, it will no longer work on reviews of biosimilars, saying that there is no longer a need to continue offering these reviews.

The current process, which had already been streamlined from a previous and more labor-intensive process, involves gathering cost information and gathering stakeholder input from patients, clinicians, and jurisdictions. Even this faster approach, says CADTH, could have the unintended effect of delaying biosimilar access, and stopping reviews of biosimilars will allow CADTH to redeploy its resources to other drug review programs.