The Argument Against a Biosimilar Switch Policy for Infliximab in Patients with Inflammatory Bowel Disease Living in Alberta

Abstract

A nonmedical switch policy is currently being considered in Alberta, which would force patients on originator biologics to biosimilar alternatives with the hypothetical aim of reducing costs to the health care system. The evidence to support the safety of nonmedical switching in patients with inflammatory bowel disease (IBD) is of low to very low quality; in fact, existing data suggest a potential risk of harm. In a pooled analysis of randomized controlled trials, one patient would lose response to infliximab for every 11 patients undergoing nonmedical switching. Switching to a biosimilar has important logistical and ethical implications including potential forced treatment changes without appropriate patient consent and unfairly penalizing patients living in rural areas and those without private drug insurance. Even in the best-case scenario, assuming perfectly executed switching without logistical delays, we predict switching 2,000 patients with Remicade will lead to over 60 avoidable surgeries in Alberta. Furthermore, nonmedical switching has not been adequately studied in vulnerable populations such as children, pregnant women, and elderly patients. While the crux of the argument for nonmedical switching is cost savings, biosimilar switching may not be cost effective: Particularly when originator therapies are being offered at the same price as biosimilars. Canadian patients with IBD have been surveyed, and their response is clear: They are not in support of nonmedical switching. Policies that directly influence patient health need to consider patient perspectives. Solutions to improve cost efficiency in health care exist but open, transparent collaboration between all involved stakeholders is required. Key Messages • The evidence evaluating the safety of nonmedical switching to a biosimilar is of very low quality and suggests potential harm to patients with IBD. • A meta-analysis of randomized controlled trials demonstrated that one patient is expected to lose response to their infliximab for every 11 patients who are switched to a biosimilar. • A nonmedical switch policy is expected to cause over 60 avoidable surgeries in Alberta. • Nonmedical switching has not been adequately studied in highly vulnerable populations including children, pregnant women and elderly patients. • Nonmedical switching has important logistical and ethical implications. • Biosimilar switching may not be cost effective, particularly when originator therapies are offered at the same price as biosimilars. • Canadian patients with IBD have significant anxiety and concern over switching.

The Importance of Countering Biosimilar Disparagement and Misinformation

“…Another recent review of 178 switching studies also concluded that for the products studied, a single switch is not intrinsically linked to an increase in immunogenicity, safety, or efficacy issues [ 37 ]. Nonetheless, the “fact” that there is a supposed controversy about the practice of switching from a reference biologic to a biosimilar was cited by another publication as part of a set of arguments against a Canadian provincial policy of switching from reference infliximab to biosimilar infliximab [ 38 ]. There is no scientific controversy about the practice of switching [ 39 ], but the false narrative persists.…”

“…Another example of negative framing is the pervasive use of the term “non-medical switching” or “non-medical substitution” when describing the transition from reference product to a biosimilar. This phrase has been used by both publications that support this practice as well as by those that warn against it [ 38 , 45 ]. However, the terms non-medical switching and non-medical substitution actually refer to formulary-driven changes between drug options that are thought to be therapeutically equivalent, but that are very different in structure [ 46 ].…”

Effect of listing strategies on utilization of antitumor necrosis factor biologics infliximab and etanercept: a cross-sectional analysis from Ontario, Canada

“…16 Our findings of differences between clinical indications may also reflect perceived policy gaps from the perspectives of those affected by policy change and a need for stronger engagement and collaboration with stakeholders. 7,19 With the complexity of using biologics, there has been greater integration of patient support programs into clinical practice; in this regard, innovator biologics typically have well-established support programs with large number of infusion centers, making them more accessible and convenient to patients in more remote geographic areas or during evenings and weekends. 11,19 This may affect infliximab more, since it has an intravenous route of delivery versus the subcutaneous route for etanercept.…”

“…7,19 With the complexity of using biologics, there has been greater integration of patient support programs into clinical practice; in this regard, innovator biologics typically have well-established support programs with large number of infusion centers, making them more accessible and convenient to patients in more remote geographic areas or during evenings and weekends. 11,19 This may affect infliximab more, since it has an intravenous route of delivery versus the subcutaneous route for etanercept. 23 Improving consideration of factors associated with biologic administration and patient care can positively affect the quality of care associated with biosimilars and enhance the success of the policy approach.…”

Infliximab Versus Biosimilars for IBD: Is It Better to Fight Than Switch?

“…Significant heterogeneity among existing observational studies limits their interpretation as well. Further, while non-medical switching policies have been enacted, there has been incomplete pharmacovigilance reporting on the patient level and pharmacoepidemiologic evaluation at the population level [11]. Lastly, since the available data pertain to single switches from originator compound to CT-P13, they incompletely reflect the multi-directional switching that may occur in practice with non-medical switching.…”