PMS89 - Canadian Public Reimbursement of Subsequent Entry Biologics (Sebs) / Biosimilars

Abstract

i) to provide an overview of the new Common Drug Review (CDR) evaluative process for SEBs by the Canadian Agency for Drugs and Technologies in Health (CADTH); ii) to illustrate the Canadian Drug Expert Committee (CDEC) recommendation from the first monoclonal antibody SEB (infliximab SEB; Inflectra) in Canada and how the recommendation compares with regulatory approval; and iii) if possible (depending on timing of listings) to highlight how the public reimbursement of infliximab SEB compares with that of the reference infliximab (Remicade). CDR’s SEB submission procedures were retrieved from CADTH’s website in order to delineate its history. The CDR recommendation of the infliximab SEB was compared to Health Canada’s approved indications. The pan-Canadian Pharmaceutical Alliance website was examined for the status of the infliximab SEB for potential negotiation. Formulary listing statuses and public reimbursement criteria are to be retrieved from provincial and federal formularies and compared to those for the reference infliximab. The current CDR SEB submission procedure represents a significant deviation from that for non-SEB products. The CDR Recommendation for the infliximab SEB included comments related to the clinical evidence demonstrating similar efficacy and safety to the reference infliximab. The indications recommended for reimbursement by the CDR are also consistent with those of Health Canada. We expect that infliximab SEB will undergo pan-Canadian Pharmaceutical Alliance negotiation, which would be followed by reimbursement decisions by the public plans. The first monoclonal antibody SEB received a positive CDR recommendation, in part, based on comparative clinical data demonstrating similar efficacy and safety. Non-monoclonal antibody SEBs lacking comparative phase III clinical studies have recently been approved by the European Medicines Agency. The CDR’s assessments of these products will be of great interest.