Presentation (CTI)

OBJECTIVES: We sought to describe Canadian HTA decisions, pricing negotiations, and reimbursement of originator biologic Remicade® (infliximab) and associated biosimilars across indications and jurisdictions.
METHODS: HTA recommendations for Remicade® and biosimilars were retrieved from CDA and corresponding submissions for these products were retrieved from the INESSS website. Information on product, clinical evidence submitted, original and updated reimbursement decisions, and reimbursement conditions were extracted from HTA reports. Reimbursement decisions by public drug plans and pCPA negotiation status for these products were also retrieved.
RESULTS: Biosimilar switching policy has been implemented in all provinces, the Northwest Territories (NWT), Yukon, and federal Non-Insured Health Benefits (NIHB) program, which has accelerated biosimilar adoption rates. Five infliximab biosimilars were covered by all provincial/territorial drug plans, except Yukon, which only covered two biosimilars (Renflexis® and Remdantry™). Remicade® is only covered by five public drug plans for select indications, which require special authorization for reimbursement. All six HTAs evaluating infliximab biosimilars for six indications concluded with positive CDA recommendations. One biosimilar, Remsima™, was withdrawn by the manufacturer (Fresenius). In corresponding INESSS submissions, all biosimilars received a positive recommendation. INESSS conducted HTAs for two additional biosimilars (Ixifi® and Avsola®), which both received a positive recommendation. Remicade® received a negative recommendation from CDA and INESSS for the treatment of ulcerative colitis (UC). Remicade® and all infliximab products, except for Remsima™ SC for the UC indication, concluded with a Letter of Intent in pCPA negotiations. Inflectra®, the first biosimilar introduced to market, had the longest negotiation process duration (309 days) compared with Remicade® and other biosimilars.
CONCLUSIONS: Biosimilar market entry has provided patients with additional treatment options for indications that were not originally reimbursed by public drug plans for the originator. Policies supporting biosimilar use have allowed provinces and federal drug plans to expand access to biologic therapies for more patients within cost constraints.