WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR BIMZELX?: CADTH recommends that bimekizumab (Bimzelx) should be reimbursed by public drug plans for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately or are intolerant to conventional therapy if certain conditions are met.
WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE?: Bimzelx should only be covered to treat adult patients with active AS based on the criteria used by each public drug plan for reimbursement of biologic disease-modifying antirheumatic drugs (bDMARDs).
WHAT ARE THE CONDITIONS FOR REIMBURSEMENT?: Bimzelx should only be reimbursed if prescribed by a rheumatologist or a clinician with experience in the treatment of adult patients with active AS who are not undergoing treatment with other bDMARDs or targeted synthetic DMARDs. The cost of Bimzelx should not exceed the least expensive bDMARD reimbursed for treating AS.
WHY DID CADTH MAKE THIS RECOMMENDATION?: Evidence from a clinical trial (BE MOBILE 2) demonstrated that Bimzelx resulted in added clinical benefit for adult patients with active moderate to severe AS who had failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) or had contraindications or intolerance to NSAID compared to placebo. Bimzelx may meet needs identified by clinicians and patients for effective and safe treatments that work well for patients with AS, including for some who do not respond adequately to currently available therapies. Based on CADTH’s assessment of the health economic evidence, Bimzelx does not represent good value to the health care system at the public list price. The committee determined that there is insufficient evidence to justify a higher cost for Bimzelx compared with the least expensive bDMARD reimbursed for AS. Based on public list prices, Bimzelx is estimated to cost the public drug plans approximately $1.5 million over the next 3 years. The estimated budget impact is sensitive to the number of patients who are expected to receive Bimzelx.
WHAT IS AS? AS is a type of arthritis that mainly affects the spine. It is a chronic condition that causes inflammation in the spinal joints, leading to back pain, stiffness, and sometimes eye problems. AS can lead to disability if left untreated. Approximately 300,000 people living in Canada have AS, although the actual number may be higher due to diagnosis challenges. UNMET NEEDS IN AS: Given the limited availability of target therapies, current treatments becoming less effective over time, and the unequal response of patients with AS to available treatment options, there is an unmet need for treatments with sustained effectiveness that are safe and work well for all patients with active AS. HOW MUCH DOES BIMZELX COST? Treatment with Bimzelx is expected to cost approximately $21,198 per patient annually.
