Budesonide Extended Release for Ulcerative Colitis

Key Message

In 2017, the Canada's Drug Agency Canadian Drug Expert Committee recommended that budesonide extended release (with multi-matrix system) not be reimbursed for the induction of remission in patients with active mild to moderate ulcerative colitis based on limitations in the evidence at that time. The limited primary clinical evidence (i.e., 1 randomized controlled trial) published since the literature searches conducted for the previous Canada's Drug Agency Reimbursement Review corroborates the clinical findings of that report. The evidence demonstrates that budesonide extended release is more effective for inducing remission in patients with mild to moderate ulcerative colitis compared to placebo. No new clinical evidence was identified describing head-to-head comparisons of budesonide extended release with active therapies. Indirect comparative evidence between budesonide extended release and other active therapies suggests minimal or no difference in remission, clinical response, or adverse events. Cost-effectiveness evidence from 1 study conducted in the Netherlands indicates that budesonide extended release is a more effective and less costly second-line therapy versus aggregated comparators for patients with mild to moderate ulcerative colitis. Evidence-based recommendations support the use of budesonide extended release for patients with mild to moderate ulcerative colitis who have not responded to 5-ASAs. No clinical or cost-effectiveness evidence or evidence-based recommendations were found describing the use of budesonide extended release in patients with moderate to severe ulcerative colitis.