The Cost-Effectiveness of Ustekinumab in Moderate to Severely Active Crohn’s Disease in Sweden

OBJECTIVES: Human monoclonal antibody ustekinumab is a novel Crohn's disease (CD) treatment option which blocks pro-inflammatory cytokines interleukins (IL)-12 and IL-23.The aim was to assess the cost-effectiveness of ustekinumab in moderate to severely active CD in Sweden. METHODS: A cost-effectiveness model with a decision tree structure for the induction phase and a Markov cohort structure for the maintenance phase was constructed. CD was represented by five health-states: remission, mild, moderate-severe, surgery and death. Ustekinumab was compared to adalimumab in a conventional-care-failure population and to vedolizumab in patients previously failingTNF-alpha-inhibitor treatment. Discontinuation probabilities, utilities and ustekinumab induction efficacy were sourced from phase III clinical trials. Maintenance and comparator efficacy came from a network meta-analysis and a treatment sequence analysis. Resource use and cost data were derived from the literature and validated by clinical experts. The analysis had a societal perspective, a life-time time-horizon, and a 2-year maximum treatment duration.The robustness of the results was tested in univariate and probabilistic sensitivity analyses (PSA). The cost-effectiveness was estimated using quality-adjusted life-years (QALYs). RESULTS: Ustekinumab dominated adalimumab in the conventional-care-failure population. The total cost was €6,984 lower for ustekinumab compared to adalimumab and the incremental QALY gain was 0.232. In theTNF-alpha-inhibitor-failure population, ustekinumab's incremental QALY gain versus vedolizumab was 0.133, at an incremental cost of €4,023, yielding an incremental cost-effectiveness ratio (ICER) of €30,282. Results were sensitive to excluding indirect costs and to increasing the treatment duration. An increased treatment duration improved cost-effectiveness versus adalimumab but increased the ICER versus vedolizumab. PSA showed that at a Swedish reference willingness to pay of €63,000 (SEK 600,000), ustekinumab had 94% probability of being cost-effective versus adalimumab, and 72% versus vedolizumab. CONCLUSIONS: The results indicate that ustekinumab dominates adalimumab in the conventional-care-failure population, and is cost-effective versus vedolizumab in the TNF-alpha-inhibitor-failure population.