OBJECTIVES : To evaluate the cost-utility of ustekinumab versus vedolizumab in patients with moderate-to-severe Crohn’s disease (CD) in Italy.

METHODS : A decision tree and 28-days Markov model cycles were used to model the induction and maintenance phase, respectively, of two identical cohorts starting ustekinumab or vedolizumab treatment. Anti-TNFα-naïve (patients failed conventional therapy) and anti-TNFα-experienced (patients failed a first line with anti-TNFα) patients were modeled separately due to the different disease evolution. Anti-TNFα-naïve patients starting ustekinumab (q12w) or vedolizumab (q8w) as first biologic line represents those patients for which anti-TNFα are contraindicated (e.g. anti-TNFα intolerant patients). Transition probabilities, response and adverse events rates, utility for disease status, and disease management treatments were retrieved from the literature. Lifetime cost considered in the analysis were drugs, administration, surgery and post-surgery complications, and management of adverse events, in the perspective of Italian National Health Service. Probabilistic and deterministic sensitivity analyses were also carried out.

RESULTS : The total simulated cohort consist of 5.4% anti-TNFα-naïve and 94.6% anti-TNFα-experienced patients. Treatment with ustekinumab is associated with higher quality of life (+0.72 QALY) than vedolizumab, with an incremental cost of €2,102 per patient. The Incremental cost-utility ratio (ICUR) results less than €3,000 per QALY. At a threshold of €10,000 per QALY, ustekinumab has 70% of probability of being the most effective drug; reaching almost 100% at a threshold of €30,000 per QALY. The main drivers of cost are the response and remission rates during the induction phase while the increase in QALY is sensitive to the increase in utility due to the lower frequency of ustekinumab administration. However, even for more conservative assumptions on efficacy of ustekinumab versus vedolizumab, the ICUR remains small (lower than €8,000 per QALY).

CONCLUSIONS : The results indicate that ustekinumab is cost-effective versus vedolizumab in a representative cohort of moderate-to-severe Crohn’s Disease patients in Italy.