Cost-Effectiveness Analysis of Crohn's Disease Treatment with Vedolizumab and Ustekinumab After Failure of Tumor Necrosis Factor-α Antagonist

Objective The aim was to evaluate the cost-effectiveness of Crohn's disease (CD) treatment with vedolizumab and ustekinumab after failure of therapy with tumor necrosis factor-alpha antagonists (anti-TNFs). Methods The Markov model incorporated the lifetime horizon, synthesis-based estimates of biologics' efficacy in relation to anti-TNF exposure, and administration of biologics reflecting clinical practice (e.g., sequence of biologics, retreatment, 12-month treatment). The utilities, non-medical costs and indirect costs were derived from a study of 200 adult patients with CD, while the healthcare costs were from a study of 1393 adults with CD who used biologics in Poland. The quality-adjusted life years (QALYs) and costs (the societal perspective) were discounted with the annual rates of 3.5 and 5%, respectively. Results The addition of vedolizumab (ustekinumab) to the sequence of available anti-TNFs (after first-line infliximab or after second-line adalimumab) led to a gain of 0.364 0.349) QALYs at an additional cost of (sic)5600.24 ((sic)6593.82). The incremental cost-effectiveness ratios (ICERs) were (sic)15,369 [ 95% confidence interval (CI) 7496-61,354] and (sic)18,878 (95% CI 9213-85,045) per QALY gained with vedolizumab and ustekinumab, respectively. Sensitivity analyses revealed a high impact on the ICERs of the relapse rate after discontinuation of biologic treatment. The highest value of vedolizumab/ustekinumab was estimated after the failure of therapies with both anti-TNFs. Conclusions CD treatment with ustekinumab or vedolizumab after failure of anti-TNF therapy appears to be costeffective at a threshold of (sic) 31,500. The replacement of the second-line anti-TNF with ustekinumab/vedolizumab and the course of the disease after discontinuation of biologics are influential drivers of the cost-effectiveness.