OBJECTIVES:

To examine the clinical and health economic impact of vedolizumab compared with conventional therapy (CT) in the treatment of moderately-to-severely active Crohn’s disease (CD) in the United Kingdom.

METHODS:

A decision-analytic Markov model compares vedolizumab with CT (aminosalicylates, corticosteroids, immunomodulators) for the treatment of patients with moderately-to-severely active CD. The primary analysis population includes patients with moderately-to-severely active CD who have failed on an anti-tumour necrosis factor-alpha (TNF-α) antagonist. Population characteristics, utility values (using the EQ-5D), efficacy and safety data have been obtained from GEMINI II and GEMINI III randomised-controlled trials. Adverse event disutilities, unit costs, probability of surgery, surgery related complications, and mortality have been obtained from published literature and/or clinical expert opinion. The base case analysis uses a lifetime horizon, with costs and outcomes discounted by 3.5% per year. Univariate and multivariate probabilistic sensitivity analyses are conducted to investigate parameter uncertainty.

RESULTS:

The incremental cost-effectiveness ratio (ICER) for vedolizumab is estimated at £21,620/QALY compared with CT. Sensitivity analyses showed that results are most sensitive to variation in the CT arm transition probabilities from the moderately-severely active state and from the remission state. The ICER was also sensitive to response assessed at week six rather than week 8 and efficacy based on GEMINI II only. When treatment with vedolizumab was continued for 2 or 3 years (instead of 1 year) the ICER increased to £24,695/QALY and £26,207/QALY respectively. The average probabilistic ICER shows vedolizumab to be £27,428/QALY gained (95% CI ICER of -£7,883 to £82,947).

CONCLUSIONS:

The economic model predicts that treatment with vedolizumab improves QALYs and is a cost-effective alternative to CT for patients who have inadequate response to CT and TNF-α antagonists. Vedolizumab has received positive recommendations from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) for the CT and anti-TNF failure population.