Abstract

Purpose: Adalimumab, a fully human monoclonal antibody targeting tumor necrosis factor, is approved for treatment of adults with moderate severe Crohn's disease (CD). CLASSIC I and CHARM are two Phase III studies of the effectiveness of adalimumab in inducing and maintaining remission, respectively, in patients with moderate to severe CD. Methods: The objective of this analysis was to evaluate the cost-effectiveness of adalimumab compared to nonbiologic therapies in the maintenance treatment of CD. A cost-utility model compared these strategies from the perspective of the UK National Health Service over 1-year and lifetime horizons. Patients were modeled in four disease states based on their Crohn's Disease Activity Index (CDAI) scores. CHARM data were directly used to estimate adalimumab arm efficacy. A regression model using CLASSIC I data was used to similarly predict the CDAI state of patients who received standard of care. Hospitalizations for both arms were modeled using the clinical trials data. Utilization of other medical resources was based on CDAI states. The cost of adalimumab was £357.50 per 40 mg vial, and the cost of standard care drugs was assumed to be zero. Costs of hospitalization and other medical resources were taken from Bassi et al., 2004. All costs were inflated to 2006 British Pounds (GBP) based on the annual UK health price index. Health utility inputs were sourced from Gregor et al., 1997. Univariate and probabilistic sensitivity analyses were conducted. Results: Compared with nonbiologic therapy, adalimumab appeared to be cost-effective in the treatment of patients with both severe CD and moderate to severe CD, with a 56-week incremental cost effectiveness ratio (ICER) of £16,064/quality-adjusted life-year (QALY) and £33,731/QALY, respectively. Sensitivity analyses demonstrated that the findings were robust. In the treatment of patients over their lifetimes, the ICERs were £5,479/QALY for patients with severe CD and £16,065/QALY for patients with moderate to severe CD. Sensitivity analyses demonstrated the robustness of the base case analysis. Conclusion: Adalimumab maintenance therapy for CD was cost-effective when compared to conventional nonbiological management. This research was funded by Abbott Laboratories, Abbott Park, IL.

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