Anti-tumor necrosis factor treatment from diagnosis is more effective and less costly than conventional "step-up" care for patients with active Crohn's disease: a cost-effectiveness analysis from the PROFILE trial.

BACKGROUND: The PROFILE trial demonstrated that "top-down" therapy in Crohn's disease, with combination infliximab and immunomodulator from diagnosis, had superior efficacy and safety over 1 year compared to conventional "accelerated step-up" management. The current study aimed to evaluate the cost-effectiveness of these alternative treatment strategies. METHODS: A Markov model was developed for the cost-effectiveness of "top-down" compared to "accelerated step-up" treatment. Parameters were informed by individual patient data from PROFILE and published data. Use of anti-tumor necrosis factor (TNF) therapy was modeled, using real-world contract drug costs from 18 PROFILE sites. Key model outcomes included healthcare costs (drug acquisition, drug administration, disease management, hospitalization, and surgery) and health outcomes [quality-adjusted life years (QALYs) gained] measured over a 5-year time horizon. RESULTS: The base-case cost-effectiveness analysis indicated that a "top-down" strategy dominated over an "accelerated step-up" approach. Initiating intravenous infliximab from diagnosis yielded an incremental gain of 0.17 QALYs per patient over a 5-year period, and was less costly, saving £1681 per patient over the same time frame. Similar clinical benefits were obtained when modeling for subcutaneous infliximab and adalimumab. The greatest cost savings were with adalimumab, totaling £10 059 per patient over 5 years. Sensitivity analyses supported robustness of the results, showing "top-down" to be the most cost-effective option in 98.7% of model simulations. CONCLUSIONS: "Top-down" treatment from diagnosis with anti-TNF results in lower healthcare resource use and better clinical outcomes in patients with Crohn's disease compared to an "accelerated step-up" strategy.