Cost-effectiveness analysis of cetuximab combined with chemotherapy as a first-line treatment for RAS wild-type metastatic colorectal cancer patients based on the TAILOR trial

<p><b>Objectives</b> Cetuximab plus leucovorin, fluorouracil, and oxaliplatin (FOLFOX-4) is superior to FOLFOX-4 alone as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer (wt mCRC), with significantly improved survival benefit by TAILOR, an open-label, randomized, multicentre, phase III trial. Nevertheless, the cost-effectiveness of these two regimens remains uncertain. The following study aims to determine whether cetuximab combined with FOLFOX-4 is a cost-effective strategy for specific RAS wt mCRC patients in China.</p> <p><b>Design</b> A combined decision tree and Markov model with three health states (stable, progressive and dead) was constructed to simulate a hypothetical cohort of patients with RAS wt mCRC. The health outcomes and utility scores were derived from the TAILOR trial and previously published sources, respectively. Costs were calculated with reference to the Chinese societal perspective. A lifetime horizon was used. Univariate and probabilistic sensitivity analyses were carried out to test the robustness of the model results.</p> <p><b>Participants</b> The included patients were newly diagnosed Chinese patients with fully RAS wt mCRC. <b>Interventions</b> Either cetuximab plus FOLFOX-4 or FOLFOX-4 alone as a first-line treatment.</p> <p><b>Main outcome measures</b> The primary outcomes are costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs).</p> <p><b>Results</b> Baseline analysis showed that the addition of cetuximab increased the QALYs by 0.383, while an increase of $62,947 was observed in relation to FOLFOX-4 chemotherapy. This led to an incremental cost-effectiveness ratio (ICER) of $164,044/QALY. Sensitivity analysis showed that across the wide variation in parameters, the ICER exceeded the willingness-to-pay threshold of $28,106/QALY, which was three times the per capita GDP in China.</p> <p><b>Conclusions</b> Despite the survival benefit, cetuximab combined with FOLFOX-4 is not a cost-effective treatment for the first line treatment of patients with RAS wt mCRC in China.</p>