OBJECTIVES:: To evaluate the efficacy, safety and cost-effectiveness of cetuximab for first-line treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC) with liver-limited disease.

METHODS:: A Markov model was developed for RASwt mCRC patients and EGFR expression with liver-limited disease who started treatment with cetuximab + chemotherapy or chemotherapy alone. The transition probabilities were populated according to the OS and PFS curves of a phase II head-to-head randomized controlled trial. The present study was conducted from a Brazilian public health system perspective and direct medical costs were obtained through micro-costing and expert opinion. Incremental cost-effectiveness ratio (ICER) was reported as R$ (BRL) per life year (LY) and budget impact analysis were conducted to assists the decision. One-way sensitivity analysis was also conducted. A 20-year time horizon was used. Future costs and health benefits were discounted at 5%.

RESULTS:: The comparison results showed that the association of cetuximab + chemotherapy presented higher cost and greater effectiveness. ICER resulted in R$56,750 per life year gained (LYG). The budget impact analysis projects additional costs around R$ 41 million in the first year after the incorporation and R$ 326 million accumulated in 5 years. Results were sensitive to changes in percentage of patients undergoing curative resection, mean body surface area, outcomes discount rates, tested patients rates and market share.

CONCLUSIONS:: The addition of cetuximab to the standard chemotherapeutic treatment of RASwt mCRC patients with liver-limited disease resulted in improved response rate and may increase the resectability rate of liver metastasis in this population. It’s worth mentioning that this treatment is cost-effective as the ICER (R$56,750/LYG) of the association of cetuximab and chemotherapy compared to chemotherapy alone results in acceptable levels that justify the higher costs due to significant clinical gains.