OBJECTIVES: 36,360 new cases of CRC are expected for 2018/19 in Brazil. 5-year survival rate for patients with mCRC diagnosed in stage IV is as low as 12% mainly due to currently limited treatment options. Regorafenib was approved for the treatment of adult patients with mCRC previously treated with, or not eligible for, available therapies in Brazil in late 2018. The objective is to determine the budget impact of the incorporation of regorafenib in SHS for 3^rd-line mCRC in comparison to best supportive care (BSC).

METHODS: Budget impact analysis (BIA) considered a 5-year time horizon. 22.7% of Brazilian population is covered by SHS. The number of 3^rd-line mCRC eligible patients was calculated based on expected rates of metastatic disease according to stage of diagnosis and progression free and overall survival rates of standard 1^st and 2^nd-line treatments applied to the number of estimated new Brazilian CRC cases. Initial market-share for regorafenib was assumed to be 40%, reaching 80% by the 5^th year in the proposed scenario. Current scenario considers all patients receive BSC. The analysis considered direct costs related to treatment and adverse events management obtained from local public sources and clinical parameters from the CORRECT study. A deterministic sensitivity analysis was done to account for parameters’ uncertainties.

RESULTS: The number of new mCRC patients eligible for 3^rd-line was estimated to be 2141 in the 1^st year, reaching 2546 in the 5^th. BIA showed overall impact of BRL 326 million for SHS in 5 years. The parameter with highest impact on the results was regorafenib’s market-share in the proposed scenario.

CONCLUSIONS: The budget impact of regorafenib’s incorporation in comparison to BSC in SHS is related to the current unmet need of mCRC treatment in Brazil for patients who previously had no other effective therapies available.