OBJECTIVES : Colorectal cancer (CRC) is the third most common cancer in men and the second in women worldwide. Each year, about 376,000 new cases were diagnosed and nearly 191,000 patients died from CRC in China. Regorafenib is an oral multi-kinase inhibitor and was approved in 2017 by CFDA as a third-line option for the treatment of patients with mCRC. While the clinical effect of regorafenib for third-line metastatic colorectal cancer has been established, the economic effect of adopting regorafenib is still unclear in China. The present study aimed to examine the cost-effectiveness of regorafenib compared to cetuximab plus irinotecan in the Chinese setting.

METHODS : A Markov model was constructed to conduct the cost-effectiveness analysis from a third-party payer perspective. The cost of oncology drug, utilization of both in-hospital and outpatient care facilities, administration of medications via parenteral routes, use of supportive care medications, clinical monitoring with lab tests and diagnostic imaging, and care for treatment-emergent severe adverse events were considered. Clinical effectiveness data were obtained from the CONCUR trial. One-way sensitivity and probability sensitivity analyses were conducted to examine the robustness of the base-case findings.

RESULTS : The model projected patients on regorafenib had an incremental gain of 0.03 QALYs relative to cetuximab plus irinotecan (0.68 vs 0.65) at a cost-saving of ¥195,756 (¥221,860 vs. ¥417,616). For the subpopulation who received no previous targeted treatment, compared to cetuximab plus irinotecan, regorafenib was expected to result in additional gains of 0.15 QALYs at cost-saving of ¥95,987. Probability sensitivity analyses shows that at the threshold of 3 times of GDP per capita of China (¥53,980*3), regorafenib has the probability of 82% to be cost-effective against with cetuximab plus irinotecan.

CONCLUSIONS : Regorafenib monotherapy is cost-saving and more effective compared with cetuximab plus irinotecan regimen in treatment patients with mCRC at third-line treatment setting in China.