Economic evaluation of newly approved cetuximab biosimilars for first-line treatment of RAS/BRAF wild-type metastatic colorectal cancer in China.

BACKGROUND: Domestic cetuximab biosimilars have recently expanded the EGFR-targeted treatment landscape for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) in China, but their economic value remains uncertain. METHODS: A three-state Markov model was developed from the Chinese healthcare system perspective to evaluate newly approved cetuximab biosimilars for first-line RAS/BRAF wild-type mCRC. Clinical inputs were derived from two phase III trials (NCT04835142 and NCT03206151), with long-term survival extrapolated from reconstructed Kaplan-Meier data. Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were estimated over a 10-year horizon using 14-day cycles, 4.5% discounting, and willingness-to-pay (WTP) thresholds of USD 29,241.86 and USD 43,862.79/QALY. Deterministic and probabilistic sensitivity analyses were conducted, and an exploratory contextual cross-trial assessment was performed. RESULTS: Reference cetuximab plus chemotherapy yielded 1.60 QALYs at a cost of USD 246,542.51, compared with 1.53 QALYs and USD 231,648.11 for A140 plus chemotherapy, resulting in an ICER of USD 193,033.41/QALY. CMAB009 plus FOLFIRI yielded 1.83 QALYs at a cost of USD 214,917.27, compared with 1.46 QALYs and USD 148,659.96 for FOLFIRI alone, resulting in an ICER of USD 179,684.65/QALY. Both ICERs exceeded the predefined WTP thresholds. Exploratory contextual analyses suggested lower modeled costs for CMAB009 than A140, but results were sensitive to survival assumptions and should not be interpreted as formal comparative evidence. CONCLUSION: Under current pricing conditions, the economic value of cetuximab biosimilars varied across trial-defined comparisons and was mainly driven by drug acquisition costs.