Benmelstobart Plus Anlotinib Is Unlikely to Be Cost-Effective for Advanced Renal Cell Carcinoma: An Integrated...

Kidney cancer (KC) is an important public-health challenge in China. Although benmelstobart plus anlotinib (BEN + AL) improves survival compared with sunitinib (SUN) for advanced renal cell carcinoma, its economic value in the Chinese healthcare system remains uncertain. Epidemiological trends in KC incidence and disability-adjusted life years (DALYs) in China from 1990 to 2023 were assessed using Global Burden of Disease 2023 data, including joinpoint regression, decomposition analysis, age- and sex-specific patterns. A partitioned survival model was developed to compare BEN + AL with SUN, informed by the phase 3 ETER100 trial. Outcomes included total costs, life-years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) at a willingness-to-pay (WTP) threshold of $ 26 896 per QALY. Sensitivity and scenario analyses were conducted to assess model stability. From 1990 to 2023, incident KC cases in China increased from 19 500 to 61 323, with the age-standardized incidence rate rising from 1.99 to 3.24 per 100 000, particularly among males. DALYs nearly doubled from 326 005 to 582 244, while the age-standardized DALY rate remained stable. Decomposition analysis showed that incidence growth was driven mainly by epidemiological change and population aging, whereas increases in DALYs were largely attributable to aging, partially offset by epidemiological improvements. In the base-case cost-effectiveness analysis, BEN + AL yielded higher effectiveness (4.67 LYs and 3.48 QALYs) than SUN (3.81 LYs and 2.73 QALYs) but at markedly higher cost ($ 192 292.58 vs $ 11 400.59), resulting in an ICER of USD 240 961.36 per QALY. Sensitivity and scenario analyses consistently showed ICERs exceeding the WTP threshold, with progression-free survival value and benmelstobart cost emerged as the primary influencing factors. While the burden of KC in China continues to rise, particularly due to population aging, BEN + AL is unlikely to be cost-effective as first-line therapy for advanced renal cell carcinoma under current pricing.