【摘要】 目的 从我国卫生体系视角出发，评估头孢地尔对比最佳可用疗法（BAT）或标准疗法（SOC）治疗确诊或疑似耐碳青霉烯类革兰氏阴性菌严重感染的经济性，并探讨其合理定价。方法 基于两项Ⅲ期临床试验（CREDIBLE-CR与GAME CHANGER）数据构建决策树模型，模拟头孢地尔在确诊耐碳青霉烯类革兰氏阴性菌感染的救治场景（场景一）与疑似上述耐药菌感染的初始经验性治疗场景（场景二）下的成本-效果。主要结局指标为增量成本-效果比（ICER），意愿支付阈值设定为2024年我国人均国内生产总值（GDP）的1～3倍。采用单因素及概率敏感性分析检验结果的稳健性，并在此基础上探索头孢地尔在我国市场的合理定价区间。结果 场景一的结果表明，头孢地尔组的治愈率高于BAT组（47.50%vs. 34.21%），但其ICER为415 065.03元/例治愈，超出3倍我国人均GDP的阈值；而场景二揭示，头孢地尔相对于SOC的ICER高达1 362 446.16元/例治愈，远超意愿支付阈值。敏感性分析表明，头孢地尔的治疗时间与价格是影响方案经济性的关键因素。在上述2个场景中，头孢地尔单价需分别降至683.47、242.00元/g以下方具经济性。结论 基于当前市场价格，头孢地尔治疗确诊或疑似耐碳青霉烯类革兰氏阴性菌严重感染在我国卫生体系中的经济性不足，需通过价格谈判或医保分层支付策略提高其可及性。更多还原

【Abstract】 OBJECTIVE To evaluate the cost-effectiveness of cefiderocol versus best available therapy(BAT) or standard-ofcare(SOC) for the treatment of confirmed or suspected carbapenem-resistant Gram-negative bacterial(CRGNB) serious infections from the perspective of the Chinese healthcare system, and to explore its reasonable pricing. METHODS A decision tree model was constructed based on data from two phase Ⅲ clinical trials(CREDIBLE-CR and GAME CHANGER) to simulate the costeffectiveness of cefiderocol in two scenarios: salvage therapy for confirmed CRGNB infection(scenario 1) and empirical therapy for suspected CRGNB infection(scenario 2). The primary outcome measure was the incremental cost-effectiveness ratio(ICER). The willingness-to-pay(WTP) was set at 1 to 3 times China’s per capita GDP in 2024. To verify the robustness of the results, oneway and probabilistic sensitivity analyses were conducted, and based on these, a reasonable price range for cefiderocol in the Chinese market was explored. RESULTS The results for scenario 1 showed that the clinical cure rate in the cefiderocol group was higher than that in the BAT group(47.50% vs. 34.21%), but its ICER was 415 065.03 yuan per cured case, exceeding three times China’s GDP per capita. Scenario 2 revealed that the ICER for cefiderocol relative to SOC was as high as 1 362 446.16 yuan per cured case, far exceeding the WTP. Sensitivity analysis indicated that the treatment duration and price of cefiderocol were key factors affecting its cost-effectiveness. In the two scenarios described above, the unit price of cefiderocol must fall below 683.47 and 242.00 yuan/g, respectively, to be considered cost-effective. CONCLUSIONS Based on the current market price, cefiderocol lacks sufficient cost-effectiveness for treating confirmed or suspected CRGNB serious infections within China’s healthcare system. To improve its accessibility, price negotiations or a tiered medical insurance payment strategy are required.更多还原