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托莱西单抗用于高胆固醇血症患者的成本-效果分析
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| 篇名： | 托莱西单抗用于高胆固醇血症患者的成本-效果分析 |
| TITLE： | Cost-effectiveness analysis of tafolecimab in patients with hypercholesterolemia |
| 摘要： | 目的 评估托莱西单抗治疗高胆固醇血症的经济性，为优化高胆固醇血症管理策略、合理配置医疗资源提供依据。方法基于中国卫生体系视角，构建11种互斥健康状态的Markov转移队列模型，模拟目标患者的进展和预后。模型周期为1年，研究时限为30年。依据CREDIT系列临床试验数据设定模型状态间的转移概率，健康效用值及医疗成本参数来自统计年鉴和已发表文献。以质量调整生命年（QALY）作为健康产出评价指标，采用成本-效果分析法，分别计算在他汀类药物基础上联用托莱西单抗150mg每2周注射1次（q2w）、450mg每4周注射1次（q4w）、600mg每6周注射1次（q6w）3种方案相对于对照方案（他汀类药物）的增量成本-效果比（ICER）。以中国1～3倍2024年人均国内生产总值（GDP）作为意愿支付阈值（WTP），贴现率为5%。通过单因素敏感性分析、概率敏感性分析及情境分析验证模型的稳健性。结果托莱西单抗150mgq2w方案较对照方案的ICER为235827.73元/QALY，低于WTP（287100元/QALY），具有一定经济性；而450mgq4w和600mgq6w方案相比于对照方案的ICER分别为329498.24和318630.51元/QALY，均高于WTP，不具有经济性。单因素敏感性分析显示，贴现率为关键影响因素。概率敏感性分析显示，在本研究设定的WTP下，托莱西单抗450mgq4w和600mgq6w方案具有经济学优势的概率分别为15.3%和22.4%，而150mgq2w方案具有经济学优势的概率达85.2%。情境分析结果显示，模拟时限在5～30年内，托莱西单抗相较于对照方案的ICER逐步降低；托莱西单抗降价超过20%时，3种给药方案均具有经济性。结论在当前中国卫生体系视角下，与单用他汀类药物相比，托莱西单抗150mgq2w方案的联用能够改善高胆固醇血症患者的健康结局，在现有WTP下具有经济性。 |
| ABSTRACT： | OBJECTIVE To evaluate the cost-effectiveness of tafolecimab in patients with hypercholesterolemia， and provide support for optimizing management strategies for hypercholesterolemia and healthcare resource allocation. METHODS From the perspective of the Chinese healthcare system， an 11-state mutually exclusive Markov cohort model was developed to simulate disease progression and prognosis in the target population. The model cycle was set to one year， with a 30-year time horizon. Transition probabilities between health states were derived from the CREDIT series of clinical trials， while health utility values and medical cost parameters were sourced from the statistical yearbook and published literature. Quality-adjusted life years （QALYs） were used as the measure of health outcomes. Cost-effectiveness analysis was employed to calculate the incremental cost- effectiveness ratio （ICER） for three dosing regimens of tafolecimab [150 mg every 2 weeks （q2w）， 450 mg every 4 weeks （q4w）， and 600 mg every 6 weeks （q6w）] in combination with statins compared with control therapy （statins）. Using 1-3 times the per capita gross domestic product （GDP） of China in 2024 as willingness-to-pay threshold（WTP）， with a discount rate of 5%. Model robustness was assessed through one-way sensitivity analysis， probabilistic sensitivity analysis， and scenario analysis. RESULTS The 150 mg q2w regimen of tafolecimab yielded an ICER of 235 827.73 yuan/QALY， which was below the WTP （287 100 yuan/ QALY）， indicating that the regimen was cost-effective. In contrast， the ICERs for the 450 mg q4w and 600 mg q6w regimens were 329 498.24 and 318 630.51 yuan/QALY， respec-tively， both exceeding the WTP and thus not cost-effective.One-way sensitivity analysis identified the discount rate as a key influencing factor. Probabilistic sensitivity analysis showed that under the WTP set in this study， the probabilities of cost-effectiveness for the 450 mg q4w and 600 mg q6w regimens were 15.3% and 22.4%， respectively， while the 150 mg q2w regimen had an 85.2% probability of being cost-effective. The situational analysis revealed that， over a simulated time horizon of 5 to 30 years， the ICER of tafolecimab was progressively reduced compared with the control regimen. When the price of tafolecimab was lowered by more than 20%， all three dosing regimens were demonstrated to be cost-effective.CONCLUSIONS Under the current Chinese healthcare system， compared with statin monotherapy， tafolecimab （150 mg q2w） combination improves health outcomes in patients with hypercholesterolemia， and is cost-effective given the current WTP. |
| 期刊： | 2025年第36卷第22期 |
| 作者： | 李彤；张新悦；冯梦文；冯振 |
| AUTHORS： | LI Tong，ZHANG Xinyue，FENG Mengwen，FENG Zhen |
| 关键字： | 托莱西单抗；他汀类；高胆固醇血症；成本-效果分析；Markov模型；药物经济学 |
| KEYWORDS： | tafolecimab； statin； hypercholesterolemia； cost-effectiveness analysis； Markov model； pharmacoeconomics |
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