摘要
Abstract
Objective To assess the cost-effectiveness of Rosuvastatin Calcium and Ezetimibe Tablets(Single-Pill Combination therapy,SPC)versus free combination treatment(FCT,Rosuvastatin 10 mg/Ezetimibe 10 mg)in Chinese adult hypercholesterolemia patients whose LDL-C was not adequately controlled receiving statin monotherapy.Methods A Markov model was constructed from the healthcare system perspective,incorporating seven health states:event-free,non-fatal revascularization,non-fatal myocardial infarction(0~1 year,>1 year),non-fatal ischemic stroke(0~1 year,>1 year),and death.LDL-C reduction data for both groups were derived from a Chinese multicenter retrospective case registry study.Clinical benefits were extrapolated from the difference in LDL-C reduction to estimate the risk difference of major adverse cardiovascular events(MACE).Costs and utility values were sourced from literature.The model used a one-year cycle length and simulated outcomes up to the Chinese life expectancy of 79 years.Both costs and effects were discounted at 5%annually.Additionally,a scenario analysis was conducted on different SPCs,including Rosuvastatin Calcium and Ezetimibe Tablets(Ⅰ)(each tablet containing 10 mg of rosuvastatin[as rosuvastatin]and 10 mg of ezetimibe)and Ezetimibe and Atorvastatin Calcium Tablets(Ⅱ)(each tablet containing 10 mg of ezetimibe and 20 mg of atorvastatin calcium[as atorvastatin]).To validate the uncertainty of the study results,one-way and probabilistic sensitivity analyses(PSA)were performed.Results At daily costs of ¥3.10 for SPC versus ¥3.22 for FCT,SPC demonstrated clear dominance with cost savings of ¥7457 and a QALY gain of 0.177.In the scenario analysis,Rosuvastatin Calcium and Ezetimibe Tablets(Ⅰ)showed similar dominance versus Ezetimibe and Atorvastatin Calcium Tablets(Ⅱ)(cost savings:¥1790;QALY gain:0.029).One-way sensitivity analysis reveals that the main factors affecting the study results are the unit cost of the minimum dose of SPC,the ratio of cardiovascular mortality change per unit LDL-C level reduction,and the ratio of revascularization rate change per unit LDL-C level reduction.PSA shows that if China's 2024 per capita GDP(¥95,749)is used as the willingness-to-pay threshold,the probability of SPC being cost-effective compared to FCT is 100%,further validating the robustness of the study results.Conclusion Compared with FCT,SPC demonstrate superior efficacy and lower costs,emerging as the dominant treatment option for Chinese adult patients with hypercholesterolemia inadequately controlled with statin monotherapy.关键词
瑞舒伐他汀依折麦布片(Ⅰ)/高胆固醇血症/成本-效果分析Key words
Rosuvastatin Calcium and Ezetimibe Tablets/Hypercholesterolemia/Cost-effectiveness analysis分类
医药卫生