Cardiology Department, Hospital Ramón y Cajal , Madrid , Spain.
J Med Econ. 2012;15 Suppl 1:45-54. doi: 10.3111/13696998.2012.726674. Epub 2012 Sep 12.
The objective of this study was to carry out a long-term cost-effectiveness analysis of rosuvastatin compared with generic atorvastatin in the treatment of patients at high cardiovascular (CV) risk (≥ 5% Systematic COronary Risk Evaluation [SCORE]) and patients with prior cardiovascular disease (CVD) in Spain.
The efficacy data from the Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin (STELLAR) study were used to simulate achievement of low-density lipoprotein cholesterol targets with different doses of rosuvastatin and generic atorvastatin for an initial period of 1 year. A Markov model was used to estimate the number of CV complications, quality-adjusted life years (QALYs), and healthcare costs (lipid-lowering treatment and CV events) for up to 20 years after initial treatment. The analysis was carried out from the perspective of the Spanish National Health System, with costs (in year 2010 euros) and effects being discounted at 3% per year.
Compared with generic atorvastatin, rosuvastatin was cost-effective (cost per QALY gained of less than €30,000) for the primary prevention of CV events in high-risk patients in most sub-groups analyzed. In patients with prior CVD, rosuvastatin was cost-effective in all sub-groups of men and most sub-groups of women. Key limitations of this study were the need to extrapolate data from a single trial to long-term modeled outcomes and the absence of other treatment options in the analysis.
For the treatment of dyslipidemic patients with high CV risk, rosuvastatin is more effective than generic atorvastatin in terms of survival and quality-of-life adjusted survival, with incremental cost-effectiveness ratios within the range generally used in Spain, in most sub-populations defined by various combinations of CV risk factors.
本研究旨在对西班牙高心血管风险（≥5%系统性冠状动脉风险评估[SCORE]）患者和有既往心血管疾病（CVD）患者进行为期长期的成本效益分析，比较瑞舒伐他汀与阿托伐他汀的通用仿制药的成本效益。
使用来自剂量比较瑞舒伐他汀与阿托伐他汀的他汀类药物治疗升高的血脂水平研究（STELLAR）的疗效数据，模拟在最初 1 年内使用不同剂量的瑞舒伐他汀和阿托伐他汀通用仿制药达到 LDL-C 目标。采用马尔可夫模型估计初始治疗后长达 20 年内的心血管并发症、质量调整生命年（QALY）和医疗保健成本（降脂治疗和心血管事件）。该分析从西班牙国家卫生系统的角度进行，成本（2010 年欧元）和效果以每年 3%的贴现率贴现。
与阿托伐他汀通用仿制药相比，瑞舒伐他汀在高危患者的心血管事件一级预防中具有成本效益（每获得一个 QALY 的成本低于 30000 欧元），在大多数分析的亚组中。在有既往 CVD 的患者中，瑞舒伐他汀在男性的所有亚组和大多数女性亚组中都具有成本效益。本研究的主要局限性是需要将单试验数据外推至长期建模结果，以及在分析中缺乏其他治疗选择。
对于高心血管风险的血脂异常患者，瑞舒伐他汀在生存和生存质量调整方面优于阿托伐他汀通用仿制药，增量成本效益比在西班牙通常使用的范围内，在各种心血管危险因素组合定义的大多数亚人群中。
