Federal University of São Paulo, SP, Brazil.
Clin Ther. 2011 Nov;33(11):1769-1780.e2. doi: 10.1016/j.clinthera.2011.09.025. Epub 2011 Oct 22.
Metastatic bone disease (MBD) is responsible for >99% of malignant tumors that affect the bone. MBD patients have increased risk of skeletal complications that are often dramatic and result in loss of function or disability, leading to rapid deterioration of quality of life. Bisphosphonates have become the standard therapy for the treatment and prevention of skeletal-related events (SREs).
The objective of this study was to evaluate the cost-effectiveness of zoledronate and clodronate in the prevention of SREs in patients with MBD.
A pharmacoeconomic analysis was performed for a hypothetical cohort of patients with MBD to compare the costs and consequences of the use of clodronate and zoledronate for treatment and prevention of SREs in MBD in Brazil. The model was constructed using decision analysis techniques. Costs were described in 5 categories-drugs, physician visits, hospitalizations, surgical/medical care, and laboratory tests-and were reported in 2008 Brazilian reais (1 BRL = 0.54 US dollar). Quality-adjusted life years gained was considered as an outcome. Sensitivity analyses tested model robustness.
The total cost of treatment of MBD in Brazil for a 5-year time-horizon was R$46,313 with clodronate and R$50,319 with zoledronate. The estimated number of quality-adjusted life years was 2.00 and 1.90 for clodronate and zoledronate, respectively. Cost-effectiveness ranking was unchanged when model time-horizon was changed to 1 or 10 years. Univariate analysis revealed the incidence of osteonecrosis as a sensitive parameter in the model. Multivariate analysis confirmed base-case results, in which >60% of model iterations favored clodronate over zoledronate.
The present pharmacoeconomic evaluation, under the premises presented, found that clodronate was dominant over zoledronate from both the public and the private health care perspectives in Brazil.
转移性骨病（MBD）负责> 99％的恶性肿瘤影响骨骼。MBD 患者发生骨骼相关并发症的风险增加，这些并发症通常很严重，导致功能丧失或残疾，从而迅速降低生活质量。双膦酸盐已成为治疗和预防骨骼相关事件（SREs）的标准疗法。
本研究旨在评估唑来膦酸和氯膦酸在预防 MBD 患者 SREs 中的成本效益。
对假设的 MBD 患者队列进行药物经济学分析，以比较氯膦酸和唑来膦酸在巴西治疗和预防 MBD 中 SREs 的成本和后果。该模型使用决策分析技术构建。成本分为 5 类 - 药物、医生就诊、住院、手术/医疗护理和实验室检查，并以 2008 年巴西雷亚尔（1 雷亚尔= 0.54 美元）报告。获得的质量调整生命年被视为结果。敏感性分析测试了模型的稳健性。
在 5 年时间范围内，巴西治疗 MBD 的总成本为氯膦酸 46313 雷亚尔，唑来膦酸 50319 雷亚尔。氯膦酸和唑来膦酸估计的质量调整生命年分别为 2.00 和 1.90。当模型时间范围更改为 1 年或 10 年时，成本效益排名保持不变。单变量分析表明，骨坏死的发生率是模型中的一个敏感参数。多变量分析证实了基础案例的结果，其中> 60％的模型迭代结果都倾向于氯膦酸而非唑来膦酸。
在提出的前提下，本药物经济学评估发现，从公共和私人医疗保健的角度来看，在巴西，氯膦酸相对于唑来膦酸具有优势。
