Zoledronic acid - A pharmacoeconomic review of its use in the management of bone Metastases
Zoledronic acid - A pharmacoeconomic review of its use in the management of bone Metastases
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DOI：
10.2165/00019053-200826030-00007
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发表时间：
2008-01-01
影响因子：
4.4
通讯作者：
Plosker, Greg L.
中科院分区：
文献类型：
--
作者：
McKeage, Kate;Plosker, Greg L.
唑来膦酸（Zometa（R））是第三代含氮肠外双膦酸盐，适用于治疗实体瘤或多发性骨髓瘤引起的骨转移和恶性高钙血症（HCM）。在晚期乳腺癌或前列腺癌患者中，与安慰剂相比，唑来膦酸4 mg每3-4周一次，持续15个月，可显著降低发生≥ 1起除HCM外的泌尿系统相关事件（SRE）的患者比例。在晚期乳腺癌或多发性骨髓瘤患者中，唑来膦酸4 mg或帕米膦酸90 mg每3-4周一次治疗长达25个月的患者SRE的发生率相似，但在乳腺癌患者中，唑来膦酸降低了SRE的风险，包括HCM，在基于这些和/或其他试验的疗效和资源使用数据比较直接成本的模拟成本效用研究中，结果各不相同。在最近一项从英国NHS角度进行的研究中，对晚期乳腺癌女性进行了为期10年的治疗期建模，静脉注射唑来膦酸和口服伊班膦酸占主导地位。就每增加一个QALY的增量成本而言，静脉注射唑来膦酸是最具成本效益的，其次是口服伊班膦酸、静脉注射帕米膦酸和静脉注射伊班膦酸。另外两项在晚期乳腺癌患者中进行的建模分析也是从NHS的角度进行的，评估了接受激素治疗或静脉化疗的患者中三种双膦酸盐治疗的成本效用。分析是在14.3个月（即预期生存期）内建模的，假设与临床乳腺癌试验的结果有显著差异。此外，唑来膦酸的疗效假设并非基于药物的临床试验。这些分析的结果表明，口服伊班膦酸比静脉注射唑来膦酸和静脉注射帕米膦酸在获得的每QALY增量成本方面更具成本效益。在一项从第三方角度对晚期前列腺癌患者进行的全球15个月模拟成本效益分析中，唑来膦酸组与未治疗组相比，每增加一个QALY的成本为159200美元（2000年数值），比普遍接受的成本效益阈值大约高出3倍。最近的一项模拟经济分析表明，在晚期乳腺癌患者的骨转移管理中，相对于无治疗，静脉注射唑来膦酸4 mg占主导地位。相比之下，在晚期前列腺癌患者中，唑来膦酸4 mg治疗与不治疗相比，每QALY增加的成本预计高于普遍接受的阈值。在一项研究中，与其他双膦酸盐相比，静脉注射唑来膦酸治疗晚期乳腺癌的成本效益高于口服或静脉注射伊班膦酸和静脉注射帕米膦酸，但在另一项研究中，其成本效益低于口服伊班膦酸。需要进一步的疗效和经济数据比较静脉注射唑来膦酸与口服伊班膦酸。同时，唑来膦酸似乎是治疗晚期乳腺癌患者骨转移的最具成本效益的静脉注射双膦酸盐，可能也适用于不同类型的晚期实体瘤患者。
Zoledronic acid (Zometa (R)) is a third-generation nitrogen-containing parenteral bisphosphonate indicated for the treatment of bone metastases due to solid tumours or multiple myeloma and for hypercalcaemia of malignancy (HCM). In patients with advanced breast or prostate cancer, zoledronic acid 4 mg every 3-4 weeks for up to 15 months significantly reduced the proportion of patients with >= 1 skeletal-related event (SRE), excluding HCM, compared with placebo. In patients with advanced breast cancer or multiple myeloma, the incidence of SREs was similar in patients treated with zoledronic acid 4 mg or pamidronic acid 90 mg every 3-4 weeks for up to 25 months but, in breast cancer patients, zoledronic acid reduced the risk of SREs, including HCM, by an additional 20% compared with pamidronic acid.In modelled cost-utility studies comparing direct costs based on efficacy and resource-use data from these and/or other trials, results have varied. In the most recent study performed from the perspective of the UK NHS and modelled over a 10-year treatment period in women with advanced breast cancer, intravenous zoledronic acid and oral ibandronic acid were dominant over no treatment. Intravenous zoledronic acid was the most cost effective, in terms of incremental costs per QALY gained, followed by oral ibandronic acid, intravenous pamidronic acid and intravenous ibandronic acid. Two other modelled analyses in patients with advanced breast cancer, also conducted from the perspective of the NHS, evaluated the cost utility of three bisphosphonate therapies in patients receiving hormonal therapy or intravenous chemotherapy. Analyses were modelled over 14.3 months (i.e. expected survival) and assumptions varied markedly from results in clinical breast cancer trials. Also, efficacy assumptions for zoledronic acid were not based on clinical trials with the drug. The results of these analyses suggest that oral ibandronic acid is more cost effective than intravenous zoledronic acid and intravenous pamidronic acid in terms of incremental cost per QALY gained.In a global, 15-month modelled cost-effectiveness analysis of patients with advanced prostate cancer, conducted from a third-party perspective, the incremental cost per QALY gained for zoledronic acid versus no treatment was $US 159 200 (year 2000 value), which is about 3-fold greater than commonly accepted thresholds for cost effectiveness.In conclusion, a recent modelled economic analysis suggests that intravenous zoledronic acid 4 mg is dominant relative to no treatment in the management of bone metastases in patients with advanced breast cancer. In contrast, in patients with advanced prostate cancer, the incremental cost per QALY gained for zoledronic acid 4 mg versus no treatment was predicted to be higher than commonly accepted thresholds. Compared with other bisphosphonates in the setting of advanced breast cancer, intravenous zoledronic acid was more cost effective than oral or intravenous ibandronic acid and intravenous pamidronic acid in one study, but less cost effective than oral ibandronic acid in another. Further efficacy and economic data comparing intravenous zoledronic acid with oral ibandronic acid are needed. Meanwhile, zoledronic acid appears to be the most cost effective intravenous bisphosphonate for the management of bone metastases in patients with advanced breast cancer and possibly in patients with different types of advanced solid tumours.