Chan Agnes L F, Leung Henry W C, Lu Chin-Li, Lin Shun Jin
School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
Ann Pharmacother. 2009 Feb;43(2):296-303. doi: 10.1345/aph.1L504. Epub 2009 Feb 3.
To identify published, original, cost-effectiveness analyses presenting cost/quality-adjusted life year (QALY) ratios for trastuzumab used as an adjuvant treatment for HER2-positive early breast cancer and to evaluate the quality of reporting the favorable cost-effectiveness ratios.
The terms trastuzumab adjuvant therapy, cost-effectiveness, quality-adjusted, QALY, and early breast cancer were searched in MEDLINE, PubMed, Embase, and CancerLit, as well as in Cochrane economic evaluation and reference lists from 1998 to June 2008. Only English-language publications were eligible.
All published studies examining cost-effectiveness outcomes on the basis of modeling or clinical trials were included. Cost-effectiveness analysis that measured health effects in units other than QALY, life year gained, neoadjuvant data, reviews, and comments were excluded. Each study was assessed independently by 2 trained reviewers.
Thirteen of the 239 articles identified met the inclusion criteria, with 23 cost-effectiveness ratios pertaining to treatment of early breast cancer. These ratios ranged from $5020/QALY to $134,610/QALY. Most studies reported favorable cost-effectiveness values (ie, below $50,000/QALY). About 84.6% were conducted using a Markov model based on data from clinical trials and 15.3% were analyzed by other economic or cost models; 84.6% reported sensitivity analysis, 11 studies (84.6%) clearly described a justification of selecting study design, and only 15.3% noted study limitations. All studies mentioned their perspective; 92.3% did not show the funding source. Methods of reporting costs, effectiveness, and time-horizons for disease states varied significantly. Nine (69.2%) studies used a discount rate of 3%, 3 studies used a discount rate of 5%, and 1 study used 3.5%. The mean quality of the studies was 4.43.
Most studies presenting the frequently proposed threshold of QALY suggest that trastuzumab may be cost-effective for treatment of early breast cancer in a 1-year treatment regimen.
识别已发表的、原创的成本效益分析，这些分析呈现了曲妥珠单抗作为HER2阳性早期乳腺癌辅助治疗的成本/质量调整生命年（QALY）比率，并评估报告有利成本效益比率的质量。
在MEDLINE、PubMed、Embase和CancerLit以及Cochrane经济评价和1998年至2008年6月的参考文献列表中搜索曲妥珠单抗辅助治疗、成本效益、质量调整、QALY和早期乳腺癌等术语。仅纳入英文出版物。
纳入所有基于模型或临床试验检查成本效益结果的已发表研究。排除以QALY以外的单位衡量健康效果、生命年增益、新辅助数据、综述和评论的成本效益分析。每项研究由2名经过培训的评审员独立评估。
在识别出的239篇文章中，有13篇符合纳入标准，有23个与早期乳腺癌治疗相关的成本效益比率。这些比率从5020美元/QALY到134,610美元/QALY不等。大多数研究报告了有利的成本效益值（即低于50,000美元/QALY）。约84.6%的研究使用基于临床试验数据的马尔可夫模型进行，15.3%通过其他经济或成本模型进行分析；84.6%报告了敏感性分析，11项研究（84.6%）明确描述了选择研究设计的理由，只有15.3%指出了研究局限性。所有研究都提到了其视角；92.3%未显示资金来源。报告疾病状态成本、效果和时间范围的方法差异很大。9项（69.2%）研究使用3%的贴现率，3项研究使用5%的贴现率，1项研究使用3.5%。研究的平均质量为4.43。
大多数呈现经常提出的QALY阈值的研究表明，曲妥珠单抗在1年治疗方案中治疗早期乳腺癌可能具有成本效益。
