Reed Shelby D, Li Yanhong, Anstrom Kevin J, Schulman Kevin A
Center for Clinical and Genetic Economics and Outcomes Research and Assessment Group, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA.
J Clin Oncol. 2009 May 1;27(13):2185-91. doi: 10.1200/JCO.2008.19.6352. Epub 2009 Mar 30.
Using data from a recent randomized trial, we evaluated the cost effectiveness of ixabepilone plus capecitabine versus capecitabine alone in patients with predominantly metastatic breast cancer considered to be taxane-resistant and previously treated with or resistant to an anthracycline.
We developed a stochastic decision-analytic model to represent data collected in the trial on medical resource use, health-related quality of life, and clinical outcomes. Estimates of overall survival were conditional on level of tumor response. We assigned monthly costs and utility weights according to periods defined by the duration of study treatment, time from discontinuation of the study drug until disease progression, and from progression until death and were specific to the level of response and receipt of subsequent therapy. Medical resources were valued in 2008 US dollars. We performed Monte Carlo simulations and sensitivity analyses to evaluate model uncertainty.
Overall survival was significantly associated with level of tumor response (P < .001). Total costs were estimated at $60,900 for patients receiving ixabepilone plus capecitabine and $30,000 for patients receiving capecitabine alone. The estimated gain in life expectancy with ixabepilone was 1.96 months (95% CI, 1.36 to 2.64 months); the estimated gain in quality-adjusted survival was 1.06 months (95% CI, 0.09 to 2.03 months). The resulting incremental cost-effectiveness ratio was $359,000 per quality-adjusted life-year (95% CI, $183,000 to $4,030,000). In sensitivity analyses, the results were robust to changes in numerous inputs and assumptions.
Addition of ixabepilone to capecitabine adds approximately $31,000 to overall medical costs and affords approximately 1 additional month of quality-adjusted survival.
利用近期一项随机试验的数据，我们评估了伊沙匹隆联合卡培他滨与单用卡培他滨相比，在主要为转移性乳腺癌且被认为对紫杉烷耐药、先前接受过蒽环类药物治疗或对其耐药的患者中的成本效益。
我们建立了一个随机决策分析模型，以呈现试验中收集的关于医疗资源使用、健康相关生活质量和临床结局的数据。总生存期的估计以肿瘤反应水平为条件。我们根据研究治疗持续时间、从停用研究药物到疾病进展的时间以及从进展到死亡所定义的时间段分配每月成本和效用权重，并且这些权重特定于反应水平和后续治疗的接受情况。医疗资源以2008年美元计价。我们进行了蒙特卡洛模拟和敏感性分析以评估模型的不确定性。
总生存期与肿瘤反应水平显著相关（P <.001）。接受伊沙匹隆联合卡培他滨的患者总费用估计为60,900美元，而单用卡培他滨的患者为30,000美元。伊沙匹隆使预期寿命估计增加1.96个月（95%可信区间，1.36至2.64个月）；质量调整生存期估计增加1.06个月（95%可信区间，0.09至2.03个月）。由此产生的增量成本效益比为每质量调整生命年359,000美元（95%可信区间，183,000至4,030,000美元）。在敏感性分析中，结果对众多输入和假设的变化具有稳健性。
在卡培他滨基础上加用伊沙匹隆使总体医疗成本增加约31,000美元，并使质量调整生存期增加约1个月。
