Le Quang A, Hay Joel W
Department of Clinical Pharmacy, Pharmaceutical Economics and Policy, University of Southern California, Los Angeles, California 90089-9004, USA.
Cancer. 2009 Feb 1;115(3):489-98. doi: 10.1002/cncr.24033.
A recent clinical trial demonstrated that the addition of lapatinib to capecitabine in the treatment of HER-2-positive advanced breast cancer (ABC) significantly increases median time to progression. The objective of the current analysis was to assess the cost-effectiveness of this therapy from the US societal perspective.
A Markov model comprising 4 health states (stable disease, respond-to-therapy, disease progression, and death) was developed to estimate the projected-lifetime clinical and economic implications of this therapy. The model used Monte Carlo simulation to imitate the clinical course of a typical patient with ABC and updated with response rates and major adverse effects. Transition probabilities were estimated based on the results from the EGF100151 and EGF20002 clinical trials of lapatinib. Health state utilities, direct and indirect costs of the therapy, major adverse events, laboratory tests, and costs of disease progression were obtained from published sources. The model used a 3% discount rate and reported in 2007 US dollars.
Over a lifetime, the addition of lapatinib to capecitabine as combination therapy was estimated to cost an additional $19,630, with an expected gain of 0.12 quality-adjusted life years (QALY) or an incremental cost-effectiveness ratio (ICER) of $166,113 per QALY gained. The 95% confidence limits of the ICER ranged from $158,000 to $215,000/QALY. A cost-effectiveness acceptability curve indicated less than 1% probability that the ICER would be lower than $100,000/QALY.
Compared with commonly accepted willingness-to-pay thresholds in oncology treatment, the addition of lapatinib to capecitabine is not clearly cost-effective; and most likely to result in an ICER somewhat higher than the societal willingness-to-pay threshold limits.
最近一项临床试验表明，在治疗HER-2阳性晚期乳腺癌（ABC）时，在卡培他滨中添加拉帕替尼可显著延长中位进展时间。本分析的目的是从美国社会角度评估这种治疗方法的成本效益。
开发了一个包含4种健康状态（疾病稳定、对治疗有反应、疾病进展和死亡）的马尔可夫模型，以估计这种治疗方法对预期寿命的临床和经济影响。该模型使用蒙特卡罗模拟来模拟典型ABC患者的临床病程，并根据缓解率和主要不良反应进行更新。转移概率根据拉帕替尼的EGF100151和EGF20002临床试验结果进行估计。健康状态效用、治疗的直接和间接成本、主要不良事件、实验室检查以及疾病进展成本均来自已发表的资料。该模型使用3%的贴现率，并以2007年美元报告。
在整个生命周期内，在卡培他滨中添加拉帕替尼作为联合治疗估计要额外花费19,630美元，预期获得0.12个质量调整生命年（QALY），即每获得一个QALY的增量成本效益比（ICER）为166,113美元。ICER的95%置信区间为每QALY 158,000美元至215,000美元。成本效益可接受性曲线表明，ICER低于100,000美元/QALY的概率小于1%。
与肿瘤治疗中普遍接受的支付意愿阈值相比，在卡培他滨中添加拉帕替尼的成本效益并不明显；而且很可能导致ICER略高于社会支付意愿阈值上限。
