Lam Simon W, Wai Maya, Lau Jessica E, McNamara Michael, Earl Marc, Udeh Belinda
Department of Pharmacy, Cleveland Clinic, Cleveland, Ohio.
Cancer Institute, Cleveland Clinic, Cleveland, Ohio.
Pharmacotherapy. 2017 Jan;37(1):94-103. doi: 10.1002/phar.1870. Epub 2017 Jan 6.
Gastric cancer is the fifth most common malignancy and second leading cause of cancer-related mortality. Chemotherapy options for patients who fail first-line treatment are limited. Thus the objective of this study was to assess the cost-effectiveness of second-line treatment options for patients with advanced or metastatic gastric cancer.
Cost-effectiveness analysis using a Markov model to compare the cost-effectiveness of six possible second-line treatment options for patients with advanced gastric cancer who have failed previous chemotherapy: irinotecan, docetaxel, paclitaxel, ramucirumab, paclitaxel plus ramucirumab, and palliative care.
The model was performed from a third-party payer's perspective to compare lifetime costs and health benefits associated with studied second-line therapies. Costs included only relevant direct medical costs. The model assumed chemotherapy cycle lengths of 30 days and a maximum number of 24 cycles. Systematic review of literature was performed to identify clinical data sources and utility and cost data. Quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated. The primary outcome measure for this analysis was the ICER between different therapies, where the incremental cost was divided by the number of QALYs saved. The ICER was compared with a willingness-to-pay (WTP) threshold that was set at $50,000/QALY gained, and an exploratory analysis using $160,000/QALY gained was also used. The model's robustness was tested by using 1-way sensitivity analyses and a 10,000 Monte Carlo simulation probabilistic sensitivity analysis (PSA). Irinotecan had the lowest lifetime cost and was associated with a QALY gain of 0.35 year. Docetaxel, ramucirumab alone, and palliative care were dominated strategies. Paclitaxel and the combination of paclitaxel plus ramucirumab led to higher QALYs gained, at an incremental cost of $86,815 and $1,056,125 per QALY gained, respectively. Based on our prespecified WTP threshold, our base case analysis demonstrated that irinotecan alone is the most cost-effective regimen, and both paclitaxel alone and the combination of paclitaxel and ramucirumab were not cost-effective (ICER more than $50,000). Both 1-way sensitivity analyses and PSA demonstrated the model's robustness. PSA illustrated that paclitaxel plus ramucirumab was extremely unlikely to be cost-effective at a WTP threshold less than $400,000/QALY gained.
Irinotecan alone appears to be the most cost-effective second-line regimen for patients with gastric cancer. Paclitaxel may be cost-effective if the WTP threshold was set at $160,000/QALY gained.
胃癌是第五大常见恶性肿瘤，也是癌症相关死亡的第二大主要原因。一线治疗失败的患者的化疗选择有限。因此，本研究的目的是评估晚期或转移性胃癌患者二线治疗方案的成本效益。
采用马尔可夫模型进行成本效益分析，以比较六种可能的二线治疗方案对先前化疗失败的晚期胃癌患者的成本效益：伊立替康、多西他赛、紫杉醇、雷莫西尤单抗、紫杉醇联合雷莫西尤单抗和姑息治疗。
该模型从第三方支付者的角度进行，以比较与所研究的二线治疗相关的终身成本和健康效益。成本仅包括相关的直接医疗成本。该模型假设化疗周期为30天，最多24个周期。进行文献系统综述以确定临床数据源以及效用和成本数据。计算质量调整生命年（QALY）和增量成本效益比（ICER）。该分析的主要结果指标是不同疗法之间的ICER，其中增量成本除以节省的QALY数量。将ICER与设定为每获得一个QALY支付意愿（WTP）阈值50,000美元进行比较，还使用了每获得一个QALY支付意愿阈值160,000美元的探索性分析。通过单因素敏感性分析和10,000次蒙特卡洛模拟概率敏感性分析（PSA）对模型的稳健性进行了测试。伊立替康的终身成本最低，与0.35年的QALY增益相关。多西他赛、单独使用雷莫西尤单抗和姑息治疗是劣势策略。紫杉醇以及紫杉醇联合雷莫西尤单抗导致更高的QALY增益，每获得一个QALY的增量成本分别为86,815美元和1,056,125美元。根据我们预先设定的WTP阈值，我们的基础病例分析表明，单独使用伊立替康是最具成本效益的方案，而单独使用紫杉醇以及紫杉醇与雷莫西尤单抗的联合方案均不具有成本效益（ICER超过50,000美元）。单因素敏感性分析和PSA均证明了模型的稳健性。PSA表明，在每获得一个QALY支付意愿阈值低于400,000美元的情况下，紫杉醇联合雷莫西尤单抗极不可能具有成本效益。
单独使用伊立替康似乎是胃癌患者最具成本效益的二线方案。如果将每获得一个QALY支付意愿阈值设定为160,000美元，紫杉醇可能具有成本效益。
