奥希替尼一线治疗表皮生长因子受体突变阳性晚期非小细胞肺癌的成本效果分析。
Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer.
机构信息
Centro de Estudos e Pesquisa de Hematologia e Oncologia, Faculdade de Medicina do ABC, Santo André, Brazil.
Department of Population Health Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City.
出版信息
JAMA Oncol. 2018 Aug 1;4(8):1080-1084. doi: 10.1001/jamaoncol.2018.1395.
IMPORTANCE
The survival of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene mutations has improved substantially in the last decade with the development of targeted tyrosine kinase inhibitors (TKIs). Osimertinib, a third-generation TKI that is approved by the US Food and Drug Administration for the treatment of patients who develop EGFR T790M mutations, has recently shown improved clinical outcomes compared with gefitinib and erlotinib for treatment-naive patients.
OBJECTIVE
The aim of this study was to assess the cost-effectiveness of osimertinib for the first-line treatment of patients with EGFR-mutated NSCLC.
DESIGN, SETTING, AND PARTICIPANTS: For this cost-effectiveness analysis, we extracted individual patient data from the FLAURA randomized clinical trial and used findings of our earlier meta-analysis to develop a decision-analytic model and determine the cost-effectiveness of osimertinib (AZD9291) compared with first- and second-generation EGFR-TKIs over a 10-year time horizon. All direct costs were based on US and Brazilian payer perspectives.
MAIN OUTCOMES AND MEASURES
The main outcome of this study was the incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained by using osimertinib compared with first- or second-generation EGFR-TKIs in previously untreated EGFR-mutated NSCLC.
RESULTS
In the base case using the data as reported in the FLAURA trial, the incremental QALY for osimertinib was 0.594 compared with the first- and second-generation EGFR-TKIs. In the United States, the osimertinib ICERs were $226 527 vs erlotinib, $231 123 vs gefitinib, and $219 874 vs afatinib. In Brazil, the ICERs were $162 329, $180 804, and $175 432, respectively. The overall survival (95% CI) reported in the FLAURA trial (hazard ratio, 0.63; 95% CI, 0.45-0.88) had the strongest association with the ICER (ranging from $84 342 to $859 771). Osimertinib price adjustments to the FLAURA trial data improved cost-effectiveness. For example, a discount of 10% on osimertinib acquisition cost was associated with a 20% decreased ICER compared with the base case ICER, and a discount of 20% on osimertinib acquisition cost was associated with a 40% decreased ICER compared with the base case ICER.
CONCLUSIONS AND RELEVANCE
At current costs, by World Health Organization cost-effectiveness threshold criteria, osimertinib is not cost-effective for first-line therapy of EGFR-mutated NSCLC in either the United States or Brazil.
重要性
在过去的十年中，随着针对表皮生长因子受体（EGFR）基因突变的靶向酪氨酸激酶抑制剂（TKI）的发展，患有晚期非小细胞肺癌（NSCLC）的患者的生存得到了极大的改善。奥希替尼是一种第三代 TKI，已被美国食品和药物管理局批准用于治疗发生 EGFR T790M 突变的患者，与吉非替尼和厄洛替尼相比，它在治疗初治患者方面显示出了更好的临床结果。
目的
本研究旨在评估奥希替尼作为 EGFR 突变 NSCLC 一线治疗的成本效益。
设计、地点和参与者：在这项成本效益分析中，我们从 FLAURA 随机临床试验中提取了个体患者数据，并利用我们之前的荟萃分析结果来开发决策分析模型，并确定奥希替尼（AZD9291）与第一代和第二代 EGFR-TKI 在 10 年时间范围内的成本效益。所有直接成本均基于美国和巴西支付者的观点。
主要结果和测量
本研究的主要结果是使用奥希替尼治疗未经治疗的 EGFR 突变 NSCLC 与第一代或第二代 EGFR-TKI 相比的增量成本效益比（ICER），以每获得质量调整生命年（QALY）的成本表示。
结果
在使用 FLAURA 试验报告的数据的基础情况下，奥希替尼的增量 QALY 为 0.594，与第一代和第二代 EGFR-TKI 相比。在美国，奥希替尼的 ICER 分别为 226527 美元比厄洛替尼、231123 美元比吉非替尼和 219874 美元比阿法替尼。在巴西，ICER 分别为 162329 美元、180804 美元和 175432 美元。FLAURA 试验报告的总生存（95%CI）（风险比，0.63；95%CI，0.45-0.88）与 ICER 具有最强的相关性（范围从 84342 美元到 859771 美元）。奥希替尼价格调整到 FLAURA 试验数据改善了成本效益。例如，奥希替尼采购成本降低 10%，与基础案例 ICER 相比，ICER 降低 20%，奥希替尼采购成本降低 20%，与基础案例 ICER 相比，ICER 降低 40%。
结论和相关性
按照世界卫生组织的成本效益阈值标准，以目前的成本计算，奥希替尼在治疗美国或巴西的 EGFR 突变 NSCLC 一线治疗方面并不具有成本效益。
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