Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Pharmacoeconomics. 2010;28(1):75-92. doi: 10.2165/10482880-000000000-00000.
Erlotinib (Tarceva), an oral epidermal growth factor receptor tyrosine kinase inhibitor, is associated with modest improvements in survival in patients with advanced non-small cell lung cancer (NSCLC) who have previously received one or more prior chemotherapy regimens. In a well designed clinical trial in this patient population, median overall survival and progression-free survival were significantly longer in patients receiving erlotinib 150 mg/day than in those receiving placebo. Erlotinib is generally well tolerated, with most adverse events being of mild to moderate severity. A large body of modelled pharmacoeconomic data suggests that second- or third-line erlotinib 150 mg/day is a cost-saving option relative to treatment with the approved second-line intravenous chemotherapies of docetaxel and pemetrexed in patients with advanced NSCLC. In patients who had received at least one prior chemotherapy regimen, erlotinib was predicted to be dominant (i.e. more effective and less costly) or cost saving (i.e. equally effective and less costly) relative to docetaxel or pemetrexed with regard to the cost per QALY or life-year gained in cost-effectiveness analyses. Although the effect of erlotinib on overall survival was generally assumed to be equivalent to that of the chemotherapies, the estimated amount of QALYs gained was slightly greater with erlotinib than with docetaxel. In cost-minimization and national budgetary impact analyses, estimated total direct costs with erlotinib were lower than those with docetaxel and pemetrexed, because of the generally lower drug acquisition, administration and adverse event management costs associated with erlotinib. Cost advantages with erlotinib were predicted across analyses, regardless of the type of model developed, specific costs that were included, country that the study was conducted in and year of costing. Sensitivity analyses consistently showed that these results were robust to plausible changes in the key model assumptions. In conclusion, in patients with advanced NSCLC, second- or third-line treatment with erlotinib is clinically effective in improving survival. Available pharmacoeconomic data from several countries, despite some inherent limitations, support the use of erlotinib as a cost-saving treatment relative to chemotherapy with docetaxel or pemetrexed in this patient population.
厄洛替尼(特罗凯)是一种口服表皮生长因子受体酪氨酸激酶抑制剂,在先前接受过一种或多种化疗方案的晚期非小细胞肺癌(NSCLC)患者中,与生存的适度改善相关。在这一患者人群中进行的一项精心设计的临床试验中,接受厄洛替尼 150mg/天治疗的患者中位总生存期和无进展生存期明显长于接受安慰剂的患者。厄洛替尼通常具有良好的耐受性,大多数不良事件为轻度至中度。大量的基于模型的药物经济学数据表明,与二线静脉化疗多西紫杉醇和培美曲塞相比,三线厄洛替尼 150mg/天是一种具有成本效益的选择,用于治疗晚期 NSCLC 患者。对于至少接受过一种化疗方案的患者,与多西紫杉醇或培美曲塞相比,厄洛替尼在成本效益分析中具有成本效益(即更有效且成本更低)或成本节约(即同样有效且成本更低)的预测,这是基于每获得一个质量调整生命年(QALY)或生命年的成本。尽管厄洛替尼对总生存的影响通常被认为与化疗药物相当,但厄洛替尼的估计 QALY 获益量略高于多西紫杉醇。在成本最小化和国家预算影响分析中,由于与厄洛替尼相关的药物获得、管理和不良事件管理成本通常较低,因此厄洛替尼的总直接成本低于多西紫杉醇和培美曲塞。无论开发的模型类型、包含的具体成本、研究进行的国家和成本计价年度如何,厄洛替尼都具有成本优势。敏感性分析一致表明,这些结果在关键模型假设的合理变化下是稳健的。总之,在晚期 NSCLC 患者中,二线或三线治疗使用厄洛替尼可显著改善生存。来自多个国家的可用药物经济学数据,尽管存在一些固有局限性,但支持在这一患者人群中,将厄洛替尼作为一种具有成本效益的治疗选择,而不是使用多西紫杉醇或培美曲塞化疗。