Wong Yu-Ning, Meropol Neal J, Speier William, Sargent Daniel, Goldberg Richard M, Beck J Robert
Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
Cancer. 2009 May 15;115(10):2081-91. doi: 10.1002/cncr.24246.
Since 1996, 6 new drugs have been introduced for the treatment of metastatic colorectal cancer. Although they are promising, these drugs frequently are given in the palliative and are much more expensive than older treatments. The objective of the current study was to measure the cost implications of treatment with sequential regimens that include chemotherapy and/or monoclonal antibodies.
A Markov model was used to evaluate a hypothetical cohort of 1000 patients with newly diagnosed, metastatic colorectal cancer. Patients supposedly received up to 3 lines of treatment before supportive care and subsequent death. Data were obtained from published, multicenter phase 2 and randomized phase 3 clinical trials. Sensitivity analyses were conducted on the efficacy, toxicity, and cost.
Using drug costs alone, treatment that included new chemotherapeutic agents increased survival at an incremental cost-effectiveness ratio (ICER) of $100,000 per discounted life-year (DLY). The addition of monoclonal antibodies improved survival at an ICER of >$170,000 per DLY. The results were most sensitive to changes in the initial regimen. Even with significant improvements in clinical characteristics (efficacy and toxicity), treatment with the most effective regimens still had very high ICERs.
Treatment of metastatic colorectal cancer with the most effective regimens came at very high incremental costs. The authors concluded that cost-effectiveness analyses should be a routine component of the drug-development process, so that physicians and patients are informed appropriately regarding the value of new innovations.
自1996年以来,已有6种新药被用于治疗转移性结直肠癌。尽管这些药物前景广阔,但它们常用于姑息治疗,且比旧疗法昂贵得多。本研究的目的是评估包含化疗和/或单克隆抗体的序贯治疗方案的成本影响。
使用马尔可夫模型评估1000例新诊断的转移性结直肠癌患者的假设队列。患者在接受支持治疗和随后死亡前最多接受3线治疗。数据来自已发表的多中心2期和随机3期临床试验。对疗效、毒性和成本进行敏感性分析。
仅使用药物成本,包含新化疗药物的治疗以每贴现生命年(DLY)100,000美元的增量成本效益比(ICER)提高了生存率。添加单克隆抗体以每DLY >170,000美元的ICER提高了生存率。结果对初始治疗方案的变化最为敏感。即使临床特征(疗效和毒性)有显著改善,最有效治疗方案的治疗仍具有非常高的ICER。
使用最有效治疗方案治疗转移性结直肠癌的增量成本非常高。作者得出结论,成本效益分析应成为药物研发过程的常规组成部分,以便医生和患者能就新创新的价值得到适当的信息。