INSERM U-645, Université de Franche-Comté, Hematology-CHU Jean Minjoz, Besançon, France.
Pharmacoeconomics. 2010;28(1):35-46. doi: 10.2165/11314070-000000000-00000.
Rituximab maintenance therapy was shown to significantly extend overall survival (OS) and progression-free survival (PFS) in relapsed/refractory follicular lymphoma (FL) in the pivotal EORTC 20981 trial.
To assess the long-term costs and cost effectiveness of rituximab maintenance therapy after induction therapy versus current standard practice (observation) from the French National Health Service perspective.
A lifetime transition model was developed comparing rituximab maintenance with observation. PFS and OS were obtained from the EORTC 20981 trial with a median follow-up of 28 months and extrapolated from 2-year Kaplan-Meier curves using a Weibull distribution. PFS and OS benefits of rituximab were conservatively assumed to last only 5 years. Utility data were obtained from a multicentre observational study using the EQ-5D questionnaire. Direct medical costs were obtained from French official sources. All costs are reported in euro, year 2006 values.
The EORTC 20981 study demonstrated that rituximab maintenance was effective in the management of relapsed/refractory FL. The model results showed that life expectancy and QALYs were increased by 22% and 28%, respectively, in patients treated with rituximab. The incremental cost-effectiveness ratios (ICERs) were euro 7612 per life-year gained and euro 8729 per QALY gained. In a one-way sensitivity analysis, most of the ICERs fell within the range of euro 7000-12,000. The results tend to show that rituximab maintenance therapy may be a cost-effective strategy in the management of relapsed/refractory FL in France, with ICERs below those observed for other therapies in the oncology field. The cost of rituximab was partly offset by the lower cost of relapse due to a longer time in the disease-free health state for patients in the rituximab arm.
在关键性 EORTC 20981 试验中,利妥昔单抗维持治疗显著延长了复发/难治性滤泡性淋巴瘤(FL)患者的总生存期(OS)和无进展生存期(PFS)。
从法国国家卫生服务体系的角度评估诱导治疗后利妥昔单抗维持治疗与当前标准治疗(观察)相比的长期成本和成本效益。
采用寿命转移模型比较利妥昔单抗维持治疗与观察治疗。通过 EORTC 20981 试验获得 PFS 和 OS,中位随访 28 个月,并使用威布尔分布从 2 年 Kaplan-Meier 曲线外推。利妥昔单抗的 PFS 和 OS 获益保守地假设仅持续 5 年。效用数据来自使用 EQ-5D 问卷的多中心观察性研究。直接医疗成本来自法国官方来源。所有成本均以欧元报告,按 2006 年价值计算。
EORTC 20981 研究表明,利妥昔单抗维持治疗在复发/难治性 FL 的治疗中是有效的。模型结果表明,接受利妥昔单抗治疗的患者的预期寿命和 QALY 分别增加了 22%和 28%。增量成本效益比(ICER)分别为每获得 1 个生命年增加 7612 欧元和每获得 1 个 QALY 增加 8729 欧元。在单向敏感性分析中,大多数 ICER 落在 7000-12000 欧元的范围内。结果表明,利妥昔单抗维持治疗可能是法国治疗复发/难治性 FL 的一种具有成本效益的策略,其 ICER 低于肿瘤学领域其他治疗方法的观察值。由于利妥昔单抗组患者在无疾病健康状态下的时间更长,复发的成本降低,部分抵消了利妥昔单抗的成本。