Best Jennie H, Hornberger John, Proctor Stephen J, Omnes Louis F, Jost Fred
Department of Pharmacy, University of Washington, Seattle, WA 98195, USA.
Value Health. 2005 Jul-Aug;8(4):462-70. doi: 10.1111/j.1524-4733.2005.00037.x.
To estimate the cost-effectiveness from a French payer perspective of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) alone compared with CHOP plus rituximab (R-CHOP) for treatment of patients with diffuse large B-cell lymphoma.
Mean patient survival, days of hospitalization, and chemotherapy costs during treatment were estimated from a Phase III trial in France, Belgium, and Switzerland. Survival during the trial was estimated using the Kaplan-Meier method; survival beyond the trial period was projected based on mortality rates from the Scottish and Newcastle Lymphoma Group database. French diagnosis-related group (DRG) payment schedules were applied to trial data to estimate cost of adverse events and drug administration. We estimated survival and cost-effectiveness [the incremental cost per quality-adjusted life-year (QALY) gained] from 4 years (median clinical trial follow-up period) to 15 years, discounted at a fixed annual rate of 3%. We used published patient preferences. We converted currency to euros, based on 2003 exchange rates.
R-CHOP resulted in a 20.6% relative increase in complete response rate (absolute increase from 63% to 76%), and a 31% decrease in risk of death at 4 years (95% CI 8-49%). Over a 15-year time horizon, mean overall survival (OS) duration was estimated to be 6.90 years for R-CHOP and 5.74 years for CHOP, a mean increase in OS of 1.16 years (or 1.07 QALYs). Total direct medical costs were 13,170 euro higher with R-CHOP, with an incremental cost-effectiveness ratio of 12,259 euro per QALY gained.
R-CHOP significantly increases mean OS up to 4 years compared with CHOP, and its cost-effectiveness ratio compares favorably with other oncology treatments in widespread use.
从法国医保支付方的角度评估单纯使用CHOP方案(环磷酰胺、多柔比星、长春新碱和泼尼松)与CHOP联合利妥昔单抗(R-CHOP)方案治疗弥漫性大B细胞淋巴瘤患者的成本效益。
从法国、比利时和瑞士开展的一项III期试验中估算患者的平均生存期、住院天数以及治疗期间的化疗费用。试验期间的生存期采用Kaplan-Meier法估算;试验期后的生存期根据苏格兰和纽卡斯尔淋巴瘤组数据库的死亡率进行预测。将法国诊断相关组(DRG)支付计划应用于试验数据,以估算不良事件和药物给药的费用。我们估算了从4年(临床试验中位随访期)至15年的生存期和成本效益[每获得一个质量调整生命年(QALY)的增量成本],按3%的固定年利率进行贴现。我们采用已发表的患者偏好数据。根据2003年汇率将货币换算为欧元。
R-CHOP方案使完全缓解率相对提高了20.6%(绝对提高从63%至76%),4年时死亡风险降低了31%(95%置信区间8%-49%)。在15年的时间范围内,R-CHOP方案的平均总生存期(OS)估计为6.90年,CHOP方案为5.74年,OS平均增加1.16年(或1.07个QALY)。R-CHOP方案的总直接医疗费用高出13,170欧元,每获得一个QALY的增量成本效益比为12,259欧元。
与CHOP方案相比,R-CHOP方案显著提高了长达4年的平均OS,其成本效益比与其他广泛使用的肿瘤治疗方法相比具有优势。