联盟 A041202/CCTG CLC.2 前瞻性经济分析：随机 III 期试验结果，比较苯达莫司汀-利妥昔单抗与伊布替尼方案治疗未经治疗的老年慢性淋巴细胞白血病患者。
A Prospective Economic Analysis of Early Outcome Data From the Alliance A041202/ CCTG CLC.2 Randomized Phase III Trial Of Bendamustine-Rituximab Compared With Ibrutinib-Based Regimens in Untreated Older Patients With Chronic Lymphocytic Leukemia.
机构信息
Division of Hematology, Department of Medicine, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada; Canadian Cancer Trials Group, Queens University, Kingston, Canada.
Canadian Cancer Trials Group, Queens University, Kingston, Canada; Department of Pharmacology and Toxicology and Institute for Health Policy Management and Evaluation, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
出版信息
Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):766-774. doi: 10.1016/j.clml.2021.06.011. Epub 2021 Jul 3.
INTRODUCTION
The Alliance A041202/CCTG CLC.2 trial demonstrated superior progression-free survival with ibrutinib-based therapy compared to chemoimmunotherapy with bendamustine-rituximab (BR) in previously untreated older patients with chronic lymphocytic leukemia. We completed a prospective trial-based economic analysis of Canadian patients to study the direct medical costs and quality-adjusted benefit associated with these therapies.
METHODS
Mean survival was calculated using the restricted mean survival method from randomization to the study time-horizon of 24 months. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tariffs applied to calculate quality-adjusted life years (QALYs). Costs were applied to resource utilization data (expressed in 2019 US dollars). We examined costs and QALYs associated ibrutinib, ibrutinib with rituximab (IR), and BR therapy.
RESULTS
A total of 55 patients were enrolled; two patients were excluded from the analysis. On-protocol costs (associated with protocol-specified resource use) were higher for patients receiving ibrutinib (mean $189,335; P < 0.0001) and IR (mean $219,908; P < 0.0001) compared to BR (mean $51,345), driven by higher acquisition costs for ibrutinib. Total mean costs (over 2-years) were $192,615 with ibrutinib, $223,761 with IR, and $55,413 with BR (P < 0.0001 for ibrutinib vs. BR and P < 0.0001 for IR vs. BR). QALYs were similar between the three treatment arms: 1.66 (0.16) for ibrutinib alone, 1.65 (0.24) for IR, and 1.66 (0.17) for BR; therefore, a formal cost-utility analysis was not conducted.
CONCLUSIONS
Direct medical costs are higher for patients receiving ibrutinib-based therapies compared to chemoimmunotherapy in frontline chronic lymphocytic leukemia, with the cost of ibrutinib representing a key driver.
简介
联盟 A041202/CCTG CLC.2 试验表明，与苯达莫司汀联合利妥昔单抗（BR）化疗免疫相比，伊布替尼为基础的治疗在未经治疗的老年慢性淋巴细胞白血病患者中具有更好的无进展生存期。我们完成了一项针对加拿大患者的基于前瞻性试验的经济学分析，以研究这些治疗方法相关的直接医疗成本和质量调整获益。
方法
使用随机分组至 24 个月研究时间点的限制性平均生存法计算平均生存时间。使用欧洲五维健康量表（EQ-5D）工具收集健康状态效用，并用加拿大关税计算质量调整生命年（QALYs）。将成本应用于资源利用数据（以 2019 年美元表示）。我们检查了伊布替尼、伊布替尼联合利妥昔单抗（IR）和 BR 治疗相关的成本和 QALYs。
结果
共纳入 55 例患者，2 例患者被排除在分析之外。接受伊布替尼（平均$189,335；P<0.0001）和 IR（平均$219,908；P<0.0001）治疗的患者比接受 BR（平均$51,345）治疗的患者，其符合方案的资源使用相关的成本更高，这主要是由于伊布替尼的采购成本更高。2 年的总平均成本分别为伊布替尼组$192,615，IR 组$223,761，BR 组$55,413（伊布替尼与 BR 相比，P<0.0001；IR 与 BR 相比，P<0.0001）。三种治疗方案的 QALYs 相似：伊布替尼单独治疗为 1.66（0.16），IR 为 1.65（0.24），BR 为 1.66（0.17）；因此，未进行正式的成本效用分析。
结论
与化疗免疫治疗相比，接受伊布替尼为基础的治疗的患者在一线慢性淋巴细胞白血病中的直接医疗成本更高，其中伊布替尼的成本是一个关键驱动因素。
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