阿特珠单抗二线治疗转移性膀胱癌患者的成本效用分析。
A cost-utility analysis of atezolizumab in the second-line treatment of patients with metastatic bladder cancer.
机构信息
Odette Cancer Centre, Sunnybrook Health Sciences Centre.
Institute of Health Policy, Management and Evaluative Sciences, University of Toronto.
出版信息
Curr Oncol. 2020 Aug;27(4):e386-e394. doi: 10.3747/co.27.5459. Epub 2020 Aug 1.
BACKGROUND
Despite initial promising results, the IMvigor211 clinical trial failed to demonstrate an overall survival (os) benefit for atezolizumab compared with chemotherapy as second-line treatment for metastatic bladder cancer (mbc). However, given lessened adverse events (aes) and preserved quality of life (qol) with atezolizumab, there might still be investment value. To evaluate that potential value, we conducted a cost-utility analysis (cua) of atezolizumab compared with chemotherapy from the perspective of the Canadian health care payer.
METHODS
A partitioned survival model was used to evaluate atezolizumab compared with chemotherapy over a lifetime horizon (5 years). The base-case analysis was conducted for the intention-to-treat (itt) population, with additional scenario analyses for subgroups by IMvigor-defined PD-L1 status. Health outcomes were evaluated through life-year gains and quality-adjusted life-years (qalys). Cost estimates in 2018 Canadian dollars for systemic treatment, aes, and end-of-life care were incorporated. The incremental cost-effectiveness ratio (icer) was used to compare treatment strategies. Parameter and model uncertainty were assessed through sensitivity and scenario analyses. Per Canadian guidelines, cost and effectiveness were discounted at 1.5%.
RESULTS
For the itt population, the expected qalys for atezolizumab and chemotherapy were 0.75 and 0.56, with expected costs of $90,290 and $8,466 respectively. The resultant icer for atezolizumab compared with chemotherapy was $430,652 per qaly. Scenario analysis of patients with PD-L1 expression levels of 5% or greater led to a lower icer ($334,387 per qaly). Scenario analysis of observed compared with expected benefits demonstrated a higher icer, with a shorter time horizon ($928,950 per qaly).
CONCLUSIONS
Despite lessened aes and preserved qol, atezolizumab is not considered cost-effective for the second-line treatment of mbc.
背景
尽管最初的结果令人鼓舞，但 IMvigor211 临床试验未能证明阿替利珠单抗与化疗相比作为转移性膀胱癌（mBC）的二线治疗在总生存期（OS）方面具有优势。然而，鉴于阿替利珠单抗的不良反应（AE）减少和生活质量（QOL）保持，它可能仍然具有投资价值。为了评估这种潜在价值，我们从加拿大医疗保健支付者的角度对阿替利珠单抗与化疗进行了成本-效用分析（CUA）。
方法
使用分区生存模型评估阿替利珠单抗与化疗在终生（5 年）的比较。基础案例分析针对意向治疗（ITT）人群进行，对 IMvigor 定义的 PD-L1 状态亚组进行了额外的情景分析。通过生命年获益和质量调整生命年（QALY）来评估健康结果。2018 年加拿大元的系统治疗、AE 和生命终末期护理成本估计被纳入其中。增量成本效果比（ICER）用于比较治疗策略。通过敏感性和情景分析评估参数和模型不确定性。根据加拿大指南，成本和效果以 1.5%贴现。
结果
对于 ITT 人群，阿替利珠单抗和化疗的预期 QALY 分别为 0.75 和 0.56，预期成本分别为 90290 加元和 8466 加元。阿替利珠单抗与化疗相比的 ICER 为每 QALY 430652 加元。对 PD-L1 表达水平为 5%或更高的患者进行情景分析，导致 ICER 降低（每 QALY 334387 加元）。与预期效益相比的观察效益的情景分析显示，ICER 更高，时间范围更短（每 QALY 928950 加元）。
结论
尽管 AE 减少和 QOL 保持，但阿替利珠单抗并不被认为是 mBC 二线治疗的一种具有成本效益的药物。
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