Roche Diagnostics, São Paulo, Brazil.
Roche Diagnostics LATAM, São Paulo, Brazil.
J Med Econ. 2020 Nov;23(11):1340-1344. doi: 10.1080/13696998.2020.1821039. Epub 2020 Sep 26.
The aim of the study was to demonstrate the clinical and economic impact of two PD-L1 IHC assays, SP142 versus 22C3, to identify the eligibility of the patients with advanced triple negative breast cancer (aTNBC) to the treatment with atezolizumab plus -paclitaxel in the Brazilian private healthcare system (BPHS).
The study performed a cost-effectiveness analysis based on a partitioned-survival model with three mutually exclusive health states: progression-free (PF), progression, and death. Data of progression-free survival and overall survival were extracted from a retrospective exploratory analysis of IMpassion130, an analytical harmonization of PD-L1 IHC assays. The analyses included only direct costs (drug acquisition and management of adverse events) that were based on CBHPM (Classificação Brasileira Hierarquizada de Procedimentos Médicos) and CMED PF18% (Câmara de Regulação do Mercado de Medicamentos) tables. A probabilistic sensitivity analysis was performed as a second-order Monte Carlo Simulation in order to evaluate the uncertainties of the model.
The SP142 assay has the potential to improve PFS and generate savings to the BPHS. The incremental cost-effectiveness ratio (ICER) was -USD 4,119.43 per month of progression-free survival.
The SP142 assay demonstrated to be a dominant alternative compared to 22C3 to guide the treatment with atezolizumab plus -paclitaxel in patients with aTNBC.
本研究旨在展示两种 PD-L1 IHC 检测方法 SP142 与 22C3 的临床和经济影响,以确定巴西私人医疗保健系统(BPHS)中晚期三阴性乳腺癌(aTNBC)患者接受阿替利珠单抗联合紫杉醇治疗的资格。
本研究基于具有三个互斥健康状态的分割生存模型进行了成本效益分析:无进展(PF)、进展和死亡。无进展生存和总生存数据来自对 IMpassion130 的回顾性探索性分析中提取,这是 PD-L1 IHC 检测方法的分析协调。分析仅包括直接成本(药物获取和不良事件管理),这些成本基于 CBHPM(巴西医疗程序分层分类)和 CMED PF18%(药品监管市场委员会)表。为了评估模型的不确定性,进行了概率敏感性分析,作为二阶蒙特卡罗模拟。
SP142 检测方法有可能改善 PFS 并为 BPHS 节省成本。增量成本效益比(ICER)为无进展生存每月 -4119.43 美元。
与 22C3 相比,SP142 检测方法在指导 aTNBC 患者接受阿替利珠单抗联合紫杉醇治疗方面是一种更优的选择。