Escudero-Vilaplana Vicente, Collado-Borrell Roberto, De Castro Javier, Insa Amelia, Martínez Alex, Fernández Elena, Sullivan Ivana, Flores Andrés, Arrabal Natalia, Carcedo David, Manzaneque Alba
Hospital Gregorio Marañón, Madrid, Spain.
Hospital Universitario La Paz, Madrid, Spain.
J Med Econ. 2023 Jan-Dec;26(1):445-453. doi: 10.1080/13696998.2023.2188844.
To assess the cost-effectiveness of adjuvant atezolizumab in the treatment of early-stage NSCLC patients (stage II-IIIA) with expression PD-L1 ≥ 50% without mutations in EGFR or ALK rearrangements in Spain.
A 5-states Markov model (DFS, locoregional recurrence, 1 L-metastatic recurrence, 2 L-metastatic recurrence, and death states) was adapted to the Spanish setting. Demographic characteristics of the hypothetical cohort, transition probabilities from the DFS state, and safety parameters were obtained from IMpower010 study (GO29527). Transition probabilities from locoregional and metastatic health states were obtained from the literature. The usual clinical practice in Spain (use of health resources, management of the disease, etc.) was obtained from a previous analysis carried out by the authors of this study. A societal perspective was considered so both direct and indirect costs were included (expressed in € of 2021). A lifetime horizon was used, so costs and health outcomes were discounted at 3% per year. Sensitivity analyses were performed to evaluate uncertainty.
Over a lifetime horizon, treatment with adjuvant atezolizumab provided greater effectiveness (+2.61 life years [LY] and +1.95 quality-adjusted life years [QALY]) and higher cost (€+22,538) than BSC. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratios (ICUR) of the analysis were €8,625/LY gained and €11,583/QALY gained, respectively. Robustness of these base-case results was confirmed by the sensitivity analyses performed. In the probabilistic sensitivity analysis, 90% of the simulations performed showed that adjuvant atezolizumab is cost-effective versus BSC, considering a threshold of €30,000/QALY.
Our results showed that adjuvant treatment with atezolizumab in patients with early-stage resected NSCLC with overexpression of PD-L1 and without EGFR and ALK mutations is cost-effective versus BSC as the ICERs and ICURs obtained are below the cost-effectiveness thresholds commonly considered in Spain, thus offering a new treatment alternative for these patients.
评估在西班牙，辅助性阿替利珠单抗治疗表皮生长因子受体（EGFR）无突变或间变性淋巴瘤激酶（ALK）重排且程序性死亡受体配体1（PD-L1）表达≥50%的早期非小细胞肺癌（NSCLC）患者（II-IIIA期）的成本效益。
采用一个五状态马尔可夫模型（无病生存期、局部区域复发、一线转移性复发、二线转移性复发和死亡状态）来适应西班牙的情况。假设队列的人口统计学特征、从无病生存期状态的转移概率以及安全性参数取自IMpower010研究（GO29527）。局部区域和转移性健康状态的转移概率取自文献。西班牙的常规临床实践（卫生资源的使用、疾病管理等）取自本研究作者之前进行的一项分析。采用社会视角，纳入直接和间接成本（以2021年欧元表示）。采用终身视角，成本和健康结果按每年3%进行贴现。进行敏感性分析以评估不确定性。
在终身视角下，与最佳支持治疗（BSC）相比，辅助性阿替利珠单抗治疗具有更高的有效性（多2.61个生命年[LY]和多1.95个质量调整生命年[QALY]）以及更高的成本（增加22,538欧元）。该分析的增量成本效益比（ICER）和增量成本效用比（ICUR）分别为每获得1 LY增加8,625欧元和每获得1 QALY增加11,583欧元。进行的敏感性分析证实了这些基础病例结果的稳健性。在概率敏感性分析中，考虑到每QALY 30,000欧元的阈值，所进行模拟的90%显示辅助性阿替利珠单抗相对于BSC具有成本效益。
我们的结果表明，对于PD-L1过表达且无EGFR和ALK突变的早期切除NSCLC患者，与BSC相比，阿替利珠单抗辅助治疗具有成本效益，因为所获得的ICER和ICUR低于西班牙通常考虑的成本效益阈值，从而为这些患者提供了一种新的治疗选择。
