Faculdade de Ciências Médicas de Minas Gerais, Alameda Ezequiel Dias, 275, Belo Horizonte, MG, 30130-110, Brazil.
Departamento de Gestão de Serviços de Saúde, Escola de Enfermagem, Universidade Federal de Minas Gerais, Av. Alfredo Balena, 190, Belo Horizonte-MG, 30130-100, Brazil.
BMC Health Serv Res. 2023 Jul 21;23(1):781. doi: 10.1186/s12913-023-09736-6.
A full understanding of the economic burden associated with treatment-related adverse events (AEs) can aid estimates of the incremental costs associated with incorporating new technologies and support cost-effective economic modeling in Brazil. In this context, the main objective of this work was to evaluate in a real-life database: (i) the direct medical cost of monitoring the occurrence of AEs (CMO); (ii) the direct medical cost of managing an identified AE (CMN); and (iii) the total direct medical cost of monitoring and managing AEs (TMC), in quarterly periods from 0 to 24 months of the monitoring of cancer patients who used a PD-1 inhibitor from the perspective of the supplementary health system in Brazil.
This study was conducted from the supplementary health system (SSS) perspective and followed the methodological guidelines related to cost-of-illness studies. A bottom-up (person-based) approach was used to assess the use of health resources to monitor and manage AEs during the use of PD-1 inhibitors, which made it possible to capture differences in the mean frequency of the use of health services with stratification results for different subgroups. As the Brazilian SSS is complex, asymmetric, and fragmented, this study used information from different sources. The methodology was divided into three parts: (i) Data Source: clinical management of AEs; (ii) Microcosting: management of the economic burden of AEs; (iii) Statistical analysis: stratification of results for different subgroups.
Analysis of the economic burden of toxicity showed higher CMO costs than CMN in all the periods analyzed. In general, for every BRL 100 on average invested in the TMC of AEs, BRL 95 are used to monitor the occurrence of the AE and only BRL 5 to manage an identified AE. This work also showed that the sociodemographic characteristics of patients, the journey of oncological treatment, and the toxicity profile affect the economic burden related to AE.
This study provided real-world evidence of the economic burden of AEs associated with the use of PD-1 inhibitors in Brazil. This work also made methodological contributions by evaluating the economic burden of AE of PD-1 inhibitors considering the kinetics of toxicity occurrence and categorizing the costs in terms of CMO, CMN and TMC.
全面了解与治疗相关不良反应 (AE) 相关的经济负担,可以帮助估计纳入新技术相关的增量成本,并支持巴西进行具有成本效益的经济建模。在此背景下,本研究的主要目的是在真实数据库中评估:(i)监测 AE 发生的直接医疗成本(CMO);(ii)管理已识别 AE 的直接医疗成本(CMN);以及(iii)监测和管理 AE 的总直接医疗成本(TMC),从巴西补充医疗保险的角度来看,监测使用 PD-1 抑制剂的癌症患者,在 0 至 24 个月的监测期内,每季度计算一次。
本研究从补充医疗保险的角度进行,并遵循与疾病成本研究相关的方法学指南。采用自下而上(基于个人)的方法来评估在使用 PD-1 抑制剂期间监测和管理 AE 的卫生资源使用情况,这使得可以捕获不同卫生服务使用频率的差异,并根据不同亚组的分层结果进行分层。由于巴西的补充医疗保险系统复杂、不对称且碎片化,本研究使用了来自不同来源的信息。该方法分为三个部分:(i)数据来源:AE 的临床管理;(ii)微观成本核算:AE 经济负担管理;(iii)统计分析:对不同亚组的结果进行分层。
毒性的经济负担分析显示,在所有分析期间,CMO 成本均高于 CMN。一般来说,在用于监测 AE 发生的 TMC 中,每投资 100 雷亚尔,就有 95 雷亚尔用于监测 AE 的发生,只有 5 雷亚尔用于管理已识别的 AE。本研究还表明,患者的社会人口统计学特征、肿瘤治疗的历程和毒性特征会影响与 AE 相关的经济负担。
本研究提供了在巴西使用 PD-1 抑制剂相关 AE 的经济负担的真实世界证据。本研究还通过评估 PD-1 抑制剂 AE 的经济负担,考虑毒性发生的动力学并按 CMO、CMN 和 TMC 对成本进行分类,在方法学方面做出了贡献。