Cergas, Centre for Research on Health and Social Care Management, SDA Bocconi School of Management, Bocconi University, Via Sarfatti, 10, Milano, 20136, Italy.
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, Bologna, 40138, Italy.
BMC Health Serv Res. 2024 Jan 22;24(1):121. doi: 10.1186/s12913-023-10443-5.
Chimeric antigen receptor T cells (CAR-T) represent an innovation but raise issues for healthcare payers because of the uncertainty on impact at market launch, high cost and important organisational impact. The literature has focused on their assessment, appraisal and market access solutions. No evidence on the costs sustained to implement CAR-T is available and a few studies reported the cost of the CAR-T clinical pathway, including the activities that are remunerated through inpatient or outpatient fee-for-service/episode. This paper aims at filling the information gap, assessing the cost of implementing CAR-T activity and the full cost of managing the CAR-T clinical pathway.
Cost analysis relied on the Activity Based Costing approach, which was applied to two Italian healthcare organisations, both CAR-T Centres authorized by the regional governments with a minimum of 20 patients treated with the first two CAR-T therapies launched on the market.
The cost of implementing CAR-T was estimated at €1.31 million (calculated for one of the organizations with complete data). Most of these costs (77%) were generated by quality assurance activity. The mean cost per patient entering the CAR-T pathway (59 and 27) and surviving at follow-up (21 and 5) ranges from €48K to €57K and from €96K to €106K, respectively. Fees for hospitalization and infusion of gene therapy accounts for more than 70% of these costs. The actual hospitalisation cost varies greatly across patients and is in general lower than the fee-for-episode paid by the region to the hospital.
Despite its limitations (exploratory nature; the time spent by staff on activities which are not remunerated through fees was estimated through interviews with the CAR-T coordinators; cost items are not fully comparable), this research highlighted the relevant organisational and economic impact of CAR-T and provided important insights for policy makers and healthcare managers: the necessity to invest resources in CAR-T implementation; the need for assessing activities which are not remunerated through fees for service / episode; the opportunity to shift from fee-for-episode / service to bundled payments for CAR-T clinical pathway.
嵌合抗原受体 T 细胞（CAR-T）代表了一种创新，但由于市场推出时的影响、高成本和重要的组织影响存在不确定性，引起了医疗保健支付者的关注。文献主要集中在对其进行评估、评估和市场准入解决方案上。目前尚无关于实施 CAR-T 所产生的成本的证据，只有少数研究报告了 CAR-T 临床路径的成本，包括通过住院或门诊按服务项目/按病例付费来补偿的活动。本文旨在填补这一信息空白，评估实施 CAR-T 活动的成本以及管理 CAR-T 临床路径的全部成本。
成本分析依赖于作业成本法，该方法应用于两家意大利医疗保健机构，这两家机构都是由地区政府授权的 CAR-T 中心，至少有 20 名患者接受了市场上推出的前两种 CAR-T 治疗方法的治疗。
实施 CAR-T 的成本估计为 131 万欧元（为一家具有完整数据的机构计算）。这些成本的大部分（77%）是由质量保证活动产生的。进入 CAR-T 途径的每位患者的平均成本（59 和 27）和随访时存活的患者的平均成本（21 和 5）范围分别为 48 至 57 千欧元和 96 至 106 千欧元。住院和基因治疗输注的费用占这些费用的 70%以上。实际住院费用因患者而异，通常低于该地区向医院支付的按病例付费。
尽管存在局限性（探索性性质；通过与 CAR-T 协调员的访谈来估算员工在未通过费用补偿的活动上花费的时间；成本项目不完全可比），但这项研究突出了 CAR-T 的重要组织和经济影响，并为政策制定者和医疗保健管理人员提供了重要见解：需要投资资源来实施 CAR-T；需要评估未通过按服务项目/按病例付费补偿的活动；有机会从按病例/服务付费转向 CAR-T 临床路径的捆绑支付。
