IMIB-Arrixaca. Medical Oncology Service, Hospital Clínico Universitario Virgen de La Arrixaca, Murcia, Spain.
Department of Medicine, The University of Chicago, Chicago, IL, USA.
BMC Health Serv Res. 2022 Jul 26;22(1):948. doi: 10.1186/s12913-022-08222-9.
Analyze the cost contributors and their impact on the drug cost avoidance (DCA) resulting from cancer clinical trials over the period of 2015-2020 in a tertiary-level hospital in Spain (HCUVA).
We performed a cross-sectional, observational, retrospective study of a total of 53 clinical trials with 363 patients enrolled. We calculated the DCA from the price of the best standard of care (i.e.: drugs that the institution would otherwise fund). A linear regression model was used to determine cost contributors and estimate their impact.
The total DCA was ~ 4.9 million euros (31 clinical trials; 177 enrollees), representing ~ 30% and ~ 0,05% approximately of the annual pharmaceutical expenditures at the HCUVA and for the Spanish Health System, respectively. Cancer type analysis showed that lung cancer had the highest average DCA by trial, indicating that treatments in these trials were the most expensive. Linear regression analysis showed that the number of patients in a trial did not significantly affect that trial's DCA. Instead, cancer type, phase trials, and intention of treatment were significant cost contributors to DCA. Compared to digestive cancer trials, breast and lung trials were significantly more expensive, (p < 0.05 and p < 0.1, respectively). Phase III trials were more expensive than Phase II (p < 0.01) and adjuvant trials were less expensive than palliative (p < 0.05).
We studied cost contributors that significantly impacted the estimated DCA from cancer clinical trials. Our work provides the groundwork to explore DCA contributors with potential to enhance public relations material and serve as a negotiating tool for budgeting, thus playing an important role to inform decisions about resource allocation.
分析 2015 年至 2020 年期间西班牙三级医院（HCUVA）癌症临床试验中导致药物成本节约（DCA）的成本因素及其影响。
我们对总共 53 项临床试验进行了一项横断面、观察性、回顾性研究，共有 363 名患者入组。我们根据最佳标准护理的价格计算 DCA（即：机构本来会资助的药物）。使用线性回归模型确定成本因素并估计其影响。
总 DCA 约为 490 万欧元（31 项试验；177 名入组者），分别约占 HCUVA 年度制药支出和西班牙卫生系统年度制药支出的 30%和 0.05%左右。癌症类型分析表明，肺癌的平均 DCA 最高，表明这些试验中的治疗费用最高。线性回归分析表明，试验中的患者人数并没有显著影响试验的 DCA。相反，癌症类型、试验阶段和治疗意图是 DCA 的重要成本因素。与消化道癌试验相比，乳腺癌和肺癌试验明显更昂贵（p<0.05 和 p<0.1，分别）。III 期试验比 II 期试验昂贵（p<0.01），辅助试验比姑息治疗试验便宜（p<0.05）。
我们研究了对癌症临床试验中估计的 DCA 有重大影响的成本因素。我们的工作为探索 DCA 贡献者奠定了基础，这些贡献者有可能增强公共关系材料，并作为预算谈判的工具，从而在告知资源分配决策方面发挥重要作用。
