CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Multidimensional Results and Reflections on CAR-T: The Italian Evidence.
Multidimensional Results and Reflections on CAR-T: The Italian Evidence.
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本研究旨在明确意大利引入CAR-T 细胞疗法(CAR-T)治疗三线弥漫大 B 细胞淋巴瘤(DLBCL)的经济和组织影响,并评估其对医院和国家医疗服务体系(NHS)的整体可持续性。分析采用意大利医院和 NHS 视角,比较 CAR-T 与最佳挽救治疗(BSC)路径,时间范围为 36 个月。通过流程图绘制和作业成本法收集 BSC 和 CAR-T 路径相关医院成本,包括不良事件管理成本。研究在两家意大利医院收集 47 例三线淋巴瘤患者接受的服务匿名行政数据(诊断和实验室检查、住院、门诊操作和治疗),并纳入所需组织投入。
经济分析显示,BSC 临床路径所需资源少于 CAR-T(不计疗法本身成本)(BSC:29,558.41 欧元;CAR-T:71,220.84 欧元,降低 58.5%)。预算影响分析显示,引入 CAR-T 将使成本增加 15%–23%,同样未计治疗成本。组织影响评估显示,从医院角度看,引入 CAR-T 疗法至少需额外投入 15,500 欧元,最多 100,897.49 欧元。结果为医疗决策者提供新的经济证据,以优化资源配置的适宜性。本分析提示,应在医院和 NHS 层面制定 CAR-T 专项报销标准;至少在意大利,目前尚无共识确定为提供这一创新治疗路径的医院设定何种合理报酬,而医院需承担及时管理不良事件的高风险。
The present study aims at defining the economic and organizational impacts of the introduction of chimeric antigen receptor T-cell therapy (CAR-T) in Italy, for the management of diffuse large B-cell lymphoma (DLBCL) patients in third-line therapy, defining the overall level of sustainability for both hospitals and the National Healthcare System (NHS). The analysis focused on CAR-T and Best Salvage Care (in the following BSC), assuming the Italian hospital and NHS perspectives, over a 36-month time horizon. Process mapping and activity-based costing methodologies were applied to collect the hospital costs related to the BSC and CAR-T pathways, including adverse event management. Anonymous administrative data on services provided (diagnostic and laboratory examinations, hospitalizations, outpatient procedures, and therapies) to 47 third-line patients with lymphoma, as well as any organizational investments required, were collected, in two different Italian Hospitals.
The economic results showed that the BSC clinical pathway required less resources in comparison with CAR-T (excluding the cost related to the therapy) (BSC: 29,558. 41 vs. CAR-T: EUR 71,220. 84, -58. 5%). The budget impact analysis depicts that the introduction of CAR-T would generate an increase in costs ranging from 15% to 23%, without considering treatment costs. The assessment of the organizational impact reveals that the introduction of CAR-T therapy would require additional investments equal to a minimum of EUR 15,500 to a maximum of EUR 100,897.
49, from the hospital perspective. Results show new economic evidence for healthcare decision makers, to optimize the appropriateness of resource allocation. The present analysis suggests the need to introduce a specific reimbursement tariff, both at the hospital and at NHS levels, since no consensus exists, at least in the Italian setting, concerning the proper remuneration for the hospitals who guarantee this innovative pathway, assuming high risks related to timely management of adverse events.
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