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CAR-T 疗法在西班牙的管理和实施的战略思考:专家共识文件。

A strategic reflection for the management and implementation of CAR-T therapy in Spain: an expert consensus paper.

机构信息

Health Economics Department, Weber Economía y Salud, C/Moreto 17, 5D, 28014, Madrid, Spain.

Department of Quantitative Methods in Economics and Management, University of Las Palmas de Gran Canaria, Las Palmas, Spain.

出版信息

Clin Transl Oncol. 2022 Jun;24(6):968-980. doi: 10.1007/s12094-021-02757-9. Epub 2022 Jan 8.

DOI:10.1007/s12094-021-02757-9
PMID:34997475
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8741571/
Abstract

CAR-T cell therapy represents a therapeutic revolution in the prognosis and treatment of patients with certain types of hematological cancer. However, they also pose new challenges in the healthcare, regulatory and financial fields. The aim of the RET-A project was to undertake a strategic reflection on the management of CAR-T therapies within the Spanish National Health System, to agree on recommendations that will help to better deal with the new context introduced by these cell therapies in the present and in the future. This think tank involved 40 key agents and opinion leaders. The experts identified three great challenges for implementing advanced therapies in Spain: therapeutic individualisation, with a multidisciplinary approach; acceleration of access times, by minimizing bureaucracy; and increase in the number of centers qualified to manage the CAR-T therapies in the NHS. The experts agreed on the ideal criteria for designating those qualified centers. They also agreed on a comprehensive CAR-T care pathway with the timings and roles which would ideally be involved in each part of the process.

摘要

嵌合抗原受体 T 细胞(CAR-T)疗法代表了在某些类型血液系统癌症的预后和治疗方面的治疗革命。然而,它们在医疗保健、监管和财务领域也带来了新的挑战。RET-A 项目的目的是对西班牙国家卫生系统中嵌合抗原受体 T 细胞疗法的管理进行战略思考,就有助于更好地应对这些细胞疗法在现在和未来带来的新情况的建议达成一致。该智库涉及 40 名关键代理和意见领袖。专家们确定了在西班牙实施先进疗法的三大挑战:个体化治疗,采用多学科方法;通过减少官僚主义来加快准入时间;增加 NHS 中有资格管理 CAR-T 疗法的中心数量。专家们就指定合格中心的理想标准达成了一致。他们还就综合的 CAR-T 护理途径达成了一致,其中包括每个过程部分中理想涉及的时间和角色。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c756/9107431/1f15f84995c4/12094_2021_2757_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c756/9107431/707e675afc6b/12094_2021_2757_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c756/9107431/b9877ed38fc6/12094_2021_2757_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c756/9107431/1f15f84995c4/12094_2021_2757_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c756/9107431/707e675afc6b/12094_2021_2757_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c756/9107431/b9877ed38fc6/12094_2021_2757_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c756/9107431/1f15f84995c4/12094_2021_2757_Fig3_HTML.jpg

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CAR T-cell treatment during the COVID-19 pandemic: Management strategies and challenges.COVID-19 大流行期间的 CAR T 细胞治疗:管理策略和挑战。
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EHA Guidance Document The process of CAR-T cell therapy in Europe.欧洲血液学协会指导文件:欧洲嵌合抗原受体T细胞疗法的流程
Hemasphere. 2019 Aug 7;3(4):e280. doi: 10.1097/HS9.0000000000000280. eCollection 2019 Aug.
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CAR T Cell Toxicity: Current Management and Future Directions.嵌合抗原受体T细胞毒性:当前管理与未来方向
Hemasphere. 2019 Mar 29;3(2):e186. doi: 10.1097/HS9.0000000000000186. eCollection 2019 Apr.
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The potential impact of CAR T-cell treatment delays on society.嵌合抗原受体 T 细胞治疗延迟对社会的潜在影响。
Am J Manag Care. 2019 Aug;25(8):379-386.
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Chimeric Antigen Receptor T Cell-Related Neurotoxicity: Mechanisms, Clinical Presentation, and Approach to Treatment.嵌合抗原受体T细胞相关神经毒性:机制、临床表现及治疗方法
Curr Treat Options Neurol. 2019 Jul 20;21(8):40. doi: 10.1007/s11940-019-0580-3.
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Associated Toxicities: Assessment and Management Related to CAR T-Cell Therapy.相关毒性:与嵌合抗原受体T细胞疗法相关的评估与管理
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