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癌症必需药物:将可行性添加到临床受益价值链的规模。

Essential cancer medicines: adding feasibility to the magnitude of clinical benefit value chain.

发表日期:2023 Sep 04
作者: F Roitberg, T Amaral, N I Cherny, R Giuliani, N J Latino, M Galotti, G Bricalli, G Curigliano, G Pentheroudakis, D Trapani
来源: ESMO Open

摘要:

癌症是一个全球性的公共卫生问题,需要高效的卫生系统投资以对人口健康产生可持续的影响。药物获取是卫生系统的关键组成部分,对提供治疗效益起到至关重要的作用。自1977年以来,世界卫生组织(WHO)已经出版了一个包含公共卫生相关疾病的关键健康干预措施的基本药物模型清单(EML)。基于疗效、安全性、治疗价值和对人群健康影响的潜力,要在EML中选择基本药物。由于癌症治疗的药物类别正在快速变化,有必要根据其内在价值选择和优先考虑特定的癌症干预措施。欧洲医学肿瘤学学会(ESMO)已经开发了一种决策方法,基于一组最低的技术规格和基于共识的程序,用于决策选择候选癌症药物,提交给WHO考虑纳入WHO EML。ESMO认为WHO EML是一个所有国家都应该在其国家EML中包含的重要药物参考指南。WHO EML上的癌症药物被用于治疗大多数癌症,并且在基于证据的ESMO临床实践指南中被医学肿瘤学家推荐用于治疗患者。本文介绍了ESMO在2019年和2021年提交给WHO EML的申请以及其相应的结果。由于新型疗法的相关成本不断上升,需要在预选可能纳入WHO EML的潜在候选药物中实施结构化、可重复、经实地测试的工具,以评估这些疗法的附加临床效益。ESMO以此重要的全球公共卫生倡议与世界卫生组织密切合作,感到自豪。 版权所有 © 2023作者。由Elsevier Ltd.出版。保留所有权利。
Cancer is a global public health problem, requiring efficient health system investments to deliver sustainable impact on population health. Access to medicines is a critical component of health systems, having a crucial role in delivering therapeutic benefits. Since 1977, the World Health Organization (WHO) has published a Model List of Essential Medicines (EML) that includes key health interventions for the prevention and control of conditions of public health relevance. Essential medicines are selected for inclusion in the EML based on the evidence of efficacy, safety, therapeutic value, and the potential to impact population health. With the rapid changes in the therapeutic landscape of cancer treatment with new medicine approvals, there is a critical need to select and prioritise specific cancer interventions based on their intrinsic value.The European Society for Medical Oncology (ESMO) has developed a decisional methodology based on a threshold with a minimum set of technical specifications and a consensus-based procedure for decisions to select candidate cancer medicines to be submitted to the WHO for consideration for the WHO EML.ESMO recognises the WHO EML as an important reference guide for medicines that all countries should include in their national EMLs. Cancer medicines on the WHO EML are used in the treatment of the majority of cancers, and are recommended in the evidence-based ESMO Clinical Practice Guidelines that medical oncologists use to treat patients. ESMO's submissions to the WHO EML in 2019 and 2021 and their respective outcomes are presented in the manuscript.Due to the rising costs associated with newly available therapies, structured, reproducible, and field-tested tools to evaluate the added clinical benefit from these therapies need to be implemented in pre-selecting potential candidate medicines to be included in the WHO EML. ESMO is proud to collaborate closely with WHO on this important global public health initiative.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.