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The value of anticancer drugs — a regulatory view
Nature Reviews Clinical Oncology ( IF 78.8 ) Pub Date : 2021-12-06 , DOI: 10.1038/s41571-021-00584-z
Francesco Pignatti 1 , Ulla Wilking 2 , Douwe Postmus 1, 3 , Nils Wilking 2 , Julio Delgado 1, 4 , Jonas Bergh 2, 5
Affiliation  

The high prices of new anticancer drugs and the marginal added benefit perceived by some stakeholders have fuelled a debate on the value of anticancer drugs in the European Union, even though an agreed definition of what constitutes a drug’s value does not exist. In this Perspective, we discuss the value of drugs from different viewpoints and objectives of decision makers: for regulators, assessment of the benefit–risk balance of a drug is a cornerstone for approval; payers rely on cost-effectiveness analyses carried out by health technology assessment agencies for reimbursement decisions; for patients, treatment choices are based on personal preferences and attitudes to risk; and clinicians can use several scales (such as the ESMO Magnitude of Clinical Benefit Scale (ESMO–MCBS)) that have been developed as an attempt to measure value objectively. Although a unique definition that fully captures the concept of value is unlikely to emerge, herein we discuss the importance of understanding different perspectives, and how regulators can help to inform different decision makers.



中文翻译:

抗癌药的价值——监管观点

新抗癌药物的高价格和一些利益相关者认为的边际附加效益在欧盟引发了关于抗癌药物价值的辩论,尽管关于什么构成药物价值的一致定义并不存在。在此观点中,我们从决策者的不同观点和目标讨论药物的价值:对于监管机构而言,评估药物的利益-风险平衡是获得批准的基石;付款人依靠卫生技术评估机构进行的成本效益分析来做出报销决定;对于患者,治疗选择基于个人偏好和对风险的态度;临床医生可以使用多种量表(例如 ESMO 临床获益量表 (ESMO–MCBS)),这些量表是为了客观地衡量价值而开发的。

更新日期:2021-12-06
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