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肿瘤学中的靶向联合治疗:在欧洲,针对单药治疗设计的具有挑战性的监管框架。

Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe.

机构信息

Netherlands Cancer Institute-Antoni van Leeuwenhoek Amsterdam, The Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, Enschede, The Netherlands.

Netherlands Cancer Institute-Antoni van Leeuwenhoek Amsterdam, The Netherlands.

出版信息

Drug Discov Today. 2023 Aug;28(8):103620. doi: 10.1016/j.drudis.2023.103620. Epub 2023 May 16.

DOI:10.1016/j.drudis.2023.103620
PMID:37201780
Abstract

The pharmaceutical value chain, including clinical trials, pricing, access, and reimbursement, is designed for classical monotherapies. Although there has been a paradigm shift that increases the relevance of targeted combination therapies (TCTs), regulation and common practice have been slow to adapt. We explored access to 23 TCTs for advanced melanoma and lung cancer as reported by 19 specialists from 17 leading cancer institutions in nine European countries. We find heterogeneous patient access to TCTs between countries, differences in country-specific regulations, and differences in the clinical practice of melanoma and lung cancer. Regulation that is better tailored to the context of combinational therapies can increase equity in access across Europe and promote an evidence-based and authorized use of combinations.

摘要

制药价值链,包括临床试验、定价、准入和报销,是专为经典单药疗法设计的。虽然已经出现了增加靶向联合疗法(TCT)相关性的范式转变,但监管和常规做法一直缓慢适应。我们调查了欧洲九个国家的 17 家领先癌症机构的 19 名专家报告的 23 种晚期黑色素瘤和肺癌的 TCT 准入情况。我们发现各国之间 TCT 的患者准入存在异质性,国家特定法规存在差异,黑色素瘤和肺癌的临床实践也存在差异。更好地针对联合疗法背景制定的法规可以增加欧洲范围内准入的公平性,并促进组合使用的基于证据和授权的使用。

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