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EMA and NICE Appraisal Processes for Cancer Drugs: Current Status and Uncertainties.癌症药物的欧洲药品管理局（EMA）和英国国家卫生与临床优化研究所（NICE）评估流程：现状与不确定性
Appl Health Econ Health Policy. 2018 Aug;16(4):429-432. doi: 10.1007/s40258-018-0393-7.
2
Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP.欧洲药品管理局（EMA）指南和监管文件的注释指南。英国临床药学杂志的一个新系列。
Br J Clin Pharmacol. 2018 Jul;84(7):1399-1400. doi: 10.1111/bcp.13599. Epub 2018 May 30.
3
Are european cancer patients getting a fair deal?欧洲癌症患者是否得到了公平的待遇？
Ann Oncol. 2001 Aug;12(8):1033-5. doi: 10.1023/a:1011655500247.
4
Differences in cancer drug assessment between Spain and the United Kingdom.西班牙和英国的癌症药物评估存在差异。
Eur J Cancer. 2015 Sep;51(13):1843-52. doi: 10.1016/j.ejca.2015.04.022. Epub 2015 Jun 25.
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[France in the European cooperation for the technological evaluation of health products].[法国参与欧洲卫生产品技术评估合作项目]
Med Sci (Paris). 2018 May;34 Hors série n°1:57-59. doi: 10.1051/medsci/201834s130. Epub 2018 Jun 18.
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Drug evaluation and approval process in the European Union.欧盟的药品评估与审批流程。
Arthritis Rheum. 2006 Feb 15;55(1):12-4. doi: 10.1002/art.21712.
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Fractured European market undermines biosimilar launches.破裂的欧洲市场削弱了生物类似药的推出。
Nat Biotechnol. 2008 Jan;26(1):5-6. doi: 10.1038/nbt0108-5.
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Rent increase hits Europe's drug regulator before Brexit move.在英国脱欧行动之前，房租上涨对欧洲药品监管机构造成冲击。
Nature. 2018 Apr;556(7702):418. doi: 10.1038/d41586-018-04917-4.
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Single technology appraisals by NICE: are they delivering faster guidance to the NHS?英国国家卫生与临床优化研究所（NICE）的单一技术评估：它们是否在为英国国民医疗服务体系（NHS）更快地提供指导意见？
Pharmacoeconomics. 2008;26(12):1037-43. doi: 10.2165/0019053-200826120-00006.
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[Editorial Letter. Drug approval].[编辑信函。药物批准]
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Public perceptions of high-cost cancer drugs and the implications for reimbursement decisions.公众对高成本抗癌药物的认知及其对报销决策的影响。
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Potential impact on cost-effectiveness estimates of using immature survival data: a case study based on transcatheter edge-to-edge repair (TEER) used for patients with severe mitral regurgitation at high surgical risk.使用不成熟生存数据对成本效益估计的潜在影响：基于经导管缘对缘修复（TEER）用于高手术风险重度二尖瓣反流患者的案例研究。
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A Comparative Analysis of Anticancer Drug Appraisals Including Managed Entry Agreements in South Korea and England.韩国和英国含管理准入协议的抗癌药物评估的对比分析。
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Exploring uncertainty and use of real-world data in the National Institute for Health and Care Excellence single technology appraisals of targeted cancer therapy.探索英国国家卫生与保健优化研究所靶向癌症治疗单一技术评估中不确定性和真实世界数据的应用。
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Joining the Dots: Linking Disconnected Networks of Evidence Using Dose-Response Model-Based Network Meta-Analysis.连点成线：使用基于剂量-反应模型的网络荟萃分析连接不相关的证据网络。
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Development and Validation of the TRansparent Uncertainty ASsessmenT (TRUST) Tool for Assessing Uncertainties in Health Economic Decision Models.健康经济决策模型不确定性透明评估工具（TRUST）的开发与验证。
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The Cancer Drugs Fund in Practice and Under the New Framework.《实践中的癌症药物基金与新框架下的癌症药物基金》
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9
Pembrolizumab for Treating Relapsed or Refractory Classical Hodgkin Lymphoma: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.派姆单抗治疗复发或难治性经典型霍奇金淋巴瘤：一项 NICE 单技术评估的循证评估组观点。
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Obinutuzumab in Combination with Chemotherapy for the First-Line Treatment of Patients with Advanced Follicular Lymphoma : An Evidence Review Group Evaluation of the NICE Single Technology Appraisal.奥滨尤妥珠单抗联合化疗治疗初治晚期滤泡性淋巴瘤患者：NICE 单技术评估的证据审查组评价。
Pharmacoeconomics. 2019 Aug;37(8):975-984. doi: 10.1007/s40273-018-0740-4.

本文引用的文献

1
The Impact of Brexit on Pharmaceuticals and HTA.英国脱欧对制药和卫生技术评估的影响。
Pharmacoecon Open. 2018 Jun;2(2):87-91. doi: 10.1007/s41669-018-0072-5.
2
European drug agency wins victory over drug companies that wanted to withhold data.欧洲药品管理局战胜了那些想要隐瞒数据的制药公司。
BMJ. 2018 Feb 7;360:k604. doi: 10.1136/bmj.k604.
3
NICE, the NHS, and Cancer Drugs.英国国家卫生与临床优化研究所、英国国家医疗服务体系与癌症药物
JAMA. 2018 Feb 27;319(8):767-768. doi: 10.1001/jama.2017.20552.
4
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.欧洲药品管理局批准的癌症药物对总生存期和生活质量有益的证据可得性：2009 - 2013年药物批准情况的回顾性队列研究
BMJ. 2017 Oct 4;359:j4530. doi: 10.1136/bmj.j4530.
5
Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.加速监管批准背景下临床疗效评估的方法学挑战：概述
J Clin Epidemiol. 2017 Oct;90:108-118. doi: 10.1016/j.jclinepi.2017.07.002. Epub 2017 Jul 12.
6
Do patient access schemes for high-cost cancer drugs deliver value to society?-lessons from the NHS Cancer Drugs Fund.高成本癌症药物的患者准入方案是否为社会带来了价值？——来自英国国家医疗服务体系癌症药物基金的经验教训。
Ann Oncol. 2017 Aug 1;28(8):1738-1750. doi: 10.1093/annonc/mdx110.
7
Cancer Drugs Fund 2.0: A Missed Opportunity?癌症药物基金2.0：一个错失的机遇？
Pharmacoeconomics. 2016 Jul;34(7):629-33. doi: 10.1007/s40273-016-0403-2.

EMA and NICE Appraisal Processes for Cancer Drugs: Current Status and Uncertainties.

作者信息

Dickson Rumona, Boland Angela, Duarte Rui, Kotas Eleanor, Woolacott Nerys, Hodgson Robert, Riemsma Rob, Grimm Sabine, Ramaekers Bram, Joore Manuela, Büyükkaramikli Nasuh, Kaltenthaler Eva, Stevenson Matt, Pandor Abdullah, Edwards Steve, Hoyle Martin, Shepherd Jonathan, Armoiry Xavier, Brazzelli Miriam

机构信息

Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Liverpool, L69 3GB, UK.

Centre for Reviews and Dissemination, University of York, York, UK.

出版信息

Appl Health Econ Health Policy. 2018 Aug;16(4):429-432. doi: 10.1007/s40258-018-0393-7.

DOI:10.1007/s40258-018-0393-7
PMID:29808296
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6028888/
Abstract
摘要