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Effectiveness of biologics in rheumatology: improving the evidence base.

机译：生物制剂在风湿病中的有效性：改善证据基础。

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摘要

This supplement arose from a workshop held in London in September 2010, sponsored jointly by Arthritis Research UK and the Medical Research Council (MRC) Trials Methodology Hub Network. The aim of the meeting was to bring together clinical rheumatologists, health economists and statisticians with an interest in the cost-effectiveness of biologic therapies in rheumatology. The impetus for the meeting lay in how best to map the growing use of biologic therapies for inflammatory arthritis with the internationally recognized UK process for deciding which new pharmaceutical products will be recommended for use in the National Health Service (NHS). In the UK, no new treatments can be introduced into the NHS unless they have been approved by the National Institute for Health and Clinical Excellence (NICE) in England and Wales (or the Scottish Medicines Commission in Scotland). The key process at NICE is a cost-effectiveness analysis of a new product (or new indication for an existing product) in relation to appropriate comparators. For assessing biologics comparators not only include a placebo, such as MTX in MTX failures, but also other potential active comparators. Assessments may study a single biologic (Single Technology Assessment) or simultaneously assess the range of agents for a specific clinical indication (Multiple Technology Assessment) [1]. The most important evidence should be based on randomized controlled trials.
机译：该补充资料来自2010年9月在伦敦举行的由英国关节炎研究协会和医学研究理事会（MRC）试用方法学中心网络共同赞助的研讨会。会议的目的是召集对风湿病生物疗法的成本效益感兴趣的临床风湿病学家，健康经济学家和统计学家。此次会议的推动力在于，如何最好地根据国际公认的英国流程来确定在炎症性关节炎中越来越多地使用生物疗法，以决定将哪些新药品推荐用于国家卫生局（NHS）。在英国，除非获得英格兰和威尔士国家卫生与临床卓越研究所（NICE）（或苏格兰苏格兰医学委员会）的批准，否则不得将新疗法引入NHS。 NICE的关键过程是相对于适当的比较器对新产品（或现有产品的新指示）进行成本效益分析。为了评估生物制剂，比较器不仅包括安慰剂（例如MTX失败的MTX），还包括其他潜在的有源比较器。评估可以研究单一生物制剂（单一技术评估），也可以同时评估特定临床指征的药物范围（多种技术评估）[1]。最重要的证据应基于随机对照试验。

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