Health technology assessment (HTA): Decisions on treatment efficiency guided by clinical judgement and pharmacoeconomics.

IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Kenneth R Paterson, David J Webb
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引用次数: 0

Abstract

Over the past 25 years, the UK has adopted health technology assessment (HTA) as a mechanism to ensure that new medicines, and new indications for existing medicines, are assessed in an open, objective and robust way so that when the UK National Health Service (NHS) adopts these therapeutic developments, it does so in a cost-effective manner, accepting those agents with an acceptable cost per quality-adjusted life year (QALY) or a discount that brings the cost below the threshold. Usually, pharmacoeconomic modelling is used to justify pricing, often relying on surrogate endpoints or extrapolation beyond the duration of existing trials data. Although cost-effectiveness is often based on robust clinical trials, there are other issues to consider, which require an understanding of clinical pharmacology and clinical judgement. Key considerations include the justification of use of surrogates and extrapolation, the appropriateness of any comparator drug studied, the difference between efficacy in trials and clinical effectiveness in real-world use, the additional costs of providing a service to deliver the medicine, and the cost of any important adverse effects that are likely to occur. Although the process in the UK is now well established, with support from clinicians and the public, there remain questions about whether the currently accepted cost/QALY is set too high, whether a special case should be made for some drugs commanding a higher cost/QALY (such as in cancer and end-of-life situations), and whether HTA should be used more broadly to assess other activities undertaken by the NHS.

卫生技术评价(HTA):以临床判断和药物经济学为指导的治疗效率决定。
在过去的25年里,英国采用了卫生技术评估(HTA)作为一种机制来确保新药物,现有和新适应症的药品,评估在一个开放的、客观的和健壮的方法,这样当英国国民健康服务(NHS)采用这些治疗的进展,它具有成本效益的方式,接受这些代理以可接受的成本每质量调整生命年(QALY)或折扣带来的成本低于阈值。通常,药物经济学模型用于证明定价的合理性,通常依赖于替代终点或超出现有试验数据持续时间的外推。虽然成本效益通常基于可靠的临床试验,但还有其他问题需要考虑,这需要了解临床药理学和临床判断。主要考虑因素包括使用替代药物和外推的合理性、所研究的任何比较药物的适当性、试验疗效与实际使用的临床疗效之间的差异、提供药物递送服务的额外成本以及可能发生的任何重要不良反应的成本。尽管在临床医生和公众的支持下,这一过程在英国已经很好地建立起来,但仍然存在一些问题,如目前接受的成本/质量aly是否设定得太高,是否应该为一些成本/质量aly较高的药物制定一个特殊的案例(如癌症和生命末期的情况),以及HTA是否应该更广泛地用于评估NHS开展的其他活动。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.30
自引率
8.80%
发文量
419
审稿时长
1 months
期刊介绍: Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology features papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment. The Journal is recognised as one of the leading publications in its field. It is online only, publishes open access research through its OnlineOpen programme and is published monthly.
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