Iliffe Steve
University College London, London, England.
CNS Drugs. 2007;21(3):177-84. doi: 10.2165/00023210-200721030-00001.
Britain's National Institute for Health and Clinical Excellence (NICE) has recently issued guidance that restricts the use of cholinesterase inhibitors and memantine for the treatment of Alzheimer's disease in the National Health Service. This stance contains lessons for designers of trials, drug regulators, health economists and those developing clinical guidelines for dementia care. The debates that took place around and within NICE were about identifying the benefits of these medicines and the beneficiaries, clarifying the costs of the medication and whom bears them, the methods of weighing benefit against cost, and the consequences of using different approaches to cost-benefit analysis. This article discusses each of these themes and outlines the changes in research and clinical practice and policy making that might flow from NICE's decisions on medication use. Outcome measures that capture changes in dementia syndromes need further development. Cost-benefit analysis needs refinement with better tools than quality-adjusted life-years, and the policy implications of restricting treatments in a progressive neurodegenerative disorder need more careful consideration.
英国国家卫生与临床优化研究所(NICE)最近发布了相关指南,限制在国民医疗服务体系中使用胆碱酯酶抑制剂和美金刚治疗阿尔茨海默病。这一立场给试验设计者、药品监管机构、卫生经济学家以及制定痴呆症护理临床指南的人员带来了启示。围绕NICE展开的以及NICE内部的争论涉及确定这些药物的益处及受益人群、厘清药物成本及承担者、权衡收益与成本的方法,以及采用不同成本效益分析方法的后果。本文探讨了上述每个主题,并概述了可能因NICE关于药物使用的决定而在研究、临床实践和政策制定方面发生的变化。捕捉痴呆症综合征变化的结果指标需要进一步完善。成本效益分析需要借助比质量调整生命年更好的工具加以改进,而在一种进行性神经退行性疾病中限制治疗的政策影响需要更审慎的考量。