Taylor R
Department of Public Health & Epidemiology, University of Birmingham, Edgbaston, England.
Pharmacoeconomics. 2001;19 Suppl 2:33-8. doi: 10.2165/00019053-200119002-00006.
In the developed world, the demand for healthcare is rising faster than supply, so that governments are faced with the need to allocate limited resources for maximum benefit. Many governments are responding to these pressures by developing health technology assessment agencies, which evaluate the cost effectiveness of new pharmaceutical and medical products relative to existing interventions. In England and Wales, the agency concerned with health technology assessment is the National Institute for Clinical Excellence (NICE). NICE brings together evidence of clinical and cost effectiveness to judge the value of the treatment relative to alternative uses of National Health Service (NHS) resources and makes recommendations on use of the treatment by the NHS in England and Wales. NICE evaluates technologies where they may result in significant impact on NHS resources or key healthcare policy. The health technology assessment includes a review of the clinical effectiveness, cost effectiveness and service impact of the technology under consideration. This health technology assessment report, together with submissions from the technology manufacturer, and patient and healthcare professionals groups, is then considered by an appraisal committee that formulates guidance to the NHS and is ultimately published by NICE. A number of countries have formal guidelines on the use of outcome measures and economic evaluations in the submissions required for health technology assessment prior to market access. These guidelines vary in both the detail and level of mandatory requirement to be followed by technology manufacturers. NICE has recently updated its guidance to technology manufacturers on their submissions. These guidelines, developed in consultation with the healthcare industry, provide detailed specification of the requirements of NICE for health outcomes data and economic evaluation. These details are described in more detail in this paper.
在发达国家，医疗保健需求的增长速度超过了供应速度，因此政府面临着为实现最大效益而分配有限资源的需求。许多政府通过设立卫生技术评估机构来应对这些压力，这些机构评估新药品和医疗产品相对于现有干预措施的成本效益。在英格兰和威尔士，负责卫生技术评估的机构是国家临床优化研究所（NICE）。NICE综合临床和成本效益证据，以判断该治疗相对于国民保健制度（NHS）资源的其他用途的价值，并就NHS在英格兰和威尔士使用该治疗提出建议。NICE对可能对NHS资源或关键医疗政策产生重大影响的技术进行评估。卫生技术评估包括对所考虑技术的临床有效性、成本效益和服务影响进行审查。然后，评估委员会会审议这份卫生技术评估报告，以及技术制造商、患者和医疗专业人员团体提交的材料，评估委员会会制定针对NHS的指南，最终由NICE发布。一些国家在市场准入前的卫生技术评估所需提交材料中，对结果指标的使用和经济评估有正式指南。这些指南在技术制造商需遵循的详细程度和强制要求水平方面各不相同。NICE最近更新了对技术制造商提交材料的指南。这些指南是在与医疗行业协商后制定的，详细说明了NICE对健康结果数据和经济评估的要求。本文将更详细地描述这些细节。
