Scott Mitchell G
Division of Laboratory and Genomic Medicine, Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
Scand J Clin Lab Invest Suppl. 2010;242:90-5. doi: 10.3109/00365513.2010.493411.
Cost-effectiveness and cost-utility studies are commonly used to make payment decisions for new drugs and expensive interventions. Such studies are relatively rare for evaluating the cost-utility of clinical laboratory tests. As medical costs continue to increase in the setting of decreased resources it is likely that new biomarkers may increasingly be examined with respect to their economic benefits in addition to clinical utility. This will represent an additional hurdle for routine use of new biomarkers. Before reaching the final economic hurdle new biomarkers will still need to demonstrate clinical usefulness. Thus a new biomarker will never make economic sense if it is not clinically useful. Once diagnostic accuracy and potential clinical usefulness is established there are several types of economic studies that new biomarkers may undergo. The most common of these are cost-utility studies which estimate the ratio between the cost of an intervention or test and the benefit it produces in the number of years gained in full health. The quantity used most often to describe this is amount of money per quality adjusted life year (QALY) gained. The threshold for being considered cost-effective is generally USD 50,000 per QALY gained. Examples of biomarkers that have been subjected to economic analyses will be provided.
成本效益研究和成本效用研究通常用于为新药和昂贵的干预措施做出支付决策。此类研究在评估临床实验室检测的成本效用方面相对较少。随着医疗成本在资源减少的情况下持续增加，除了临床效用外，新的生物标志物可能会越来越多地从经济效益方面进行审视。这将成为新生物标志物常规应用的又一障碍。在跨越最终的经济障碍之前，新的生物标志物仍需证明其临床实用性。因此，如果一种新的生物标志物没有临床实用性，它在经济上就永远没有意义。一旦确定了诊断准确性和潜在的临床实用性，新的生物标志物可能会进行几种类型的经济研究。其中最常见的是成本效用研究，该研究估计一项干预措施或检测的成本与其在完全健康状态下所获得的生命年数中产生的效益之间的比率。最常用于描述这一情况的指标是每获得一个质量调整生命年（QALY）所花费的金额。被认为具有成本效益的阈值通常是每获得一个QALY为50,000美元。将提供已进行经济分析的生物标志物实例。
