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个性化医疗检测的经济价值:我们已知的和需要了解的。

The economic value of personalized medicine tests: what we know and what we need to know.

作者信息

Phillips Kathryn A, Ann Sakowski Julie, Trosman Julia, Douglas Michael P, Liang Su-Ying, Neumann Peter

机构信息

1] Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, California, USA [2] UCSF Philip R. Lee Institute for Health Policy, San Francisco, California, USA [3] UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA [4] UCSF Institute for Human Genetics, Center for Business Models in Healthcare, Chicago, Illinois, USA.

Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, California, USA.

出版信息

Genet Med. 2014 Mar;16(3):251-7. doi: 10.1038/gim.2013.122. Epub 2013 Oct 17.

Abstract

PURPOSE

There is uncertainty about when personalized medicine tests provide economic value. We assessed evidence on the economic value of personalized medicine tests and gaps in the evidence base.

METHODS

We created a unique evidence base by linking data on published cost-utility analyses from the Tufts Cost-Effectiveness Analysis Registry with data measuring test characteristics and reflecting where value analyses may be most needed: (i) tests currently available or in advanced development, (ii) tests for drugs with Food and Drug Administration labels with genetic information, (iii) tests with demonstrated or likely clinical utility, (iv) tests for conditions with high mortality, and (v) tests for conditions with high expenditures.

RESULTS

We identified 59 cost-utility analyses studies that examined personalized medicine tests (1998-2011). A majority (72%) of the cost/quality-adjusted life year ratios indicate that testing provides better health although at higher cost, with almost half of the ratios falling below $50,000 per quality-adjusted life year gained. One-fifth of the results indicate that tests may save money.

CONCLUSION

Many personalized medicine tests have been found to be relatively cost-effective, although fewer have been found to be cost saving, and many available or emerging medicine tests have not been evaluated. More evidence on value will be needed to inform decision making and assessment of genomic priorities.

摘要

目的

个性化医疗检测何时能产生经济价值尚不确定。我们评估了个性化医疗检测经济价值的证据以及证据基础中的差距。

方法

我们通过将塔夫茨成本效益分析登记处已发表的成本效用分析数据与衡量检测特征并反映可能最需要进行价值分析之处的数据相链接,创建了一个独特的证据基础:(i)当前可用或处于研发后期的检测;(ii)针对带有遗传信息的食品药品监督管理局标签药物的检测;(iii)具有已证实或可能具有临床效用的检测;(iv)针对高死亡率疾病的检测;(v)针对高支出疾病的检测。

结果

我们确定了59项研究个性化医疗检测的成本效用分析研究(1998 - 2011年)。大多数(72%)的成本/质量调整生命年比率表明,检测虽成本较高,但能带来更好的健康状况,近一半的比率低于每获得一个质量调整生命年50,000美元。五分之一的结果表明检测可能节省资金。

结论

许多个性化医疗检测已被发现具有相对成本效益,尽管被发现能节省成本的较少,且许多现有的或新兴的医疗检测尚未得到评估。需要更多关于价值的证据来为决策制定和基因组优先事项评估提供信息。

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