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预先药物遗传学检测:探索美国支付方的知识和观点。

Preemptive pharmacogenetic testing: exploring the knowledge and perspectives of US payers.

机构信息

Department of Pharmacy Administration, University of Mississippi School of Pharmacy, Oxford, Mississippi, USA.

Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.

出版信息

Genet Med. 2019 May;21(5):1224-1232. doi: 10.1038/gim.2017.181. Epub 2017 Oct 26.

Abstract

PURPOSE

Preemptive pharmacogenetic testing aims to optimize medication use by having genetic information at the point of prescribing. Payers' decisions influence implementation of this technology. We investigated US payers' knowledge, awareness, and perspectives on preemptive pharmacogenetic testing.

METHODS

A qualitative study was conducted using semistructured interviews. Participants were screened for eligibility through an online survey. A blended inductive and deductive approach was used to analyze the transcripts. Two authors conducted an iterative reading process to code and categorize the data.

RESULTS

Medical or pharmacy directors from 14 payer organizations covering 122 million US lives were interviewed. Three concept domains and ten dimensions were developed. Key findings include clinical utility concerns and limited exposure to preemptive germ-line testing, continued preference for outcomes from randomized controlled trials, interest in guideline development, importance of demonstrating an impact on clinical decision making, concerns of downstream costs and benefit predictability, and the impact of public stakeholders such as the Food and Drug Administration and Centers for Medicare and Medicaid Services.

CONCLUSION

Both barriers and potential facilitators exist to developing cohesive reimbursement policy for pharmacogenetics, and there are unique challenges for the preemptive testing model. Prospective outcome studies, more precisely defining target populations, and predictive economic models are important considerations for future research.

摘要

目的

预防性药物遗传学检测旨在通过在开出处方时提供遗传信息来优化药物使用。支付方的决策影响该技术的实施。我们调查了美国支付方对预防性药物遗传学检测的知识、意识和观点。

方法

采用半结构式访谈进行定性研究。参与者通过在线调查进行资格筛选。采用归纳和演绎相结合的混合方法对转录本进行分析。两位作者进行了迭代阅读过程,对数据进行编码和分类。

结果

对来自 14 个支付方组织的 12200 万美国人的医疗或药剂主任进行了访谈。确定了三个概念领域和十个维度。主要发现包括对临床实用性的担忧和对预防性种系检测的有限了解,继续偏好随机对照试验的结果,对指南制定的兴趣,对证明对临床决策有影响的重要性,对下游成本和收益可预测性的担忧,以及食品和药物管理局和医疗保险和医疗补助服务中心等公共利益相关者的影响。

结论

制定药物遗传学统一报销政策既存在障碍,也存在潜在的促进因素,而预防性检测模式存在独特的挑战。前瞻性的结果研究、更准确地定义目标人群以及预测性的经济模型是未来研究的重要考虑因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b96b/5920773/fb043fc0b289/nihms907298f1.jpg

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