Deverka P A
Division of Pharmacotherapy, UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, NC 27599-7360, USA.
Public Health Genomics. 2009;12(3):149-57. doi: 10.1159/000189627. Epub 2009 Feb 10.
Initial enthusiasm for the potential of pharmacogenomics (PGx) to transform medical practice has been tempered by the reality that the process of biomarker discovery, validation, and clinical qualification has been disappointingly slow, with a limited number of PGx tests entering the marketplace since the initial publication of the human genome sequence. Reasons for the delays include the complexity of the underlying science as well as clinical, economic, and organizational barriers to the effective delivery of personalized health care. Nevertheless, payers are interested in using PGx services to ensure that drug use is safer and more effective, particularly in the settings of medications that are widely used, have significant risks of serious adverse events, have poor or highly variable drug response, or are very expensive. However, public and private payers have specific evidence requirements for new health care technologies that must be met prior to obtaining favorable coverage and reimbursement status. These evaluation criteria are frequently more rigorous than the current level of evidence required for regulatory approval of new PGx tests or PGx-related drug labeling. To support payer decision-making, researchers will need to measure the impact of PGx testing on clinical and economic outcomes and demonstrate the net benefit of PGx testing as compared to usual care. By linking payer information needs with the current PGx research agenda, there is the opportunity to develop the data required for informed decision-making. This strategy will increase the likelihood that PGx services will be both reimbursed and used appropriately in clinical practice.
药物基因组学（PGx）改变医疗实践的潜力最初引发了人们的热情，但生物标志物发现、验证和临床鉴定过程令人失望地缓慢，自人类基因组序列首次公布以来，进入市场的PGx检测数量有限，这一现实使这种热情有所降温。延迟的原因包括基础科学的复杂性以及有效提供个性化医疗保健的临床、经济和组织障碍。尽管如此，支付方有兴趣使用PGx服务，以确保药物使用更安全、更有效，特别是在广泛使用、有严重不良事件重大风险、药物反应不佳或高度可变或非常昂贵的药物使用场景中。然而，公共和私人支付方对新的医疗保健技术有特定的证据要求，在获得有利的保险覆盖和报销状态之前必须满足这些要求。这些评估标准通常比新PGx检测或与PGx相关的药物标签监管批准所需的当前证据水平更为严格。为了支持支付方的决策，研究人员需要衡量PGx检测对临床和经济结果的影响，并证明与常规治疗相比PGx检测的净效益。通过将支付方的信息需求与当前的PGx研究议程联系起来，有机会开发出明智决策所需的数据。这种策略将增加PGx服务在临床实践中得到报销和合理使用的可能性。
