Are patients willing to incur out-of-pocket costs for pharmacogenomic testing?
Are patients willing to incur out-of-pocket costs for pharmacogenomic testing?
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DOI：
10.1038/tpj.2016.72
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发表时间：
2017-01
期刊：
影响因子：
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通讯作者：
Roger VL
中科院分区：
文献类型：
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作者：
Bielinski SJ;St Sauver JL;Olson JE;Wieland ML;Vitek CR;Bell EJ;Mc Gree ME;Jacobson DJ;McCormick JB;Takahashi PY;Black JL;Caraballo PJ;Sharp RR;Beebe TJ;Weinshilboum RM;Wang L;Roger VL
药物反应的遗传调节可引起严重的、可能危及生命的药物不良反应，可增加对药物-药物相互作用的易感性，并可降低或增强治疗效果。因此，药物基因组学在临床上的应用可以避免药物不良反应，最大限度地提高药物疗效。理想情况下，根据个体患者的遗传特征选择药物将对特定适应症产生最佳效果。在过去的十年中，美国食品和药物管理局已经鉴定出大量具有临床实用性的药物基因组学变体，并将其纳入药物标签中。1认识到药物基因组学有可能以具有临床意义的方式立即影响患者的护理，奥巴马总统在他的精准医学倡议讲话中强调了“在正确的时间，每次向正确的人提供正确的治疗”的重要性。2然而，将药物基因组学纳入临床实践已被证明是缓慢和具有挑战性的。这些挑战中的一些包括（1）由于使用传统的反应性（而不是先发制人）药物基因组学测试的排序而延迟治疗的开始，（2）缺乏对商业电子健康记录系统的支持以整合基因组数据并在护理点实现自动化临床决策支持，（3）针对功效的先发制人测试的益处的证据有限，与避免罕见毒性的测试相反，（4）基因型数据解释的复杂性和（5）健康保险公司对药物基因组学测试的有限覆盖和报销。鉴于这些挑战，大规模先发制人的药物基因组学的早期实施仅限于大型医疗中心，这些医疗中心有大量的机构支持来支付成本。4-6将这些努力扩大到愿意自掏腰包支付费用的患者群体，可以促进更广泛的采用。然而，愿意自掏腰包的患者类型以及这些患者愿意为药物基因组学检测支付的金额尚不清楚。直接面向消费者的基因检测公司提供了一些线索，病人可能愿意支付药物基因组学检测。23andMe是最广泛使用的直接面向消费者的基因检测公司，为超过100万客户提供健康相关信息以及血统信息。2007年，测试成本最初为999美元，2012年降至99美元，2015年随着新的食品和药物管理局合规报告的引入而提高到199美元。23和我com）。客户可以访问他们的原始遗传数据，但解释报告的健康相关部分只包括一小部分罕见疾病携带者状态的结果。进一步限制这些结果的效用是缺乏与个体患者的电子健康记录的集成以用于当前和未来的医疗护理。显然，大量的消费者愿意支付直接面向消费者的基因检测;然而，仍有待确定的是，哪些类型的患者愿意承担自付费用，让他们的医疗保健提供者订购基因检测，以及这些患者愿意自付多少钱。在实际的医疗保健情况下，患者可能期望基因检测的费用应由其医疗保险计划支付。为了解决这些问题，我们调查了参与马约诊所正确药物、正确剂量、正确时间方案（RIGHT方案）研究的患者。4、正确的协议是…
Genetic modulation of drug response can cause serious, potentially life-threatening adverse drug reactions, can increase susceptibility to drug–drug interactions and can diminish or enhance therapeutic efficacy. As a result, the clinical implementation of pharmacogenomics at the bedside could make it possible to avoid adverse drug reactions and maximize drug efficacy. Ideally, selection of medications based on the genetic profile of individual patients will produce optimal effects for specific indications. Over the past decade, a large number of pharmacogenomic variants with demonstrated clinical utility have been identified and incorporated into drug labels by the US Food and Drug Administration. 1 Recognizing that pharmacogenomics has the potential to immediately impact the care of patients in a clinically meaningful manner, President Obama highlighted the importance of ‘delivering the right treatments, at the right time, every time to the right person’in his Precision Medicine Initiative Remarks. 2 However, the incorporation of pharmacogenomics into clinical practice has proved slow and challenging. Some of those challenges include (1) delay in the initiation of therapy due to the use of traditional reactive, as opposed to preemptive, ordering of pharmacogenomic testing,(2) lack of support for commercial electronic health record systems to integrate genomic data and enable automated clinical decision support at the point of care,(3) limited evidence of the benefit for preemptive testing for efficacy, as opposed to testing to avoid rare toxicities,(4) complexity of interpretation of the genotype data and (5) limited coverage and reimbursement of pharmacogenomic testing by health insurance companies. 3 Given these challenges, early implementation of large-scale preemptive pharmacogenomics has been restricted to large medical centers with substantial institutional support to cover the costs. 4–6 Expansion of these efforts to patient populations willing to pay out of pocket to defray costs could facilitate wider adoption. However, the types of patients willing to pay out of pocket and the amount these patients would be willing to pay for pharmacogenomic testing are unknown. Direct-to-consumer genetic testing companies provide some clues as to what patients might be willing to pay for pharmacogenomic testing. 23andMe is the most widely used direct-to-consumer genetic testing company that provides healthrelated information as well as ancestry information to over1 000 000 customers. 7 Cost of testing was initially $999 in 2007, was lowered to $99 in 2012 and was raised to $199 in 2015 with the introduction of a new Food and Drug Administration compliant report (www. 23andMe. com). Customers have access to their raw genetic data, but the health-related portion of the interpreted report includes only a small set of results for rare disease carrier status. Further limiting the utility of these results is the lack of integration with individual patient’s electronic health record for use in current and future medical care. Clearly, large numbers of consumers are willing to pay for direct-to-consumer genetic testing; however, it remains to be determined what types of patients would be willing to incur out-of-pocket costs to have their health-care provider order genetic testing, and what amount would these patients be willing to pay out of pocket. It may be that in the actual health-care context, patients have the expectation that the costs of genetic testing should be covered by their health insurance plan. To address these questions, we surveyed patients participating in the Mayo Clinic Right Drug, Right Dose, Right Time Protocol (RIGHT Protocol) study. 4 The RIGHT Protocol is …