J Manag Care Spec Pharm. 2018 Jul;24(7):583-588. doi: 10.18553/jmcp.2018.24.7.583.
Precision medicine, the customization of health care to an individual's genetic profile while accounting for biomarkers and lifestyle, has increasingly been adopted by health care stakeholders to guide the development of treatment options, improve treatment decision making, provide more patient-centered care, and better inform coverage and reimbursement decisions. Despite these benefits, key challenges prevent its broader use and adoption. On December 7-8, 2017, the Academy of Managed Care Pharmacy convened a group of stakeholders to discuss these challenges and provide recommendations to facilitate broader adoption and use of precision medicine across health care settings. These stakeholders represented the pharmaceutical industry, clinicians, patient advocacy, private payers, device manufacturers, health analytics, information technology, academia, and government agencies. Throughout the 2-day forum, participants discussed evidence requirements for precision medicine, including consistent ways to measure the utility and validity of precision medicine tests and therapies, limitations of traditional clinical trial designs, and limitations of value assessment framework methods. They also highlighted the challenges with evidence collection and data silos in precision medicine. Interoperability within and across health systems is hindering clinical advancements. Current medical coding systems also cannot account for the heterogeneity of many diseases, preventing health systems from having a complete understanding of their patient population to inform resource allocation. Challenges faced by payers, such as evidence limitations, to inform coverage and reimbursement decisions in precision medicine, as well as legal and regulatory barriers that inhibit more widespread data sharing, were also identified. While a broad range of perspectives was shared throughout the forum, participants reached consensus across 2 overarching areas. First, there is a greater need for common definitions, thresholds, and standards to guide evidence generation in precision medicine. Second, current information silos are preventing the sharing of valuable data. Collaboration among stakeholders is needed to support better information sharing, awareness, and education of precision medicine for patients. The recommendations brought forward by this diverse group of experts provide a set of solutions to spur widespread use and application of precision medicine. Taken together, successful adoption and use of precision medicine will require input and collaboration from all sectors of health care, especially patients. DISCLOSURES This AMCP Partnership Forum and the development of the proceedings document were supported by Amgen, Foundation Medicine, Genentech, Gilead, MedImpact, National Pharmaceutical Council, Precision for Value, Sanofi, Takeda, and Xcenda.
精准医疗，即根据个体的基因谱和生物标志物及生活方式定制医疗保健，已越来越多地被医疗保健利益相关者采用，以指导治疗方案的制定、改善治疗决策、提供更以患者为中心的护理，并更好地为覆盖范围和报销决策提供信息。尽管有这些好处，但一些关键挑战仍阻碍了其更广泛的应用和采用。2017 年 12 月 7 日至 8 日，管理式医疗药师协会召集了一组利益相关者，讨论这些挑战，并提出建议，以促进精准医疗在整个医疗保健环境中的更广泛采用和使用。这些利益相关者代表制药行业、临床医生、患者权益倡导者、私人支付方、设备制造商、健康分析、信息技术、学术界和政府机构。在为期两天的论坛中，与会者讨论了精准医疗的证据要求，包括一致的方法来衡量精准医学检测和治疗的效用和有效性、传统临床试验设计的局限性以及价值评估框架方法的局限性。他们还强调了精准医学中证据收集和数据孤岛的挑战。医疗系统内部和之间的互操作性阻碍了临床进展。当前的医疗编码系统也无法涵盖许多疾病的异质性，使医疗系统无法全面了解其患者群体，从而无法为资源分配提供信息。支付方在精准医学中面临的证据有限等挑战，以告知覆盖范围和报销决策，以及法律和监管障碍，阻碍了更广泛的数据共享，也在论坛上被指出。虽然整个论坛上分享了广泛的观点，但与会者在两个总体领域达成了共识。首先，需要有更通用的定义、阈值和标准来指导精准医学中的证据生成。其次，当前的信息孤岛阻碍了有价值数据的共享。需要利益相关者之间的合作，以支持更好地共享、提高认识和教育患者精准医学。这个由不同领域的专家组成的小组提出的建议为推动精准医学的广泛应用和应用提供了一系列解决方案。总之，成功采用和应用精准医学需要医疗保健各个领域，特别是患者的投入和合作。披露 本次 AMCP 合作论坛和会议文件的制定得到了安进、Foundation Medicine、基因泰克、吉利德科学、MedImpact、国家制药理事会、精准价值、赛诺菲、武田和 Xcenda 的支持。
