Yankah Sandra E, Nafie Maryam, Hendricks-Sturrup Rachele M, Lu Christine Y
Duke-Robert J. Margolis, MD, Institute for Health Policy, Washington, DC 20004, USA.
School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2006, Australia.
J Pers Med. 2025 Jun 3;15(6):232. doi: 10.3390/jpm15060232.
Sources and evidence cited to inform payer coverage decisions on pharmacogenomic (PGx) testing in psychiatry are presently underexplored. We conducted a qualitative and quantitative assessment of publicly available coverage policies from 14 US payers, examining the number and both the type and source of citations across policies and coverage decisions. Payers were classified as for-profit or mutual fund versus non-profit or government, and their coverage decisions were categorized as either coverage (limited or specified) or no coverage. Among 32 unique sources cited, peer-reviewed literature as a single source was most frequently cited across all policies. Of 207 peer-reviewed papers cited across all policies, 40% ( = 83) were psychiatry-specific real-world evidence (RWE) studies. No statistically significant relationships were observed when comparing variance in the number of citations per policy by payer type ( = 0.22) or coverage decision ( = 0.75; unadjusted variance of 61.25 and an adjusted variance of 60.98 for both comparisons). For-profit or mutual fund payers and/or payers providing no coverage cited systematic reviews and non-randomized controlled cohort RWE studies most often. Non-profit or government payers and/or payers providing coverage cited case series or case-control RWE studies most often. Six psychiatry-specific RWE studies and contributions from 13 distinct sources were often cited, regardless of payer type or coverage decision. RWE, among several sources, are cited in many forms and to varying degrees among payers providing coverage decisions for PGx testing in psychiatry, with coverage determinations being largely based on how certain payers interpret evidence on the clinical value of testing.
目前，用于为精神病学领域药物基因组学（PGx）检测的医保覆盖决策提供信息的来源和证据尚未得到充分探索。我们对14家美国医保机构公开的覆盖政策进行了定性和定量评估，研究了各项政策及覆盖决策中引用的数量、类型和来源。医保机构被分为营利性或共同基金型与非营利性或政府型，其覆盖决策被归类为覆盖（有限或特定）或不覆盖。在被引用的32个独特来源中，同行评审文献作为单一来源在所有政策中被引用的频率最高。在所有政策中引用的207篇同行评审论文中，40%（= 83篇）是精神病学领域的真实世界证据（RWE）研究。比较不同医保机构类型（= 0.22）或覆盖决策（= 0.75；两种比较的未调整方差均为61.25，调整后方差均为60.98）下每项政策引用数量的差异时，未观察到统计学上的显著关系。营利性或共同基金型医保机构和/或不提供覆盖的医保机构最常引用系统评价和非随机对照队列RWE研究。非营利性或政府型医保机构和/或提供覆盖的医保机构最常引用病例系列或病例对照RWE研究。无论医保机构类型或覆盖决策如何，六项精神病学领域的RWE研究以及13个不同来源的贡献经常被引用。在为精神病学领域PGx检测提供覆盖决策的医保机构中，RWE以多种形式被引用，且程度各异，覆盖决策很大程度上取决于某些医保机构如何解读检测临床价值的证据。
