Alzheimer's disease blood-based biomarker testing: A stakeholder-informed assessment of coverage considerations.

IF 3.4 3区 医学 Q2 NEUROSCIENCES
Patricia A Deverka, Jalayne J Arias, Grace A Lin, Jessica Zwerling, Kathryn A Phillips
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Abstract

BackgroundRecently published clinical studies suggest that blood-based biomarker tests (BBMTs) for Alzheimer's disease (AD) provide value, but in the U.S., neither public nor private payers currently cover these tests.ObjectiveTo describe considerations for payer coverage of AD BBMTs that would need to be addressed to facilitate timely diagnosis and equitable patient access if clinical utility is demonstrated.MethodsWe performed a targeted literature review to characterize predictable coverage barriers for BBMTs and inform the development of an interview guide. We conducted semi-structured interviews with clinicians, researchers, test developers, and a patient advocate and former payer (N = 12) to assess the barriers and refine the proposed key considerations for obtaining payer coverage.ResultsStakeholders noted that payers will require evidence of clinical validity and utility of BBMTs as part of their coverage determinations contingent on the specific indication for testing, with insufficient evidence for screening applications currently. Stakeholders also agreed that there are evidence gaps for use of BBMTs in patients from ethnic and racial minority communities that must be addressed. Given the shortage of memory specialists, stakeholders noted that limiting testing coverage authorization to specialists could be harmful to patients, particularly the underserved. Interviewees also agreed that patients with mild cognitive impairment or early-stage AD could benefit from earlier diagnosis to avoid progressing to moderate disease and limiting eligibility for new disease-modifying therapies.ConclusionsIf BBMTs meet criteria for clinical utility, anticipating and planning for coverage and reimbursement before widespread implementation will be critical to ensuring broad, equitable access to BBMTs.

阿尔茨海默病血液生物标志物检测:对覆盖考虑的利益相关者知情评估。
最近发表的临床研究表明,基于血液的生物标志物测试(BBMTs)对阿尔茨海默病(AD)提供了价值,但在美国,目前无论是公共还是私人付款人都不包括这些测试。目的描述在证明临床效用的情况下,为促进及时诊断和公平获取患者所需解决的AD bbmt付款人覆盖的考虑因素。方法我们进行了一项有针对性的文献综述,以表征bbmt可预测的覆盖障碍,并为访谈指南的制定提供信息。我们与临床医生、研究人员、测试开发人员、患者倡导者和前付款人(N = 12)进行了半结构化访谈,以评估障碍并完善获得付款人覆盖的建议关键考虑因素。利益相关者指出,支付方将需要bbmt的临床有效性和效用证据,作为其覆盖范围确定的一部分,这取决于具体的检测适应症,目前筛查应用的证据不足。利益攸关方还一致认为,必须解决少数民族和种族少数群体患者使用bbmt的证据差距问题。鉴于记忆专家的短缺,利益相关者指出,限制对专家的测试覆盖授权可能对患者有害,特别是对服务不足的患者。受访者还同意,轻度认知障碍或早期AD患者可以从早期诊断中获益,以避免发展为中度疾病,并限制新的疾病改善疗法的资格。结论:如果BBMTs符合临床应用标准,在广泛实施之前对覆盖范围和报销进行预测和规划对于确保BBMTs广泛、公平地获得至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Alzheimer's Disease
Journal of Alzheimer's Disease 医学-神经科学
CiteScore
6.40
自引率
7.50%
发文量
1327
审稿时长
2 months
期刊介绍: The Journal of Alzheimer''s Disease (JAD) is an international multidisciplinary journal to facilitate progress in understanding the etiology, pathogenesis, epidemiology, genetics, behavior, treatment and psychology of Alzheimer''s disease. The journal publishes research reports, reviews, short communications, hypotheses, ethics reviews, book reviews, and letters-to-the-editor. The journal is dedicated to providing an open forum for original research that will expedite our fundamental understanding of Alzheimer''s disease.
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