Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.
Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), University of California, San Francisco, San Francisco, CA, USA.
Genet Med. 2021 Apr;23(4):614-620. doi: 10.1038/s41436-020-01042-4. Epub 2021 Jan 8.
ApoE-e4 has a well-established connection to late-onset Alzheimer disease (AD) and is available clinically. Yet, there have been no analyses of payer coverage policies for ApoE. Our objective was to analyze private payer coverage policies for ApoE genetic testing, examine the rationales, and describe supporting evidence referenced by policies.
We searched for policies from the eight largest private payers (by member numbers) covering ApoE testing for late-onset AD. We implemented content analysis methods to evaluate policies for coverage decisions and rationales.
Seven payers had policies with positions on ApoE testing. Five explicitly state they do not cover ApoE and two apply generic preauthorization criteria. Rationales supporting coverage decisions include: reference to guidelines or national standards, inadequate data supporting testing, characterizing testing as investigational, or that testing would not alter patients' clinical management.
Seven of the eight largest private payers' coverage policies reflect standards that discourage ApoE testing due to a lack of clinical utility. As the field advances, ApoE testing may have an important clinical role, particularly considering that disease-modifying therapies are under evaluation by the US Food and Drug Administration. These types of field advancements may not be consistent with private payers' policies and may cause payers to reevaluate existing coverage policies.
载脂蛋白 E4（ApoE-e4）与晚发性阿尔茨海默病（AD）有着明确的关联，并且已经在临床上得到应用。然而，目前还没有对 ApoE 支付方报销政策进行分析。我们的目的是分析私人支付方针对 ApoE 基因检测的报销政策，考察其理由，并描述政策中引用的支持证据。
我们搜索了覆盖晚发性 AD 的 ApoE 检测的来自八个最大的私人支付方（按会员人数计算）的政策。我们采用内容分析方法来评估覆盖决策和理由的政策。
有七个支付方制定了有关 ApoE 检测的政策。其中五个明确表示不涵盖 ApoE，两个应用通用的预授权标准。支持覆盖决策的理由包括：参考指南或国家标准、缺乏支持检测的充分数据、将检测描述为研究性的、或检测不会改变患者的临床管理。
八个最大的私人支付方中的七个支付方的覆盖政策反映了标准，这些标准由于缺乏临床效用而不鼓励进行 ApoE 检测。随着该领域的发展，ApoE 检测可能具有重要的临床作用，特别是考虑到美国食品和药物管理局正在评估疾病修饰疗法。这些类型的领域进展可能与私人支付方的政策不一致，并可能导致支付方重新评估现有的覆盖政策。
