Continuum (Minneap Minn). 2022 Jun 1;28(3):937-941. doi: 10.1212/CON.0000000000001164.
This article addresses the potential legal ramifications for neurologists caring for patients with Alzheimer disease (AD) who elect neither to prescribe aducanumab nor to refer patients with AD for treatment with aducanumab. To prevail against a neurologist for failing to prescribe aducanumab or refer for aducanumab treatment, the plaintiff would have to establish that the neurologist's failure to prescribe the medication or refer for treatment was a breach of the standard of care. The standard of care is conceptualized as the generally accepted approach to diagnosing or treating a condition. However, the controversy surrounding the US Food and Drug Administration's (FDA's) approval process for aducanumab (which was based on the drug's efficacy at reducing brain amyloidosis rather than on clinically meaningful efficacy) as well as the American Academy of Neurology (AAN) position statement on aducanumab and the recent decision by the Centers for Medicare & Medicaid Services (CMS) to limit Medicare coverage of the drug and its associated costs to patients enrolled in qualifying clinical trials indicate that aducanumab cannot yet be considered the standard of care for the treatment of AD. Although deciding not to prescribe aducanumab does not violate the standard of care, neurologists treating patients with AD and not recommending this treatment should explain to their patients and their patients' surrogate decision makers why they are not recommending the treatment.
本文探讨了照顾选择不处方阿杜卡奴单抗或不推荐 AD 患者接受阿杜卡奴单抗治疗的阿尔茨海默病（AD）患者的神经科医生可能面临的法律后果。为了让神经科医生因未开处方或未推荐阿杜卡奴单抗治疗而承担责任，原告必须证明神经科医生不开药或不推荐治疗违反了护理标准。护理标准被概念化为普遍接受的诊断或治疗疾病的方法。然而，围绕美国食品和药物管理局（FDA）批准阿杜卡奴单抗的过程存在争议（该批准基于该药物在减少脑淀粉样蛋白沉积方面的疗效，而不是基于临床意义上的疗效），以及美国神经病学学会（AAN）关于阿杜卡奴单抗的立场声明和最近医疗保险和医疗补助服务中心（CMS）决定限制医疗保险对该药物及其相关费用的覆盖范围，仅限于参加合格临床试验的患者，这表明阿杜卡奴单抗尚不能被视为 AD 治疗的标准护理方法。尽管决定不处方阿杜卡奴单抗并不违反护理标准，但治疗 AD 患者而不推荐该治疗的神经科医生应向患者及其患者的代理人解释为什么不推荐该治疗。
