PDF(Pubmed)
Abstract：
The Centers for Medicare and Medicaid Services (CMS) has recently issued a national coverage determination for US Food and Drug Administration (FDA)-approved anti-amyloid monoclonal antibodies (mAbs) for the treatment of Alzheimer\'s disease (AD) under coverage with evidence development (CED). CED schemes are complex, costly, and challenging, and often fail to achieve intended objectives because of administrative and implementation issues. AD is a heterogeneous, progressive neurodegenerative disorder with complex care pathway that additionally presents scientific challenges related to the choice of study design and methods used in evaluating CED schemes. These challenges are herein discussed. Clinical findings from the US Veterans Affairs healthcare system help inform our discussion of specific challenges to CED-required effectiveness studies in AD.
摘要：
医疗保险和医疗补助服务中心（CMS）最近发布了美国食品和药物管理局（FDA）批准的用于治疗阿尔茨海默病（AD）的抗淀粉样蛋白单克隆抗体（mAb）的全国覆盖范围确定。CED方案很复杂，昂贵的,具有挑战性，由于行政和实施问题，往往无法实现预期目标。AD是一种异构的，具有复杂护理途径的进行性神经退行性疾病，这也带来了与评估CED方案的研究设计和方法选择相关的科学挑战。本文讨论了这些挑战。美国退伍军人事务医疗保健系统的临床发现有助于我们讨论CED所需的AD有效性研究的具体挑战。
