医疗保险和医疗补助服务中心（CMS）发布了有关Aduhelm（Aducanumab）报道的国家政策。
争议有包围了阿尔茨海默氏症的毒品aduhelm生物基因（NSDQ：BIIB）和Eisai（TYO：4523）自去年FDA的快速批准以来。FDA咨询委员会的三名成员辞职批准后。大约一周后，非营利性监督小组由于批准，公民呼吁FDA官员高调辞职。
2021年8月，HHS监察长办公室宣布在该机构批准阿尔茨海默氏症毒品的争议之后，它将审查FDA的加速批准途径。
昨天的CMS政策指出，Aduhelm和FDA批准的针对淀粉样蛋白的任何未来的单克隆抗体将受到Medicare的覆盖范围，并提供证据开发（CED）。作为决定的一部分，CMS将为参加CMS批准的研究的医疗保险提供增强的访问和覆盖范围。
班级中获得传统FDA批准的任何新药都可以在Medicare患者可以使用的其他护理环境中获得，例如门诊部或输液中心。
CMS还裁定，对于FDA尚未决定显示临床益处的药物，Medicare将在FDA-或NIH批准的试验中涵盖它们，并将中心设置为通过覆盖该药物和任何相关的相关性来支持FDA为参加这些试验的Medicare患者提供服务。
“阿尔茨海默氏病是一种高度破坏性的疾病，会影响数百万美国人及其家人。CMS有责任确保患有Medicare的患者可以公平且适当地获得在Medicare人群中使用的合理和必要的疗法。”“这一最终的国家覆盖范围确定反映了CMS对向美国公众提供透明，可信赖，基于证据的决定的承诺 - 不考虑成本，这仅在对公众反馈进行彻底分析后才做出。通过这一决定，我们为患有Medicare的人创造了一条途径，以快速获得FDA确定的药物，并鼓励制造商和试验管理员确保临床试验招募种族多样化的参与者。”
Aduhelm is currently the only monoclonal antibody directed against amyloid that has been granted FDA approval through its accelerated program for the treatment of Alzheimer’s disease, with both FDA and NIH approving clinical trials that are ongoing to continue to study the drug and ensure there is a “reasonable assurance of a clinical benefit.”
Eisaiissued a statement following the CMS policy ruling saying that it respects that the CMS has committed to “quickly reconsider the National Coverage Determination (NCD) once an anti-amyloid drug for the treatment of [Alzheimer’s] has met the [CED] requirements with quality evidence.”
“Eisai anticipates completing our anti-amyloid-beta (Aβ) protofibril antibody lecanemab’s rolling submission of a Biologics License Application to the FDA under the accelerated approval pathway in the first quarter of our fiscal year 2022, which began April 1, 2022,” the statement said. “Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai believes Clarity AD has a robust design, which could meet the “high level of evidence” criteria set forth by CMS in the NCD decision memo if the result is positive; therefore, creating the potential for CMS to reconsider full coverage of lecanemab should it be approved by the Food and Drug Administration. We look forward to engaging constructively with CMS to ensure appropriate Medicare beneficiaries have access to this potential new therapy.”
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