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Journal of Prevention of Alzheimer's Disease

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Aducanumab (AduhelmTM) was approved by the United States (US) Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease on June 7, 2021. Soon after, the approved labeling was adjusted to direct treatment to mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia reflecting the severity of cognitive impairment among participants in the clinical trials that led to the approval (1, 2).

Individuals over age 65 in the US are entitled to have the cost of prescription drugs partially paid by the Center for Medicare and Medicaid Services (CMS; “Medicare”) if they participate in an approved insurance plan. Most people pay a monthly fee for this benefit. When a new agent becomes available it may be subject to a National Coverage Determination (NCD) to ascertain if CMS will pay for the drug and under what circumstances. CMS covers drugs that are considered “reasonable and necessary” for the treatment of an illness. The covered treatment must be shown to meaningfully improve health outcomes. The NCD process can lead to approval of coverage, denial for coverage, or limited coverage (3).

On January 11, 2022, Medicare Issued its draft NCD on Coverage with Evidence Development (CED) for aducanumab which limits coverage to patients participating in CMS-approved randomized controlled clinical trials supported by the US National Institutes of Health (NIH) (3). This decision, if sustained, would greatly limit and delay availability of aducanumab to patients who could benefit from treatment. This decision has many foreseeable adverse consequences. The draft proposal must be understood in the context of the available efficacy data and the process of accelerated approval. These are discussed here followed by a description of the CMS proposal to limit the coverage of aducanumab to participants in trials. The proposed CED is not in the best interest of patients with early AD or the field of AD treatment development. The current decision is a draft of the proposed CED and is subject to change until a final decision is rendered on April 11th, 2022. Public comment on the decision is invited until February 10, 2022, and there is an opportunity to modify this draft determination ( medicare-coverage-database/search.aspx).

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Alzheimer's disease--Treatment


Public Affairs, Public Policy and Public Administration

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