Trending Clinical Topic: Aducanumab

Ryan Syrek

Disclosures

August 06, 2021

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Since its approval by the US Food and Drug Administration (FDA) in early June – against its own advisory panel's recommendations – aducanumab has stayed in the headlines. Amid ongoing debate about the FDA's actions and concerns about what it means for patients, an expert panel has now released the first recommendations for its use (see Infographic below), leading to this week's top trending clinical topic.

Guidance on the appropriate use of aducanumab (Aduhelm), an anti-amyloid drug, was published online on July 27 in The Journal of Prevention of Alzheimer's Disease to coincide with a presentation at the Alzheimer's Association International Conference 2021. In addition to specifying who should and should not be considered for potential use, the panel made recommendations regarding titration, suggesting that aducanumab should be titrated to the highest dose to maximize opportunity for efficiency. The importance of safety monitoring was also reiterated. Patients are advised to undergo MRI at least 1 year before aducanumab treatment is initiated or at baseline if any evidence suggests a focal brain event since the last MRI.

Even if all guidelines are followed, it is unclear whether aducanumab will be effective. The Institute for Clinical and Economic Review asked one of its expert panels, the California Technology Assessment Forum, to consider the available data about aducanumab and requested that members vote on whether evidence suggested a net benefit of aducanumab plus supportive care vs supportive care alone. All 15 panelists voted no.

Shortly after aducanumab's approval, three members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee resigned. FDA's current acting commissioner, Janet Woodcock, MD, called for a federal investigation into approval proceedings. In a tweet on July 9, she stated that she had sent a letter to the Office of the Inspector General. The letter explains that concerns around these issues "could undermine the public's confidence in FDA's decision." Others are defending the decision as "appropriate and warranted." In a viewpoint article published online on July 13 in JAMA Internal Medicine, leaders of the Center for Drug Evaluation and Research outlined the rationale for approving the drug against the advice of the FDA's own advisory panel.

Despite this, the drug is likely to receive national coverage, according to the Centers for Medicare & Medicaid Services (CMS). The agency intends to post a draft decision memo on its coverage approach by January 12, 2022, and then finalize policy by April 12. Coverage decisions are currently being made at the local level by Medicare's administrative contractors, CMS said in a press release. The announcement followed separate public calls for such a review by America's Health Insurance Plans and the Alzheimer's Association.

Experts are already warning primary care physicians (PCPs) about concerns related to the drug. In a commentary, Kenneth W. Lin, MD, MPH, says concerns go beyond the approval's impact on public trust in the FDA. Lin suggests that aducanumab may cause healthcare spending to skyrocket and will probably increase pressure on PCPs to screen older patients for mild cognitive impairment during wellness visits or other checkups. From new guidelines for its use to continued fallout over its approval, news on aducanumab continues to dominate, resulting in this week's top trending clinical topic.

Read more clinical information on aducanumab.

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