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Biogen’s Alzheimer’s treatment Aduhelm limited to clinical trial participants in the US

Biogen and The Alzheimer's Association fear that the approach will unfairly exclude patients from therapies and create further healthcare inequities


In a recent announcement, the US Centers for Medicare & Medicaid Services (CMS) stated that coverage of Biogen’s Aduhlem (aducanumab) – and other US Food and Drug Administration (FDA) approved anti-amyloid monoclonal antibodies for Alzheimer's disease – will be limited exclusively to participants in qualified clinical trials.

The decision to restrict coverage is likely to influence insurers throughout the US, while the broader impact of the restriction is expected to affect other drug manufacturers that have been working to produce amyloid-targeting therapies.

CMS’ decision is preliminary, with a final decision due to be made in April 2022, following a 30-day period for public comment. For Aduhelm and similar therapies, the policy will set national guidance on how Medicare treats these particular drugs in the future.

Six months after the FDA granted Aduhelm accelerated approval, CMS has requested further evidence ahead of any payment for the drug, priced at $28,000 a year.

The drug was given clearance on the strict condition that Biogen conducted an additional trial to confirm the benefits of using Aduhelm. However, regulators said at the time that the top priority was to provide patients with access to a potentially life-changing drug.

CMS officials made it clear that the risk-over-benefit needed significant consideration for patients receiving the treatment. Following a thorough analysis, CMS discovered that although Aduhelm had the potential to help patients with Alzheimer's disease, the drug also had the potential to cause harm.

Dr Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality, siad: “Our foremost goal is to protect beneficiaries from potential harm from an intervention without known benefits in the Medicare population.”

In a statement, officials from CMS reported that headaches, falls, dizziness and potential brain haemorrhage could be possible side effects.

The officials also added that trials must be demographically representative of Medicare patients suffering with Alzheimer's, given that the disease disproportionately affects people of colour in the US.

Medicare’s website summarised that qualifying studies must be randomised, controlled trials examining whether the use of amyloid therapies result in a statistically significant change in cognitive function for patients with mild Alzheimer's.

In an emailed statement, Biogen said the trial requirements mean that patients who could benefit from accessing the drug would be excluded.

Biogen added that the limited coverage ‘will significantly limit patient access to an FDA-approved treatment, especially for underserved patients’.

Echoing Biogen’s comments, Harry Johns, chief executive officer of the Alzheimer’s Association added: “With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities.”

Article by
Fleur Jeffries

12th January 2022

From: Regulatory



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