Key TakeawaysThe FDA approved Aduhelm in June 2021 for the treatment of Alzheimer’s disease.In January 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposal which would limit coverage of the drug to people enrolled in Aduhelm clinical trials.The proposal was finalized on April 7, and will apply to other drugs in the same class as Aduhelm.

Key Takeaways

The FDA approved Aduhelm in June 2021 for the treatment of Alzheimer’s disease.In January 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposal which would limit coverage of the drug to people enrolled in Aduhelm clinical trials.The proposal was finalized on April 7, and will apply to other drugs in the same class as Aduhelm.

Why Is the FDA Approval of a New Alzheimer’s Drug So Controversial?

How Does Aduhelm Work?

Aduhelm is a monoclonal antibody administered as a monthly infusion. In clinical trials, the drug reduced amyloid plaques, which can be seen via imaging in the brains of people who have Alzheimer’s disease. There was no indication in the trial, however, that reducing the plaques improved memory in patients with the disease.

The Food and Drug Administration (FDA) is requiring Biogen to continue with clinical trials of the drug even after the approval. The agency said the approval could be withdrawn if the benefit of taking the drug can’t be shown.

Even if the FDA withdraws its approval, experts think the introduction of Aduhelm was an important advancement in Alzheimer’s treatment.

Ronald Petersen, MD, PhD, director of the Mayo Clinic Alzheimer’s Disease Research Center, told Verywell that “what’s likely necessary to treat Alzheimer’s is a cocktail of several drugs with different mechanisms of action.”

Why Is Clinical Trial Participation a Stipulation for Treatment?

The clinical trial requirement under which CMS could allow reimbursement is calledcoverage with evidence development(CED) and is a highly unusual process for a drug, saysDavid Farber,a partner in the FDA and Life Sciences department at the Washington, DC office of law firm King & Spalding.

Farber told Verywell that the CMS decision would also extend to other drugs in the same class as Aduhelm. At least two companies, including Eli Lilly, are working on similar drugs.

“If the requirement is maintained, even if similar drugs down the line show themselves to be more effective [than Aduhelm], patients might still have to enroll in clinical trials to get the medication,” Farber said. “That would be a hardship for many, especially minorities and people who don’t live in larger cities where clinical trials are more commonly held.”

What Is the Purpose of Clinical Trials?

Exacerbating Health Disparities

Several advocacy groups representing Alzheimer’s patients and older adults expressed frustration with theCMS proposalback in January. In a statement,Sue Peschin, president and CEO of the Alliance for Aging Research, called the requirement for clinical trial participation to take the drug “overly restrictive, medically unethical [and] unlikely to meet the agency’s goal to address health equity.”

Difference Between Alzheimer’s and Lewy Body Dementia

A Warranted Proposal?

Many physicians have been hesitant to prescribe Aduhelm, not just because of the cost, but also because its effectiveness is unclear. The FDA approval noted potential side effects including brain swelling, confusion, headache, dizziness, and diarrhea.

Constantine George Lyketsos, MD, director of the Memory and Alzheimer’s Treatment Center at Johns Hopkins Medicine, thinks the CMS made a good decision.

More randomized controlled studies are needed, Lyketsos said.

While few people with Alzheimer’s disease have taken the drug so far, Aduhelm will prove costly for all Medicare beneficiaries in 2022. Anticipating widespread use of the drug, CMS raised the monthly Medicare premium rate $21.60 for everyone in the coverage program, although that decision is also under review.

What This Means For YouIf you or a loved one has been diagnosed with Alzheimer’s disease, talk to a healthcare provider about whether Aduhelm may be suitable. They may know about ongoing clinical trials for Aduhelm or other drugs that are being investigated for the condition. It’s unlikely, but not impossible, that your insurer is paying for Aduhelm at this time.

What This Means For You

If you or a loved one has been diagnosed with Alzheimer’s disease, talk to a healthcare provider about whether Aduhelm may be suitable. They may know about ongoing clinical trials for Aduhelm or other drugs that are being investigated for the condition. It’s unlikely, but not impossible, that your insurer is paying for Aduhelm at this time.

3 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Chapman M.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.Alzheimer’s News Today. Published Dec 30, 2021.Salloway S, Chalkias S, Barkhof F, et al.Amyloid-related imaging abnormalities in 2 phase 3 studies evaluating aducanumab in patients with early Alzheimer disease.JAMA Neurol. 2022;79(1):13. doi:10.1001/jamaneurol.2021.4161Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.

3 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Chapman M.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.Alzheimer’s News Today. Published Dec 30, 2021.Salloway S, Chalkias S, Barkhof F, et al.Amyloid-related imaging abnormalities in 2 phase 3 studies evaluating aducanumab in patients with early Alzheimer disease.JAMA Neurol. 2022;79(1):13. doi:10.1001/jamaneurol.2021.4161Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Chapman M.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.Alzheimer’s News Today. Published Dec 30, 2021.Salloway S, Chalkias S, Barkhof F, et al.Amyloid-related imaging abnormalities in 2 phase 3 studies evaluating aducanumab in patients with early Alzheimer disease.JAMA Neurol. 2022;79(1):13. doi:10.1001/jamaneurol.2021.4161Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.

Chapman M.Alzheimer’s Association welcomes Aduhelm price cut, but presses on.Alzheimer’s News Today. Published Dec 30, 2021.

Salloway S, Chalkias S, Barkhof F, et al.Amyloid-related imaging abnormalities in 2 phase 3 studies evaluating aducanumab in patients with early Alzheimer disease.JAMA Neurol. 2022;79(1):13. doi:10.1001/jamaneurol.2021.4161

Food and Drug Administration.FDA grants accelerated approval for Alzheimer’s drug.

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