Aduhelm for Alzheimer's: 10 Things to Know

Doctor William C Lloyd Healthgrades Medical Reviewer
Medically Reviewed By William C. Lloyd III, MD, FACS
Written By Sarah Lewis, PharmD on July 28, 2021
  • male patient sitting in infusion room reading a book while drug administered into vein
    What to Know About Aduhelm for Alzheimer’s
    Alzheimer’s disease is the most common form of dementia, affecting more than 6 million Americans. It starts mildly, but typically progresses over several years. As it worsens, people have trouble with communication, daily activities, and behavior. Ultimately, Alzheimer’s disease is fatal. Treatments to date have only been able to alleviate symptoms, slow progression of the disease, and make quality of life better. So, a breakthrough treatment that could actually improve or reverse clinical outcomes would be life-changing for Alzheimer’s patients and their loved ones. Find out if Aduhelm for Alzheimer’s fits the bill.
  • Pharmaceutical medicine pills on magnetic brain resonance scan mri background. Pharmacy theme, health care, drug prescription for tumor, alzheimer, mental illness treatment medication
    1. Aduhelm is a first-of-its-kind treatment.
    Aduhelm is the brand name for aducanumab (pronounced “ad-ju-CAN-u-mab”). The “mab” part of the name is a clue to the kind of drug it is. Aducanumab is biologic, specifically a monoclonal antibody (mab). It targets a protein called amyloid beta. This protein forms plaques in the brain of people with Alzheimer’s. Aduhelm reduces these amyloid plaques. This is a very different mechanism than other Alzheimer’s drugs, such as donepezil (Aricept). These drugs work by increasing chemical messengers in the brain to enhance cell-to-cell communication. The aducanumab FDA approval is the first new approval for an Alzheimer’s treatment since 2003.
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    2. Not everyone is celebrating Aduhelm’s approval.
    There has been a lot of controversy surrounding the FDA (Food and Drug Administration) approval of Aduhelm. Three members of the FDA’s outside advisory panel resigned over the approval. The FDA routinely uses panels to gather independent expert advice on scientific, technical and policy issues. And the FDA usually follows the panels’ advice to approve or not approve. In this case, the Peripheral and Central Nervous System Drugs Advisory Committee did not support approval of Aduhelm. They cited insufficient evidence that the drug worked. The FDA’s own statisticians also had a problem with the strength of the evidence.
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    3. Aduhelm gained approval through the Accelerated Approval Program.
    The FDA has an Accelerated Approval Program for drugs and biologics. It allows for early approval and access of products that treat serious conditions or fill an unmet need. The program lets drug companies use surrogate markers instead of demonstrating a clinical benefit, such as survival rates. Examples of a surrogate marker could be a lab test or an imaging exam. You can see changes in these markers in a much shorter time than it takes to see a clinical benefit. But surrogate markers do not always translate into clinical benefits.
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    5. Studies must still confirm the anticipated clinical benefit of Aduhelm.
    An accelerated approval has a condition—drug companies must complete studies showing the presumed clinical benefit and submit them to the FDA. The FDA can then confirm a full approval or rescind the accelerated approval. However, critics point out that these trials are not always completed as expected. One study looked at accelerated approvals between 2009 and 2013 with at least three years allowed to complete these trials. Of the 24 approvals, only 42% completed the required trials within three years. Eight approvals still had no confirmatory evidence five years after approval. The final report on Aduhelm is not due until 2030.
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    6. Aduhelm’s approval limits its use to early-stage Alzheimer’s disease.
    The two studies that evaluated Aduhelm for accelerated approval enrolled people with mild to moderate Alzheimer’s. Initially, the drug’s labeling did not limit its use to this population. The FDA subsequently revised the labeling, stating it is indicated for patients with mild Alzheimer’s dementia or mild cognitive impairment due to Alzheimer’s disease. This helped clarify exactly who is expected to benefit from the drug to address the initial criticism.
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    7. Aduhelm is a high-cost drug.
    Like other biologics, Aduhelm is expensive, costing about $56,000 a year. On one hand, the prices of drugs like this are worth the breakthroughs they provide. For example, sofosbuvir (Sovaldi)—a biologic for hepatitis C—costs about $84,000 for a 12-week course. However, Sovaldi, and others like it, basically cures hepatitis C—a formerly lifelong infection with treatment that had serious side effects and little success. So, one could argue a clear clinical benefit and cost savings from a lifetime of disease offsets the high price. Right now, it is unclear whether Aduhelm will show its expected clinical benefits.
  • Hand holding a 2017 Medicare health insurance card in medical office with X-ray on computer screen in background
    8. Aduhelm would fall under Medicare Part B.
    Because doctors infuse Aduhelm, it falls under Medicare Part B coverage instead of the prescription Part D. This means beneficiaries will have a 20% coinsurance—or about $11,500 a year—to pay out of pocket. But it’s unclear at this time how Medicare will handle Aduhelm. Typically, it covers approved products unconditional of cost. However, Aduhelm could end up costing Medicare more than all other Part B drugs combined and translate to increased premiums. Decision makers at CMS (Centers for Medicare and Medicaid Services) will have to weigh whether to cover the drug and whether to set coverage limits or conditions.
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    9. Drug price is not the only cost with Aduhelm.
    Critics of the accelerated approval also point to the safety of Aduhelm. It has side effects that can be serious, such as brain swelling and bleeding. This requires brain imaging with an MRI (magnetic resonance imaging) scan. Doctors should order an MRI before starting the drug and before the 7th and 12th infusion. This means the annual price tag could be well above the drug cost alone. Unfortunately, these side effects are not rare. Brain swelling occurred in 35% of drug recipients in the clinical trials vs. 3% in the placebo arm. Brain bleeding or a marker of bleeding was seen in 19% and 15% of drug recipients compared to 7% and 2% in placebo.
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    10. Rely on your doctor’s advice regarding Aduhelm.
    All healthcare decisions come down to risk and benefit. The decision to use Aduhelm is no different. Your doctor is best able to evaluate your individual circumstances and make a recommendation. Working with a highly experienced Alzheimer’s doctor is vital. Seeking a second opinion may give you more information and answers about whether Aduhelm is right for you.
Aduhelm for Alzheimer's: 10 Things to Know | FDA Approval of Aducanumab

About The Author

Sarah Lewis is a pharmacist and a medical writer with over 25 years of experience in various areas of pharmacy practice. Sarah holds a Bachelor of Science in Pharmacy degree from West Virginia University and a Doctor of Pharmacy degree from Massachusetts College of Pharmacy. She completed Pharmacy Practice Residency training at the University of Pittsburgh/VA Pittsburgh Healthcare System. 
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  11. Henry B. Drug pricing and challenges to hepatitis C treatment access. J Health Biomed Law. 2018;14:265-283.
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  13. US Lawmakers Launch Investigation into FDA Approval and Price of New Alzheimer's Drug. CNN. 

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Last Review Date: 2021 Jul 7
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