Aduhelm, The New Alzheimer’s Drug: 5 Things to Know

ACROSS AMERICA — The Food and Drug Administration approved a new treatment on Monday for Alzheimer’s disease for the first time since 2003.

Aduhelm, created by Biogen Inc., received accelerated approval by the FDA and will quickly hit the markets. The company plans to start shipping doses within two weeks, The Associated Press reported. Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said Aduhelm is the first drug to target and treat Alzheimer’s disease.

But what does this mean for the estimated 6.2 million Americans ages 65 and older who are living with Alzheimer’s?

1. What Are The Costs?

Aduhelm will cost patients $56,000 a year for the typical treatment — an infusion every four weeks, according to Biogen. That comes out to a whopping $4, 312 per infusion. The company also said it expects the prices of the drug to remain constant over the next four years.

Most insurance companies will likely request proper patient documentation demonstrating the need for Aduhelm before they agree to cover it.

Insurers will “likely require pre-approval for brain scans” to determine if Aduhelm is the correct treatment for a patient, Lance Grady of Avalere Health told The Associated Press.

The Medicare program is expected to cover treatment in most cases. Robert Laszewski, a health care consultant and former insurance executive, told The Associated Press that, like any other drug, FDA approval does not mean the drug is appropriate for everyone.

2. What Does Accelerated Approval Mean?

Although it may take many years to determine a drug’s effect and benefits, Congress passed the Food and Drug Administration Safety Innovations Act in 2012. The act allows the FDA to accelerate drug approval for serious conditions that “fill an unmet medical need” if the drug has an effect on “an intermediate clinical endpoint.”

• Related: First New Alzheimer’s Treatment In 18 Years Gets FDA Nod

The marker will help the FDA predict the benefits of the drug. For FDA approval, Aduhelm does not need to cure the patient; it just needs to reduce plaque buildup. Reducing plaque buildup is reasonably likely to benefit Alzheimer’s patients, slowing dementia, and therefore is eligible for accelerated approval. Meeting this standard can occur much earlier than an approval based on a complete clinical trial.

3. What Testing Preceded FDA Approval?

Aduhelm’s efficacy was determined in three separate, randomized studies totaling 3,482 patients, the FDA said. Before it was approved, the researchers found that patients who received the treatment had a significant reduction of plaque buildup in the brain, based on the dosage and time Aduhelm was given, compared to the patients who received placebo doses.

The FDA said Biogen is still required to conduct new randomized trials to verify the benefits.

4. What Are Drug’s Side Effects?

The FDA warns that common side effects of Aduhelm include headaches, falling, diarrhea, amyloid-related abnormalities on scans, confusion, delirium, altered mental status and disorientation.

Other possible side effects include temporary swelling in areas of the brain, dizziness, vision changes or nausea.

5. Does The Drug Reverse Alzheimer’s Damage?

No. The drug is only intended to slow cognitive decline and ease the symptoms of the disease, mainly reducing the plaque buildup

The Associated Press contributed to this report.