5 Things to Know About the New Alzheimer's Drug, Aducanumab

2. It's been approved for everyone who has Alzheimer's disease …

But will physicians prescribe it to patients in later stages?

Another topic of debate surrounding aducanumab: The clinical trials studied the drug in people who were in the early to mild stages of Alzheimer's with evidence of amyloid plaques. But the drug's label does not limit its use to this population (an estimated 2 million of the 6.2 million Americans living with Alzheimer's), even though “it's never been tested in people with moderate to severe disease,” points out James E. Galvin, a professor of neurology and director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine.

Research suggests that antibody therapies, like aducanumab, are more likely to help Alzheimer's patients earlier in the disease course, before irreversible brain damage is more widespread. “And I think that will be a difficult conversation when patients or their family members bring up Aduhelm, if the patient is already in the moderate to severe stage of disease,” Galvin says.

3. It's not available yet …

But will hospitals and health centers be ready for the demand when it is?

This past year we've seen vaccines in arms hours after clearing federal authorization. But the time it takes to go from approved to available won't be as quick with aducanumab. Biogen says it will be a few weeks before the drug — which is a monthly intravenous infusion, not a pill — starts shipping out to over 900 sites across the country.

Still, it may take some time before these sites are ready and able to administer it. “I think each center is now wrestling with the challenges — where this is going to be infused, who's going to infuse it, which personnel are going to be available for monitoring for safety,” Isaacson says. Other questions: How long will patients be on the medication, which does not cure or reverse the disease? Will it be one year, or several?

"There are just lots of logistical and operational concerns to be sorted out. I would expect that over the coming few months, more and more centers will be able to accommodate patients, but it's going to be a very metered and I would say a step-by-step progression,” Isaacson adds.

4. The drug will cost $56,000 a year …

But will Medicare and other insurers cover it?

Not long after the FDA announced aducanumab's approval, Biogen put a price on its new therapy: $56,000 a year. While there are plenty of drugs on the market with price tags that tower over this, the decision has drawn criticism from some advocacy groups, including the Alzheimer's Association, which calls the cost “simply unacceptable.”

Insurers are still deciding whether to cover aducanumab. Medicare would likely bear the biggest burden, since most of the 6.2 million Americans living with Alzheimer's disease are 65 and older. If just 500,000 beneficiaries went on the drug, total spending for aducanumab in one year would be nearly $29 billion, a Kaiser Family Foundation (KFF) analysis found.

That amount “far exceeds spending on any other drug” covered under Medicare Part B (which accounts for prescription drugs given in a doctor's office or hospital outpatient setting) or Part D (prescription drugs you can take yourself), the KFF report states. “To put this $29 billion amount in context, total Medicare spending for all Part B drugs was $37 billion in 2019,” the authors add. If 1 million beneficiaries receive aducanumab, spending will exceed $57 billion a year.

Even if Medicare takes on aducanumab, patients, including those with supplemental insurance, could be left with thousands of dollars in out-of-pocket expenses. And other factors will likely add to that bill, including imaging scans. Patients in the clinical trials underwent positron emission tomography (PET) scans to establish evidence of the amyloid plaques that the drug targets, and these scans are often not covered by insurance. Routine MRIs are also needed to monitor for side effects.

5. Aducanumab can come with side effects …

But are the risks worth it for a drug that still needs to prove its effectiveness?

Like all drugs, aducanumab can come with side effects. The most common observed during clinical trials were brain swelling and tiny brain bleeds. Headaches, falls, diarrhea and confusion were also reported.

In most cases, these microscopic brain bleeds are asymptomatic, “but they need to be closely monitored,” Galvin says. The drug's label calls for MRIs before the seventh infusion and 12th infusion to do just that. If the bleeds go undetected and worsen, they could lead to cognitive complications.

"These are the types of questions that I think a patient and their loved ones should think about and consider and discuss with their providers to determine whether Aduhelm is the right choice for them,” Galvin says about the risks.

Bottom line: It's going to be ‘case-by-case’

The excitement that patients and their loved ones are feeling in light of aducanumab's approval is understandable, but it's going to require “a very frank discussion” about the risks, the costs, the commitment and the clinical trial data before anything is prescribed, Isaacson warns. “The approach I've been taking is that each decision about whether or not to offer this as a treatment has to be made on a case-by-case basis,” he adds.

Another option for people with Alzheimer's disease is to consider enrolling in a clinical trial testing another anti-amyloid drug — and there are several, some of which are producing promising data, Karlawish adds. This is also a decision that patients should make with their doctors.

And when it comes to scheduling these conversations? “Patients have to have patience, family members have to have patience,” Isaacson says. “This is new. We're all still trying to figure it out together.”