Phones have been ringing off the hook at memory clinics across America and here’s what callers urgently want to know.
Can I get the new Biogen drug?
It’s a question many people with mild cognitive impairment are asking these days, and perhaps you’re one of them.
The drug Aduhelm is highly controversial. There are serious questions about its effectiveness, its safety, and the cost.
You have every right to wonder. This new FDA-approved drug called Aduhelm is intended for people with MCI or the early stages of Alzheimer’s dementia, and we’ve been waiting almost 20 years for a medicine like this. So yes, it’s long overdue, and there’s a huge pent-up demand for it.
But is Aduhelm right for you? There are many reasons it might not be, and even if it is, that’s something that should only be concluded after careful consultation with your doctor.
Those difficult discussions are taking place in clinical settings across the country, and so they should be. The drug Aduhelm is highly controversial. There are serious questions about its effectiveness. About its safety. And about the cost.
At the same time, there are patients who’ve been taking it in clinical trials for years and insist it’s made a profound difference in their cognition. And there are respected neurologists who say the same.
I’m not here to sanction the drug or to scare you away from it. When I write about medicine, which I rarely do, my only goal is to help you be a better advocate for your own care. I can’t tell you whether you’re a good candidate for Aduhelm, or whether it will benefit you. But I can tell you that if you are thinking about taking this drug, it needs to be an informed choice, made in partnership with a medical professional who takes the time to discuss it in detail and educate you on all aspects of it.
To help guide that conversation, here are 10 questions to ask your doctor about Aduhelm:
1. Is this new drug Aduhelm meant for everyone who has cognitive impairment?
The short answer is no. The drug is intended for people whose cognitive impairment is due to underlying Alzheimer’s disease. It used to be assumed that most people with MCI had Alzheimer’s disease, but we’ve discovered that’s not the case. There are many possible causes of MCI, and if the cause of yours is something other than Alzheimer’s, this drug will not benefit you.
2. But I don’t know if I have Alzheimer’s. My doctor hasn’t told me what’s causing my MCI, or thinks it’s due to something else. Does that mean I can’t be considered for this drug?
This is why a conversation with your doctor or a memory specialist is so important. There are tests that can tell if you have Alzheimer’s disease, but these tests are expensive or invasive and usually not covered by insurance, so most people with MCI don’t get those tests, even if the doctor strongly suspects they have Alzheimer’s.
For many years, doctors have had the option of prescribing other Alzheimer’s drugs like Aricept or Namenda to people who have MCI without the patient first being tested for Alzheimer’s. But don’t expect that to be the case with Aduhelm.
Most experts agree that Aduhelm should only be given to people who have been tested for Alzheimer’s, and the Alzheimer’s is confirmed. So if you are seriously interested in receiving this drug, you will need to talk to your doctor, to discuss whether you are a good candidate to be tested for Alzheimer’s in order to be eligible for this medication. Not everyone with MCI is.
3. How effective is this new drug? How well does it work? Will it help me?
Don’t assume, just because this drug has FDA approval, that it is effective. In reality, the evidence is underwhelming, and that’s being charitable. The drug-maker Biogen abandoned clinical trials on this drug in 2019 after an independent review concluded that it wasn’t working. But later, Biogen found some evidence that it seemed to help a subgroup of patients who took a higher dose toward the end of the study. For most people who received this drug, it didn’t benefit them at the dose it was given. When Biogen asked for FDA approval based on this subgroup, a panel of 11 technical experts reviewed all of the evidence around the drug and not one of those experts recommended in favor of approval.
4. So how did this drug manage to get approval from the FDA?
That’s what Congress wants to know. It’s launched an investigation into the FDA’s decision, and the FDA acting commissioner also asked for a federal probe of the agency’s approval process. It’s possible the approval could be rescinded. And the FDA approval is conditional anyway, pending further study needed to confirm the drug actually works.
You need to be aware of this, and it’s something to discuss with your doctor. Do you want to start receiving a drug whose status and effectiveness remain in doubt, and take the risk that the FDA approval gets revoked after you’ve already begun receiving it? That is a possibility you have to be prepared to accept.
5. Is this drug safe to take?
That’s another issue you’ll want to bring up with your doctor when considering whether the drug is appropriate for you. As with any drug, you need to know and accept the risks involved in taking Aduhelm.
About 40 percent of the people who received the drug in clinical trials experienced side effects.
About 40 percent of the people who received the drug in clinical trials experienced side effects, with the main one being what are called Amyloid-Related Imaging Abnormalities, or ARIA. That’s a swelling of the brain and people who had ARIAs reported headaches, dizziness, nausea or fatigue. For most, symptoms occurred within the first eight months of taking the drug and were minor and manageable, but a few patients had more serious problems. It’s recommended that people who take Aduhelm get a brain MRI twice within the first year in order to monitor for ARIAs.
6. What does this drug cost? Is it covered by insurance?
Brace yourself, because this drug comes with sticker shock. The drug costs $56,000 per year, and expenses relating to getting tested for Alzheimer’s and receiving blood tests and brain MRIs can potentially double that cost.
It’s not clear whether Medicare and private insurers will cover Aduhelm, and you’ll want clarity on that before you begin treatment. You also need to get really clear with your doctor about what your co-pay and out-pocket-costs would be. Those are likely to be substantial and perhaps even prohibitive.
Right now, Biogen is under intense scrutiny over the price it has set for Aduhelm. The Alzheimer’s Association issued a statement calling the pricing “simply unacceptable” and called upon Biogen to lower the price. Perhaps that kind of pressure will push the price down. And in fairness to Biogen, it should be noted that the drug-maker says it is working with insurance companies to get the drug covered and also plans to offer cost subsidies of its own.
7. How is this drug administered? What will be involved in taking it?
People assume that once a drug is prescribed to them, they drive to the pharmacy, pick up a bottle of pills and go home and take those pills. Aduhelm is not that kind of drug. It is given by infusion once a month, a process that takes about an hour. So make sure to ask your doctor what that process involves and be ready to commit to monthly visits for your infusion.
8. What is the profile of the people who Biogen said this drug appeared to work for? Do I fit that profile?
Initially, the FDA approved the use of Aduhelm for anyone with Alzheimer’s disease. But the agency quickly regrouped and recommended instead that it should only be given to people with Alzheimer’s who are at the stage of “mild cognitive impairment or mild dementia,” because that is the population the drug was tested on. That single decision cut the number of people who are eligible for Aduhelm by two-thirds.
Beyond that, we know that the people in the Aduhelm clinical trials ranged in age from 50 to 85, with average age of 70, and that they generally did not have other major health issues.
9. Realistically, what is the best outcome I might get from this drug?
This new drug does not cure, reverse or prevent Alzheimer’s. Still, among the subgroup of patients who the FDA based its approval on, Biogen says they declined at a slower rate than those who didn’t get the medicine. There is real significance to that.
Even slowing down the progression of the disease would be a win for someone with Alzheimer’s, allowing them to extend their quality of life.
Even slowing down the progression of the disease would be a win for someone with Alzheimer’s, allowing them to extend their quality of life. No other drug has been able to do that.
Leading up to the FDA decision, I talked to Jeff Borghoff, an Alzheimer’s patient who had been taking Aduhelm for years via clinical trials and is convinced it made a difference for him.
Borghoff told me he still functions “cognitively very well,” and he described what it meant to see all of his children graduate from college and to attend his daughter’s wedding last fall — all things he didn’t think he’d get to experience when he was diagnosed with Alzheimer’s six years ago. “To be there cognitively present at the wedding and dancing and having a good time, those are the things we put the label ‘priceless’ on,” he said.
But remember, the burden is still on Biogen to demonstrate that Aduhelm provides that benefit consistently enough across a large group of patients to justify continued approval by the FDA.
10. Is the drug available now? If not, when will I be able to get it?
Biogen is moving quickly to make the drug available, and some patients were getting it within a week or two of FDA approval. But the rollout will take time, and even many of the leading medical centers in the country are not offering it yet. Your doctor will give you their best estimate of when they’ll have the drug, but prepare to be patient as you wait your turn. It could be a while.
But also, please understand that some doctors or medical clinics may decide not to administer the drug, based on concerns about its effectiveness or cost. Just in the past couple of day, the Cleveland Clinic and Mount Sinai Health System have announced that they will not give Aduhelm to patients.