On Thursday, the Food and Drug Administration gave full approval to the drug Leqembi for patients in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the $26,500-a-year cost of the drug. The decisions by the two federal agencies will vastly increase access to the drug, but also present patients and their families with a dilemma.
There are many factors, both financial and medical, that must be weighed. Here are answers to some crucial questions:
How well does the drug work?
Leqembi does not cure Alzheimer’s disease and the drug does not improve patients’ memory or cognitive abilities. It also does not prevent the disease from getting worse. What Leqembi can do is modestly slow cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggested that the drug may slow the decline by about five months over an 18-month period for those patients.
How the drug can affect a patient’s daily life can vary widely. For some people, Leqembi can mean several extra months during which they can follow a prescription, keep a checkbook, or perform other activities without assistance. For others, the impact may be much more subtle and barely noticeable.
Are there any risks involved in taking it?
Yes. The drug can cause swelling or bleeding in the brain that is often mild or moderate and resolves on its own, but can be severe and very rarely fatal. The FDA was so concerned about these side effects that it required a “black-box warning” — the most urgent level — on the drug’s label, stating that the drug can cause “serious and life-threatening events.”
Higher-risk patients include those on blood thinners, those who have had more than four microscopic bleeds in the brain, and those with an Alzheimer’s disease-linked gene mutation called APOE4 — especially if they have two copies of the mutation. They, along with their doctors, should consider whether the increased safety risk outweighs their desire for a drug that can slow cognitive decline somewhat.
A large clinical trial of the drug found that nearly 13 percent of patients who received Leqembi experienced brain swelling, but most of those cases were mild or moderate. Less than 2 percent of patients who received the placebo experienced such swelling. Most brain swellings caused no symptoms and generally resolved within a few months.
About 17 percent of patients who received Leqembi experienced cerebral hemorrhages, compared with 9 percent of patients who received placebo. The most common symptom of brain hemorrhage was dizziness, the study said.
Who is eligible to take Leqembi?
Leqembi — which is given every two weeks by intravenous infusions at a doctor’s office or clinic — will be available to people diagnosed with early-stage Alzheimer’s and those with a pre-Alzheimer’s condition called mild cognitive impairment. About 1.5 million people in the United States fit that description. Another 5 million people with Alzheimer’s disease are not eligible for Leqembi because their disease has progressed too far.
The FDA-required label on the drug instructs doctors not to treat patients without testing to confirm they have one of the hallmarks of Alzheimer’s disease: a buildup in the brain of the protein amyloid, which attacks Leqembi. Amyloid levels can be assessed with PET scans, epidural, or newly available blood tests.
How much will we have to pay?
Most patients will be old enough for Medicare, which has said it will pay 80 percent of the drug’s $26,500 annual cost. Patients would be left with about $6,600 in out-of-pocket payments, which could put the drug out of financial reach for many. Some or all of that co-payment may be covered by the supplemental private insurance plans that many Medicare patients have.
However, there may be tens of thousands of dollars in additional costs, including medical visits for the infusions and regular brain scans. Some Alzheimer’s experts have estimated that the total cost of taking Leqembi could be as high as about $90,000 a year. At 80 percent coverage, the treatment could potentially leave patients saddled with $18,000 a year in out-of-pocket costs.
How should people and their families decide?
Talk to your doctor. If your doctor isn’t well versed in Alzheimer’s treatment, consider talking to a specialist. The most important thing is to discuss the decision with medical experts who will carefully explain the risks for your specific situation.
To know those risks, request genetic testing to determine if you have the APOE4 gene mutation. People with two copies of that mutation — about 15 percent of Alzheimer’s patients — are at particularly high risk for brain swelling and bleeding.
There are also other factors to consider. Would it be a burden to go to a clinic every two weeks for an IV?
And, most importantly, how do you and your family view your current cognitive state and how does it affect your life? Because Leqembi is for people with mild symptoms, some people may be less inclined to take safety risks, but others may find it especially important to try a medication that can keep them in this mild phase a little longer.