On Thursday, the Food and Drug Administration gave full approval to Leqembi for patients in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the drug’s $26,500 per year cost. The decisions of the two federal agencies will greatly increase access to the drug but also present a dilemma for patients and their families.
There are many financial and medical factors that need to be weighed. Here are answers to some important questions:
How well does the drug work?
Leqembi is not a cure for 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 indicated that the drug may slow decline by about five months over an 18-month period for these patients.
The way a medication may affect a patient’s daily life is likely to vary widely. For some people, Leqembi may mean several additional months of being able to follow a recipe, balance a checkbook, or accomplish other activities without assistance. For others, the effect may be more subtle and barely noticeable.
Are there risks from taking it?
Yes. The drug can cause swelling or bleeding in the brain that is often mild or moderate and clears up on its own but can be serious and in very rare cases it can be fatal. The US Food and Drug Administration (FDA) was so concerned about these side effects that it required a “black box warning” – the most urgent level – on the medicine labelsaying the drug could cause “serious and life-threatening events”.
Patients at higher risk include those with blood thinners, those who have had more than four microscopic hemorrhages in the brain and those who have an Alzheimer’s disease-related gene mutation called APOE4 — especially if they have two copies of the mutation. They, along with their physicians, should consider whether the increased safety risks outweigh their desire for a drug that might even slightly slow cognitive decline.
A large clinical trial of the drug found that approximately 13 percent of patients treated with Leqembi experienced brain swelling, but most of these cases were mild or moderate. Less than 2 percent of patients receiving the placebo experienced this swelling. Most cases of brain swelling cause no symptoms and generally resolve within a few months.
About 17 percent of patients given Leqembi experienced bleeding in the brain, compared to 9 percent of patients who received a placebo. The study said that the most common symptom of brain hemorrhage is dizziness.
Who is eligible to take Leqembi?
Leqembi — which is given by injection into a vein in a doctor’s office or clinic every two weeks — will be available to people diagnosed with early-stage Alzheimer’s disease and to those with a pre-Alzheimer’s condition called mild cognitive impairment. This description applies to about 1.5 million people in the United States. Another 5 million people with Alzheimer’s disease will not qualify for Leqembi because their disease is too advanced.
The FDA-required label on the drug instructs doctors not to treat patients without testing to ensure they have one of the hallmarks of Alzheimer’s disease: a buildup of amyloid protein in the brain, which Lekembe attacks. Amyloid levels can be assessed by positron emission tomography, spinal taps, or newly available blood tests.
How much do we have to pay?
Most patients will be old enough to get Medicare, which said it will pay for 80 percent of the drug’s $26,500 annual cost. Patients would be left with about $6,600 in co-payments, which could put the drug out of reach for many. Some or all of this co-pay may be covered by supplemental private insurance policies that many Medicare patients have.
However, there are likely tens of thousands of dollars in additional costs – including medical visits for injections and regular brain scans. Some Alzheimer’s experts have estimated that the total cost of taking Leqembi could be as high as approx $90,000 per year. With 80 percent coverage, the treatment would likely leave patients with $18,000 annually 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 treatments, consider speaking with a professional. The most important thing is to discuss the decision with medical experts who will carefully explain the risks of your particular condition.
To find out about these risks, order a genetic test to determine if you have the APOE4 gene mutation. People who have two copies of this mutation — about 15 percent of Alzheimer’s patients — are at particular risk of brain swelling and bleeding.
There are other factors to consider as well. Is it a burden to go to a clinic to get an injection every two weeks?
And most importantly, how do you and your family perceive 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 consider it especially important to try a medication that may keep them in this mild phase for a little longer.