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THURSDAY, the Food and Drug Administration has given full approval to the drug Leqembi for patients who are in the early stages of Alzheimer’s disease, and Medicare said it would cover 80% of the drug’s cost of $26,500 per year. The decisions of the two federal agencies will dramatically increase access to the drug, but also present a dilemma for patients and their families.
Many factors, both financial and medical, must be considered. Here are the answers to some crucial questions:
How well does the drug work?
Leqembi is not a cure for Alzheimer’s disease and the medicine does not improve memory or cognitive abilities in patients. 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 the drug could slow decline by around five months over an 18-month period for these patients.
How the drug might affect a patient’s daily life is likely to vary widely. For some people, Leqembi can mean several extra months to be able to follow a recipe, balance a checkbook, or perform other activities without help. For others, the impact might be much more subtle and barely noticeable.
Are there any risks to take?
Yes. The drug can cause swelling or bleeding in the brain that is often mild or moderate and goes away on its own, but can be serious and in very rare cases can be fatal. The FDA was so concerned about these side effects that it required a “black box warning” – the most urgent level – on the drug labelclaiming that the drug can cause “serious and life-threatening events”.
Patients most at risk include those taking blood thinners, those who have had more than four microscopic bleeds in the brain, and those who have a genetic mutation linked to Alzheimer’s disease called APOE4, especially if they have two copies of the mutation. They should, with their doctors, consider whether the increased safety risk outweighs their desire for a drug that might slightly slow cognitive decline.
A large clinical trial of the drug found that nearly 13% of patients given Leqembi experienced brain swelling, but most of these cases were mild or moderate. Less than 2% of patients receiving placebo experienced such swelling. Most brain swellings caused no symptoms and usually resolved within a few months.
About 17% of patients receiving Leqembi had a brain haemorrhage, compared with 9% of patients receiving placebo. The most common symptom of brain bleeds was dizziness, according to the study.
Who can take Leqembi?
Leqembi – which is given by intravenous infusion 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 disease called mild cognitive impairment. About 1.5 million people in the United States fit this description. Another five million people with Alzheimer’s disease will not be 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 Leqembi attacks. Amyloid levels can be assessed using PET scans, spinal taps, or newly available blood tests.
How much will we have to pay?
Most patients will be old enough for Medicare, which said it would pay 80% of the drug’s $26,500 annual cost. Patients would end up with around $6,600 in copayments, which could put the drug out of financial reach for many. Some or all of this co-payment may be covered by the supplemental private insurance policies that many Medicare patients have.
However, there are potentially tens of thousands of dollars in additional costs, including doctor visits for infusions and regular brain scans. Some Alzheimer’s disease experts have estimated that the total cost of taking Leqembi could be around $90,000 per year. With 80% coverage, the treatment could potentially leave patients struggling with $18,000 a year in out-of-pocket costs.
How should people and their families decide?
Talk to your doctor. If your doctor is unfamiliar with treatments for Alzheimer’s disease, 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 find out about these risks, request genetic testing to determine if you have the APOE4 gene mutation. People with two copies of this mutation – about 15% of Alzheimer’s disease patients – are at particularly high risk of brain swelling and bleeding.
There are also other factors to consider. Would going to a clinic for a drug infusion every two weeks be a burden?
And, most importantly, how do you and your family perceive your current cognitive state and how does it affect your life? Since Leqembi is for people with mild symptoms, some people might be less inclined to take the safety risks, but others might find it especially important to try a medicine that might keep them a little longer. longer at this benign stage.
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