On Thursday, the Food and Drug Administration granted full approval of Lekhembi, a treatment for patients with early-stage Alzheimer’s disease, and announced that Medicare will cover 80% of the $26,500 annual drug treatment. Decisions by two federal agencies would greatly increase access to the drug, but also pose a dilemma for patients and their families.
There are many factors to consider, both financial and medical. Here are the answers to some important questions.
How well does the medicine work?
Rekembi is not a treatment for Alzheimer’s disease, and the drug does not improve a patient’s memory or cognitive abilities. Nor can it prevent the disease from getting worse. What Rekembi can do is moderately slow cognitive decline in patients in the early stages of the disease. Data from large clinical trials suggest that the drug may delay decline by about five months over an 18-month period in these patients.
How this drug affects a patient’s daily life can vary greatly. For some, Rekumbi may mean a few more months before following a recipe and being able to balance a checkbook or accomplish other activities without help. For others, the effect may be much more subtle and barely noticeable.
Are there any risks in taking it?
yes. This drug can cause swelling and bleeding in the brain, which is often mild or moderate and resolves on its own, but can be serious and, very rarely, fatal. The FDA is very concerned about these side effects and has requested a “black box warning” at its most urgent level. on the drug labelsaid the drug could cause “serious and life-threatening events”.
Patients at increased risk include those taking blood thinners, those with four or more microscopic hemorrhages in the brain, and those with a genetic mutation associated with Alzheimer’s disease called APOE4, especially Yes, if there are two copies of that mutation. They should consider with their physicians whether the increased safety risks outweigh the desire for drugs that may moderately slow cognitive decline.
A large clinical trial of the drug found that nearly 13 percent of patients receiving Rekumbi experienced brain swelling, but most of those cases were mild or moderate. Less than 2 percent of patients who received placebo experienced such swelling. Most brain swelling causes no symptoms and usually resolves within a few months.
Approximately 17% of patients receiving Rekembi experienced a cerebral hemorrhage, compared with 9% of those receiving placebo. Dizziness was the most common symptom of a brain hemorrhage, according to the study.
Who is eligible to take Rekumbi?
Lekhembi, administered by intravenous infusion every two weeks in clinics and clinics, will be available for people diagnosed with early-stage Alzheimer’s disease and for people with a pre-Alzheimer’s disease 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 too advanced to qualify for Rekumbi.
The FDA-mandated label of the drug tells doctors not to treat patients without testing to confirm the accumulation of the protein amyloid in the brain, one of the hallmarks of Alzheimer’s disease. Amyloid levels can be assessed with a PET scan, spinal tap, or newly available blood test.
how much do i have to pay?
Most patients are old enough for Medicare, which has announced it will pay 80% of the $26,500 annual drug bill. Patients would be left with about $6,600 in out-of-pocket costs, which could make the drug financially out of reach for many. Some or all of that out-of-pocket expense may be covered by additional private insurance policies that many Medicare patients have.
However, additional costs such as hospital visits for IV drips and regular brain scans can cost tens of thousands of dollars.Some Alzheimer’s experts estimate that the total cost of taking Rekembi is about $90,000 per year. At 80% coverage, treatment could cost patients $18,000 annually out of pocket.
How should I judge myself and my family?
Please consult your doctor. If your doctor is not familiar with treating Alzheimer’s disease, consider seeing a specialist. Most importantly, discuss your decision with a health care professional who will carefully explain the risks in your particular situation.
To know these risks, ask for a genetic test to determine if you have the APOE4 gene mutation. People with two of the mutations, about 15 percent of people with Alzheimer’s disease, are at particularly high risk of brain swelling and bleeding.
There are other factors to consider as well. Will it be a burden to go to the drip of medicine every two weeks?
And importantly, how do you and your family perceive your current cognitive state and how is it impacting your life? Some people may not want to take safety risks because it is intended for people with disabilities, but others may find it particularly important to try drugs that may keep this mild stage a little longer. not.
