On Thursday, the Food and Drug Administration (FDA) granted full approval to Leqembi, a drug for early-stage Alzheimer’s disease. Medicare has also announced that it will cover 80% of the drug’s $26,500 annual cost. While these decisions increase access to the medication, they present a dilemma for patients and their families. Here, we provide answers to some crucial questions.
How effective is Leqembi?
Leqembi is not a cure for Alzheimer’s and does not improve memory or cognitive abilities. It also does not halt disease progression. However, it can modestly slow down cognitive decline in patients in the early stages of the disease. A large clinical trial suggested that the drug may delay decline by approximately five months over 18 months for these patients. The impact of the drug on a patient’s daily life can vary greatly. Some individuals may experience several additional months of independence in activities like cooking and financial management, while others might notice subtler improvements.
What are the risks associated with Leqembi?
There are risks involved in taking Leqembi. The drug can cause mild to moderate brain swelling or bleeding, which typically resolves on its own but can be serious and, in rare cases, fatal. Concerned about these side effects, the FDA has mandated a “black-box warning” on the drug’s label, signifying the most urgent level of warning. Patients at higher risk include those on blood thinners, those who have experienced multiple microscopic bleeds in the brain, and those with the APOE4 gene mutation associated with Alzheimer’s. These individuals, along with their doctors, must carefully consider whether the potential safety risks outweigh the modest cognitive decline benefits.
Who is eligible for Leqembi?
Leqembi, administered through intravenous infusions every two weeks, will be available for individuals diagnosed with early-stage Alzheimer’s or a pre-Alzheimer’s condition known as mild cognitive impairment. Approximately 1.5 million people in the United States fit this description, while an additional 5 million with advanced Alzheimer’s will not qualify for the medication. The FDA requires doctors to confirm the presence of amyloid protein buildup in the brain, a hallmark of Alzheimer’s, before prescribing Leqembi. This confirmation can be achieved through PET scans, spinal taps, or newly available blood tests.
How much will Leqembi cost?
Most patients will be eligible for Medicare coverage, which will pay for 80% of the drug’s $26,500 annual cost. This leaves patients with roughly $6,600 in co-payments, potentially making the drug financially unattainable for many. Additional costs, such as medical visits for infusions and regular brain scans, could amount to tens of thousands of dollars. Some experts estimate that the total annual cost of taking Leqembi could reach $90,000. With an 80% coverage, patients may still face $18,000 in out-of-pocket expenses.
How should individuals and families make a decision?
It is crucial to consult with a doctor or specialist experienced in Alzheimer’s treatments. These experts will help explain the specific risks for each individual situation. Genetic testing for the APOE4 gene mutation is recommended to determine the risk of brain swelling and bleeding, especially for those with two copies of the mutation. Other factors to consider include the burden of traveling to a clinic for infusions every two weeks and how individuals and their families perceive the current cognitive condition and its impact on daily life. Some may be less inclined to take safety risks, while others may prioritize preserving the mild stage of the disease for a longer period.
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