The Food and Drug Administration Approves Lecanemab for Alzheimer's Patients
by Don Drake, Connelly Law Offices, Ltd.
"Alzheimer's disease is a disorder of the brain that destroys memory and cognitive skills and progresses to interfering with the ability to carry out even the simplest tasks," said professional fiduciary and certified elder law Attorney RJ Connelly III. "Experts state that more than 6 million people 65 and older may have Alzheimer's. This disease is the seventh leading cause of death in this country and the most common cause of dementia in seniors."
"Given these numbers, the Food and Drug Administration (FDA) has approved a new drug for Alzheimer's patients called Lecanemab (Leqembi). This drug is a monoclonal antibody therapy administered intravenously and has been shown to reduce the toxic buildups of amyloid proteins in the brain, which is a hallmark of Alzheimer's disease."
It's essential for those with the disease or having a loved one with Alzheimer's to understand that this is not a cure but can change the course of the disease for those in the early stage. Lecanemab can slow the symptoms of the disease and add six months of a healthy life, but it does not restore any memory loss. According to the FDA, the drug can potentially cause life-threatening side effects, including bleeding and swelling of the brain, which affected one in seven of the trial participants.
"The FDA's approval may allow those in the early stages of the disease to have access to the treatment before the end of summer," said Attorney Connelly. "But there are some requirements that need to be met."
Qualifying for Treatment
According to the Daily Mail, to qualify for treatment, patients must show that they are indeed in the early stages of Alzheimer's. Doctors will need to determine if their brains contain the amyloid deposits through the use of a PET Scan. "With more than six million Americans said to have the disease, it is estimated that between 360,000 and 640,000 may have early onset Alzheimer's," stated Attorney Connelly. But that does not mean many will be able to obtain this treatment.
The makers of the drug estimate that somewhere around 100,000 will be able to get the drug by 2026 due to the barriers with health insurance and the mountain of paperwork and bureaucratic obstacles that stand in the way. The drug cost, which Medicare will cover "in the appropriate settings," is $26,500 annually. However, Medicare may not cover ancillary costs that can add up to thousands of dollars annually.
"These ancillary costs will include the costs of PET scans and repeated MRIs which could bring the total cost of treatment with Lecanemab to over $31,000 annually," said Attorney Connelly.
According to the Alzheimer's Association website, "those on Medicaid only (not dual eligible) with some exceptions, state Medicaid programs will cover all FDA-approved drugs. While all drugs must be covered across state Medicaid programs, utilization management restrictions and drug list placement can vary significantly."
As written in the Daily Mail, some experts are unconvinced about the drug's benefits and expressed concerns about the significant health risks attached to the drug's use. The risks the Daily Mail cited among those who received the drug include:
Seventeen percent had brain bleeding, compared with nine percent in the placebo group, and 13 percent had brain swelling, compared with just two percent of those given a placebo.
In an earlier study, about seven percent of trial participants dropped out due to adverse effects compared to less than three percent of placebo recipients.
Overall, 14 percent of people who received the drug suffered a severe adverse reaction in the trial compared to 11 percent of those who did not.
The companies behind the drug, Eisai in Tokyo and Biogen in Cambridge, Massachusetts, said thirteen trial participants died.
However, most neurologists have stated that the drug does show "tremendous promise for millions of Americans."
Lecanemab versus aducanumab
Lecanemab is the second approved treatment that works with the underlying biology of Alzheimer's that can change the course of the disease for those in the early stages. According to the Alzheimer's Association website, each drug works differently and at different stages of beta-amyloid plaque formation, ultimately slowing the progression of the disease and reducing clinical decline.
"It's important to remember that all drugs have side effects," said Attorney Connelly. "Like all treatment protocols, ask questions of your medical provider so you can make an informed decision about the benefits and risks of all approved medications. For those I have talked to about these new drugs, there is a renewed optimism that researchers are moving closer to the goal of understanding this disease. Anything that can help those with Alzheimer's live a full life for longer periods is welcome."