What to know about Alzheimer’s drug Leqembi REVEALED: who can get it and what it costs

The Food and Drug Administration granted full approval for the most effective drug to treat Alzheimer’s disease in decades.

The federal regulators’ decision follows a unanimous recommendation from agency neurologists last month and opens the door to broader coverage of federally sponsored health care.

An estimated 6.5 million Americans age 65 and older have Alzheimer’s disease and are eligible for Medicare, the government-sponsored health insurance program for senior citizens, which covers nearly 20 percent of the total cost of the medication.

The list price for the drug, which will be marketed as Leqembi, is set at $26,500 and patients participating in the program, whose annual income hovers around $29,000, will pay more than $5,000 a year.

The actual number of people receiving the drug is a fraction of the total number of Alzheimer’s patients in the US, because the IV medication is intended for people in the early stages of the disease’s progression, estimated at about 640,000.

How does the drug work?

Leqembi is a monoclonal antibody therapy administered intravenously twice a month to reduce the toxic buildup of clumps of toxic amyloid proteins in the brain, a hallmark of Alzheimer’s disease, and slow symptoms of the mind-wasting disease.

In patients with Alzheimer’s disease, the amyloid proteins pile up and stick together to form different sized clumps that later become plaques in the brain.

Healthy brains are capable of clearing those plaques, but in the context of Alzheimer’s disease, the deposits of amyloid beta proteins build up over time and form “sticky” plaques in the brain. They are thought to disrupt communication between cells and activate the immune system, causing inflammation.

When the buildup of amyloid in the brain reaches a tipping point, it leads to the formation of tangles of a protein called tau.

The formation of these tangles disrupts the normal functioning of brain cells by interfering with the transport of essential molecules such as neurotransmitters involved in intercellular communication and nutrients such as glucose and oxygen.

Over time, the buildup of plaques and tau tangles damage synapses in critical brain regions, including the hippocampus critical for memory formation, as well as the entorhinal cortex that relays sensory information from the outer cortex of the brain to the hippocampus.

That buildup also damages the parietal lobe of the brain, which is intimately involved in sensory perception, spatial awareness, and the ability to sustain attention.

But by reducing the buildup of sticky plaques, the IV drug was found to slow the rate of cognitive decline.

The drug slowed the rate of cognitive decline by 27 percent after 18 months, representing a five to six month delay.

Who will be able to get it?

The drug’s full FDA approval opens the door to potentially millions, though the actual number of people who will receive it is significantly smaller because it targets people in the early stages of the disease, estimated at between 360,000 and 640,000 people .

It will also depend on how much a person can afford to pay. Despite the fact that Medicare has expanded coverage of the drug to those participating in clinical trials, the cost will still be prohibitive for many.

The list price of drugmakers Eisai in Tokyo and Biogen in Cambridge, Massachusetts was $26,500, creating a cost barrier that millions of potential beneficiaries would not be able to overcome.

But under Medicare’s coverage rules, those who qualify for the drug are responsible for a 20 percent coinsurance, meaning the government will cover all but 20 percent of the total cost.

While this represents a significant reduction in price, hundreds of thousands of people, possibly more, remain responsible for about $5,300 a year.

That estimate does not include the high additional cost of living with Alzheimer’s, which more often than not means paying a caregiver to come to the patient’s home or requiring the patient to be placed in a long-term residential care facility so they can live 24 hours a day. hours of care per day.

Why are experts downplaying it?

The FDA’s panel of experts determined last month that the drug’s benefits far outweighed the risks of using it.

But some experts question the usefulness of the drug. While one panel member, Dr. Merit Cudkowicz, called the clinical evidence “very clear” and “very robust,” others expressed concern about the significant health risks associated with the lab-made antibody.

Of those who received Leqembi during the study, 17 percent had brain hemorrhage, compared with nine percent in the placebo group, and 13 percent had brain swelling, compared with only two percent of those who received a placebo.

In a previous study, about seven percent of trial participants dropped out due to side effects, compared to less than three percent of placebo recipients.

Overall, 14 percent of people who received the drug experienced a serious side effect during the study, compared to only 11 percent of those who did not receive the drug.

The companies behind the drug, Eisai in Tokyo and Biogen in Cambridge, Massachusetts, have said 13 trial participants have died.

The drug comes with a ‘boxed warning’ because it can cause cerebral bleeding and swelling.

An extended portion of the drug’s main study recorded three patient deaths believed to be related to the drug.

About 21 percent of the trial participants who received the drug experienced brain swelling or bleeding, compared with 9 percent of those who received a placebo.

The boxed warning also says that patients with two copies of a genetic variant that increases the risk of developing Alzheimer’s disease appear to be at a higher risk of complications.

Therefore, genetic testing – if possible – should take place before a patient receives the drug, the warning reads.