The first drug to show that it slows Alzheimer’s is on sale, but treatment for most patients is still several months away.
Two big factors behind the slow debut, experts say, are scant insurance coverage and a long setup time needed by many health systems.
Patients who surmount those challenges will step to the head of the line for a drug that delivers an uncertain benefit. Here’s a closer look.
THE SITUATION
The U.S. Food and Drug Administration approved Leqembi, from Japanese drugmaker Eisai, in early January. It’s for patients with mild or early cases of dementia tied to Alzheimer’s disease.
Regulators used the FDA’s accelerated pathway, which allows drugs to launch before they’re confirmed to benefit patients. In studies, Leqembi modestly slowed the fatal disease, but doctors aren’t sure yet how that translates into things like greater independence for patients.
Patients get the drug by IV every two weeks. Eisai says the company has shipped Leqembi to U.S. specialty drug distribution centers. From there, it can be delivered overnight to hospitals or medical centers.
Eisai spokeswoman Libby Holman said prescriptions for the drug have been written, and they expect patients to start receiving it “very soon.”
HONS
FILE - This Dec. 21, 2022, image provided by Eisai in January 2023 shows vials and packaging for their medication Leqembi. Leqembi, the first drug to show that it slows Alzheimer’s, was approved by the U.S. Food and Drug Administration in early January 2023, but treatment for most patients is still several months away. Two big factors behind the slow debut, according to experts, are scant insurance coverage and a long setup time needed by many health systems. (Eisai via AP, File)
COST AND COVERAGE
A year’s treatment will run about $26,500. Patients who can afford that without insurance will be able to start the treatment if they are deemed a candidate for Leqembi and they find a doctor and health care system prepared to help them.
There are currently few options outside self-pay. Most of the patients who may be candidates for this drug are on Medicare, and the federal program’s coverage is narrow so far. It has said it will cover treatments like Leqembi only for patients enrolled in certain research trials designed to test the drug.
There are no such studies currently accepting new patients.
“There’s a theoretical door (to coverage) that’s completely slammed shut,” said Robert Egge, chief public policy officer for the nonprofit Alzheimer’s Association.
Medicare made that coverage decision last year when another Alzheimer’s drug, Biogen’s Aduhelm, hit the market.
Health insurers, which run Medicare Advantage coverage, have been sticking to that decision, said a spokesman for the trade group America’s Health Insurance Plans.
The Centers for Medicare and Medicaid Services, which oversees Medicare, said after Leqembi’s approval that it may reconsider its coverage stance, something the Alzheimer’s Association has urged it to do.
Coverage also is likely to change if the drug receives full approval from the FDA. That could happen later this year.
In the meantime, Eisai has an assistance program that provides Leqembi for free to some patients, including those on Medicare. It’s based partly on financial need.
DIAGNOSING
It can take anywhere from several months to more than a year for doctors to diagnose a patient and then figure out if that person is a candidate for Leqembi, according to Dr. Sarah Kremen, a neurologist with the Cedars-Sinai health system in Los Angeles.
That can depend on where a patient lives and the physician’s expertise.
First, a doctor must determine whether a patient has mild dementia.
Then the doctor has to decide what caused the condition. It could stem from Alzheimer’s, Parkinson’s disease, a stroke or a brain injury.
If it’s related to Alzheimer’s disease, doctors must determine whether the patient’s brain has an amyloid protein. The new drug aims to slow the progression of Alzheimer’s by removing that protein.
After all that, some doctors may hesitate to prescribe Leqembi because they don’t have a good idea yet for how the drug will help the patient or affect their everyday life, Kremen said. They have to consider that uncertainty against the brain swelling and bleeding that can develop in patients taking it.
“I think this benefit versus harm issue is going to weigh heavily,” she said.
DELIVERING TREATMENT
Health systems must first develop plans for delivering drugs like Leqembi before they start offering it. That can take months, although some may have started before regulators approved the drug.
This planning might include training nurses on how to give the drug and making sure prescribing doctors know how to recognize candidates for it. Care providers also need a plan for how patients will be monitored once they start taking it.
Patients need repeated brain scans to check for side effects.
Doctors may want to know that such a plan is in place before they feel comfortable writing a prescription, Kremen noted.
Hospital systems also will have to figure out how many patients might come to them for this drug and be able to cover all the costs tied to it. Those might include clinic, nursing, radiologist and pharmacy fees.
“Frankly, the hospital systems are going to have to decide if they want to offer it,” Kremen said. “Is it worth the cost?”
Eisai estimates that about 100,000 people will be diagnosed and eligible to receive Leqembi in the United States by 2026. Representatives of the drugmaker declined to estimate how many people might receive it this year.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
shurkin_son // Shutterstock
According to The Centers for Disease Control and Prevention (CDC), “Dementia is not a specific disease, but is rather a general term for the impaired ability to remember, think, or make decisions that interfere with doing everyday activities.” The most common type of dementia is Alzheimer’s disease, though there are several types of dementia including frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and vascular dementia (VaD) to name a few. Globally, more than 50 million people have dementia, and an estimated 10 million new cases are reported each year. Projections show that the number of affected individuals will reach 82 million in 2030 and 152 million by 2050.
A dementia diagnosis comes after a series of tests of memory, problem-solving, and other cognitive abilities performed by a health care provider. Blood tests, brain scans, and physicals are carried out to help doctors figure out the underlying cause. Dementia is broken down into early, mid, and late stages, with a worsening of symptoms as the condition progresses.
The long-term effects of dementia can be difficult for both those affected and their caregivers, family, and friends, and can include a lack of family recognition, difficulty walking, and significant memory impairment. The afflicted person becomes completely dependent on others for care. Early diagnosis is especially important and can help with planning both at home, with preventive care and other measures such as reminders, and at work. It also enables dementia patients to access clinical trials and available therapies that may improve cognitive functioning and overall quality of life.
Neural Effects consulted the CDC’s list of warning signs for dementia and Alzheimer’s disease to review what adults should look for before seeking an official medical diagnosis. This list may also prove helpful for those who’ve noticed loved ones who are experiencing one or more early signs of dementia.
shurkin_son // Shutterstock
According to The Centers for Disease Control and Prevention (CDC), “Dementia is not a specific disease, but is rather a general term for the impaired ability to remember, think, or make decisions that interfere with doing everyday activities.” The most common type of dementia is Alzheimer’s disease, though there are several types of dementia including frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and vascular dementia (VaD) to name a few. Globally, more than 50 million people have dementia, and an estimated 10 million new cases are reported each year. Projections show that the number of affected individuals will reach 82 million in 2030 and 152 million by 2050.
A dementia diagnosis comes after a series of tests of memory, problem-solving, and other cognitive abilities performed by a health care provider. Blood tests, brain scans, and physicals are carried out to help doctors figure out the underlying cause. Dementia is broken down into early, mid, and late stages, with a worsening of symptoms as the condition progresses.
The long-term effects of dementia can be difficult for both those affected and their caregivers, family, and friends, and can include a lack of family recognition, difficulty walking, and significant memory impairment. The afflicted person becomes completely dependent on others for care. Early diagnosis is especially important and can help with planning both at home, with preventive care and other measures such as reminders, and at work. It also enables dementia patients to access clinical trials and available therapies that may improve cognitive functioning and overall quality of life.
Neural Effects consulted the CDC’s list of warning signs for dementia and Alzheimer’s disease to review what adults should look for before seeking an official medical diagnosis. This list may also prove helpful for those who’ve noticed loved ones who are experiencing one or more early signs of dementia.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
LightField Studios // Shutterstock
Forgetting recently learned information is one of the earliest signs of dementia. Name recall, as well as remembering important dates and events, becomes difficult for people in the early stages of dementia. Often they need to rely on memory aids, like wall calendars, sticky notes, digital reminders, or help from family members for things like taking medications at the correct time and arriving on the right date to appointments. Asking the same question several times or repeating stories is very common. While this sign is seen often in dementia, it is also a typical sign of aging as well as mild cognitive impairment, which can be, but is not always, an early warning indicator of Alzheimer’s disease. Memory loss may also be a sign of depression; B12 deficiency; kidney, brain, thyroid, or liver disorders; or a side effect of certain medications.
LightField Studios // Shutterstock
Forgetting recently learned information is one of the earliest signs of dementia. Name recall, as well as remembering important dates and events, becomes difficult for people in the early stages of dementia. Often they need to rely on memory aids, like wall calendars, sticky notes, digital reminders, or help from family members for things like taking medications at the correct time and arriving on the right date to appointments. Asking the same question several times or repeating stories is very common. While this sign is seen often in dementia, it is also a typical sign of aging as well as mild cognitive impairment, which can be, but is not always, an early warning indicator of Alzheimer’s disease. Memory loss may also be a sign of depression; B12 deficiency; kidney, brain, thyroid, or liver disorders; or a side effect of certain medications.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
Phase4Studios // Shutterstock
An occasional mix-up while balancing a checkbook can be a common sign of aging. Losing track of monthly bills can be a more serious sign. An inability to concentrate or difficulty following a familiar recipe may warrant a doctor’s visit. Planning may become almost impossible for those in the earliest stages of dementia and indicates a deficit in executive functioning. Difficulties with problem-solving can also signal other health issues ranging from serious conditions like a brain tumor to less insidious conditions such as stress.
Phase4Studios // Shutterstock
An occasional mix-up while balancing a checkbook can be a common sign of aging. Losing track of monthly bills can be a more serious sign. An inability to concentrate or difficulty following a familiar recipe may warrant a doctor’s visit. Planning may become almost impossible for those in the earliest stages of dementia and indicates a deficit in executive functioning. Difficulties with problem-solving can also signal other health issues ranging from serious conditions like a brain tumor to less insidious conditions such as stress.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
Monkey Business Images // Shutterstock
Often in early dementia, the simplest tasks become increasingly difficult. While older people may have trouble with operating a computer or the settings on a television remote—and this can be a normal symptom of aging—those with dementia can’t perform daily tasks that were once a part of their routine. Getting dressed can become a major undertaking. The real difficulty actually comes with the sequence or order of doing things. Writing out the steps to tasks such as preparing a meal and leaving them in easily accessible places can be helpful.
Monkey Business Images // Shutterstock
Often in early dementia, the simplest tasks become increasingly difficult. While older people may have trouble with operating a computer or the settings on a television remote—and this can be a normal symptom of aging—those with dementia can’t perform daily tasks that were once a part of their routine. Getting dressed can become a major undertaking. The real difficulty actually comes with the sequence or order of doing things. Writing out the steps to tasks such as preparing a meal and leaving them in easily accessible places can be helpful.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
Jacob L. // Shutterstock
Often people in the early stages of dementia forget the time and even lose track of months and seasons. While many retired people may forget what day it is because they no longer go to work and live by a calendar, the sort of confusion surrounding time is much more severe in those with dementia. Losing track of where they are or how they got to certain places is common and should be investigated by a doctor. This type of confusion may be acute and occur suddenly or may happen over time. Those afflicted will often experience periods of confusion surrounding time and place and then revert to their old selves. Perception of time and time distortion are also issues for those struggling with dementia. They may believe they haven’t seen a loved one for months or years, when in fact it was only days ago.
Jacob L. // Shutterstock
Often people in the early stages of dementia forget the time and even lose track of months and seasons. While many retired people may forget what day it is because they no longer go to work and live by a calendar, the sort of confusion surrounding time is much more severe in those with dementia. Losing track of where they are or how they got to certain places is common and should be investigated by a doctor. This type of confusion may be acute and occur suddenly or may happen over time. Those afflicted will often experience periods of confusion surrounding time and place and then revert to their old selves. Perception of time and time distortion are also issues for those struggling with dementia. They may believe they haven’t seen a loved one for months or years, when in fact it was only days ago.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
photo8313 // Shutterstock
Difficulty understanding visual images and spatial relations can impact depth perception, which can cause an increased risk of falling and can make feeding and bathing more challenging. Driving difficulty due to problems with spatial relations is quite common, and navigating turns and changing lanes can become dangerous. Often people with dementia are forced to give up driving. Reading also becomes a problem, not only because of the visuospatial issues, but also due to an inability to understand words. A 2016 study of visuospatial skills in dementia patients found that those with certain types of dementia, including Alzheimer’s disease, dementia of Lewy bodies, and vascular dementia, performed poorly in comparison to controls when examining space and object perception. The study found that significant impairment of visuospatial functions occurs in the early stages of dementia and worsens as the disease progresses.
photo8313 // Shutterstock
Difficulty understanding visual images and spatial relations can impact depth perception, which can cause an increased risk of falling and can make feeding and bathing more challenging. Driving difficulty due to problems with spatial relations is quite common, and navigating turns and changing lanes can become dangerous. Often people with dementia are forced to give up driving. Reading also becomes a problem, not only because of the visuospatial issues, but also due to an inability to understand words. A 2016 study of visuospatial skills in dementia patients found that those with certain types of dementia, including Alzheimer’s disease, dementia of Lewy bodies, and vascular dementia, performed poorly in comparison to controls when examining space and object perception. The study found that significant impairment of visuospatial functions occurs in the early stages of dementia and worsens as the disease progresses.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
wavebreakmedia // Shutterstock
While aging can cause an occasional problem with finding the right word, communication issues are much more significant in the early stages of dementia. Following conversations and finding the correct words for objects is difficult for those with dementia, and this early warning sign should be brought to a doctor’s attention. Aphasia, a type of language disorder, impacts communication including speech, writing, and language comprehension. According to the Mayo Clinic, “Primary progressive aphasia is a type of frontotemporal dementia.” Of course, there are other medical conditions that can cause language and communication issues including strokes, brain tumors, and brain injuries.
wavebreakmedia // Shutterstock
While aging can cause an occasional problem with finding the right word, communication issues are much more significant in the early stages of dementia. Following conversations and finding the correct words for objects is difficult for those with dementia, and this early warning sign should be brought to a doctor’s attention. Aphasia, a type of language disorder, impacts communication including speech, writing, and language comprehension. According to the Mayo Clinic, “Primary progressive aphasia is a type of frontotemporal dementia.” Of course, there are other medical conditions that can cause language and communication issues including strokes, brain tumors, and brain injuries.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
CGN089 // Shutterstock
Misplacing things could mean putting objects in strange places, like placing car keys in the microwave, and it is a common sign of dementia. Those struggling may also have difficulty in retracing their steps to find the things they’ve lost. This lack of ability to retrace steps differentiates this as a sign of dementia versus a normal sign of aging. It can be both dangerous and frustrating. As the disease progresses, the afflicted person may accuse others of stealing things that have been misplaced.
CGN089 // Shutterstock
Misplacing things could mean putting objects in strange places, like placing car keys in the microwave, and it is a common sign of dementia. Those struggling may also have difficulty in retracing their steps to find the things they’ve lost. This lack of ability to retrace steps differentiates this as a sign of dementia versus a normal sign of aging. It can be both dangerous and frustrating. As the disease progresses, the afflicted person may accuse others of stealing things that have been misplaced.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
Monkey Business Images // Shutterstock
During the early stages of dementia, decision-making is impacted and can cause poor judgment. People may spend money foolishly or have a hard time remembering to feed and walk a pet. They may also pay less attention to grooming and personal hygiene. Those struggling with dementia are especially susceptible to scams involving money. One poor decision should not be considered an indicator of dementia though. Instead, look for a pattern which might include things like constantly wearing summer dresses even though it’s winter, or walking in a busy area and not paying attention to traffic lights.
Monkey Business Images // Shutterstock
During the early stages of dementia, decision-making is impacted and can cause poor judgment. People may spend money foolishly or have a hard time remembering to feed and walk a pet. They may also pay less attention to grooming and personal hygiene. Those struggling with dementia are especially susceptible to scams involving money. One poor decision should not be considered an indicator of dementia though. Instead, look for a pattern which might include things like constantly wearing summer dresses even though it’s winter, or walking in a busy area and not paying attention to traffic lights.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
Nikodash // Shutterstock
Not wanting to participate in social activities once enjoyed, like golf or going to church, may be a sign of dementia. Because of an inability to follow conversations or participate in hobbies and comprehend them in a familiar way, things like watching a favorite sport or going to family dinners might become less enjoyable. This may cause people with dementia to withdraw. They may sleep more frequently or spend more time sitting in front of the television. Social withdrawal could also be a symptom of depression, anxiety, or post-traumatic stress disorder.
Nikodash // Shutterstock
Not wanting to participate in social activities once enjoyed, like golf or going to church, may be a sign of dementia. Because of an inability to follow conversations or participate in hobbies and comprehend them in a familiar way, things like watching a favorite sport or going to family dinners might become less enjoyable. This may cause people with dementia to withdraw. They may sleep more frequently or spend more time sitting in front of the television. Social withdrawal could also be a symptom of depression, anxiety, or post-traumatic stress disorder.
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Nasal vaccine for Alzheimer’s disease tested in first human trial
Monkey Business Images // Shutterstock
While being sad or experiencing a shift in mood can happen to almost anyone occasionally, mood and personality changes may be early indicators of serious health issues. These can include mental health conditions, hormonal changes, or substance abuse problems. When those with dementia experience these symptoms, they can manifest as fear, suspicion, and getting easily upset or becoming irritable over minor things. Things that never would have bothered them before often will now. They may also lose patience more quickly. The National Institute on Aging recommends doing several things to help navigate these changes in mood and personality, including having a daily routine and using humor when appropriate.
This story originally appeared on Neural Effects and was produced and distributed in partnership with Stacker Studio.
Monkey Business Images // Shutterstock
While being sad or experiencing a shift in mood can happen to almost anyone occasionally, mood and personality changes may be early indicators of serious health issues. These can include mental health conditions, hormonal changes, or substance abuse problems. When those with dementia experience these symptoms, they can manifest as fear, suspicion, and getting easily upset or becoming irritable over minor things. Things that never would have bothered them before often will now. They may also lose patience more quickly. The National Institute on Aging recommends doing several things to help navigate these changes in mood and personality, including having a daily routine and using humor when appropriate.
This story originally appeared on Neural Effects and was produced and distributed in partnership with Stacker Studio.
