Some private insurers are balking at paying for the first drug fully approved to slow mental decline in Alzheimer's patients.
Insurers selling coverage in North Carolina, Pennsylvania and New York, among other states, told The Associated Press they won't cover Leqembi with insurance offered on the individual market and through employers because they still see the $26,000-a-year drug as experimental.
Their decision stands in contrast to Medicare, which will wind up covering most patients who take the drug. The federal coverage program mainly for people ages 65 and older announced shortly after Leqembi received full approval last month that it will cover the treatment while still tracking its safety and effectiveness.
Leqembi is the first medicine that's been convincingly shown to slow the cognitive decline caused by Alzheimer's disease, though only modestly. The U.S. Food and Drug Administration approved the IV drug for patients with mild dementia and other symptoms caused by early Alzheimer's.
People are also reading…
FILE - This image provided by Eisai in January 2023 shows vials and packaging for their medication, Leqembi. Several health plans in the U.S. will not cover the recently approved Alzheimer’s drug for certain customers, exposing those patients to thousands of dollars in potential costs. Their decision stands in contrast to Medicare. The federal coverage program mainly for people ages 65 and older announced in July 2023 that it will cover Leqembi shortly after regulators gave the drug full approval. (Eisai via AP, File)
That approval came after regulators reviewed data from a large study in which the drug slowed memory and thinking decline by about five months in those who got the treatment compared with those who got a dummy drug. Some Alzheimer's experts say the delay is likely too subtle for patients or their families to notice.
Alzheimer's mainly affects the elderly. About 76% of the people taking Leqembi will be covered by Medicare, according to the Japanese drugmaker Eisai, which developed the drug and is co-marketing it with Cambridge, Massachusetts-based Biogen Inc.
But people under 65 — even, rarely, as young as their 30s — also can get diagnosed. They are more likely to have commercial coverage.
"That's why we're just dumbfounded that commercial plans are not covering it," said Christine Mann, chief operating officer of the Buffalo, N.Y.-area Dent Neurologic Institute, which will provide the IV drug to patients. "It's almost like discrimination against these patients."
The full picture on commercial insurance is still emerging in the patchwork U.S. system of coverage.
Companies saying no so far include Highmark, which provides Blue Cross and Blue Shield coverage in New York, Pennsylvania, Delaware and West Virginia; Blue Cross and Blue Shield of North Carolina, which has about 1.8 million commercial customers; and Philadelphia-based Independence Blue Cross.
Highmark and the North Carolina plan say they are still monitoring Leqembi and could re-evaluate their decision.
Independence Blue Cross made its decision after reviewing published, peer-reviewed studies and publicly available FDA materials.
"That re-evaluation made it clear to us that the existing evidence does not allow for conclusions to be drawn about the safety and effectiveness of Leqembi," said Dr. Heidi Syropoulos, a medical director with the insurer.
A Highmark spokesman said that company made its decision after also consulting with specialists to determine if the drug's benefit outweighs its side effects, which include brain bleeding and swelling.
Prominent insurers that will cover the drug for commercial plans include Kaiser Permanente and Elevance Health, the largest provider of Blue Cross-Blue Shield plans in the United States. A spokesman for another big health insurer, UnitedHealthcare, declined to comment when contacted by AP.
Because Medicare covers the drug, patients with privately run Medicare Advantage plans will receive coverage, said Juliette Cubanski, of the non-profit KFF, which researches health care issues.
Many other insurers say they have yet to make a decision.
Most insurers will probably cover the drug but heavily restrict its use through things like requiring pre-approval, said Greg Warren, a health actuary and member of the Society of Actuaries.
For commercial coverage, insurers often pay for treatments that have full FDA approval. But that is not guaranteed.
Tufts Medical Center in Boston maintain a database that includes more than 11,000 commercial insurance coverage decisions on specialty drugs. In 2% of the decisions, insurers did not cover the FDA-approved use, said researcher James Chambers.
Chambers said they have found that the decision to not cover a drug largely happens when the evidence supporting the drug is considered questionable.
The denials for Leqembi don't surprise Jack Hoadley, a health policy researcher with Georgetown University's Center on Health Insurance Reforms.
He noted Leqembi's serious side effects and high cost. The price doesn't include the cost for repeated brain scans patients need to check for side effects.
But Hoadley said insurers also may have a hard time explaining themselves.
"It's going to be a harder-to-justify decision for them if they know that Medicare has made a decision to cover it," he said.
Patients who don't get coverage through a commercial plan may eventually receive it through Medicare or state- and federally funded Medicaid programs.
But waiting is risky. Those who advance out of early-stage Alzheimer's may no longer qualify for Leqembi.
Bonnie Bortz has been caring for her 38-year-old daughter, Jaime, who has early-onset Alzheimer's like her father did.
Bortz, who lives in the Buffalo suburb of Cheektowaga, is confident Jaime will get help paying for Leqembi because she will soon start on Medicare, which is available to some people under 65 with Alzheimer's. Still, that hasn't happened yet, and Bortz is anxious for treatment to begin.
She's watched Jaime progress from repeatedly losing her phone and keys to struggling to help her 7-year-old daughter with homework.
"I don't want to get to the next stages of all this," Bonnie Bortz said. "I want more time."
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group. The AP is solely responsible for all content.
___
10 potential early signs of dementia
Memory loss that disrupts daily life
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.
Challenges in planning or solving problems
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.
Difficulty completing familiar tasks at home, at work, or at leisure
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.
Confusion with time or place
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.
Trouble understanding visual images and spatial relations
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.
New problems with words in speaking or writing
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.
Misplacing things and losing the ability to retrace steps
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.
Decreased or poor judgment
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.
Withdrawal from work or social activities
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.
Changes in mood and personality
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.
Â
This story originally appeared on Neural Effects and was produced and distributed in partnership with Stacker Studio.
