First drug to slow Alzheimer's disease gets full FDA and Medicare approval for early-stage cases; drug is still in clinical trials at UK

Dr. Jim Jackson of Morehead receives a lecanemab infusion
at UK's Sanders-Brown Center on Aging. (UK file photo) 

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration has granted full approval for the first drug to slow down the progression of Alzheimer's disease, opening the door for Medicare to pay for it.

"This is the first medicine ever that actually changes the disease in the brain, removes a component of the disease and can extend quality of life for patients who are developing and who are in the early stages of Alzheimer’s disease," Dr. Greg Jicha, director of clinical trials at the University of Kentucky Sanders-Brown Center on Aging, said at a news conference on Friday. 

Jicha stressed that the drug is not a cure, but instead has been shown in clinical trials to slow the disease process by 27% to 40%. 

Lecanemab, marketed by Japanese drug maker Eisai and U.S. partner Biogen under the brand Leqembi, is an antibody that targets amyloid plaques, which are found in brains of people with Alzheimer's. It is administered twice a month, intravenously; the firms have estimated treatment will cost $26,500 a year. 

The drug has been on the market since January 2023 under an accelerated approval from the FDA but was not broadly covered by Medicare. Following the FDA's full approval of the drug, Medicare, which primarily serves adults age 65 and older, will now cover it for those who qualify. 

With the Centers for Medicare and Medicaid Services' announcement, Jicha said the approval would make coverage more likely by other insurers, including Medicaid, which is a federal-state program.

Jicha also said he hopes Esail will have patient-assistance programs to ensure that anyone who qualifies for the drug has access to it. 

“I really think it behooves all of us to ensure that this medicine is accessible to everybody,” he said. “No matter what their socioeconomic status, no matter what their geographic limitations are, everyone who has early Alzheimer’s disease deserves the opportunity as long as the medicine is going to be safe for them.”

Dr. Jim Jackson, a retired pediatrician from Morehead, participated in an 18-month lecanemab study at UK and is now part of what his wife, Sharon, called an "extension study." 

"I felt that it was really a good opportunity to be part of something that can improve life for many, many people," he said at the news conference. Later adding, "I would be very happy to recommend this drug. I've been tickled to death to be in the study." 

Jicha said there are some side effects to the drug, including amyloid-relating imaging abnormalities (ARIA), typically a temporary swelling and/or bleeding in certain areas of the brain that usually resolve over time. He said people with two copies of a well-known Alzheimer's risk gene may be more at risk of ARIA. 

Sharon Jackson said her husband has responded well to the drug and has had no side effects. When he started the clinical trial, she said, "Jim had a little bit of memory issues and I can plausibly say that it has not progressed very much. . . . I can see that this medication, from what I understand about Alzheimer's, seems to be holding him pretty steady."

Who qualifies for the drug?

The medication will only be available to those in the early stages of the disease, and doctors willhave to verify that there is a buildup of amyloid in the brain before they can prescribe, Jicha said. Also, he said the drug must be administered by specialists who understand how to provide the treatment and to monitor for safety. 

“This medicine is only for those with mild memory problems, what we call mild cognitive impairment or folks that are in the mild stage of Alzheimer’s,” Jicha said, because benefits are uncertain for those in “a more moderate or severe stage.”

The drug is not available to people at risk of Alzheimer's, but Jicha said ongoing clinical trials are evaluating the usefulness of the drug for this group.   

The Alzheimer's Association promoted early detection and diagnosis in its press release celebrating the full approval of lecanemab. 

"With this approval, early detection and diagnosis are even more critical to ensure individuals receive the most benefit at the earliest point possible. If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis and to discuss treatment options," says the release. 

In Kentucky, 75,000 people 65 and older are living with Alzheimer's and that number is expected to increase by 15% in the next few years, to 86,000 in 2025, according to the Alzheimer's Association. Further, the association says 11.2% of people aged 45 and older have subjective cognitive decline.

Some people have misgivings. "Providers and health researchers who have doubts about the drug’s safety and efficacy say the decision exemplifies broader problems with FDA’s approval process," Jessica Karins of Inside Health Policy reports. "The critics raise concerns with the safety profile of the early-stage Alzheimer’s treatment . . . and say the difficulty of measuring cognitive decline means it remains unclear how much the drug can slow the progression of Alzheimer’s disease."

Kentucky dropped one spot in latest America's Health Rankings Report for seniors, to 49th; ranked last in health outcomes

By Melissa Patrick
Kentucky Health News

A new report shows that Kentucky continues to be one of the worst states in which to grow old, which isn't great news for the one in six Kentuckians who are already over the age of 65 and the growing number of Baby Boomers who will soon fall into that category.

Kentucky ranks 49th for seniors' health in the most recent America's Health Rankings Report, down one slot from last year. Mississippi is the only state ranked worse. Kentucky has been in the bottom 10 states for senior health since 2013, the first year AHR did the report.

The report looked at 34 measures of senior health that are known to influence health, which were then broken into five categories.

Kentucky ranked in the bottom 10 states in four of the five main categories, 49th for behaviors; 47th for community and environment; 44th for clinical care; and 50th for health outcomes.

Its highest ranking was for senior health policies, 32nd. This ranking was largely driven by positive scores in two categories, one that shows Kentucky has a low percentage of seniors living in nursing homes who require a low level of care, 7.4%; and another that shows the state has a high percentage of seniors with prescription drug coverage, 87%.

Other good news is that only 5.5% of Kentucky seniors are heavy drinkers, though it was 4% three years ago. The state also has a high percentage of seniors who are managing their diabetes, 81.6%.

This year, the report also looked at how many seniors had avoided care due to cost. It found that in Kentucky, 7% of seniors said there was a time in the past year when they needed to see a doctor, but could not because of cost. Nationally, that rate was 5.2%.

It also took a national look at young seniors, between the ages of 65 and 74, and found that compared with 15 years ago, smoking rates are 16% lower, early deaths are 22% lower and those reporting they are in better health is 11% higher. However, the report also found excessive drinking in this age-group is 42% higher, obesity is 36% higher, diabetes is 36% higher and suicide rates are 16% higher.

Ongoing challenges in Kentucky

The report says its purpose is to promote data-driven discussions that can drive positive changes and improve the health of seniors -- and most of Kentucky's data shows a lot of room for improvement.

Kentucky seniors rank No. 2 in smoking, at 12.5%. The report notes that it's never too late to stop smoking, and that even in older adults it has been shown to improve health outcomes.

Kentucky also ranks in the bottom five states for several other measures.

It ranks 47th for physical inactivity, with 36% of the state's seniors reporting they were inactive. Overall, the report found that females are 1.2 times more likely than males to be inactive.

It also ranks 47th for community support expenditures, which are used for funding personal care, meals, transportation and nutrition-education programs for seniors, at $225 dollars per adult aged 60 and older in poverty, compared with the average of $571 dollars for all states.

Kentucky ranked 46th for home-delivered meals to seniors, delivering meals to only 4.9% of its seniors aged 60 and older who have difficulty living independently. The national average for this measure is 8.9%, and the top ranked state for this measure, New Hampshire, delivers meals to 37.5% of seniors in need.

Kentucky ranks as the worst state for its high number of preventable hospitalizations, at 76.6 discharges per 1,000 Medicare enrollees. The national average for this measure is 49.4.

They are also more likely to die early. The report found 2,369 deaths per 100,000 adults aged 65 to 74 in Kentucky, compared to 1,791 nationwide.

Kentucky seniors also suffer from more mental distress than seniors in other states, 10%, compared to 7.9% nationwide.

The state's seniors also rank last among states for volunteerism by seniors, with only 18.9% volunteering, and nearly last, 48th, for the number of seniors reporting high health status, 31.7%. The national average for these measures are 28% and 41.3% respectively.

Despite some improvements, Kentucky continues to rank near the bottom of all states for senior health

By Melissa Patrick
Kentucky Health News

Kentucky ranks 48th for seniors' health in the most recent America's Health Rankings Report -- a potential source of great concern, since the senior population in Kentucky, and the rest of the nation, is only growing larger. Only Mississippi and Louisiana ranked worse than Kentucky.

The U.S. Census Bureau estimates that one in five Americans will be over the age of 65 by 2030, and by 2035, seniors will outnumber children younger than 18.

The report looked at 34 measures of senior health that included factors that influence health, which were broken into four categories: behaviors, community and environment, policy and clinical care, and health outcomes. Kentucky also ranked 48th in both of these broad categories.

It also highlighted two supplemental measures, senior suicide and risk for social isolation, which has been linked to increased mortality, poor health status and greater use of health-care resources.

The report found Kentucky seniors are at a high risk for social isolation, scoring in the bottom 10 states for four of the six indicators used to measure this risk, including seniors who are divorced, separated, or widowed; poverty; disability, and difficulty living independently. This indicator was also broken down by county. (See map.)

Since the 2014 report was published, the national suicide rate among seniors increased by 12 percent, to 16.6 deaths per 100,000 adults 65 and older, but it remained the same in Kentucky at 20 deaths per 100,000.

Kentucky senior health strengths and improvements

Despite their low health ranking, Kentucky's seniors have shown many improvements on the health front and have some solid strengths.

For example, the report found that only 4.5 percent of Kentucky seniors are heavy drinkers and only 6.9 percent who require a low amount of care are in nursing homes, ranking the state seventh and eighth, respectively.

Kentucky also ranked high for the percentage of seniors with prescription-drug coverage, 87 percent; those with a dedicated health-care provider, 95.2 percent; and diabetes management, 81.6 percent.

And while many Kentucky senior-health measures ranked near the bottom, they showed some improvement. For example, senior dental visits, which ranked 44th in the nation, rose to 58.6 percent from 57 percent in 2017; the number of home-health workers per 1,000 adults 75 and older (45th) increased to 62.6 per 1,000, from 56.5; the percentage of adults having teeth extracted (47th) decreased to 22 percent from 23.9 percent; and the number of nursing home beds with four- and five-star ratings (45th) increased to 35.6 percent from 29.5 percent in 2017.

Challenges persist

Smoking plagues every age group in Kentucky, with Kentucky seniors ranking 49th for for this measure, at 12.4 percent -- though the researchers say it's never too late to quit.

"Cessation, even in senior smokers, can have profound benefits on current health and long-term outcomes," the report says. "For example, the risk of dying of lung cancer drops by half 10 years after cessation."

Kentucky also ranks near the bottom for its low number of "able-bodied" seniors, 57.7 percent, compared to the national average of 64.8 percent; and its high number of preventable hospitalizations, 76.6 per 1,000 Medicare enrollees.

And though Kentucky's flu vaccination rate is higher than many states, the number of Kentuckians who got vaccinated this year dropped 12 percentage points, from 67.3 percent to 59.4 percent.

This is important because "around 71 to 85 percent of flu-related deaths occur in individuals aged 65 and older, and half of flu-related hospitalizations were among older adults in 2015-16," says the report.

Kentucky also ranks low, 44th, for the number of seniors who were enrolled in hospice during the last six months of life after a diagnosis that held a high probability of death: only 43.4 percent. In the state with the highest health ranking, Utah, nearly 66 percent who met this criteria enrolled in hospice.

Food insecurity is also an issue for Kentucky seniors, with 18 percent saying they had faced the threat of being hungry in the past 12 months.

Kentucky ranked 49th for home-delivered meals to seniors, delivering only 3.8 meals per 100, compared to the national average of 9.1 per 100. Utah, ranked first for senior health, delivered 19.1 meals per 100; New Hampshire, ranked second, delivered 33.7 meals per 100.

The report also shows Kentucky ranks 39th for the share of seniors (49.1 percent) who participate in the Supplemental Nutrition Assistance Program, formerly called food stamps; only 42 percent of eligible seniors participate in the program.

"The purpose of the report is to promote data-driven discussions among individuals, community leaders, the media, policy makers and public health officials that can drive positive change and improve the health of seniors," says the report.

Rural areas have many obstacles to mental health care, including lack of anonymity and fear of stigma

"Mental illnesses such as anxiety and depression are common among older adults in rural areas, affecting 10 to 25 percent of that population. But many of those people with them suffer in silence rather than seeking treatment," Emily Gurnon reports for Next Avenue as part of a special report for the John A. Hartford Foundation.

A study by researchers at the Wake Forest School of Medicine shed some light on why rural seniors often forego treatment. They questioned 478 adults aged 60 or older in rural North Carolina, and found that the most common answer was "I should not need help." Other frequently cited reasons were not knowing where to go, distance to access treatment, mistrust of counselors or therapists, not wanting to talk about private matters with a stranger, and fear of stigma.

The relative lack of anonymity in rural areas and small towns could contribute to a rural senior's refusal to seek treatment for mental health issues. Dennis Mohatt, vice president of the behavioral mental health program at the Western Interstate Commission for Higher Education and director of its Center for Rural Mental Health Research, told Gurnon, "Your neighbors don’t have a clue in a city if you’re going to go get some help. But everybody [in a small town] will know if your pickup truck is parked outside of the mental health provider’s office."

Some seniors may believe that seeking help for mental illness may signal to others that they are weak or unable to be self-reliant. A study of rural veterans, half of whom were seniors, found this to be a potent barrier to seeking mental health treatment. The veterans rated independence and self-reliance very highly, and cited an emphasis on stoicism and concern about stigma as reasons that would make them less likely to seek help.