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."

This is the last week to sign up for health insurance on Healthcare.gov for 2019 coverage; deadline is Saturday, Dec. 15

By Melissa Patrick
Kentucky Health News

With just a few days left to enroll in a health-insurance plan on Healthcare.gov, it's time to sign up if you want federally subsidized coverage for 2019. Enrollment under the Patient Protection and Affordable Care Act, otherwise known as Obamacare, ends Saturday, Dec. 15.

Screenshot of Healthcare.gov website

If you need help with enrolling or simply have questions, there are more than 600 application assisters and more than 2,000 insurance agents available to help -- and their services are free, Edith Slone, director of the Kentucky Health Benefit Exchange, said on a Dec. 3 video posted on the Cabinet for Health and Family Services Facebook page.

And even though you will be automatically re-enrolled in a 2019 marketplace plan if you already have one, that doesn't mean you shouldn't check out the other options.

Slone said open enrollment is a good time for an "annual health care checkup" to make sure your coverage suits your needs. Has the number of people in your household has changed? Has your income or medical needs changed? Or are your providers still in your plan network?

And don't assume you can't afford coverage.

Slone said 80 percent of Kentuckians who sign up on healthcare.gov will qualify for a tax credit or subsidy to reduce their monthly payments. And while premiums have gone up this year, most enrollees' cost will be about the same because the credits are calculated to offset premium increases.

Whether Slone's Facebook message is reaching the Kentuckians who need to hear it is uncertain, especially since five weeks into the six-week enrollment period, 6,142 fewer Kentuckians had enrolled on the federal exchange than at the same time last year.

Kentucky's enrollment on the federal exchange during November was 30,172, compared to 36,314 who had enrolled by that time last year, according to the Centers for Medicaid and Medicare Services. Nationally, 406,277 fewer people had signed up compared to last November. However, these numbers don't reflect any automatic re-enrollments.

There are many possible reasons for lower enrollment, including the removal of the individual mandate that imposed a penalty for not having health insurance, expansion of availability of "short-term" plans, and huge cuts to many states' in-person outreach and advertising budgets -- though Kentucky still funds its application-assister program.

But the most likely reason is that people don't know it's time to sign up, which is a problem because if you miss the deadline -- and don't qualify for a special enrollment period -- you won't get another chance until next year.

According to a Kaiser Family Foundation poll taken last month, only one in four people who buy their own insurance or who are uninsured knew the correct deadline for open enrollment -- Dec. 15. And fewer than half of those polled said they had heard or seen any advertising in the past 30 days from an insurance company attempting to sell health insurance. Only 31 percent said they had heard or seen information about how to get health insurance under the health-care law.

Kentucky's Cabinet for Health and Family Services said in an Oct. 30 news release that it was targeting its outreach efforts through direct mail, text messages, phone calls, e-mail and community outreach events held by local assisters. The cabinet has also posted some outreach messaging on its Facebook and Twitter accounts.

In Arkansas, there seems to be a greater sense of official urgency. The state Health Insurance Marketplace issued a news release on Dec. 3 that emphatically reaches out to its citizens to tell them to "hurry" and sign up for open enrollment because the Dec. 15 deadline is looming.

"Those families and individuals are one catastrophic illness away from potential financial bankruptcy. We insure everything else important in our lives -- homes, autos, boats -- why not our health?" says the release from Brett Kirkman, chairman of the marketplace board.

Nationally, celebrities such as late-night television talk-show hosts Stephen Colbert and Jimmy Kimmel have stepped up their efforts to let people know the deadline is looming.

Kentucky's cabinet has not issued another news release to encourage sign-ups, and did not respond to a request for comment as to whether it plans to.

Where can I find help?

The state-based call center is available at 855-459-6328 to help assist Kentuckians with where to go for coverage, answer questions and pre-screen for eligibility. The Healthcare.gov customer service center (800-318-2596) is also available 24 hours a day, seven days a week.

Click here to find an assister or click here to find an insurance agent or an assister. Click here to see a list of outreach events in each county.

Healthcare.gov provides a shopping tool to allow you to preview 2019 plans and estimated prices before you log in.

The Kaiser Family Foundation also offers a Health Insurance Marketplace Calculator to provide estimates of health insurance premiums and subsidies for people purchasing insurance on their own on Healthcare.gov. It allows you to enter your income, age and family size to estimate your eligibility for subsidies and how much you should spend on health insurance. It will also allow you to see if you qualify for Medicaid.