Everyday tasks like cooking take longer for Betsy Groves these days.
“I have more trouble with short-term memory and day-to-day things,” she said. “I used to be able to look at the recipe and it would be in my brain. I wouldn’t have to look at the cookbook again but now, I have to look frequently, all the time.”
That sounds small, but for Groves, it’s a sign of worse things to come.
She was diagnosed with Alzheimer’s disease two years ago, which means she’ll likely experience a progressive decline in her memory and other important mental functions that could eventually lead to physical changes that prevent her from walking and even swallowing.
No cure exists, but medications and management strategies may temporarily improve the symptoms. The landscape shifted in 2021, when the FDA approved Aduhelm, the first Alzheimer’s drug showing some promise in slowing Alzheimer’s progression and the first Alzheimer’s-related medicine approved in almost two decades. But after controversy over its approval, safety and effectiveness, the Centers for Medicare & Medicaid Services (CMS) sharply curbed coverage of the pricey drug and subsequent treatments like it, limiting access for millions of patients.
On Thursday, CMS said it would grant full coverage of new Alzheimer’s drugs that work similarly to Aduhelm as soon as they receive full FDA approval, but with what some say are still unreasonable caveats.
“CMS restrictions are severe, which effectively is noncoverage of these Alzheimer’s drugs,” said Robert Egge, chief public policy officer of nonprofit Alzheimer’s Association.
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What’s the Aduhelm controversy?
The new Alzheimer’s drugs are supposed to remove plaque, which many researchers believe form and damage and kill brain cells, adversely affecting memory and other mental functions. Once plaques are removed, brain cells are expected to stop dying, and thinking, memory, function and behavior will stop deteriorating.
Biogen’s Aduhelm was the first of these drugs, but study results were mixed, with only one of two large studies showing improvement in patients. Even then, improvement was marginal, but safety questions were big, researchers said. Despite an FDA advisory panel’s recommendation not to approve the drug, the FDA did so anyway with accelerated approval to treat serious conditions with an unmet medical need. Manufacturers must study the drug further to confirm its clinical benefit. If these post-approval conditions aren’t met, the FDA can withdraw its approval.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said then in a statement: “available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”
Aduhelm was also extremely expensive, originally $56,000 a year, boosting Medicare Part B premiums by a whopping 14.5% in 2022. The price was later cut in half, but CMS ultimately decided to severely restrict coverage to patients enrolled in a qualifying clinical trial. Adjusting to the price cut and smaller-than-expected use due to restrictions, Medicare premiums dipped in 2023.
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Aren’t there two other promising Alzheimer’s drugs?
Yes. Japanese pharmaceutical Eisa and Biogen received FDA accelerated approval in January for Leqembi and believes it can win full FDA approval by July 6, but U.S.-based Eli Lilly’s donanemab was denied, with the FDA requesting 12-month testing on more patients. Eli Lilly expects results around midyear. Both, like Aduhelm, remove plaque from the brain.
Leqembi costs about $26,500 annually, likely making it unaffordable for most people. Access will depend on whether Medicare covers the drug.
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Is Medicare covering Leqembi?
CMS is sticking to the same policy it put on Aduhelm last year, only paying for patients enrolled in approved clinical trials to determine if the drugs are safe and effective, and appropriate for Medicare users, said Anna Kaltenboeck, principal and head of prescription drug reimbursement at healthcare research firm ATI Advisory.
“Alzheimer’s drugs are really unique in that you can’t tell quickly if they work,” she said. “Trials have only been over a year and a half, so CMS doesn’t know if they’re reasonable and necessary – what are the side effects, and will they continue to work?”
Kaltenboeck also noted that trial patients weren’t necessarily as diverse as Medicare patients, so more studies should be done. “CMS is doing what it’s supposed to, to figure it out,” she said. “CMS is paying for the drugs but demanding information.”
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When could Medicare change its policy on these Alzheimer’s drugs?
If the FDA grants full approval to Leqembi this summer, as expected, Medicare said on Thursday it would give the drug broader coverage the same day. However, patients must be enrolled in a registry; critics say no other medication faces similar restrictions.
“We continue to believe that registry as a condition of coverage is an unnecessary barrier,” Alzheimer’s Association said in a statement after the CMS announcement. “Registries should not be a requirement for coverage of a FDA-approved treatment. “
CMS defended its stance, saying “registries are common tools in clinical settings that have successfully gathered information on patient outcomes for decades.” However, the agency’s decision falls under its authority to regulate medical devices, not a medication like Leqembi, critics note. Most fully approved FDA drugs get Medicare coverage because the FDA has deemed them safe and effective.
CMS also said it’s working with multiple organizations to open their own registries so clinicians can submit data into a nationwide, CMS-facilitated portal but offered few details. It said more information will be released as registries come online.
Some experts are concerned that requiring data collection through patient registries could cause some lower-income people and rural Americans to miss out. Whether any registries will exist when full coverage is expected to be granted this summer also is questionable.
Registries often take a year or more to establish, which means patients wouldn’t have immediate access to Leqembi if CMS mandates registry participation for coverage, nonprofit Alliance for Aging Research said.
In April, CMS Administrator Chiquita Brooks-LaSure also said in a Congressional hearing she was not aware of any registries being developed and CMS hasn’t issued details on how to establish one.
Notably, Veterans Health Administration (VHA), the largest health system in the country, said in March it would widely cover Leqembi for those who meet requirements, making it the first insurer in the country to do so. VHA didn’t return requests for comment on their decision.
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Should Medicare move faster to cover these new Alzheimer’s drugs?
It’s complicated.
“The strict rules appear to be necessary to protect older, vulnerable patients until doctors and Medicare can learn more about the safety and effectiveness of these new drugs,” said Mary Johnson, senior policy analyst at nonprofit The Senior Citizens League. “The danger of falls or brain swelling suggests that these drugs could potentially be linked to strokes.”
And though Medicare doesn’t base its decisions on cost, it’s no secret Medicare’s facing a funding crisis and these drugs are expensive. If just 5% of the 6.7 million older U.S. adults with Alzheimer’s disease take Leqembi, at the annual list price of $26,500, this would add $8.9 billion to Medicare Part B spending annually, assuming all are enrolled in Part B, according to the nonpartisan research group KFF. A 10% take-up rate would amount to $17.8 billion in higher spending, it said.
For context, the projected Medicare spending on Leqembi would be roughly equal to spending on the top 3 Part B drugs combined in 2021 based on the 5% take-up rate, KFF said. At the 10% take-up rate, projected spending on this one drug alone would exceed spending on the top 10 Part B drugs in 2021 and would represent close to half of the total $40 billion spent on the 600+ Part B covered drugs in 2021.
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“Higher Medicare Part B spending would likely lead to higher Medicare Part B premiums, which are set to cover roughly 25% of program costs,” KFF said. And still, the out-of-pocket expense for Leqembi after Medicare coinsurance requirements may make the drug out of reach for many, it said.
“The question becomes does that improve quality of life and health outcomes in view of the side effect risks and high costs?” asks Johnson, who is a senior herself and has worked as a primary caregiver for senile dementia patients. “Would slowing the disease by a few months change anything? This is one of those healthcare questions for which there is no easy answer.” Only hard decisions.”
For those like Groves, who suffer from early, mild Alzheimer’s, the drugs could buy her more memories.
“I’m anxious and hopeful I can get access to the drug, and it gives me more time with my grandchildren and family,” she said. “But I also accept this is beyond me. It’s the government. If I worry about this all the time, I’d be a wreck.”
Medora Lee is a money, markets, and personal finance reporter at USA TODAY. You can reach her at mjlee@usatoday.com and subscribe to our free Daily Money newsletter for personal finance tips and business news every Monday through Friday morning.
