Activists gather in Washington, D.C., to call on Medicare to cover two Alzheimer’s drugs approved by the Food and Drug Administration. (Courtesy of Alzheimer’s Association of South Dakota)
Deaths from Alzheimer’s disease jumped 177% in South Dakota between 2000 and 2019, and the state’s mortality rate is higher than the national average.
Those are some of the reasons Jon Carroll went to Washington, D.C., recently to decry an action by the Centers for Medicare and Medicaid Services (CMS). The agency decided that Medicare will not cover two treatments approved by the Food and Drug Administration in January to treat the disease — thus far the only two drugs shown to slow cognitive decline for Alzheimer’s patients.
That’s not the main reason he told his story to Congress on behalf of the South Dakota chapter of the Alzheimer’s Association.
Carroll’s call to action is personal, as he lost his wife Viola to Alzheimer’s in 2017, when she was 62 years old. He hopes some of the 250,000 people denied coverage for the drugs so far get the chance to spend more time with their loved ones before they begin to lose touch.
“They’ve finally got something that helps, and you can’t get it,” said Carroll, of Sioux Falls. “I would have given anything to have eight more months with my wife before she began the decline.”
The decision not to cover an FDA-approved medicine unless patients are part of a clinical trial is “unprecedented,” according to the association.
The out-of-pocket cost for the drugs, Lecanemab and Aduhelm, is more than $26,000 a year unless patients are part of a clinical trial. Each was granted accelerated approval by the FDA, an approach that’s been used in recent years to speed certain drugs to market. Medicare has spent billions on drugs with accelerated approval, but placed restrictions on the Alzheimer’s treatments.
The issue has sparked calls for answers from two-thirds of South Dakota’s congressional delegation. Sen. Mike Rounds has been particularly vocal on the issue.
The drugs are expensive and only help at the onset of Alzheimer’s, he told South Dakota Searchlight, but “there’s a good possibility that there would be a real improvement in quality of life” if Medicare were to reverse itself and cover the treatments.
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South Dakota issue
Rounds was part of a bipartisan group of 20 U.S. senators to sign a letter to Medicare administrators on Feb. 17 demanding answers on the agency’s refusal to cover the new drugs for all patients.
About 13 million Americans will live with the disease by 2050, the letter says. It also notes that Alzheimer’s and dementia “cost the nation $321 billion” in 2022 alone.
The decision not to cover treatments unless the patient is part of clinical trials is especially troubling for smaller states, the senators wrote.
“This decision creates a barrier to care for older Americans, especially individuals living in rural and underserved areas,” the letter says.
That’s a meaningful distinction for South Dakota, according to Thomas Elness, director of public policy for the state chapter of the Alzheimer’s Association.
Around 11% of South Dakota seniors have the disease, with 26,000 caregivers putting in around 34 million hours of unpaid care annually.
The FDA approval of the first drugs that can help would be “revolutionary” news, Elness said, but for the Medicare coverage decision.
“It’s shocking and appalling that finally, after a decade of highly targeted research and investments, that we’d have these treatments and not have them available,” he said.
Rounds tweeted about the issue in February. Rep. Dusty Johnson told South Dakota Searchlight that he wants to understand why the drugs aren’t covered.
“I have asked CMS to clarify why they are putting up barriers to access life-saving drugs and look forward to hearing their rationale,” Johnson said in a prepared statement. “If research continues to show improvement in Alzheimer’s patients, I hope CMS reverses course and continues to allow these critical drugs to be given to our most vulnerable.”
Sen. John Thune, through a spokesman, declined to comment on the situation.
The new drugs do not cure Alzheimer’s. They also come with caveats about possible side effects and timing, and some researchers have questioned their value.
Clinical trials have shown that the drugs have the potential to help patients with early-stage Alzheimer’s disease, which needs confirmation through PET scans or spinal taps.
Each drug targets the plaques that kill neurons in the brains of Alzheimer’s patients. But that approach has been subject to scrutiny by researchers, who questioned the relative value of the positive effects. Skeptics were concerned that the cost or potential side effects of clearing plaques from the brain would outweigh the potential benefits. The drugs’ approval was met with controversy, both for the price and the manner of its approval.
Aduhelm, and later Lecanemab, were granted “accelerated approval” by the FDA, meaning their approval was fast-tracked based on expected clinical benefits. The typical approval process takes several years and requires clearer proof of patient benefits.
That process hasn’t stopped Medicare from covering treatments approved in that accelerated fashion before. Medicare has paid billions for accelerated approval cancer drugs like Keytruda and Opdivo.
Those costs have come under scrutiny. One study published in the Journal of the American Medical Association last year found that Medicare had covered $224 million to pay for such drugs to treat conditions the FDA later learned were not improved upon by their use.
Even when the treatments have been effective, the price is significant. Another 2022 study found that Medicare and Medicaid had pumped $1.8 billion into accelerated approval treatments by 2019.
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Rounds: Penny-wise and pound-foolish
Medicare administrators have said little publicly about the decision not to cover the Alzheimer’s treatments, but Rounds said concerns about immediate cost gloss over the long-term value of coverage. The agency responded to the senators in late February.
“While they’re trying to be penny-wise, they might very well be pound-foolish in that Alzheimer’s right now is costing us, I think they’ve indicated, even the last couple of years, close to a third of a trillion dollars a year,” Rounds said.
Much of that money goes to cover long-term care coverage in assisted living facilities and nursing homes, so Rounds argues that encouraging the continued development of similar drugs by covering the first two made available would ultimately reduce costs.
The CMS response to the senators’ letter didn’t address their concerns, Rounds said. The letter says “there is not yet evidence meeting the criteria for reconsideration” for Medicare, and that further studies may produce such evidence.
“Which is another way of telling us to pound sand,” Rounds said.
All the cost considerations swirling around the medicines, Rounds said, distract from what he sees as the most important point for most Americans: The drugs could have a meaningful impact on the lives of the afflicted and their families.
“The sooner we get these new drugs out and get the improvements going, along with the quality of life improvements for people that have this disease, the better off we’re all going to be,” Rounds said.
That’s what matters most to Carroll. Near the end of her life, Jon Carroll said, he would ask his wife to bring him a screwdriver, but she might bring him a bowl or a spoon. She’d wander off in public or holler outside the house, prompting well-being checks from police. He sometimes found himself flagging down strangers to ask them to check on his wife when she’d be in a public restroom for a concerning period of time.
When things got difficult for the Carrolls, Jon could do little more than keep track of and care for Vi.
Given how widespread the disease has become, Carroll said, the drug coverage issue ought to be a concern for everyone.
“If you don’t get aware of the issues now, you’re not going to have time to think about it when someone you love gets Alzheimer’s,” Carroll said.
That’s a message Jack and Mary Mortenson of Sioux Falls want people to take to heart, as well. The disease is a drag on caregivers, particularly those who remain in the workforce as they care for their family members, and the economy.
Jack is in an early stage of Alzheimer’s, but he’s already noticed changes.
“It’s been a slow regression of what I can think and do. I’m still doing very well, but there’s a whole lot of stuff I used to do that I can no longer do,” Mortenson said.
He’s always been a problem-solver, a person who could find a way to fix things around the house. Mary Mortenson said they’d never hired a plumber, electrician or any other sort of contractor until recently. Jack used to apply those skills to build sets for Harrisburg High School theater performances or in his work as a videographer.
Alzheimer’s has changed that.
Until recently, he had three big tool cabinets at HHS. One day he came in to see that one of them was unlocked. He asked around to find out who might have opened them, but the only other person with a key said no one but Jack had been there.
He misses his work with students, but he said he felt like he had no choice but to leave the set work behind.
“We’re working with power tools and that kind of stuff, and I didn’t want the kids to get hurt because I wasn’t doing things right,” he said. “So I gave up that really fine job, and it’s been just downhill from there … I’m just slowly losing the ability to do a lot of things that I used to do.”
Mary Mortenson struggles to understand why Medicare won’t let patients make the call on the drugs that could help families like theirs.
“This may be something that Jack and his doctor would choose, or it may be something he and his doctor would choose not to use,” Mary Mortenson said. “But that shouldn’t be dependent on whether it’s available or not. And so our position is Medicare needs to pay for this medicine, like it pays for every other medicine that the FDA approves.”
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