Doctor shows a patient an image of his brain from an MRI scan.
The powerful Alzheimer’s Disease lobby is fighting a multi-billion-dollar battle on two fronts. It is quietly trying to limit restrictions the Food and Drug Administration puts on the use of new drugs aimed at slowing the progression of the brain disease. And it is publicly pressing Medicare to pay for the widespread use of the monoclonal antibodies FDA already has conditionally approved as well as others in the pipeline.
While the FDA approves drugs for use, it doesn’t decide who pays for them. And, for now, the Centers for Medicare and Medicaid Services (CMS) permits Medicare to pay for these medications under only limited circumstances.
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Who Will Pay?
Unless Medicare widely covers these drugs, they will be unaffordable for the vast majority of consumers and the market will dry up. For example, the most recent anti-Alzheimer’s drug to win FDA approval is lecanemab. It is being marketed by drugmakers Biogen
BIIB
As a result, powerful lobbying groups such as the Alzheimer’s Association and USAgainstAlzheimer’s, which get substantial funding from the drug industry, are aggressively pushing CMS to approve widespread Medicare payments for these costly medications.
Is CMS unreasonably limiting patient access to a drug that could improve the quality of life for millions of people with early-stage memory loss? Or is its caution a prudent decision that saves taxpayers’ and Medicare enrollees’ money and signals that these drugs are not yet ready for widespread clinical use, because both their benefits and risks remain uncertain?
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A new analysis by researchers at RAND Corporation, UCLA, and Harvard University concludes Leqembi and the testing that will be necessary for those taking it, would increase Medicare drug costs by $2 billion to $5 billion annually. That could well require Medicare to boost enrollee premiums for Medicare Part B, which would pay for these drugs.
In 2021, Medicare raised its base Part B premium by 14.5 percent or about $22-a-month. A main reason, it said, was its expectation that it would have to pay for a similar drug called Aduhelm. After Medicare decided to limit coverage of that drug to only patients in trials, it announced it would roll back some of that premium increase.
For now, Medicare will pay only for enrollees who take Leqembi and similar drugs in carefully-monitored clinical trials or who participate in federal registries that will collect data on patient outcomes. By contrast, the Veterans Administration has agreed to pay for the drug for vets age 65 or older with early stage Alzheimer’s Disease.
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Following FDA’s Lead
CMS Administrator Chiquita Brooks-LaSure told a congressional committee in April that Medicare would cover Leqembi under whatever final guidelines FDA approves. FDA is expected to make its final decision by July.
If it does give final approval to Leqembi and similar drugs, the next key question will be whether it imposes any restrictions on its recommended use. For example, will it include a warning label for patients who may be at high risk for brain bleeds? Depending on how they are written, those guidelines could significantly shrink the market for these drugs.
FDA’s initial label specifies the drug is appropriate only for people with early-stage Alzheimer’s (not any of the many other forms of dementia and not those with later stage disease). It also requires users to undergo costly imaging tests that currently are not covered by Medicare either, another bone of contention.
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The Lobbying Campaign
While these decisions should be based on science, the Alzheimer’s lobby is rolling out its political big guns. Members of Congress are demanding that Medicare pay. Advocates allege racial bias in Medicare’s reluctance to cover the drugs. Why? Because they say trials and even registries are less likely to include Black and Hispanic patients as well as those living in rural communities.
In one unusual advocacy move, drugmaker Eli Lilly, which has applied for FDA approval of its own monoclonal antibody, purchased what effectively was a two-hour infomercial presented by the online news service The Hill. It featured lawmakers, researchers, and representatives of advocacy groups all urging CMS to pay for these drugs. No researchers who questioned the drug’s safety or efficacy were interviewed.
Uncertain Benefits
A research trial found that Leqembi can slow the progression of early-stage Alzheimer’s for a period of months. However, its long-term benefits are not yet known, its value to different population groups is unclear, and the drug appears to result in severe side effects, even death, for some patients.
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An analysis by the independent Institute for Clinical and Economic Review (ICER) concluded, “Current evidence is not adequate to demonstrate a net health benefit of lecanemab when compared to supportive care alone.”
Notwithstanding these uncertainties, the Alzheimer’s Association says it is “appalled” by CMS’s reluctance to broadly cover these drugs. CMS has received nearly 10,000 public comments for and against its initial decision to limit coverage.
Publicly and privately, directly and through surrogates, the drug industry is using all its muscle to get government to approve and pay for drugs with real promise, and real risks.