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Alzheimer's patient

Intern Susan Garner-Titus helps New Bridge on the Charles Assisted Living resident Irving as he takes part in a class called Glued Together as part of art and music therapy sessions for Alzheimer patients on October 16, 2012. (Photo: Essdras M Suarez/The Boston Globe via Getty Images)

Doctors Urge Medicare to Deny Coverage for Alzheimer’s Drug With Unproven Efficacy and Safety

If Medicare decides to cover up to 80% of Aduhelm's cost, "many beneficiaries would pay thousands of dollars of out-of-pocket costs for a drug with substantial risks and without proven clinical benefit."

Kenny Stancil

As Medicare officials grapple with whether to cover Aduhelm—an Alzheimer's medication approved by federal regulators despite a lack of evidence that the exorbitantly priced and potentially dangerous drug helps patients—many doctors are urging them not to.

"This doesn't meet Medicare's 'reasonable and necessary' criteria because the FDA themselves says there's no direct evidence of improved cognition."

Medicare plans to issue a preliminary decision this month on whether the federal health insurance program for U.S. residents 65 and older will cover Aduhelm, a monoclonal antibody also known by its scientific name, aducanumab, the New York Times reported Friday. Following a public comment period, the high-stakes coverage decision is expected to be finalized by mid-April.

"Please, please, please, do not cover this medicine," Dr. James Castle, an Illinois neurologist who treats Alzheimer's patients, wrote last July in the comment section of the Centers for Medicare and Medicaid Services (CMS) website. "Send a strong and clear message to the pharmaceutical industry that they need to show proof of both efficacy and safety before releasing their medicines on the market."

The U.S. Food and Drug Administration (FDA) has faced sharp criticism for approving Aduhelm in June even though clinical trials exposed serious safety risks—41% of patients experienced brain bleeding or swelling—and failed to demonstrate that the drug benefits Alzheimer's patients. Three advisers resigned in protest.

"Hopefully the planned investigation of the FDA will get to the bottom of why this medicine was ever cleared by the FDA," Castle added, referring to FDA acting commissioner Janet Woodcock's request for an independent probe into the agency's review of Aduhelm, which followed an exposé showing "inappropriately close collaboration" between FDA officials and drugmaker Biogen.

Regulators in the European Union on December 16 recommended against authorizing Aduhelm, and Canada's leading Alzheimer's research groups said last year that approving it "cannot be justified," meaning that Medicare's forthcoming decision could determine the drug's fate.

The Times reported:

Roughly 80% of potential Aduhelm patients are old enough to receive Medicare, making the program's coverage decision crucial. Private insurers often follow Medicare's lead.

Medicare almost always pays for FDA-approved drugs, at least for the medical conditions designated on their label, health policy experts said. But with Aduhelm, Medicare officials have undertaken a monthslong review that could result in no coverage, full coverage, or limited coverage.

James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, called the deliberations by CMS "truly unprecedented."

Sean Tunis, a former official with CMS who is now a senior fellow at the Tufts Medical Center, said that if Medicare denies coverage for Aduhelm, "it will be the first time ever that CMS has declined to pay for a drug that was approved by the FDA for its on-label indication."

The looming coverage decision will also affect the financial well-being of Medicare and millions of seniors.

In November, officials at CMS announced that one of the largest-ever increases in Medicare Part B premiums would be implemented in 2022—due in large part to the possibility of covering Aduhelm, whose price tag at the time was $56,000 per year.

Sen. Bernie Sanders (I-Vt.) implored President Joe Biden to intervene to prevent the rate hike. In a December 3 letter to the White House, Sanders wrote that "the notion that one pharmaceutical company can raise the price of one drug so much that it could negatively impact 57 million senior citizens and the future of Medicare is beyond absurd. With Democrats in control of the White House, the House, and the Senate, we cannot let that happen."

Amid weak sales and on the same day that 18 scientists released a statement that slammed the FDA's approval of Aduhelm as "indefensible in both scientific and clinical terms" and called for its immediate withdrawal from the market, Biogen on December 20 slashed the drug's price.

The company is now charging $28,200 for an annual supply of infusions, which are administered monthly and necessitate regular MRI scans to monitor for potentially devastating side effects.

Following Biogen's announcement, David Mitchell, the founder of Patients for Affordable Drugs, argued that "the 50% price cut for Aduhelm demonstrates how arbitrary drug prices are." He added that there should be a corresponding roll back in Medicare's planned premium increase.

And yet, despite Aduhelm's reduced price and even though Medicare's coverage of the drug remains uncertain, the Medicare Part B premium hike went into effect on Saturday, after Biden refused to heed Sanders' advice to "take executive action to reinstate and expand the reasonable pricing clause that was established in 1989 by the National Institutes of Health requiring drug makers to charge reasonable prices for prescription drugs and treatments that receive federal funding."

As the Times noted on Friday, Aduhelm's "new price is still much higher than many analysts have said is warranted." The Institute for Clinical and Economic Review, an independent non-profit organization, has estimated that the drug should have a price tag no higher than $3,000 to $8,400 per year.

"The total cost to Medicare would depend on the terms it sets and how many patients decide to use Aduhelm," the newspaper added. "About 1.5 million Americans may be eligible because they have mild Alzheimer's-related dementia."

Chambers told the Times that "while it of course depends on Aduhelm's utilization, it seems that even at $28,000 a year, Aduhelm would still be one of Medicare's biggest drug expenses."

In a recent joint statement, the American Academy of Neurology, American Neurological Association, and Child Neurology Society said that if Medicare decides to cover Aduhelm, which typically means paying 80% of its cost, "many beneficiaries would pay thousands of dollars of out-of-pocket costs for a drug with substantial risks and without proven clinical benefit."

The Times explained that "in evaluating Aduhelm, Medicare officials are supposed to decide if it is a 'reasonable and necessary' treatment."

According to Tunis, that phrase typically "means adequate evidence of improved health outcomes." 

"If you go strictly by what the language is, this doesn't meet Medicare's 'reasonable and necessary' criteria because the FDA themselves says there's no direct evidence of improved cognition," he told the newspaper.

According to the Times, "Tunis, who also works as a consultant, including advising Biogen, before Aduhelm was approved, about Medicare's various options for coverage... added that the FDA's requirement that Biogen conduct another trial (which will take years while Aduhelm is available to patients) 'implies that the cognitive benefits have not yet been shown.'"

Michael Greicius, medical director of the Stanford Center for Memory Disorders and a co-author of an open letter signed by 180 Alzheimer's doctors, told the Times that "I'm still quietly hoping that January is going to roll around and they're going to say: 'Look, we're not going to cover this. The evidence is too poor.'"

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