As Medicare officials grapple with whether to cover Aduhelm — an Alzheimer’s medication approvedFederal regulators despite the absence of evidence that the exorbitantly priced potentially dangerous drug helps patients — many doctors are urging them not to.
Medicare will make a preliminary determination this month about whether Medicare’s federal insurance program for U.S. residents aged 65 and over will cover Aduhelm (a monoclonal antibody) also known by its scientific title, aducanumab. The New York Times reported Friday. After a period for public comment, the high-stakes coverage determination is expected to be finalized around mid-April.
“Please, please, please, do not cover this medicine,” Dr. James Castle, an Illinois neurologist who treats Alzheimer’s patients, wroteLast July, in the comments section of the Centers for Medicare & 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, or FDA, has come under fire. 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 advisors resignedIn 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.
December 16th, 2008: European Union Regulators 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.
Experts in health policy said that Medicare almost always covers FDA approved drugs, at the very least for the medical conditions listed on their labels. Aduhelm is a Medicare official who has been conducting a long review that could lead to no coverage, full coverage or limited coverage.
James Chambers is a researcher at the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center. called the deliberations by CMS “truly unprecedented.”
Sean Tunis, a former CMS official who is now a senior Fellow at the Tufts Health 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 financial well-being and financial security of Medicare and millions more seniors will be affected by the looming coverage decision.
CMS officials will be available for November. 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.
Senator Bernie Sanders (I-Vt.), asked President Joe Biden to intervene in order to stop the rate rise. 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.”
Unless action is taken soon Medicare premiums will skyrocket in order to cover a questionable Alzheimer’s drug, Aduhelm, that costs $56,000 a year. That is insane. This premium hike on 57million seniors must be stopped immediately. The time is running out.
— Bernie Sanders (@SenSanders) December 16, 2021
Despite the weak sales, and on the same date 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 charging $28,200 per year for infusions. These are administered monthly and require regular MRI scans to monitor 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.
Aduhelm was reduced by 50%, a sign of how arbitrarily drug prices are. Drug corporations simply try to make as much money as they can. Even at $28200 it is more than the ICER price between $3000-8400. Medicare must now reverse the Part B premium increases. https://t.co/ucnxJNaxGx
— David Mitchell (@DavidP4AD) December 21, 2021
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 spoke at 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 joint statement, the American Academy of Neurology (ACN), American Neurological Association (ANA), and Child Neurology Society (CNS) released a statement. 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 is the medical director at Stanford Center for Memory Disorders. He is also 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 not sufficient.’”