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leqembi
Sanders Raises Fresh Concerns Over 'Outrageous' Price of New Alzheimer's Drug
"Not only does the high price of Leqembi threaten Medicare's finances, it will also negatively impact seniors on fixed incomes suffering from Alzheimer’s who simply cannot afford to pay."
Jul 10, 2023
Sen. Bernie Sanders on Monday reiterated his concerns over the staggering price tag of a newly approved Alzheimer's medication after the Biden administration failed to respond to his letter last month urging swift executive action to force down the cost.
In a new letter to Health and Human Services Secretary Xavier Becerra, Sanders (I-Vt.) wrote that the current $26,500 list price for Leqembi is "outrageous" and demanded that the Biden administration explain "why the cost of this drug cannot be reduced to $8,900—which is the price independent experts believe it should cost based on its effectiveness."
Sanders, the chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, raised particular alarm over the drug's possible impact on Medicare's finances.
Shortly after the Food and Drug Administration (FDA) approved Leqembi last week, the Centers for Medicare and Medicaid Services announced that Medicare will cover the treatment "broadly"—a contrast from its decision last year to limit coverage of Aduhelm, a different high-priced Alzheimer's drug.
KFF estimates that if 5% of people with Alzheimer's disease use Leqembi—also known as lecanemab—Medicare's annual outlays for the IV infusion treatment would be $8.9 billion, a spending increase that could push premiums up for all Medicare recipients.
As Sanders wrote, "Not only does the high price of Leqembi threaten Medicare's finances, it will also negatively impact seniors on fixed incomes suffering from Alzheimer’s who simply cannot afford to pay the 20% co-payment of more than $5,000 a year for this drug."
"With a median income of about $30,000 a year for seniors on Medicare the purchase of this one drug would amount to over one-
sixth of their limited income. For one drug! That is unacceptable," the senator continued. "A prescription drug is not effective if a patient who needs that drug cannot afford it."
"If I do not receive an adequate and timely response, I will be inviting you to attend a HELP Committee hearing so that you can explain to the American people why we pay, by far, the highest prices in the world for prescription drugs."
Sanders first wrote to the Biden administration about Leqembi's cost on June 7, when he warned that the price tag proposed by manufacturers Biogen and Eisai was "unconscionable" and "grossly unfair to seniors suffering from Alzheimer's disease."
But Becerra never responded to Sanders' June letter, the senator wrote Monday.
Sanders requested in his new letter that Becerra provide answers to the fresh series of questions by July 21.
Among the questions Sanders wants answered is whether Becerra is "prepared to use [his] existing authority, under 28 U.S.C. Section 1498, to break the patent monopoly on exorbitantly priced prescription drugs."
"If I do not receive an adequate and timely response," Sanders wrote, "I will be inviting you to attend a HELP Committee hearing so that you can explain to the American people why we pay, by far, the highest prices in the world for prescription drugs and how those outrageous prices threaten Medicare beneficiaries and patients throughout the country."
On top of concerns about its potential harms to Medicare's financial health, experts and consumer advocates have said they're worried about the Leqembi's effectiveness and safety for Alzheimer’s patients, citing the drug's impacts on some trial subjects.
Dr. Robert Steinbrook, director of Public Citizen's Health Research Group, said in a statement last week that "the FDA's decision to grant full approval for lecanemab to treat adult patients with Alzheimer’s disease is misguided and very disappointing."
"The evidence for the drug's clinical benefits does not outweigh its substantial health risks," Steinbrook argued. "The fact that a black box warning for brain swelling and bleeding risks has been added to the prescribing information for lecanemab underscores the substantial safety concerns."
"Patients with Alzheimer's disease and their families are understandably desperate for better treatments," he added. "When it approves drugs for Alzheimer's disease with little or no benefit and significant health risks, the FDA fails patients and the public."
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Sanders to Biden: Don't Let Big Pharma Bankrupt Medicare With 'Unconscionable' Price of Alzheimer's Drug
"We must substantially lower the price that Medicare pays for prescription drugs like Leqembi," said the Vermont Independent, "and HHS has the power to do just that."
Jun 07, 2023
U.S. Sen. Bernie Sanders on Wednesday urged the Biden administration to use the "full extent" of its executive authority to lower the "outrageously high" price of a new Alzheimer's treatment being reviewed by federal regulators.
"Alzheimer's is a horrible disease," Sanders (I-Vt.), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, wrote in a
letter to Xavier Becerra, secretary of the U.S. Department of Health and Human Services (HHS). "We must do everything possible to find a cure for the millions of people who suffer from it. But we cannot allow pharmaceutical companies to bankrupt Medicare and our federal government in the process."
At issue is Leqembi, a drug developed by Eisai, a Japanese pharmaceutical corporation, and Biogen, a U.S. company that previously sought to charge $56,000 for an annual supply of a different Alzheimer's treatment called Aduhelm. Following a pressure campaign led by Sanders and other drug affordability advocates, Biogen reduced the price of Aduhelm—whose efficacy and safety have been questioned by doctors—to $28,200 per year.
"A prescription drug is not effective if a patient who needs that drug cannot afford to take it."
"Despite concerns among the scientific community about the clinical benefit of Leqembi, its manufacturers... plan to charge $26,500 per year for this drug even though the Institute for Clinical and Economic Review, an independent non-profit organization, has estimated that this drug should be sold for as little as $8,900 per year based on its effectiveness," Sanders wrote.
"If just 10% of the 6.7 million older adults with Alzheimer's disease take Leqembi, the Kaiser Family Foundation has estimated that it would cost $17.8 billion—or nearly half of what Medicare Part B spent on all drugs in 2021," noted the Vermont Independent. "And this is just for one drug. As you know, many of the new drugs coming onto the market are even more expensive. This is not sustainable."
Moreover, "the introduction of Leqembi at this unconscionable price would be grossly unfair to seniors suffering from Alzheimer's disease who simply could not afford to pay the 20% co-payment of more than $5,000 a year for this drug," the progressive lawmaker continued. "With a median income of about $30,000 a year for seniors on Medicare the purchase of this one drug would amount to over one-sixth of their limited income."
"People with Alzheimer's disease deserve a drug that is safe, effective, and affordable," he added. "A prescription drug is not effective if a patient who needs that drug cannot afford to take it."
\u201cAlzheimer\u2019s is a horrible disease and we must find a cure. But we cannot allow pharmaceutical companies to bankrupt Medicare in the process. We must substantially lower the price that Medicare pays for prescription drugs like Leqembi, and HHS has the power to do just that.\u201d— Bernie Sanders (@Bernie Sanders) 1686152167
Sanders pointed out that the U.S. Food and Drug Administration (FDA) plans to convene an advisory meeting on Leqembi this week.
"As it considers whether to grant full approval of this drug, FDA has a special responsibility to restore the public trust after its inappropriate relationship with Biogen during the agency's review" of Aduhelm, wrote Sanders, alluding to evidence that the pharmaceutical firm and those tasked with regulating it collaborated before the medicine received a green light.
If the FDA approves Leqembi, HHS "must protect patients and substantially reduce the price," Sanders stressed.
The senator went on the remind Becerra—who routinely expressed support for invoking executive authority to rein in soaring drug prices before he joined the White House—of the powers at his disposal:
Under current law, Medicare has the responsibility to determine whether Leqembi is "reasonable and necessary" for the treatment of Alzheimer's. In my view, charging an outrageously high price for this drug is not reasonable. It will prevent seniors who need this drug from receiving treatment. It will undermine the finances of Medicare. And it will increase the premiums of over 60 million seniors who receive Medicare whether they need to take this drug or not.
If Biogen and Eisai refuse to lower the price of this drug, HHS has the authority (under 28 U.S.C. Section 1498) to break the patent monopoly on Leqembi. Further, HHS can direct the Center for Medicare and Medicaid Innovation to launch a new demonstration project that would limit payment for Leqembi to reflect the drug's actual benefit.
Sanders told Becerra that he and other HELP committee members "look forward to discussing this important issue with you as soon as possible." The panel "would like to know how Biogen and Eisai came up with a cost of $26,500 and what the cost of this drug will mean to the finances of Medicare," Sanders wrote. It "would also like your estimate as to how much Medicare premiums will go up for all seniors if Biogen and Eisai are allowed to charge $26,500 for Leqembi, as well as how many seniors who need this drug would not be able to afford to pay a 20% co-payment for it."
Sanders' letter comes one day after the pharmaceutical giant Merck sued the Biden administration over an Inflation Reduction Act provision that empowers Medicare to directly negotiate the prices of a small number of ultra-expensive prescription medicines with drugmakers.
It also comes less than a month after Sanders condemned Big Pharma CEOs for years of deadly price gouging and reiterated the need to make all prescription drugs affordable at a HELP committee hearing.
"I know that our guests from the drug companies will tell us how much it costs to develop a new drug and how often the research for new cures is not successful," Sanders said in May. "I get that. But what they are going to have to explain to us is why, over the past decade, 14 major pharmaceutical companies... spent $747 billion on stock buybacks and dividends."
"They will also have to explain how as an entire industry pharma spent $8.5 billion on lobbying and over $745 million on campaign contributions over the past 25 years to get Congress to do its bidding," Sanders continued. "Unbelievably, last year, drug companies hired over 1,700 lobbyists including the former congressional leaders of both major political parties—that's over three pharmaceutical industry lobbyists for every member of Congress."
As Sanders put it, "That could well explain why we pay the highest prices for prescription drugs in the world and why today drug companies can set the price of new drugs at any level they wish."
"While Americans pay outrageously high prices for prescription drugs, the pharmaceutical industry and the [pharmacy benefit managers] make enormous profits," the lawmaker lamented. "In 2021, 10 major pharmaceutical companies in America made over $100 billion in profits—a 137% increase from the previous year. The 50 top executives in these companies received over $1.9 billion in total compensation in 2021 and are in line to receive billions more in golden parachutes once they leave their companies."
"In other words, Americans die, get sicker than they should, and go bankrupt because they cannot afford the outrageous cost of prescription drugs, while the drug companies and the PBMs make huge profits," he added. "That has got to change and this committee is going to do everything possible to bring about that change."
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