Senator Bernie Sanders (I-VT) arrives at the US Capitol on June 1, 2023 in Washington, DC.

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Sen. Bernie Sanders on Wednesday called on the U.S. Department of Health to take action to ensure that seniors can actually afford expensive Alzheimer’s treatment. Leqembi.

In a letter to HHS Secretary Xavier Becerra, Sanders, who chairs the Senate Health Committee, called the $26,500 annual price tag for Leqembi set by the drugmaker Eisai and Biogen “unscrupulous.”

Independent Vermont said the current price of the drug would pose a significant financial burden Medicare and increase insurance premium for seniors. Medicare is a federal program that provides health coverage primarily to older Americans.

Sanders said the “extremely high price” of Leqembi “will prevent seniors who need this drug from treatment.”

The lawmaker wrote that HHS should use its authority to break Leqembi’s patent monopoly if Eisai and Biogen refuse to lower the price of the treatment.

He also said the Centers for Medicare and Medicaid Services could also limit how much it pays for Leqembi to reflect the drug’s true benefit.

Most Medicare patients suffering from Alzheimer’s disease would not be able to afford the 20% co-pay of more than $5,000 a year for Leqembi, Sanders said. The co-pay for the drug represents one-sixth of the $30,000 median income of Medicare beneficiaries, he said.

“This would clearly not only be unaffordable for many seniors, it would be an absurd and unfair government policy,” wrote Sanders, a Democratic Socialist who is behind the Democratic majority in the Senate.

Co-payments, along with co-insurance and deductibles, are the costs of drugs and health services that patients must pay personally out of pocket, as opposed to their health insurance.

In his letter to Becerra, Sanders said, “Mr. Secretary: As you well know, a prescription drug is not effective if the patient who needs it cannot afford it.”

The nonprofit Institute for Clinical and Economic Review estimates that Leqembi should sell for $8,900 to $21,500 a year, significantly less than Eisai’s list price.

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But Eisai said its $26,500 annual list price for Leqembi is lower than the company’s estimate of a total cost of $37,600 for each patient. Eisai developed Leqembi and conducted a clinical trial of the drug, which is manufactured by Biogen.

Medicare plans to cover Leqembi if the Food and Drug Administration approves the treatment.

CMS Administrator Chiquita Brooks-LaSur said last week that Medicare would cover Leqembi the same day the treatment receives the green light from the FDA.

The FDA is expected to decide by July 6 whether to approve Leqembi.

The FDA’s panel of independent advisors is scheduled to meet Friday to vote on whether data from the clinical trial support Leqembi’s clinical benefit for patients.

FDA is not obligated to follow the advice of its advisors. But a positive vote from the expert panel would weigh in favor of the drug’s approval.

Medicare, which operates independently of the FDA, decides whether to cover the cost of a drug based on its own determination of whether the treatment is “reasonable and necessary” for patients.

In his letter, Sanders said that at current costs, Leqembi would “undercut Medicare funding.”

“And it will raise premiums for the more than 60 million seniors who get Medicare, whether they need to take the drug or not,” Sanders wrote.

A study published in the leading medical journal JAMA Internal Medicine found that Leqembi could cost Medicare $5 billion a year. And individual Medicare patients could face $6,600 in annual out-of-pocket costs for the drug, depending on the state they live in and whether they have supplemental insurance, the study found.

Leqembi received accelerated approval from the FDA in January. However, Medicare severely limits coverage for Alzheimer’s antibody drugs that are cleared through this accelerated pathway.

This Medicare policy was enacted after the controversial approval of another Alzheimer’s antibody drug made by Biogen and Eisai called Aduhelm.

The FDA accelerated approval of Aduhelm in June 2021, even though the agency’s independent advisers said the drug had not demonstrated clinical benefit for patients.

Three independent FDA advisers resigned over the agency’s decision. A congressional investigation subsequently found that the approval was “riddled with irregularities”.

The companies valued Aduhelm at $56,000 a year.

Sanders said in his letter Wednesday that “the FDA has a special responsibility to restore public trust after its inappropriate relationship with Biogen during the review of the previous Alzheimer’s drug Aduhelm.”

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