Senator Bernie Sanders (I-VT) arrives at the U.S. Capitol on June 1, 2023 in Washington, DC.
Anna Moneymaker | Getty Images
Senator Bernie Sanders urged the US Department of Health and Human Services on Wednesday to take action to be certain that seniors can actually afford Leqembi’s expensive Alzheimer’s treatment.
Sanders, who chairs the Senate Committee on Biogen “unconscionable.”
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The Vermont Independent said the current cost of the drug would put a big financial burden on Medicare and increase premiums for seniors. Medicare is a federal program that gives medical insurance primarily to older Americans.
Sanders said Leqembi’s “outrageously high price” would “prevent seniors who need the drug from receiving treatment.”
The legislator wrote that HHS should use its powers to interrupt Leqembi’s patent monopoly if Eisai and Biogen refused to lower the price of the treatment.
He also said the Centers for Medicare and Medicaid Services may limit how much Leqembi pays to reflect the actual advantages of the drug.
Sanders said most Medicare Alzheimer patients would not give you the option to pay the 20% co-pay over $5,000 a yr for Leqembi. He said drug co-payments accounted for one-sixth of the $30,000 median income of Medicare beneficiaries.
“This will surely not only be unaffordable for many seniors, but it surely could be absurd and unjust government policy,” wrote Sanders, a Democratic Socialist who works with the Democratic majority in the Senate.
Co-pay, together with co-insurance and deductibles, are the costs of drugs and health services that patients must pay themselves out of pocket, unlike medical insurance.
Sanders in his letter told Becerry: “Mr. Secretary: as you well know, a prescription drug isn’t effective if the patient who needs it cannot afford it.”
The Institute for Clinical and Economic Review, a non-profit organization, estimated that Leqembi should sell for $8,900 to $21,500 a yr, well below Eisai’s list price.
But Eisai said its $26,500 annual list price for Leqembi is lower than the company’s estimate of $37,600 for each patient’s total drug value. Eisai developed Leqembi and conducted clinical trials 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 last week said Medicare would cover Leqembi the same day the treatment received the green light from the FDA.
The FDA is predicted to make a choice by July 6 on whether to approve Leqembi.
A panel of independent FDA advisors is scheduled to satisfy on Friday to vote on whether clinical trial data support Leqembi’s clinical advantages to patients.
The FDA is under no obligation to follow the advice of its advisors. But the positive vote of the panel of experts would weigh in favor of the drug.
Medicare, which operates independently of the FDA, decides to cover drug costs based by itself determination of whether treatment is “reasonable and mandatory” for patients.
In his letter, Sanders said that at current costs, Leqembi is “undermining Medicare funds.”
“And it’s going to increase the premiums of the greater than 60 million seniors who receive Medicare, whether or not they must take the drug or not,” Sanders wrote.
A study published in JAMA Internal Medicine, a number one medical journal, found that Leqembi could cost Medicare $5 billion a yr. The study found that individual Medicare patients can incur $6,600 in annual out-of-pocket costs for the drug, depending on which state they live in and whether or not they have supplemental insurance.
Leqembi received accelerated approval from the FDA in January. But Medicare is severely limiting the coverage of Alzheimer’s antibody drugs which are cleared under this accelerated pathway.
This Medicare policy was enforce after the controversial approval of one other Alzheimer’s antibody drug made by Biogen and Eisai called Aduhelm.
The FDA advanced the approval of Aduhelm in June 2021, though the agency’s independent advisors said the drug showed no clinical profit to patients.
Three independent FDA advisors have resigned from the agency’s decision. A Congressional investigation subsequently found that the approval was “riddled with irregularities.”
The businesses valued Aduhelm at $56,000 per yr.
In his Wednesday letter, Sanders said that “the FDA has a special responsibility to revive public trust after an inappropriate relationship with Biogen during the agency’s review of its earlier Alzheimer’s drug, Aduhelm.”