Sen. Bernie Sanders (I-VT) arrives to the U.S. Capitol Constructing on June 01, 2023 in Washington, DC.
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Sen. Bernie Sanders on Wednesday called on the U.S. Health and Human Services Department to take motion to make sure seniors can actually afford the expensive Alzheimer’s treatment Leqembi.
Sanders, who chairs the Senate Health Committee, in a letter to HHS Secretary Xavier Becerra called the $26,500 annual price tag for Leqembi set by drugmakers Eisai and Biogen “unconscionable.”
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The Vermont independent said the drug’s current cost would put a considerable financial burden on Medicare and increase premiums for seniors. Medicare is the federal program that gives health coverage to primarily older Americans.
Sanders said the “outrageously high price” of Leqembi “will prevent seniors who need this drug from receiving treatment.”
The lawmaker wrote that HHS should use its authority to interrupt Leqembi’s patent monopoly if Eisai and Biogen refuse to lower the treatment’s price.
He also said the Centers for Medicare and Medicaid Services could also limit how much it pays for Leqembi to reflect the drug’s actual profit.
Most Medicare patients affected by Alzheimer’s wouldn’t find a way to afford the 20% co-payment of greater than $5,000 a 12 months for Leqembi, Sanders said. The co-pay for the drug represents a sixth of the $30,000 median income of Medicare beneficiaries, he said.
“That may clearly not only be unaffordable to many seniors it might be an absurd and unfair government policy,” wrote Sanders, a democratic socialist who caucuses with the Democratic majority within the Senate.
Co-payments, together with coinsurance and deductibles, are medication and health services costs that patients must personally pay for out of pocket, versus being covered by their medical insurance.
Sanders, in his letter, told Becerra, “Mr. Secretary: As you well know, a prescription drug is just not effective if a patient who needs that drug cannot afford to take it.”
The Institute for Clinical and Economic Review, a nonprofit organization, has estimated that Leqembi ought to be sold for $8,900 to $21,500 per 12 months, significantly lower than Eisai’s list price.
But Eisai has said its $26,500 annual list price for Leqembi is lower than the corporate’s estimate of the $37,600 total value of the drug for every patient. Eisai developed Leqembi and conducted clinical trial of the drug, which is being 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 that Medicare will cover Leqembi on the identical day the treatment receives the greenlight from FDA.
The FDA is predicted to make a call by July 6 on whether to approve Leqembi.
The FDA’s panel of independent advisors is scheduled to satisfy Friday to vote on whether data from a clinical trial support Leqembi’s clinical profit to patients.
The FDA is just not obligated to follow the recommendation of its advisors. But a positive vote from the expert panel would weigh in favor of the drug’s approval.
Medicare, which operates independently from the FDA, decides whether to cover the associated fee of a drug based by itself determination of whether a treatment is “reasonable and mandatory” for patients.
Sanders in his letter said that at its current cost, Leqembi “will undermine the funds of Medicare.”
“And it’s going to increase the premiums of over 60 million seniors who receive Medicare whether or not they must take this 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 per 12 months. And individual Medicare patients could face annual out-of-pocket costs for the drug of $6,600 depending on the state they live in, and whether or not they have supplemental insurance, the study found.
Leqembi received accelerated approval from the FDA in January. But Medicare severely limits coverage of Alzheimer’s antibody drugs which are cleared under that expedited pathway.
That Medicare policy was put in force after the controversial approval of one other Alzheimer’s antibody drug made by Biogen and Eisai called Aduhelm.
The FDA expedited the approval Aduhelm in June 2021 though the agency’s independent advisors said the drug didn’t show a clinical profit to patients.
Three of the FDA’s independent advisors resigned over the agency’s decision. A congressional investigation subsequently found the approval was “rife with irregularities.”
The businesses priced Aduhelm at $56,000 per 12 months.
Sanders, in his letter Wednesday, said the “FDA has a special responsibility to revive the general public trust after its inappropriate relationship with Biogen in the course of the agency’s review of a previous Alzheimer’s drug, Aduhelm.”