Sen. Bernie Sanders on Wednesday called on the U.S. Health and Human Services Department to take action to ensure seniors can actually afford the expensive Alzheimer’s treatment Leqembi.
The Vermont independent said the drug’s current cost would put a substantial financial burden on Medicare and increase premiums for seniors. Medicare is the federal program that provides 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 break 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 benefit.
Most Medicare patients suffering from Alzheimer’s would not be able to afford the 20% co-payment of more than $5,000 a year 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 would clearly not just be unaffordable to many seniors it would be an absurd and unfair government policy,” wrote Sanders, a democratic socialist who caucuses with the Democratic majority in the Senate.
Co-payments, along with coinsurance and deductibles, are medication and health services costs that patients must personally pay for out of pocket, as opposed to being covered by their health insurance.
Sanders, in his letter, told Becerra, “Mr. Secretary: As you well know, a prescription drug is 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 should be sold for $8,900 to $21,500 per year, significantly less than Eisai’s list price.
But Eisai has said its $26,500 annual list price for Leqembi is lower than the company’s estimate of the $37,600 total value of the drug for each 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 same day the treatment receives the greenlight from FDA.
The FDA is expected to make a decision by July 6 on whether to approve Leqembi.
The FDA’s panel of independent advisors is scheduled to meet Friday to vote on whether data from a clinical trial support Leqembi’s clinical benefit to patients.
The 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 from the FDA, decides whether to cover the cost of a drug based on its own determination of whether a treatment is “reasonable and necessary” for patients.
Sanders in his letter said that at its current cost, Leqembi “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,” Sanders wrote.
A study published in JAMA Internal Medicine, a leading medical journal, found that Leqembi could cost Medicare $5 billion per year. 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 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 that are cleared under that expedited pathway.
That Medicare policy was put into effect after the controversial approval of another Alzheimer’s antibody drug made by Biogen and Eisai called Aduhelm.
The FDA expedited the approval Aduhelm in June 2021 even though the agency’s independent advisors said the drug did not demonstrate a clinical benefit 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 companies priced Aduhelm at $56,000 per year.
Sanders, in his letter Wednesday, said the “FDA has a special responsibility to restore the public trust after its inappropriate relationship with Biogen during the agency’s review of a prior Alzheimer’s drug, Aduhelm.”