Sanders condemns Alzheimer’s therapy value and requires HHS motion

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

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Senator Bernie Sanders on Wednesday called on the US Department of Health and Human Services to take action to ensure seniors can actually afford expensive Leqembi Alzheimer’s treatment.

Sanders, chair of the Senate Health Committee, in a letter to HHS Secretary Xavier Becerra, cited the $26,500 annual price for Leqembi set by drugmakers Eisai and biogenic “incomprehensible.”

The Vermont independent said the drug’s current cost would place a significant financial burden on Medicare and increase premiums for seniors. Medicare is the federal program that provides health insurance primarily to older Americans.

Sanders said Leqembi’s “outrageously high price” “will discourage treatment from seniors who need this drug.”

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

He also said the Centers for Medicare and Medicaid Services could also cap the amount of compensation for Leqembi to reflect the drug’s actual benefits.

Most Medicare patients with Alzheimer’s could not afford the 20 percent co-payment of more than $5,000 a year for Leqembi, Sanders said. The co-payment for the drug accounts for one-sixth of the average Medicare beneficiary’s income of $30,000, he said.

“Not only would that obviously be unaffordable for many senior citizens, it would be absurd and unfair government policy,” wrote Sanders, a Democratic Socialist who sits with the Democratic Senate majority.

Co-payments, along with co-insurance and deductibles, are costs of medication and healthcare services that the patient must personally pay out of their own pocket and are not covered by their health insurance.

Sanders said in his letter to Becerra, “Mr. Secretary: As you 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, estimates that Leqembi should sell for $8,900 to $21,500 a year, well below Eisai’s list price.

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However, Eisai indicated that Leqembi’s annual list price of $26,500 is lower than the company’s estimate of the drug’s total value for each patient of $37,600. 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 said last week that Medicare will cover Leqembi the same day the treatment gets the FDA green light.

The FDA is expected to make a decision on the approval of Leqembi by July 6.

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

The FDA is under no obligation to follow the advice of its advisors. However, a positive vote by the panel of experts would speak in favor of the drug being approved.

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

Sanders said in his letter that at current costs, Leqembi “will undermine Medicare’s finances.”

“And it will increase the premiums of over 60 million seniors who receive Medicare, whether or not they need to take that drug,” Sanders wrote.

A study published in JAMA Internal Medicine, a leading medical journal, found that Leqembi could cost Medicare $5 billion a year. And individual Medicare patients could face $6,600 in annual costs for the drug, depending on what 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 approved under this accelerated approval process.

That Medicare policy came into effect following the controversial approval of another Alzheimer’s antibody drug called Aduhelm, made by Biogen and Eisai.

The FDA accelerated approval of Aduhelm in June 2021, although the agency’s independent advisors said the drug has not shown clinical benefit for patients.

Three of the FDA’s independent advisors resigned as a result of the agency’s decision. A Congressional investigation subsequently found the permit was “riddled with irregularities.”

The companies priced Aduhelm at $56,000 per year.

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

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