Medicare will take over Alzheimer’s remedy Leqembi after FDA approval

Chiquita Brooks-LaSure testifies before the Senate Finance Committee during her nomination hearing for Administrator of the Centers for Medicare & Medicaid Services in Washington on Thursday, April 15, 2021.

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Medicare will cover new Alzheimer’s treatment Leqembi for all patients eligible under the drug’s label when the Food and Drug Administration fully approves the drug in July, a federal official told congressmen Wednesday.

Official Chiquita Brooks-LaSure testified before Congress Wednesday for the first time since being confirmed as the administrator of the Centers for Medicare and Medicaid Services.

Brooks-LaSure has been harshly criticized by Democratic and Republican members of the House Health Subcommittee over Medicare’s controversial coverage policy for new Alzheimer’s treatments.

The Food and Drug Administration approved Leqembi, a collaboration of biogenic And Eisai Antibody treatment accelerated in January.

Twice-monthly intravenous infusions of the drug, commonly known as lecanemab, have shown promise in slowing the progression of early-stage Alzheimer’s disease.

But Medicare, which primarily provides health insurance for seniors, will currently only cover most of Leqembi’s costs for patients participating in federally approved clinical trials.

Because Eisai’s clinical trial for the drug has already concluded, this policy means Medicare enrollees with Alzheimer’s won’t have access to the treatment, which costs $26,500 a year, unless they pay out of pocket

Brooks-LaSure told the committee Wednesday that guidelines will change if the FDA approves the drug in July, as expected.

“Eligible individuals are based on the FDA label,” Brooks-LaSure testified.

“If the FDA approves the drug, that will be the basis of which demographics people will get the drug in, regardless of which populations they think it’s appropriate for,” she said.

Rep. Nanette Barragan, D-CA, pressed Brooks-LaSure for clarity.

“So you’re basically saying that all patients for whom the drug lecanemab is indicated and all future therapies will be covered in the class after full approval?” Barragan asked.

Brooks-LaSure replied, “That’s right.”

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The FDA’s label for Leqembi under the agency’s accelerated approval says the treatment was intended for use in patients with mild dementia caused by Alzheimer’s and tests have confirmed that they have brain plaques associated with the disease, among other things.

It’s unclear if the FDA’s label would change in any way once Leqembi receives full approval in July.

CMS’ insurance policy for Alzheimer’s drugs has caused confusion and controversy.

The agency has said Medicare will cover patients who participate in federally approved “registries,” which collect data about the drug after the treatment has received full approval.

The requirement to participate in CMS-approved registries has raised concerns that access to Leqembi could remain restricted even after full FDA approval.

Brooks-LaSure said Wednesday that a registry “does not in any way prevent people from having access to the drug.”

“All we state is that people taking the drug will have their doctors enter that information into a private registry,” the CMS administrator said.

But the registries have yet to be set up for patients.

Brook-LaSure said the goal is to have the registries ready for registration by July 6, should the FDA fully approve Leqembi by that date.

“Private sector companies can start setting them up now,” Brooks-LaSure told the committee.

Rep. Anna Eshoo, D-CA, criticized Medicare for not giving patients and doctors clear information about what exactly the registries are and how they will work.

“If doctors don’t know, if patients don’t know, and Medicare doesn’t seem to really know what this registry entails, how are Medicare patients possibly going to get the drug starting in July?” Eshoo asked.

Rep. Morgan Griffith, R-VA, accused CMS of effectively undermining the FDA’s accelerated approval of Leqembi by imposing restrictions that make the drug largely inaccessible to seniors.

Unlike Medicare, the Veterans Health Administration has agreed to cover Leqembi for veterans who are over the age of 65 and meet other eligibility criteria.

“You have turned yourself into a scientific regulator by refusing to pay for the Alzheimer’s drugs that this subcommittee and committee have been working hard on on a bipartisan basis to ensure they are available to Alzheimer’s patients,” Griffith said to Brooks-LaSure.

Brooks-LaSure told the committee that Medicare is bound by law.

“Our legal requirement is to determine whether a drug is appropriate and necessary for the Medicare population,” the CMS administrator said.

Griffith asked, “So you’re saying we need to change your laws?

“Of course, Congress has the power to change our rules,” Brooks-LaSure said.

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