Chiquita Brooks-LaSure testifies earlier than the Senate Finance Committee throughout her nomination listening to to be administrator of the Facilities for Medicare & Medicaid Companies in Washington on Thursday, April 15, 2021.
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Medicare will cowl the brand new Alzheimer’s remedy Leqembi for all sufferers eligible beneath the medicine’s label if the Meals and Drug Administration totally approves the drug in July, a federal official advised members of Congress on Wednesday.
The official, Chiquita Brooks-LaSure testified earlier than Congress Wednesday for the primary time since her affirmation as administrator of the Facilities for Medicare and Medicaid Companies.
Brooks-LaSure confronted pointed criticism from Democrat and Republican members of the Home Subcommittee on Well being over Medicare‘s controversial protection coverage for brand new Alzheimer’s therapies.
The Meals and Drug Administration accepted Leqembi, which is a collaboration by Biogen and Eisai antibody remedy, on an expedited foundation in January.
Twice-monthly intravenous infusions of the drug, generically often known as lecanemab, have proven promise in slowing the development of early Alzheimer’s illness.
However Medicare, which primarily gives well being protection to senior residents, at present will solely cowl nearly all of prices for Leqembi for sufferers collaborating in federally accepted scientific trials.
As a result of Eisai’s scientific trial for the drug has already concluded, that coverage means Medicare-enrollees with Alzheimer’s can’t entry the remedy, which prices $26,500 per 12 months except they pay out of pocket
Brooks-LaSure on Wednesday advised the committee that the coverage will change when the FDA approves the drug, as anticipated in July.
“The individuals who can be eligible can be primarily based on the FDA label,” Brooks-LaSure testified.
“When FDA approves the drug, whichever populations they are saying it’s acceptable for, that would be the foundation of which individuals will get the drug,” she stated.
Rep. Nanette Barragan, D-CA, pressed Brooks-LaSure for readability.
“So that you’re mainly saying that each one sufferers indicated for the drug lecanemab and any future therapies within the class can have protection upon full approval?” Barragan requested.
Brooks-LaSure answered: “That is proper.”
The FDA’s label for Leqembi beneath the company’s expedited approval says the remedy must be used for sufferers who’ve delicate dementia because of Alzheimer’s, and have confirmed by way of testing that they’ve mind plaque related to the illness, amongst different situations.
It’s unclear if the FDA’s label would change in any approach if Leqembi receives full approval in July.
CMS’ protection coverage for Alzheimer’s medication has created confusion and sparked controversy.
The company has stated that Medicare will cowl sufferers who take part in federally accepted “registries” that gather information on the drug after the remedy receives full approval.
The requirement to take part in registries accepted by CMS has sowed concern that entry to Leqembi may nonetheless be restricted even after full FDA approval.
Brooks-LaSure on Wednesday stated {that a} registry “by no means limits folks from gaining access to the drug.”
“All that we’re indicating is that people who’re taking the drug, their medical doctors will put that data in a privately owned registry,” the CMS administrator stated.
However the registries nonetheless have to be arrange for sufferers.
Brook-LaSure stated the aim is to have the registries prepared for enrollment by July 6 ought to the FDA totally approve Leqembi on that date.
“Non-public sector entities proper now can begin setting them up,” Brooks-LaSure advised the committee.
Rep. Anna Eshoo, D-CA, criticized Medicare for not offering clear data to sufferers and medical doctors about what precisely the registries are and the way they are going to work.
“If medical doctors do not know, if sufferers do not know, and Medicare does not actually appear to know what this registry entails, how are Medicare sufferers going to get the drug doubtlessly starting in July?” Eshoo requested.
Rep. Morgan Griffith, R-VA, accused CMS of successfully undercutting the FDA’s expedited approval of Leqembi by imposing restrictions that make the drug largely unavailable to seniors.
In contrast to Medicare, the Veterans Well being Administration has agreed to cowl Leqembi for veterans who’re over age 65 and meet different eligibility standards.
“You have turned your self right into a scientific regulatory physique by denying paying for the Alzheimer’s medicine that this subcommittee and this committee on a bipartisan foundation labored laborious to ensure was obtainable to sufferers of Alzheimer’s,” Griffith advised Brooks-LaSure.
Brooks-LaSure advised the committee that Medicare is sure by regulation.
“Our requirement by regulation is to do a dedication of whether or not a drug is cheap and needed for the Medicare inhabitants,” the CMS administrator stated.
Griffith requested: “So that you say we have to change your legal guidelines?
“In fact, Congress has the authority to vary our guidelines,” Brooks-LaSure stated.
