Chiquita Brooks-LaSure testifies earlier than the Senate Finance Committee throughout her nomination listening to to be administrator of the Centers for Medicare & Medicaid Services in Washington on Thursday, April 15, 2021.
Caroline Brehman | CQ-Roll Call, Inc. | Getty Images
Medicare will cover the brand new Alzheimer’s therapy Leqembi for all patients eligible below the medicine’s label if the Food and Drug Administration totally approves the drug in July, a federal official informed 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 Centers for Medicare and Medicaid Services.
Brooks-LaSure confronted pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare‘s controversial protection coverage for new Alzheimer’s therapies.
The Food and Drug Administration permitted Leqembi, which is a collaboration by Biogen and Eisai antibody therapy, 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.
But Medicare, which primarily offers well being protection to senior residents, presently will solely cover the vast majority of prices for Leqembi for patients taking part in federally permitted medical trials.
Because Eisai’s medical trial for the drug has already concluded, that coverage means Medicare-enrollees with Alzheimer’s can not entry the therapy, which prices $26,500 per 12 months until they pay out of pocket
Brooks-LaSure on Wednesday informed the committee that the coverage will change when the FDA approves the drug, as anticipated in July.
“The individuals who will be eligible will be based mostly on the FDA label,” Brooks-LaSure testified.
“When FDA approves the drug, whichever populations they are saying it’s applicable for, that will be the idea of which individuals will get the drug,” she mentioned.
Rep. Nanette Barragan, D-CA, pressed Brooks-LaSure for readability.
“So you are mainly saying that all patients indicated for the drug lecanemab and any future therapies within the class will have protection upon full approval?” Barragan requested.
Brooks-LaSure answered: “That’s proper.”
The FDA’s label for Leqembi below the company’s expedited approval says the therapy ought to be used for patients who’ve delicate dementia resulting from Alzheimer’s, and have confirmed by testing that they’ve mind plaque related to the illness, amongst different circumstances.
It is unclear if the FDA’s label would change in any approach if Leqembi receives full approval in July.
CMS’ protection coverage for Alzheimer’s medicine has created confusion and sparked controversy.
The company has mentioned that Medicare will cover patients who take part in federally permitted “registries” that accumulate knowledge on the drug after the therapy receives full approval.
The requirement to take part in registries permitted by CMS has sowed concern that entry to Leqembi may nonetheless be restricted even after full FDA approval.
Brooks-LaSure on Wednesday mentioned {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 info in a privately owned registry,” the CMS administrator mentioned.
But the registries nonetheless should be arrange for patients.
Brook-LaSure mentioned the aim is to have the registries prepared for enrollment by July 6 ought to the FDA totally approve Leqembi on that date.
“Private sector entities proper now can begin setting them up,” Brooks-LaSure informed the committee.
Rep. Anna Eshoo, D-CA, criticized Medicare for not offering clear info to patients and medical doctors about what precisely the registries are and the way they will work.
“If medical doctors do not know, if patients do not know, and Medicare would not actually appear to know what this registry entails, how are Medicare patients going to get the drug probably 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.
Unlike Medicare, the Veterans Health Administration has agreed to cover Leqembi for veterans who’re over age 65 and meet different eligibility standards.
“You’ve 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 exhausting to ensure was out there to patients of Alzheimer’s,” Griffith informed Brooks-LaSure.
Brooks-LaSure informed 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 mentioned.
Griffith requested: “So you say we have to change your legal guidelines?
“Of course, Congress has the authority to alter our guidelines,” Brooks-LaSure mentioned.
