- Medicare will cover the Alzheimer's treatment Leqembi for all patients the Food and Drug Administration determines are eligible for the medication if the drug receives full approval in July, the CMS administrator said.
- "When FDA approves the drug, whichever populations they say it is appropriate for, that will be the basis of which people will get the drug," CMS Administrator Chiquita Brooks-LaSure said.
- But the Alzheimer's Association says access to the drug will remain restricted due to a requirement that patients participate in registries that collect data.
- Medicare currently severely restricts access to the medication, which costs $26,500 per year, because the FDA has approved it only on an expedited basis in January.
Medicare will cover the new Alzheimer's treatment Leqembi for all patients eligible under the medication's label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday.
The official, Chiquita Brooks-LaSure testified before Congress Wednesday for the first time since her confirmation as administrator of the Centers for Medicare and Medicaid Services.
Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare's controversial coverage policy for new Alzheimer's treatments.
Twice-monthly intravenous infusions of the drug, generically known as lecanemab, have shown promise in slowing the progression of early Alzheimer's disease.
But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the majority of costs for Leqembi for patients participating in federally approved clinical trials.
Because Eisai's clinical trial for the drug has already concluded, that policy means Medicare-enrollees with Alzheimer's cannot access the treatment, which costs $26,500 per year unless they pay out of pocket
Brooks-LaSure on Wednesday told the committee that the policy will change when the FDA approves the drug, as expected in July.
"The people who will be eligible will be based on the FDA label," Brooks-LaSure testified.
"When FDA approves the drug, whichever populations they say it is appropriate for, that will be the basis of which people will get the drug," she said.
Rep. Nanette Barragan, D-CA, pressed Brooks-LaSure for clarity.
"So you're basically saying that all patients indicated for the drug lecanemab and any future therapies in the class will have coverage upon full approval?" Barragan asked.
Brooks-LaSure answered: "That's right."
The FDA's label for Leqembi under the agency's expedited approval says the treatment should be used for patients who have mild dementia due to Alzheimer's, and have confirmed through testing that they have brain plaque associated with the disease, among other conditions.
It is unclear if the FDA's label would change in any way if Leqembi receives full approval in July.
CMS' coverage policy for Alzheimer's drugs has created confusion and sparked controversy.
The agency has said that Medicare will cover patients who participate in federally approved "registries" that collect data on the drug after the treatment receives full approval.
The requirement to participate in registries approved by CMS has sowed concern that access to Leqembi could still be limited even after full FDA approval.
The Alzheimer's Association, which lobbies on behalf of people with the disease, has called on CMS to drop the registry requirement and have Medicare cover Leqembi like any other drug approved by the FDA.
Brooks-LaSure on Wednesday said that a registry "in no way limits people from getting access to the drug."
"All that we are indicating is that individuals who are taking the drug, their doctors will put that information in a privately owned registry," the CMS administrator said.
But the registries still need to be set up for patients.
Brook-LaSure said the goal is to have the registries ready for enrollment by July 6 should the FDA fully approve Leqembi on that date.
"Private sector entities right now can start setting them up," Brooks-LaSure told the committee.
Rob Egge, the Alzheimer's Association chief policy officer, said the registry system will limit patient access and make CMS' promise of broad coverage an "empty proclamation."
Egge said the association is not aware of any substantive work that has been done to set up registries for patients who would be eligible for Leqembi.
"There's no reason for confidence that any registry is going to be an easy and simple process, on that scale especially," Egge said.
The Alzheimer's Association is "deeply troubled" that the administrator called on private entities to do the job, Egge said.
"That's not their responsibility," Egge said. "This is their policy and these are the consequences."
Rep. Anna Eshoo, D-CA, criticized Medicare for not providing clear information to patients and doctors 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 really seem to know what this registry entails, how are Medicare patients going to get the drug potentially beginning in July?" Eshoo asked.
Rep. Morgan Griffith, R-VA, accused CMS of effectively 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 are over age 65 and meet other eligibility criteria.
"You've turned yourself into a scientific regulatory body by denying paying for the Alzheimer's medication that this subcommittee and this committee on a bipartisan basis worked hard to make sure was available to patients of Alzheimer's," Griffith told Brooks-LaSure.
Brooks-LaSure told the committee that Medicare is bound by law.
"Our requirement by law is to do a determination of whether a drug is reasonable and necessary for the Medicare population," the CMS administrator said.
Griffith asked: "So you say we need to change your laws?
"Of course, Congress has the authority to change our rules," Brooks-LaSure said.