Alzheimer’s sufferers and their households welcomed the information on Jan. 6 that the U.S. Meals and Drug Administration (FDA) approved a new treatment for Alzheimer’s disease. Lecanemab, marketed as Leqembi, is made by Eisai and Biogen for individuals within the early levels of the illness. The FDA granted lecanemab accelerated approval based mostly on early part testing outcomes, and it’s now reviewing the businesses’ accomplished knowledge for consideration of conventional, full approval. It’s solely the second drug authorized to deal with Alzheimer’s, not simply tackle signs.
Docs can now prescribe the medicine, however many sufferers gained’t have the ability to afford it. Eisai stated the drug, which is given each two weeks by way of an IV infusion at a health care provider’s workplace or clinic, will value about $26,500 a 12 months. Whereas it’s not clear but how lengthy individuals might want to take the drug, Ivan Cheung, Eisai Inc.’s CEO, estimated that most individuals would possibly have to take it at the least three years.
Right here’s what to find out about why lecanemab will probably be out of attain for many sufferers.
Medicare gained’t cowl lecanemab
The Facilities for Medicare and Medicaid Companies (CMS) doesn’t cowl drugs granted accelerated—not full—approval in lecanemab’s class: therapies that concentrate on a protein referred to as amyloid within the brains of Alzheimer’s sufferers. That call goes again to the drug that preceded lecanemab, referred to as aducanumab (model title: Aduhelm), which the FDA approved in 2021. The FDA’s controversial approval was based mostly on the outcomes of two research: one which confirmed sufferers benefited from the drug in comparison with these receiving placebo, and one other that confirmed no distinction between the 2 teams. The FDA determined to approve the drug as a result of there have been no therapies for Alzheimer’s, and aducanumab would tackle the pressing and unmet want to provide sufferers one thing that they assumed, based mostly on the info, would decelerate its development.
Due to the conflicting knowledge, nonetheless, CMS determined to not reimburse for aducanumab except individuals have been enrolled in persevering with scientific trials to solidify the drug’s effectiveness. The coverage additionally utilized to all future therapies that used the identical technique of tackling amyloid within the mind—comparable to lecanemab, which targets a special type of the identical protein. This implies sufferers who aren’t collaborating in a scientific trial of the drug must foot the invoice. Personal insurance coverage corporations usually follows CMS’s lead.
Will Medicare change its coverage and begin reimbursing for lecanemab?
CMS stated it might take into account altering its coverage when the whole set of knowledge on lecanemab, together with the outcomes from the part 3 research, have been submitted to the FDA. Eisai provided that knowledge to the FDA on the identical day it acquired accelerated approval. The part 3 outcomes have been additionally published within the New England Journal of Drugs on Jan. 5. “Day by day we reduce the timeline to get conventional approval is at some point nearer to lifting the restrictions to entry for Medicare beneficiaries,” says Cheung.
In a statement after lecanemab’s approval, CMS administrator Chiquita Brooks-LaSure stated, “CMS is inspecting accessible info and will rethink its present protection based mostly on this overview.”
What Medicare’s coverage means for sufferers
For now, sufferers must wait till the FDA points a standard approval for lecanemab to be able to obtain reimbursement for the drug. That might be expensive in additional than simply monetary methods. As a result of lecanemab is indicated particularly for individuals within the earliest levels of delicate Alzheimer’s-related dementia, ready extra months may make many individuals ineligible to learn from the therapy as a result of they’ll have progressed to extra advances levels of the illness, past the attain of lecanemab’s demonstrated effectiveness.
Whereas the whole knowledge units on lecanemab’s security and effectiveness at the moment are accessible for medical doctors to think about, “what’s lacking is entry,” says Maria Carrillo, chief scientific officer of the Alzheimer’s Affiliation. “Not having entry based mostly on the accelerated approval is a detriment to our affected person neighborhood.” The Affiliation estimates that every day, greater than 2,000 individuals transfer from delicate dementia to extra superior Alzheimer’s, which lessens their possibilities of having the ability to profit from lecanemab. CMS’s coverage may probably deny hundreds of individuals the prospect to gradual their cognitive decline and push again the extra extreme results of their illness. “That’s not acceptable, and unprecedented,” says Carrillo. “We really feel it’s flawed.”
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