Alzheimer’s sufferers and their households welcomed the information on Jan. 6 that the U.S. Meals and Drug Administration (FDA) permitted a brand new remedy for Alzheimer’s illness. Lecanemab, marketed as Leqembi, is made by Eisai and Biogen for folks 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 permitted to deal with Alzheimer’s, not simply deal with signs.
Docs can now prescribe the treatment, however many sufferers gained’t have the ability to afford it. Eisai stated the drug, which is given each two weeks through an IV infusion at a physician’s workplace or clinic, will price about $26,500 a 12 months. Whereas it’s not clear but how lengthy folks might want to take the drug, Ivan Cheung, Eisai Inc.’s CEO, estimated that most individuals would possibly must take it at the very least three years.
Right here’s what to learn 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 medicines granted accelerated—not full—approval in lecanemab’s class: therapies that focus 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 identify: Aduhelm), which the FDA permitted 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 deal with 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, nevertheless, CMS determined to not reimburse for aducanumab until folks had been enrolled in persevering with medical 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—equivalent to lecanemab, which targets a distinct type of the identical protein. This implies sufferers who aren’t taking part in a medical trial of the drug should foot the invoice. Non-public insurance coverage firms usually follows CMS’s lead.
Will Medicare change its coverage and begin reimbursing for lecanemab?
CMS stated it might think about altering its coverage when the entire set of information on lecanemab, together with the outcomes from the part 3 research, had been submitted to the FDA. Eisai supplied that knowledge to the FDA on the identical day it obtained accelerated approval. The part 3 outcomes had been additionally printed within the New England Journal of Drugs on Jan. 5. “Every single day we lower the timeline to get conventional approval is sooner or later nearer to lifting the restrictions to entry for Medicare beneficiaries,” says Cheung.
In a press release after lecanemab’s approval, CMS administrator Chiquita Brooks-LaSure stated, “CMS is analyzing obtainable data and should rethink its present protection based mostly on this evaluate.”
What Medicare’s coverage means for sufferers
For now, sufferers should wait till the FDA points a conventional approval for lecanemab in an effort 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 folks within the earliest levels of gentle Alzheimer’s-related dementia, ready extra months might make many individuals ineligible to learn from the remedy 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 entire knowledge units on lecanemab’s security and effectiveness at the moment are obtainable for docs to contemplate, “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 folks transfer from gentle dementia to extra superior Alzheimer’s, which lessens their possibilities of having the ability to profit from lecanemab. CMS’s coverage might probably deny hundreds of individuals the possibility to sluggish 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 incorrect.”
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