Onelzheimer’s patients and their families welcomed the news on January 6 that the U.S. Food and Drug Administration (FDA) Approves a new treatment for Alzheimer’s disease. Lecanemab, marketed as Leqembi, is manufactured by Eisai and Biogen for people in the early stages of the disease. The FDA granted accelerated approval for lecanemab based on early-stage trial results, and the agency is now reviewing companies’ complete data for a full, traditional approval review. It is the second drug approved to treat Alzheimer’s disease, not just to address the symptoms.
Doctors can now prescribe the drug, but many patients won’t be able to afford it. Eisai says the drug, given every two weeks through an intravenous infusion in a doctor’s office or clinic, will cost about $26,500 a year. While it’s still unclear how long people will need to take the medication, Ivan Cheung, CEO of Eisai Inc., estimates that most people may need to take the medication for at least three years.
Here’s what to know about why lecanemab would be out of reach for most patients.
Medicare will not cover lecanemab
The Centers for Medicare and Medicaid Services (CMS) does not cover the quickly approved—but not full—drugs in lecanemab’s formulary: treatments that target a protein called amyloid in the brain of Alzheimer’s patients. That decision goes back to the drug that preceded lecanemab, called aducanumab (brand name: Aduhelm), which the FDA acceptance The FDA’s controversial approval is based on the results of two studies: one that found patients benefited from the drug compared to those who took a placebo, and another that showed no difference between the two groups. The FDA decided to approve the drug because there is no cure for Alzheimer’s disease, and aducanumab will address the urgent and unmet need to give patients what they think, based on the data. , will slow the progression of the disease.
However, due to conflicting data, CMS has decided not to reimburse aducanumab unless people are enrolled in ongoing clinical trials to reinforce the drug’s effectiveness. This policy also applies to all future therapies that use the same amyloid processing strategy in the brain—such as lecanemab, which targets a different form of the same protein. This means that patients who do not participate in clinical trials of the drug will have to pay the bill. Private insurers often follow CMS’s lead.
Will Medicare change its policy and start paying for lecanemab?
CMS said it will consider changing its policy when the complete data set on lecanemab, including results from phase 3 studies, is submitted to the FDA. Eisai provide that data to the FDA on the same day it received expedited approval. Stage 3 results also published inside New England Journal of Medicine “Every day we shorten the traditional approval period is one day closer to lifting access restrictions for Medicare beneficiaries,” said Cheung.
in one declare upon approval of lecanemab, CMS administrator Chiquita Brooks-LaSure said, “CMS is examining available information and may review current relevance based on this assessment.”
What Medicare Policy Means for Patients
For now, patients will have to wait until the FDA issues traditional approval for lecanemab to get a refund for the drug. That can be costly not only financially. Because lecanemab is specifically indicated for people in the earliest stages of mild Alzheimer’s-related dementia, waiting many more months could disqualify many people from benefiting from treatment because they will progress to more advanced stages of the disease, beyond the proven therapeutic potential of lecanemab. efficiency.
“While complete data sets on the safety and effectiveness of lecanemab are now available for review by physicians, “what is lacking is the possibility,” said Maria Carrillo, chief scientific officer of the Alzheimer’s Association. accessibility”. “Not having access based on quick approval is a detriment to our patient community.” The association estimates that each day, more than 2,000 people go from mild dementia to more severe Alzheimer’s disease, which reduces their chances of getting benefits from lecanemab. CMS policy has the potential to deny thousands of people the opportunity to slow cognitive decline and reverse the more severe effects of their disease. “That’s unacceptable and unprecedented,” Carrillo said. “We feel that is wrong.”
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