(CNN) — The US Food and Drug Administration (FDA) on Thursday gave full approval to Alzheimer’s drug Lekambi, the first proven effective in slowing the memory-damaging disease.
The Centers for Medicare and Medicaid Services (CMS) said Thursday that they will expand coverage of the drug, expanding access to one million people with early forms of the disease.
“Today’s decision is the first evidence that a drug that targets the underlying process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Neurology Center’s Office of Neurology. . “This confirmatory study has confirmed that this is a safe and effective treatment for Alzheimer’s patients.”
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Pharmaceutical companies Eisai and Biogen received fast-track approval for Leqembi in January based on evidence that it reverses the buildup of amyloid plaques in the brain associated with Alzheimer’s disease. However, due to an earlier CMS coverage decision that covers many older people with Alzheimer’s through Medicare, the drug has not been widely adopted. Treatment costs $26,500 per year before insurance coverage.
“You had this treatment at your fingertips and all of a sudden Medicare said, ‘Yes, but you can’t get it yet,’” explains Joe Montmini, 59, who was diagnosed with early-onset Alzheimer’s in the early 50s. “Getting that kind of insurance coverage is incredibly important,” he adds. “Getting this insurance coverage is incredibly important…because the treatment is amazing, but I can’t afford to pay the $26,000 it costs.”
“The Beginning of a New Era”
The drug is approved only for people with early forms of Alzheimer’s disease, with mild cognitive impairment or mild dementia, who have confirmed amyloid plaques in the brain. Dr. Lawrence Honig, professor of neurology at Columbia University Medical Center in Irving, estimates that this group makes up about one-sixth of the more than 6 million Americans currently diagnosed with Alzheimer’s disease.
People with more advanced forms of the disease may not be helped by the drug, he said, and they may face greater safety risks.
“It’s not that we know it’s bad for people with moderate or severe disease, it’s that we don’t know it,” said Honig, who has advised drug companies working on drugs for Alzheimer’s.
Lekambi has been shown to slow cognitive decline and function by 27% in an 18-month clinical trial.
“The treatments we have now are just the beginning of a new era,” Honig said. “We hope the treatment will be more effective.”
The Alzheimer’s Association said in a statement Thursday that it welcomes the FDA’s full approval.
“This treatment, while not a cure, may give people in the early stages of Alzheimer’s disease more time to maintain their independence and do what they love,” said Dr. Joanne Pike, group president and CEO. “It gives people more months of recognition from their spouses, children and grandchildren. It also means that the individual has more time to drive safely, manage family finances accurately and quickly, and participate fully in hobbies and interests.”
However, the drug also has side effects and requires regular monitoring of brain imaging. About 13% of trial participants experienced brain swelling or bleeding, and these risks may be higher for certain groups depending on their genetics or blood-thinning medications. According to the FDA, a boxed warning is included in the prescribing information to alert patients and caregivers to the potential risks associated with these side effects.
Health systems are gearing up to expand the use of the drug.
“It’s complicated, and because of all these complications, we tried to be very careful and take our time getting the system ready,” said Dr. Georges Naasan, Medical Director of Mount Sinai’s Behavioral Neuroscience and Neuropsychology Department.
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The drug is administered as an intravenous infusion once every two weeks. Infusion centers are preparing for a possible influx of new patients.
“In some areas, I expect we will probably get 15-20% more patient referrals for this drug,” said Sue Rottura, COO of Vivo Infusion, which claims to provide infusion services to approximately 50,000 patients. in USA. that in Florida clinics, we may need to increase the capacity of these clinics, and this may mean more days, more hours (or) offering weekend hours.
Pharmaceutical company Eisai said it doesn’t expect everyone with early-stage Alzheimer’s to immediately seek to use the drug.
“The number will be much smaller, at least for now,” said Ivan Cheng, CEO of Eisai US. “Perhaps in a few years, when these therapeutic options become available and these tests are reimbursed, this number will increase, but I don’t think that a million people will come in the next two years.”
Monmini is waiting to see if he is eligible for the brain imaging drug, for which Eisai said he is also awaiting a CMS decision on coverage soon. If so, he won’t hesitate to jump at the opportunity to spend more time with his wife and two kids, who he says are in their 20s and just starting their careers.
“They often call me and ask for advice about work, and I like these calls, but I’m worried that one day I won’t be able to help them,” says Monminy. “Like any parent, I would like them to get married and start a family. Basically, I want to experience a lot of activities that most people take for granted.”
Extended Medicare coverage
Earlier this year, CMS said it would provide broader coverage for Leqembi if the drug receives traditional FDA approval.
“Today, CMS reaffirms our commitment to helping people with Alzheimer’s gain early access to innovative treatments that can lead to better care and better outcomes,” Administrator Chiquita Brooks-Lasur said in a statement Thursday. “With the FDA’s decision, CMS will publicize this drug extensively while continuing to collect data that will help us understand how the drug works. This is good news for the millions of people in this country and their families affected by this drug.” debilitating disease.”
Medicare beneficiaries may have to bear certain costs for Leqembi. Those enrolled in traditional Medicare will be responsible for co-insurance of 20% of the Medicare-approved amount after Part B excess is covered.
The amount that Medicare Advantage or add-on plan members will have to pay depends on their policy.
The coverage also has some conditions. Medicare will cover approved drugs when the doctor and clinical team are involved in gathering evidence of how those drugs work in the real world, also known as the registry, CMS said. This information will help evaluate the benefit of the drug to Medicare recipients.