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Alzheimer’s disease drug Leqembi is seen in this undated posted photo obtained by Reuters on January 20, 2023.
Isai | via Reuters
Medicare He agreed to pay for Leqembi’s treatment of Alzheimer’s disease, a major turning point for patients diagnosed with the early stages of the disease.
Leqembi is the only drug on the market now that has been shown to slow the progression of early-stage Alzheimer’s disease in a clinical trial. The monoclonal antibody, given twice monthly through an IV, slowed cognitive decline by 27% over the course of 18 months in the trial.
Leqembi is made by the Japanese pharmaceutical company Eisai and its partner Biogenheadquartered in Cambridge, Massachusetts.
Medicare’s decision to cover Leqembi, which came moments after the US Food and Drug Administration approved the drug Thursday, promises to make treatment more accessible to patients.
Medicare coverage is critical for most patients to have any hope of being able to afford Leqembi. Eisai priced Leqembi at $26,500 a year before insurance coverage, which is too expensive for Medicare patients, whose average income is about $30,000.
Medicare foots the majority of the bill, though many patients will still face several thousand dollars out of their own pockets.
Patients on traditional Medicare will pay 20% of Leqembi’s bill, according to the federal Centers for Medicare and Medicaid Services. That means those patients could see an annual bill of more than $5,000, according to an estimate from KFF, a nonprofit group that researches healthcare issues.
People with Medicare Advantage plans typically pay 20% more for drugs like Leqembi, up to the out-of-pocket limit, which was about $5,000 on average for in-network services, according to the KFF.
Patients with supplemental insurance such as Medigap or Medicaid may pay less, according to the KFF.
People with modest means may not be able to afford an out-of-pocket Leqembi even with Medicare coverage, said Tricia Newman, a Medicare expert at KFF.
Newman said this is particularly worrisome because blacks and Hispanics are more likely to develop Alzheimer’s disease but are likely to have lower incomes.
If demand for Leqembi is high, there are also concerns that patients could face long waiting times to see specialists and receive injections.
What are the terms of coverage?
Medicare has certain conditions that must be met for patients to be eligible for Leqembi coverage.
Leqembi coverage requirements
- You must be enrolled in Medicare.
- You must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease with evidence of amyloid plaques in the brain.
- You should have a doctor participate in the record who collects information about the tests you have had as part of your diagnosis, notes if you are taking blood thinners and documents if you have side effects from Leqembi.
To be diagnosed with Alzheimer’s disease or mild cognitive impairment, patients should undergo a cognitive assessment and undergo a positron emission tomography scan or a spinal tap to detect the amyloid protein associated with the disease. PET scans are the most common way to detect amyloid because they are less invasive.
Medicare currently covers one PET scan per age for amyloid detection. A spokesperson for the agency said CMS is reconsidering this policy and plans to release a proposed rule soon.
The requirement for clinicians to enter patient information into the registration system is controversial. The Alzheimer’s Association and some members of Congress worry that data collection requirements will create unnecessary red tape for patients to receive treatment.
The federal Centers for Medicare and Medicaid Services has created a nationwide portal that is supposed to make it easier for doctors to enter required information about their patients. CMS has released a video showing clinicians how to navigate the system:
Doctors have access to free registration in this location.
The record is simple and unlikely to be a burden to patients and doctors, said Dr. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota.
What are the benefits and risks?
Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether Leqembi’s benefits outweigh the risks, according to CMS.
Although Leqembi slightly slowed cognitive decline in clinical trials, the treatment also carries serious risks of brain swelling and bleeding. In the trial, 13% of patients given Leqembi had swelling and 14% had bleeding.
Swelling and bleeding were usually mild, with no obvious symptoms, but these episodes can be fatal, according to an independent Food and Drug Administration review of clinical trial data. When symptoms do appear, they include headache, confusion, dizziness, vision changes, and nausea.
People who have two copies of a gene mutation called APOE4 are at increased risk of swelling and bleeding and patients should be tested to confirm if they have the mutation before taking Leqembi, according to the US Food and Drug Administration. A CMS spokesperson said Medicare covers testing for the APOE4 mutation.
And according to the Food and Drug Administration, patients who take anticoagulants appear to be more likely to have bleeding in the brain.
Three patients who received Leqembi died in the trial, although the Food and Drug Administration could not determine if these deaths were related to the treatment.
Patients who have been appropriately diagnosed and informed should be able to decide for themselves whether they want to take Leqembi after weighing the benefits of the treatment against the risks of potentially serious side effects, Knopman said.
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