Alzheimer’s disease drug Leqembi is seen in this undated handout image obtained by Reuters on January 20, 2023.
Eisai | via Reuters
medical insurance Leqembi has agreed to pay for the Alzheimer’s disease treatment, in a major turning point for patients diagnosed with the early stages of the disease.
Leqembi is currently the only drug on the market that has been shown in clinical trials to slow the early progression of Alzheimer’s disease. In trials, a monoclonal antibody administered intravenously twice a month slowed cognitive decline by 27% over 18 months.
Leqembi is produced by Japanese drugmaker Eisai and its partners Biogenheadquartered in Cambridge, Massachusetts.
Medicare’s decision to cover Leqembi comes shortly after the U.S. Food and Drug Administration fully approved the drug on Thursday, promising to make the treatment more accessible to patients.
Medicare coverage is critical for most patients as they look to be able to afford Leqembi. Eisai has priced Leqembi at $26,500 a year without insurance, which is expensive for Medicare patients with a median income of about $30,000.
Medicare covers most of the cost, though many patients will still face thousands of dollars in out-of-pocket costs.
Patients with traditional health insurance will pay 20 percent of their Leqembi bill, according to the Centers for Medicare and Medicaid Services. That means the bill for these patients could exceed $5,000 a year, according to estimates from the KFF, a nonprofit that studies health care issues.
People with Medicare Advantage plans also typically pay 20 percent more for drugs like Leqembi up to the out-of-pocket cap, which averages about $5,000 for in-network services, according to KFF.
Patients with supplemental insurance such as Medigap or Medicaid may pay less, KFF said.
Even with health insurance coverage, people with modest incomes may not be able to afford Leqembi’s out-of-pocket costs, said Tricia Neuman, a KFF health insurance expert.
That’s especially concerning, Newman said, because blacks and Hispanics are at higher risk for Alzheimer’s disease, but are also more likely to have lower incomes.
There are also concerns that patients may have to wait a long time to see a specialist and receive an infusion if demand for Leqembi is high.
Medicare specifies that patients must meet certain criteria 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 and have evidence of amyloid plaques on the brain.
- You must have a doctor on a registry that collects information about the tests you have as part of your diagnosis, keeps track of whether you are taking blood thinners, and keeps track of whether you have had side effects from Leqembi.
To be diagnosed with Alzheimer’s disease or mild cognitive impairment, a patient must undergo a cognitive assessment and undergo a PET scan or spinal tap to detect amyloid associated with the disease. PET scans are the most common method of detecting amyloid because they are less invasive.
Currently, Medicare covers once-in-a-lifetime PET scans to detect amyloid. A CMS spokesperson said CMS is reconsidering the policy and plans to issue a proposed rule soon.
The requirement for physicians to enter patient information into the registry is controversial. The Alzheimer’s Association and some members of Congress worry that the data-collection requirements would add unnecessary red tape to patient care.
The Centers for Medicare and Medicaid Services has created a nationwide portal designed to make it easy for doctors to enter required information about patients. CMS released a video showing doctors how to navigate the system:
Physicians have access to a free-to-use registry on this site.
Dr. David Knopman, a neurologist at the Mayo Clinic in Minnesota who specializes in Alzheimer’s disease, said the registry is so simple that it’s unlikely to burden patients and doctors.
Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to discuss with their doctor whether the benefits of Leqembi outweigh the risks, according to CMS.
Although Leqembi modestly slowed cognitive decline in clinical trials, the treatment also carries serious risks of brain swelling and bleeding. In the trial, 13 percent of patients treated with Leqembi experienced swelling and 14 percent experienced bleeding.
Swelling and bleeding are usually mild with no obvious symptoms, but these events can be fatal, according to an independent review of clinical trial data by the Food and Drug Administration. When symptoms do occur, they include headaches, confusion, dizziness, vision changes, and nausea.
People with two mutated copies of the APOE4 gene are at higher risk of swelling and bleeding, and patients should be tested to see if they have the mutation before taking Leqembi, the FDA said. A CMS spokesperson said Medicare covers APOE4 mutation testing.
Patients taking anticoagulant drugs also appear to have a higher risk of bleeding in the brain, according to the FDA.
Three patients treated with Leqembi in the trial died, although the FDA was unable to determine whether the deaths were treatment-related.
Properly diagnosed and informed patients should be able to decide for themselves whether to take Leqembi after weighing the benefits of treatment against the risks of potentially serious side effects, Knoppman said.