The Alzheimer’s drug Leqembi can be seen in this undated handout image obtained by Reuters on January 20, 2023.
Eisai | through Reuters
Medicare has agreed to pay for the treatment of Alzheimer Leqembi, 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 a clinical trial to slow the progression of early-stage Alzheimer’s disease. The monoclonal antibody, administered intravenously twice a month, slowed cognitive decline by 27% over 18 months in the trial.
Leqembi is made by Japanese drug manufacturer Eisai and its partner biogenbased in Cambridge, Mass.
Medicare’s decision to cover Leqembi, which came shortly after the Food and Drug Administration fully approved the drug Thursday, promises to make the treatment more accessible to patients.
Medicare coverage is crucial for most patients to have any hope of being able to afford Leqembi. Eisai has priced Leqembi at $26,500 per year excluding insurance coverage, which is extremely expensive for Medicare patients, who have an average income of about $30,000.
Medicare foots the bulk of the bill, though many patients still face several thousand dollars in out-of-pocket costs.
Patients with traditional Medicare pay 20% of the bill for Leqembi, according to the federal Centers for Medicare and Medicaid Services. That means these patients could face an annual bill of more than $5,000, according to an estimate by KFF, a nonprofit organization that researches health care issues.
People on Medicare Advantage plans also typically pay 20% for drugs like Leqembi, up to their own maximum amount, which averaged about $5,000 for in-network services, according to KFF.
Patients with additional insurance such as Medigap or Medicaid may pay less, according to KFF.
People of modest means may not be able to afford the out-of-pocket costs for Leqembi, even with Medicare coverage, said Tricia Neuman, a Medicare expert at KFF.
This is particularly concerning because black and Hispanic people are at higher risk for Alzheimer’s, but also more likely to be on lower incomes, Neuman said.
If demand for Leqembi is high, there are also concerns that patients will face long waits to see specialists and receive infusions.
What are the cover conditions?
Medicare has imposed certain conditions that patients must meet in order to qualify for Leqembi coverage.
Leqembi Coverage Requirements
- You must be enrolled in Medicare.
- You must have been diagnosed with mild cognitive impairment or mild Alzheimer’s disease with evidence of amyloid plaque in the brain.
- You must have a doctor participate in a registry that collects information about the tests you’ve had as part of your diagnosis, notes whether you’re taking any blood thinners, and documents whether you’ve had any side effects from Leqembi.
To be diagnosed with Alzheimer’s or mild cognitive impairment, patients must undergo a cognitive evaluation and undergo a PET scan or epidural to detect the amyloid protein associated with the disease. PET scans are the most common method of detecting amyloid because they are less invasive.
Medicare currently covers a single PET scan per lifetime to detect amyloid. CMS is reconsidering this policy and plans to issue a proposed rule soon, an agency spokesman said.
The requirement that doctors enter patient information into a registration system is controversial. The Alzheimer’s Association and some members of Congress are concerned that the required data collection creates unnecessary burdens for patients to receive treatment.
The federal Centers for Medicare and Medicaid Services has set up a nationwide portal to make it easy for doctors to enter required information about their patients. CMS has released a video showing doctors how to navigate the system:
Doctors have access to the free-to-use registry on this website.
Dr. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said the registry is minimalistic and unlikely to be cumbersome for patients and doctors.
What are the benefits and risks?
Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease should talk to their doctor about whether the benefits of Leqembi outweigh the risks, according to CMS.
While Leqembi slightly slowed cognitive decline in the clinical trial, the treatment also carries serious risks of brain swelling and bleeding. In the study, 13% of patients receiving Leqembi had swelling and 14% had bleeding.
The swelling and bleeding were usually mild, with no obvious symptoms, but these episodes can be fatal, according to the independent review of the clinical trial data by the Food and Drug Administration. When symptoms are present, they include headache, confusion, dizziness, vision changes, and nausea.
People with two copies of a gene mutation called APOE4 are at greater risk for swelling and bleeding, and patients should be tested to confirm whether they have the mutation before taking Leqembi, the FDA said. Medicare will cover testing for the APOE4 mutation, a CMS spokesperson said.
And patients taking anticoagulants also seem to have a higher risk of brain hemorrhage, according to the FDA.
Three patients who received Leqembi during the study died, although the FDA was unable to conclude whether these deaths were related to the treatment.
Knopman said properly diagnosed and informed patients should be able to decide for themselves whether to take Leqembi after weighing the benefits of the treatment against the risks of potentially serious side effects.