Alzheimer’s drug Leqembi is seen in this undated documentary image obtained by Reuters on January 20, 2023.
Eisai | via Reuters
Health Insurance agreed to pay for Alzheimer’s treatment Leqembia major turning point for patients detected at an early stage of the disease.
Leqembi is the only drug on the market today that has been shown to slow the progression of early-stage Alzheimer’s disease in a clinical trial. Monoclonal antibodies, administered twice monthly intravenously, slow down cognitive decline 27% increase in 18 months of testing.
Leqembi is produced by a Japanese drug manufacturer Eisai and its partner biologybased in Cambridge, Massachusetts.
Medicare’s decision to cover Leqembi, which came shortly after the Food and Drug Administration fully approved the drug on Thursday, promises more treatment accessible for patients.
Medicare coverage is vital for most patients to have any hope of being able to afford Leqembi. Eisai valued Leqembi at $26,500 per year before insurance was available, a hefty price tag for Medicare patients, whose median income is around $30,000.
Medicare is collecting the bulk of the bill, although many patients will still have to pay several thousand dollars in out-of-pocket costs.
Patients with traditional Medicare will pay 20% of the bill for Leqembi, according to the federal Centers for Medicare and Medicaid Services. That means these patients could end up with more than $5,000 in annual bills, according to estimates from KFF, a nonprofit group that researches healthcare issues.
According to the KFF, people with a Medicare Advantage plan also typically pay 20% for drugs like Leqembi, up to the maximum they pay out-of-pocket, averaging about $5,000 for in-network services.
According to KFF, patients with additional insurance such as Medigap or Medicaid may pay less.
Tricia Neuman, a Medicare specialist at KFF, says people with modest incomes may not be able to afford Leqembi’s out-of-pocket costs even with Medicare coverage.
This is particularly worrisome because Blacks and Hispanics have a higher risk of Alzheimer’s disease but are also more likely to have a lower income, Neuman said.
If demand for Leqembi is high, there are also concerns that patients may face long periods. meantime to see a specialist and receive an infusion.
What are the insurance conditions?
Medicare has imposed certain conditions that must be met in order for patients to be eligible for Leqembi coverage.
Leqembi insurance claim
- You must be enrolled in Medicare.
- You must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease with evidence of amyloid plaques on the brain.
- You must have a physician participating in the registry that collects information about the tests you have had as part of your diagnosis, notes whether you are taking blood thinners, and Make a note of whether you experience Leqembi side effects.
To be diagnosed with Alzheimer’s disease or mild cognitive impairment, patients must undergo cognitive evaluation and a PET scan or lumbar puncture to detect disease-associated amyloid proteins. PET scans are the most common method for amyloid detection because they are less invasive.
Medicare currently covers a lifetime PET scan to detect amyloid. An agency spokesman said CMS is reviewing the policy and plans to issue a proposed rule soon.
Requiring doctors to enter patient information into the registry is controversial. The Alzheimer’s Association and some members of Congress worry that the data collection requirement creates unnecessary bureaucracy for patients to receive treatment.
The federal Centers for Medicare and Medicaid Services has set up a nationwide portal to make it easier for doctors to enter essential information about their patients. CMS released a video showing doctors how to navigate the system:
Doctors can access the registry for free at this site.
Dr David Knopman, a neurologist specializing in Alzheimer’s disease at the Mayo Clinic in Minnesota, says registration is simple and effortless for patients and doctors.
What are the benefits and risks?
According to CMS, patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether the benefits of Leqembi outweigh the risks.
Although Leqembi modestly slowed cognitive decline in clinical trials, the treatment also carries a risk of serious brain swelling and bleeding. In the trial, 13% of patients taking Leqembi experienced swelling and 14% experienced bleeding.
Swelling and bleeding are often 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.
According to the FDA, people with two copies of a mutation in a gene called APOE4 have a higher risk of swelling and bleeding, and patients should be tested to confirm they have the mutation before taking Leqembi. A CMS spokesperson said Medicare covers APOE4 mutation testing.
And patients taking anticoagulants also seem to have a higher risk of bleeding in the brain, according to the FDA.
Three patients taking Leqembi in the trial died, although the FDA could not conclude whether these deaths were related to the treatment.
Knopman said patients who are properly diagnosed and informed should be able to decide for themselves whether they want to take Leqembi after weighing the benefits of treatment against the risk of potentially serious side effects.
