What patients and doctors should know

Alzheimer’s drug Leqembi can be seen in this undated handout picture obtained by Reuters on January 20, 2023.

Eisai | via Reuters

Medicare has agreed to fund Leqembi’s Alzheimer’s treatment, a major game-changer for patients diagnosed with the disease in its early stages.

Leqembi is currently the only drug on the market that has been shown in a clinical study to slow the progression of early stages of Alzheimer’s disease. The monoclonal antibody, given intravenously twice a month, slowed cognitive decline by 27% over an 18-month period in the study.

Leqembi is made by Japanese drugmaker Eisai and its partner biogenicbased in Cambridge, Massachusetts.

Medicare’s decision to acquire Leqembi, which came shortly after the drug was fully approved by the Food and Drug Administration on Thursday, promises to make the treatment more accessible to patients.

For most patients, Medicare coverage is critical to being able to afford Leqembi at all. Eisai has priced Leqembi before insurance coverage at $26,500 per year, which is prohibitively expensive for Medicare patients, who have an average income of about $30,000.

Medicare covers most of the bill, though many patients still face thousands of dollars in out-of-pocket expenses.

According to the Federal Centers for Medicare and Medicaid Services, patients with traditional Medicare coverage pay 20% of the bill for Leqembi. That means these patients could be billed more than $5,000 annually, according to an estimate by KFF, a nonprofit group that studies healthcare issues.

People with Medicare Advantage plans also typically pay 20% for drugs like Leqembi, up to their maximum deductible, which the KFF said averaged about $5,000 for on-net services.

According to the KFF, patients with supplementary insurance such as Medigap or Medicaid may pay less.

People of modest means might not be able to afford the cost of Leqembi even with Medicare insurance, said Tricia Neuman, Medicare expert at KFF.

This is of particular concern because black and Hispanic people are at higher risk for Alzheimer’s disease but are also more likely to have lower incomes, Neuman said.

When demand for Leqembi is high, there are also concerns that patients may have to wait long to see a specialist and receive IV fluids.

Which insurance conditions apply?

Medicare has set certain conditions that must be met for patients to be eligible for Leqembi insurance.

Leqembi coverage requirements

• You must be enrolled in Medicare.
• You must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease with signs of amyloid plaque in the brain.
• You’ll need a doctor to participate in a registry that collects information about the tests you’ve had as part of your diagnosis, to determine if you’re taking blood thinners, and to document if you’ve had any side effects with Leqembi.

To be diagnosed with Alzheimer’s or mild cognitive impairment, patients must undergo cognitive testing and undergo a PET scan or spinal biopsy 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 life to detect amyloid. CMS is reconsidering this policy and plans to issue a proposed rule soon, an agency spokesman said.

The requirement that doctors must enter information about the patient in a register system is controversial. The Alzheimer’s Association and some members of Congress fear that mandatory data collection will add unnecessary bureaucracy to treating patients.

The Federal Centers for Medicare and Medicaid Services have created a statewide portal to make it easier for physicians to enter the necessary information about their patients. CMS has released a video showing doctors how to navigate the system:

Physicians can access the free register on this website.

dr David Knopman, an Alzheimer’s neurologist at the Mayo Clinic in Minnesota, said the registry is minimalist and likely won’t be a burden on patients and doctors.

What are the benefits and risks?

Patients who have been diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether Leqembi’s benefits outweigh its risks, according to CMS.

Although 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 the patients receiving Leqembi experienced swelling and 14% bleeding.

The swelling and bleeding were usually mild with no obvious symptoms, but these episodes can be fatal, based on the Food and Drug Administration’s independent review of clinical trial data. When symptoms do occur, they include headache, confusion, dizziness, blurred vision, and nausea.

People with two copies of a gene mutation called APOE4 are at higher risk of swelling and bleeding, and patients should be tested before taking Leqembi to confirm if they have the mutation, the FDA said. Medicare covers testing for the APOE4 mutation, a CMS spokesman said.

And patients taking anticoagulants also appear to be at higher risk of cerebral hemorrhage, according to the FDA.

Three patients who received Leqembi in the study died, although the FDA could not determine whether these deaths were related to the treatment.

Knopman said appropriately diagnosed and informed patients should be able to make their own decision about taking Leqembi after weighing the benefits of the treatment against the risks of potential serious side effects.