The Alzheimer’s drug Leqembi is seen on this undated news image obtained by Reuters on January 20, 2023.
Hey | via Reuters
medical care agreed to pay for Leqembi’s Alzheimer’s treatment, a significant turning point for patients diagnosed with the early stages of the disease.
Leqembi is currently the one drug in the marketplace that has been shown in a clinical trial to slow the progression of the early stages of Alzheimer’s disease. The monoclonal antibody, administered intravenously twice a month, slowed cognitive decline by 27% over the 18-month study.
Leqembi is produced by Japanese drug manufacturer Eisai and its partner Biogenbased in Cambridge, Massachusetts.
Medicare’s decision to incorporate Leqembi, which comes moments after the Food and Drug Administration fully approved the drug on Thursday, guarantees to make the treatment more accessible to patients.
Medicare coverage is critical for many patients to have any hope of having the ability to afford Leqembi. Eisai valued Leqembi at $26,500 a yr before insurance, which is incredibly expensive for Medicare patients with a mean income of around $30,000.
Medicare covers most bills, although many patients will still must pay several thousand dollars in running costs.
Traditional Medicare patients pays 20% of the Leqembi bill, in line with the federal Medicare and Medicaid Service Centers. Which means these patients could see an annual bill of greater than $5,000, in line with estimates by KFF, a non-profit group that studies health care issues.
In accordance with the KFF, those with Medicare Advantage plans typically pay 20% for drugs like Leqembi, as much as a maximum out-of-pocket amount, which averaged around $5,000 for online services.
In accordance with KFF, patients with additional insurance, akin to Medigap or Medicaid, will pay less.
People of modest means may not find a way to cover the fee of Leqembi out of pocket, even with Medicare coverage, said Tricia Neuman, a Medicare expert at KFF.
That is of particular concern because blacks and Hispanics usually tend to develop Alzheimer’s disease, but also they are more prone to be on lower incomes, Neuman said.
If the necessity for Leqembi is high, there’s also concern that patients may face long waiting times to see specialists and receive infusions.
What are the insurance conditions?
Medicare has imposed certain conditions that should be met to ensure that patients to be eligible for Leqembi coverage.
Leqembi coverage requirements
- You need to be registered with Medicare.
- You need to have been diagnosed with mild cognitive impairment or mild Alzheimer’s disease with evidence of amyloid plaque within the brain.
- You need to have a health care provider who participates in a registry that collects information concerning the tests done as a part of the diagnosis, records whether you take blood thinners and documents if you’ve had unwanted side effects with Leqembi.
To diagnose Alzheimer’s disease or mild cognitive impairment, patients must undergo a cognitive evaluation and undergo a PET scan or lumbar puncture to detect the amyloid protein related to the disease. PET scans are essentially the most common approach to detecting amyloid because they’re less invasive.
Medicare currently covers one lifetime PET scan for amyloid screening. The CMS is reconsidering the policy and plans to issue the proposed rule soon, an agency spokesman said.
The requirement for physicians to enter patient information into the registry system is controversial. The Alzheimer’s Association and some members of Congress are concerned that the information collection requirement creates unnecessary bureaucracy for patients in search of treatment.
The Federal Medicare and Medicaid Service Centers have created a nationwide portal to assist doctors enter the required details about their patients. CMS has released a video that shows doctors find out how to navigate the system:
Doctors have access to a free register on this website.
Dr. David Knopman, an Alzheimer’s neurologist on the Mayo Clinic in Minnesota, said the registry is minimalistic and unlikely to be a burden on patients and doctors.
What are the advantages and risks?
In accordance with the CMS, patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease must seek advice from their doctor about whether the advantages of taking Leqembi outweigh the risks.
Although Leqembi barely slowed cognitive decline in a clinical trial, the treatment also carries serious risks of brain swelling and bleeding. Within the study, 13% of patients receiving Leqembi developed swelling and 14% experienced bleeding.
Swelling and bleeding were often mild with no obvious symptoms, but these episodes might be fatal, in line with an independent review of clinical trial data by the Food and Drug Administration. When symptoms do occur, they include headache, confusion, dizziness, vision changes, and nausea.
In accordance with the FDA, individuals with two copies of a gene mutation called APOE4 usually tend to experience swelling and bleeding, and patients should be tested to see in the event that they have the mutation before taking Leqembi. Medicare covers APOE4 mutation testing, a CMS spokesperson said.
In accordance with the FDA, patients taking anticoagulants also appear to have a better risk of bleeding into the brain.
Three patients who received Leqembi within the study died, although the FDA was unable to find out if these deaths were related to treatment.
Knopman said properly diagnosed and informed patients should find a way to come to a decision for themselves whether or not they wish to take Leqembi after weighing the advantages of treatment against the chance of potential serious unwanted side effects.