This undated handout image, obtained by Reuters on January 20, 2023, shows the Alzheimer’s drug Rekumbi.
Eisai | via Reuters
Medicare agreed to pay for treatment for Alzheimer’s disease Rekembiis a major turning point for patients diagnosed with early stage disease.
Lekhembi is the only drug currently on the market that has demonstrated in clinical trials its ability to slow the progression of early-stage Alzheimer’s disease.Twice-monthly intravenous administration of monoclonal antibody slowed response rate cognitive decline The trial saw a 27% increase in 18 months.
Rekembi was made by a Japanese pharmaceutical company. Eisai and its partners Biogenbased in Cambridge, Massachusetts.
The Medicare decision to target Lekumbi, which came shortly after the Food and Drug Administration fully approved the drug on Thursday, promises further improvements in treatment. accessible to the patient.
Medicare coverage is essential for most patients to have hope of being able to afford Rekumbi. Eisai puts Rekembi at $26,500 a year before insurance coverage, which is absurdly high for a Medicare patient whose average income is about $30,000.
Medicare covers most of the bills, but many patients still face thousands of dollars out-of-pocket.
Traditional Medicare patients will pay 20% of Rekumbi’s bill, according to the Federal Centers for Medicare and Medicaid Services. That means these patients could be billed more than $5,000 a year, according to calculations by KFF, a nonprofit that researches medical issues.
Medicare Advantage plan members typically pay 20% of their out-of-pocket limit for drugs such as Rekumbi, but average about $5,000 for in-network services, according to the KFF.
Patients with supplemental insurance, such as Medigap and Medicaid, may pay less, according to the KFF.
KFF Medicare expert Tricia Newman said poor people may not be able to afford Lekembi out-of-pocket, even if they have Medicare.
This is particularly worrying because black and Hispanic people are at higher risk of Alzheimer’s but also more likely to have lower incomes, Neumann said.
There are also concerns that if demand for Rekembi is high, patients may stay for a long time. waiting time See a specialist and get a drip.
What are the terms of compensation?
Medicare imposes certain conditions that patients must meet to be eligible for Rekumbi coverage.
Rekumbi compensation requirements
- You must be enrolled in Medicare.
- Mild cognitive impairment or mild Alzheimer’s disease should be diagnosed when amyloid plaques are found in the brain.
- You must be evaluated by a physician who participates in a registry that collects information about tests you have had as part of your diagnosis, records whether you are taking blood thinners, and records whether you have had side effects from Rekumbi. not.
To be diagnosed with Alzheimer’s disease or mild cognitive impairment, patients must undergo a cognitive assessment and undergo a PET scan or spinal tap 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 now covers a once-in-a-lifetime PET scan to detect amyloid. CMS is reviewing this policy and plans to publish a proposed rule soon, a department spokesperson said.
The requirement for physicians to enter information about their patients into registration systems is controversial. The Alzheimer’s Association and some lawmakers are concerned that data collection mandates will create unnecessary bureaucracy in patient care.
The Federal Centers for Medicare and Medicaid Services has established a nationwide portal to make it easy for doctors to enter necessary information about their patients. CMS has released a video showing doctors how to operate the system.
Doctors have access to free-to-use registries on this website.
Dr. David Knopman, an Alzheimer’s neurologist at the Mayo Clinic in Minnesota, said the registry was minimal and unlikely to be a burden for patients and doctors.
What are the benefits and risks?
According to CMS, patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease should talk to their doctor about whether the benefits of Rekembi outweigh the risks.
Lekhembi slightly slowed cognitive decline in clinical trials, but the treatment also comes with serious risks of swelling and bleeding in the brain. In the trial, 13% of patients receiving Rekumbi had swelling and 14% had bleeding.
The swelling and bleeding are usually mild with no obvious symptoms, but these symptoms can be fatal, according to an independent review of clinical trial data from the Food and Drug Administration. Symptoms, when present, include headache, confusion, dizziness, vision changes, and nausea.
According to the FDA, people with two copies of a genetic mutation called APOE4 are at increased risk of swelling and bleeding, and patients should be tested to see if they have the mutation before taking Lekembi. A CMS spokesperson said Medicare also covers testing for APOE4 mutations.
Patients taking anticoagulants also appear to be at increased risk of stroke, according to the FDA.
Three patients who received Rekumbi died in the trial, but the FDA was unable to conclude whether these deaths were related to treatment.
Knopman said properly diagnosed and informed patients should be able to decide for themselves whether to take Rekembi after weighing the benefits of the treatment against the risks of potential serious side effects. .
