The Alzheimer’s drug Leqembi is seen on this undated handout image obtained by Reuters on January 20, 2023.
Eisai | via Reuters
Medicare has agreed to pay for the Alzheimer’s treatment Leqembi, a serious turning point for patients who’re diagnosed with the early stages of the disease.
Leqembi is the one drug available on the market right away that has demonstrated the power to slow the progression of early stages of Alzheimer’s disease in a clinical trial. The monoclonal antibody, administered twice monthly through intravenous means, slowed cognitive decline by 27% over 18 months within the trial.
Leqembi is made by Japanese drugmaker Eisai and its partner Biogen, which relies in Cambridge, Massachusetts.
Medicare’s decision to cover Leqembi, which got here moments after the Food and Drug Administration fully approved the drug Thursday, guarantees to make the treatment more accessible to patients.
Medicare coverage is crucial for many patients to have any hope of with the ability to afford Leqembi. Eisai has priced Leqembi at $26,500 per yr before insurance coverage, which is awfully expensive for Medicare patients, who’ve a median income of about $30,000.
Medicare is picking up the vast majority of the bill, though many patients will still face several thousand dollars in out-of-pocket costs.
Patients with traditional Medicare can pay 20% of the bill for Leqembi, in line with the federal Centers for Medicare and Medicaid Services. Meaning these patients could see an annual bill of greater than $5,000, in line with an estimate from KFF, a nonprofit group that researches health-care issues.
Individuals with Medicare Advantage plans also typically pay 20% for drugs corresponding to Leqembi, as much as their out-of-pocket maximum, which was about $5,000 on average for in-network services, in line with KFF.
Patients with supplemental insurance corresponding to Medigap or Medicaid might pay less, in line with KFF.
People of modest means won’t give you the chance to afford the out-of-pocket costs for Leqembi even with Medicare coverage, said Tricia Neuman, an authority on Medicare at KFF.
This is especially concerning because Black and Hispanic persons are at higher risk of Alzheimer’s disease but are also more more likely to have lower incomes, Neuman said.
If demand for Leqembi is high, there are also concerns that patients might face long wait times to see specialists and receive infusions.
What are the coverage conditions?
Medicare has imposed certain conditions that have to be fulfilled for patients to grow to be eligible to have Leqembi covered.
Leqembi coverage requirements
- You could be enrolled in Medicare.
- You could be diagnosed with mild cognitive impairment or mild Alzheimer’s disease with evidence of amyloid plaque on the brain.
- You could have a physician who’s participating in a registry that collects information on the tests you’ve got taken as a part of your diagnosis, notes whether you might be on blood thinners and documents whether you’ve gotten had unintended effects from Leqembi.
To get diagnosed with Alzheimer’s or a light cognitive impairment, patients must undergo a cognitive evaluation and have a PET scan or spinal tap to detect the amyloid protein related to the disease. PET scans are essentially the most common method to detect amyloid because they’re 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 spokesperson said.
The requirement that doctors enter information on the patient right into a registry system is controversial. The Alzheimer’s Association and a few members of Congress are anxious the data-collection requirement creates unnecessary red tape for patients to get treated.
The federal Centers for Medicare and Medicaid Services has arrange a nationwide portal that’s presupposed to make it easy for doctors to enter the required details about their patients. CMS has released a video that shows doctors tips on how to navigate the system:
Doctors can access the free-to-use registry at this website.
Dr. David Knopman, a neurologist who makes a speciality of Alzheimer’s disease on the Mayo Clinic in Minnesota, said the registry is minimalist and unlikely to be burdensome to patients and physicians.
What are the advantages and risks?
Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease must check with their doctor about whether the advantages of Leqembi outweigh the risks, in line with CMS.
Although Leqembi modestly slowed cognitive decline within the clinical trial, the treatment also carries serious risks of brain swelling and bleeding. Within the trial, 13% of patients who received Leqembi had swelling and 14% had bleeding.
The swelling and bleeding were typically mild, without obvious symptoms, but these episodes could be fatal, in line with the Food and Drug Administration’s independent review of the clinical trial data. When symptoms do present, they include headache, confusion, dizziness, vision changes and nausea.Â
Individuals with two copies of a gene mutation called APOE4Â are at higher risk of swelling and bleeding and patients needs to be tested to substantiate whether or not they have the mutation before taking Leqembi, in line with the FDA. Medicare covers testing for the APOE4 mutation, a CMS spokesperson said.
And patients on anticoagulants also appear to have the next risk of brain bleeding, in line with the FDA.
Three patients who received Leqembi within the trial died, although the FDA was unable to conclude whether these deaths were related to the treatment.
Knopman said appropriately diagnosed and informed patients should give you the chance to make a decision for themselves whether or not they need to take Leqembi after weighing the advantages of treatment against the risks of potential serious unintended effects.
