The first drug to prove that it slows the progression of Alzheimer’s disease is now available, but treatment for the majority of patients is a long way off.
Two major reasons for the slow start according to experts are a lack of insurance coverage as well as the long time required for setup by a variety of health systems.
The patients who can overcome those obstacles can be at the top of the line to receive the drug that will provide the potential for a baffling benefit. Here’s an in-depth look.
THE SITUATION
The U.S. Food and Drug Administration approved Leqembi from Japanese drug maker Eisai in the beginning of January. It’s intended for people with mild or early forms of dementia that are linked to Alzheimer’s disease.
Regulators opted for the FDA’s accelerated route that allows medicines to be approved prior to being proven to be beneficial to patients. The study found that Leqembi moderately decreased the risk of death However, doctors aren’t quite sure whether that will translate into factors like increased independence for patients.
Patients are given the drug through an infusion at least every 2 weeks. Eisai reports that the company has delivered Leqembi through U.S. specialist drug distribution centers. From there, it will be shipped by overnight delivery to medical facilities or hospitals.
Eisai spokesperson Libby Holman said prescriptions for the drug are being prepared, and they expect patients to begin receiving the drug “very shortly.”
COST AND COVERAGE
The cost of a year’s treatment is around $26,500. Patients who are able to pay for it without insurance can begin the treatment when they’re deemed to be a suitable candidate for Leqembi treatment and have the right doctor and health system ready to aid them.
There are no options currently apart from self-pay. The majority of patients who could be potential candidates for this medication are currently on Medicare and Medicare’s coverage is limited to date. The program has stated that they will provide treatments such as Leqembi only for those who are enrolled in specific research trials to examine the drug.
There aren’t any studies that currently accept new patients.
“There’s an idea of a entrance (to coverage) that’s shut completely,” said Robert Egge the chief of public policy for the non-profit Alzheimer’s Association.
Medicare took the decision to cover Medicare last year , after another Alzheimer’s drug, Biogen’s aduhelm was released on the market.
Health insurers, who offer Medicare Advantage coverage, have stuck to this decision according to a spokesperson for the American Association of Health Insurance Plans.
The Centers for Medicare and Medicaid Services which manages Medicare, announced following Leqembi’s endorsement that it might reconsider its policy on coverage and this is something that is something that the Alzheimer’s Association has urged it to consider doing.
The coverage also could change when the drug gets all-inclusive approval from FDA. This could happen later in the year.
At present, Eisai has an assistance program that offers Leqembi no cost to certain patients, such as those who are on Medicare. It’s partly based on financial needs.
DIAGNOSING
It could take from several months to over an entire an entire year before doctors identify the patient, and determine if the patient is a candidate for the Leqembi according to Dr. Sarah Kremen, a neurologist at the Cedars-Sinai health system in Los Angeles.
This is contingent on where the patient lives as well as the physician’s experience.
A doctor first needs to determine if a patient suffers from mild dementia.
The doctor will then determine the cause of the problem. It could be caused by Parkinson’s disease or Alzheimer’s disease. stroke, or brain injury.
If it’s linked to Alzheimer’s disease, physicians must determine if the patient’s brain contains the amyloid-like protein. The drug is designed to slow the progress of Alzheimer’s by eliminating the protein.
In all likelihood, doctors might be reluctant to prescribe Leqembi since they don’t have a clear concept of what the drug’s effects will be on the patient or impact the way they live their lives Kremen added. It is important to take into account the there is a risk of brain swelling and bleeding that may occur in people who are who are taking the drug.
“I believe that this issue of harm versus benefit will be a major factor,” she said.
DELIVERING TREATMENT
Health systems have to first come up with plans to distribute drugs such as Leqembi before they can begin offering the drug. It could take months however some have begun before the regulators had allowed the drug.
This could include the training of nurses on how to administer the medication, and making sure that doctors prescribing the medication are aware of the best potential candidates for the drug. Health care providers also require a strategy for how patients are closely monitored after they begin taking the drug.
Patients will require a series of brain scans to monitor for any adverse reactions.
Doctors might want to be aware that a plan like this has been put in place prior to when they are at ease writing prescriptions Kremen stated.
Hospitals also must determine how many patients could be brought to them for this medication and also be able to pay all costs associated with it. This could include the cost of a nursing clinic or radiologist fees, as well as pharmacy charges.
“Frankly the hospital systems will need to decide if they’d like to provide the service,” Kremen said. “Is it worth the price?”
Eisai estimates that 100,000 people could be diagnosed and eligible for Leqembi within the United States by 2026. The drugmaker’s representatives declined to say how many could be eligible for the drug this year.