The first drug to show that it slows Alzheimer’s is on sale, but treatment for most patients is still several months away.
Experts say two major factors are the lack of coverage for insurance and the long time required by health systems to set it up.
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It is possible for patients to overcome those obstacles and be the first in line to receive a drug with uncertain benefits. Here’s a closer look.
THE SITUATION
Leqembi was approved by the U.S. Food and Drug Administration in January. It is a Japanese drugmaker Eisai. It’s for patients with mild or early cases of dementia tied to Alzheimer’s disease.
Regulators used the FDA’s accelerated pathway, which allows drugs to launch before they’re confirmed to benefit patients. In studies, Leqembi modestly slowed the fatal disease, but doctors aren’t sure yet how that translates into things like greater independence for patients.
Every two weeks, patients receive the medication by intravenous (IV) injection. According to Eisai, the company has sent Leqembi into U.S. special drug distribution centers. It can then be shipped overnight to medical or hospital centers.
Libby Holman, spokeswoman for Eisai, stated that prescriptions have already been filled and patients will begin receiving the drug. “very soon.”
COST and Coverage
A year’s treatment will run about $26,500. If they’re deemed eligible for Leqembi, and find an appropriate doctor and system to assist them, patients who are financially able will be able start treatment.
At the moment, there are few other options than self-pay. Most of the patients who may be candidates for this drug are on Medicare, and the federal program’s coverage is narrow so far. The FDA has stated that it will only cover Leqembi treatments for those who are enrolled in research studies to evaluate the drug.
These studies are not currently available for new patients.
“There’s a theoretical door (to coverage) that’s completely slammed shut,” said Robert Egge, chief public policy officer for the nonprofit Alzheimer’s Association.
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Medicare made that coverage decision last year when another Alzheimer’s drug, Biogen’s Aduhelm, hit the market.
Health insurers, which run Medicare Advantage coverage, have been sticking to that decision, said a spokesman for the trade group America’s Health Insurance Plans.
The Centers for Medicare and Medicaid Services, which oversees Medicare, said after Leqembi’s approval that it may reconsider its coverage stance, something the Alzheimer’s Association has urged it to do.
If the FDA approves the drug, coverage will likely change. This could occur later in the year.
In the meantime Eisai provides Leqembi at no cost to patients on Medicare. It’s based partly on financial need.
DIAGNOSING
Doctors can take several months or more to diagnose patients and determine if they are eligible for Leqembi. Dr. Sarah Kremen is a neurologist with Cedars-Sinai Health System in Los Angeles.
That can depend on where a patient lives and the physician’s expertise.
A doctor first needs to determine if a patient is suffering from mild dementia.
The doctor will then have to determine what is causing the problem. It could stem from Alzheimer’s, Parkinson’s disease, a stroke or a brain injury.
If it’s related to Alzheimer’s disease, doctors must determine whether the patient’s brain has an amyloid protein. The new drug aims to slow the progression of Alzheimer’s by removing that protein.
After all that, some doctors may hesitate to prescribe Leqembi because they don’t have a good idea yet for how the drug will help the patient or affect their everyday life, Kremen said. It is important to balance the potential brain swelling and bleeding in Leqembi patients.
“I think this benefit versus harm issue is going to weigh heavily,”Sie said.
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DELIVERING TREATMENT
Before they can offer Leqembi, health systems need to develop plans that will allow them to deliver the drug. This can take several months. However, some people may be able to start offering the drug before regulatory approval.
Planning might involve training nurses to administer the drug, and making sure that doctors are able to identify candidates. It is also important to plan how the patient will be monitored after they have started taking it.
To check for side effects, patients will need to have brain scans performed several times.
Kremen said that physicians may be interested in knowing that such a plan exists before they are able to write prescriptions.
Also, hospitals will need to calculate how many patients may be coming to them for the drug in order to provide reimbursement. These could include pharmacy, clinic and nursing fees.
“Frankly, the hospital systems are going to have to decide if they want to offer it,”Kremen stated. “Is it worth the cost?”
Eisai predicts that approximately 100,000 Americans will have been diagnosed with Leqembi by 2026. Representatives for the drugmaker did not estimate how many would receive it this year.
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This article was contributed by the Associated Press
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