The first drug to show that it slows Alzheimer’s is on sale, but treatment for most patients is still several months away.
Two big factors behind the slow rollout, experts say, are poor insurance coverage and the long setup times required by many healthcare systems.
Patients who overcome these challenges will move to the front of the line for a drug of uncertain benefit. Here’s a closer look.
The US Food and Drug Administration approved Leqembi, from Japanese drugmaker Eisai, in early January. It is for patients with mild or early cases of dementia related to Alzheimer’s disease.
Regulators have used the FDA’s fast track, which allows drugs to be launched before they’re confirmed for the benefit of patients. In studies, Leqembi has modestly slowed the deadly disease, but doctors aren’t yet sure how that translates into things like greater independence for patients.
Patients receive the drug intravenously every two weeks. Eisai says the company shipped Leqembi to specialty drug distribution centers across the United States. From there, it can be delivered overnight to hospitals or medical centers.
Eisai spokeswoman Libby Holman said prescriptions for the drug have been written and they expect patients to start receiving it “very soon.”
COST AND COVERAGE
One year’s treatment will cost about $26,500. Patients who can afford it without insurance will be able to start treatment if they are deemed candidates for Leqembi and find a doctor and health care system prepared to help them.
There are currently very few options outside of automatic payment. Most patients who could be candidates for this drug are on Medicare, and coverage from the federal program is limited so far. It said it would cover treatments like Leqembi only for patients enrolled in certain research studies designed to test the drug.
There are currently no such studies accepting new patients.
“There is a theoretical door (to coverage) that is completely closed,” said Robert Egge, chief public policy officer for the nonprofit Alzheimer’s Association.
Medicare made this coverage decision last year when another Alzheimer’s drug, Biogen’s Aduhelm, hit the market.
Health insurers, which administer Medicare Advantage coverage, have complied with that decision, a spokesperson for trade group America’s Health Insurance Plans said.
The Centers for Medicare and Medicaid Services, which oversees Medicare, said after Leqembi’s approval that it may reconsider its coverage position, something the Alzheimer’s Association has urged it to do.
Coverage is also likely to change if the drug receives full FDA approval. That could happen later this year.
Meanwhile, Eisai has an assistance program that provides free Leqembi to some patients, including those on Medicare. It is based in part on financial need.
It can take doctors several months to more than a year to diagnose a patient and then figure out if that person is a candidate for Leqembi, according to Dr. Sarah Kremen, a neurologist at Cedars-Sinai Health System in Los Angeles. .
This may depend on where a patient lives and the experience of the doctor.
First, a doctor must determine if a patient has mild dementia.
Then the doctor has to decide what caused the condition. It could result from Alzheimer’s, Parkinson’s disease, a stroke, or a brain injury.
If it is related to Alzheimer’s disease, doctors must determine whether the patient’s brain has amyloid protein. The new drug aims to slow the progression of Alzheimer’s by removing that protein.
After all of that, some doctors may be hesitant to prescribe Leqembi because they don’t yet have a good idea of how the drug will help the patient or affect their daily life, Kremen said. They need to consider that uncertainty versus brain swelling and bleeding that can develop in patients taking it.
“I think this issue of benefit versus harm is going to weigh heavily,” he said.
Healthcare systems must first develop plans for delivering drugs like Leqembi before starting to offer it. This can take months, although some may be started before regulators approve the drug.
This planning could include training nurses on how to administer the drug and making sure prescribers know how to recognize candidates. Healthcare providers also need a plan for monitoring patients once they start taking it.
Patients need repeated brain scans to check for side effects.
Doctors may want to know such a plan is in place before they feel comfortable writing a prescription, Kremen noted.
Hospital systems will also need to understand how many patients could come to them for this drug and be able to cover all costs associated with it. These could include clinical, nursing, radiological and pharmaceutical expenses.
“Frankly, hospital systems are going to have to decide if they want to offer that,” Kremen said. “Is it worth the cost?”
Eisai estimates that about 100,000 people will be diagnosed and eligible to receive Leqembi in the United States by 2026. Representatives for the drugmaker declined to estimate how many people could receive it this year.
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The Associated Press Health and Science Department receives support from the Science and Educational Media Group of the Howard Hughes Medical Institute. The AP is solely responsible for all content.