The first drug shown to slow Alzheimer’s is on the market, but treating most patients is still several months away.
Two big factors in the slow debut, experts say, are low insurance coverage and a long set-up time, which many healthcare systems require.
Patients who overcome these challenges will move to the front of the line a drug of uncertain benefit. Here’s a closer look.
THE SITUATION
The Approved by the US Food and Drug Administration Leqembi by Japanese drugmaker Eisai in early January. It is for patients with mild or early-stage dementia associated with Alzheimer’s disease.
Regulators took advantage of the FDA’s expedited path, which allows drugs to get to market before they’re confirmed to benefit patients. In studies, Leqembi has slightly slowed the deadly disease, but doctors aren’t yet sure how that translates into things like greater patient independence.
Patients receive the drug intravenously every two weeks. Eisai says the company shipped Leqembi to US specialty drug distribution centers. From there it can be delivered to hospitals or medical centers overnight.
Libby Holman, spokeswoman for Eisai, said prescriptions have been issued for the drug and they expect patients to receive it “very soon.”
COSTS AND COVERAGE
A year’s treatment costs about $26,500. Patients who can afford it without insurance can start treatment if they are considered candidates for Leqembi and find a doctor and health care system willing to help them.
There are currently only a few options outside of self-payers. Most patients who might be candidates for this drug are on Medicare, and federal program coverage to date has been low. It has said it will only cover treatments like Leqembi for patients participating in specific research studies to test the drug.
There are currently no such trials enrolling new patients.
“There’s a theoretical door (to reporting) that’s being slammed completely,” said Robert Egge, chief public policy officer for the nonprofit Alzheimer’s Association.
Medicare made that coverage decision last year when another Alzheimer’s drug, Biogen’s Aduhelm, came to market.
Health insurers that cover Medicare Advantage are sticking to that decision, a spokesman for trade group America’s Health Insurance Plans said.
This was announced by the Centers for Medicare and Medicaid Services, which oversees Medicare, following Leqembi’s approval it can reconsider its reporting stance, something the Alzheimer’s Association has urged it to do.
Coverage is also likely to change once the drug receives full FDA approval. That could happen this year.
Meanwhile, Eisai has a support program that Leqembi is giving to some patients, including those on Medicare, for free. It is based in part on financial need.
DIAGNOSIS
according to dr Sarah Kremen, a neurologist at Cedars-Sinai Health Care System in Los Angeles, it can take anywhere from several months to more than a year for doctors to diagnose a patient and then figure out if that person is a candidate for Leqembi.
This can depend on where the patient lives and the expertise of the doctor.
First, a doctor must determine whether a patient has mild dementia.
Then the doctor has to decide what caused the disease. It could be from Alzheimer’s, Parkinson’s, a stroke, or a brain injury.
If it’s related to Alzheimer’s disease, doctors need to determine if the patient’s brain contains an amyloid protein. The new drug aims to slow the progression of Alzheimer’s by removing this protein.
After all that, some doctors might be reluctant to prescribe Leqembi because they don’t yet have a good idea of how the drug will help the patient or affect their daily lives, Kremen said. You must take into account this uncertainty regarding brain swelling and bleeding that may occur in patients taking it.
“I think this benefit-harm issue will weigh heavily,” she said.
PERFORM TREATMENT
Healthcare systems must first develop plans to provide medicines like Leqembi before they start offering them. That can take months, although some may have started before regulators approved the drug.
That planning could include training nurses on how to administer the drug and ensuring prescribers know how to identify candidates for it. Healthcare providers also need a plan for how patients will be monitored once they start taking it.
Patients need repeated brain scans to check for side effects.
Physicians may want to know such a plan is in place before they feel comfortable writing a prescription, Kremen noted.
Hospital systems also need to figure out how many patients might be coming to them for this drug and be able to cover any associated costs. These may include clinic, nursing, radiologist and pharmacy fees.
“Honestly, the hospital systems have to decide if they want to offer it,” Kremen said. “Is it worth the price?”
Eisai estimates that by 2026, approximately 100,000 people in the United States will be diagnosed and eligible for leqembi. Representatives from the drugmaker declined to estimate how many people might receive it this year.
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