Why a new Alzheimer’s drug is having a slow US debut

Leqembi, from Japanese drugmaker Eisai, in early January. 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.

There are currently few options outside 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. It has said it will cover treatments like Leqembi only for patients enrolled in certain research trials designed to test the drug.“There’s a theoretical door that’s completely slammed shut,” said Robert Egge, chief public policy officer for the nonprofit Alzheimer’s Association.

In the meantime, Eisai has an assistance program that provides Leqembi for free to some patients, including those on Medicare. It’s based partly on financial need.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, according to Dr. Sarah Kremen, a neurologist with the Cedars-Sinai health system in Los Angeles.First, a doctor must determine whether a patient has mild dementia.

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. They have to consider that uncertainty against the brain swelling and bleeding that can develop in patients taking it.DELIVERING TREATMENT

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