Sales of Alzheimer’s drug Leqembi may be slow at first: analysts

Sales of the Alzheimer’s disease drug Leqembi may initially be slow due to logistical requirements, but could pick up in 2024, analysts said after the breakthrough treatment was approved in the United States.

Wall Street is mulling Thursday’s approval of Leqembi by the Food and Drug Administration — a milestone in treating the disease, even if the drug isn’t a cure.

Leqembi, drug makers Eisai and biogenicis the first drug that has been shown to slow the progression of Alzheimer’s disease in people in the early stages of the memory-destroying disease.

Medicare announced Thursday that it now covers antibody treatment for patients enrolled in the Seniors Insurance Program, expanding access to those who cannot afford the drug’s high price of $26,500 a year. . But coverage comes with several conditions.

Analysts say some Medicare requirements and new guidelines on Leqembi’s prescription label could potentially hurt sales of the drug — at least in the short term.

“While logistical hurdles make accessibility to the drug difficult for the next 6-12 months, we expect to see sales pick up from mid-2024,” Guggenheim analyst Yatin Suneja wrote Thursday. .

Medicare will pay for Leqembi as long as patients find healthcare providers participating in a registry or database that tracks the drug’s benefits and risks.

The initial process of creating a ledger is a logistical hurdle that “will take time and could be somewhat tedious at first,” Jefferies analyst Michael Yee said in a research note Thursday.

Yee added that the company’s channel checks suggest physicians view the registry requirement “as a potential real-world challenge — at least in the initial phase.” But he noted that this may ease as the drug’s launch progresses.

Another hurdle could be related to a testing requirement on the drug’s prescription label.

The FDA recommends doctors test patients for a genetic mutation known as ApoE4 before starting treatment. Those with this mutation are at greater risk of brain swelling and bleeding if they take Leqembi. About 15% of people with Alzheimer’s have ApoE4, according to the National Institute on Aging.

The testing requirement makes the drug “even harder to prescribe,” Stifel analyst Paul Matteis wrote Thursday.

“The strong suggestion to test, for most clinicians, will add another hurdle” in addition to other “substantial infrastructure requirements,” he wrote.

This includes navigating Medicare registry requirements and coordinating PET and MRI scans to screen for dangerous drug side effects.

Jefferies’ Yee also pointed to MRI monitoring — a requirement on the drug’s prescription label — as another short-term logistical challenge.

The label says patients should have multiple MRI scans during the first year of treatment to check for signs of ARIA, a side effect that causes swelling or bleeding in the brain and can be fatal in rare cases.

Yee said MRI scheduling and reimbursements take time and noted that there is a fixed capacity for equipment and MRI scans.

Prescription labeling requirements won’t impact overall adoption of Leqembi because “doctors were already planning to treat patients accordingly anyway,” SVB Securities analyst Marc Goodman wrote Thursday. .

But Goodman, like other analysts, also noted that “we continue to expect a slow ramp in 2023 and an acceleration toward 2024.”