Jay Reinstein, who has Alzheimer’s, receives an injection for a PET scan on June 20, 2023 at MedStar Georgetown University Hospital in Washington, DC.
Michael Robinson Chavez | Michael Robinson Washington Post | Getty Images
Sales of Alzheimer’s disease drug Leqembi may initially be slowed by logistical needs, but could pick up in 2024, analysts said. Approval In the U.S
Wall Street is discussing the U.S. Food and Drug Administration’s approval of Leqembi on Thursday, a milestone in the treatment of the disease, although the drug does not cure the disease.
Leqembi, from drugmaker Eisai and Biogenis the first drug shown to slow the progression of Alzheimer’s disease in patients in its early stages.
Medicare announced Thursday that it will now pay for the antibody treatment for patients enrolled in senior citizens’ insurance plans, opening up more opportunities for those who can’t afford the drug’s hefty $26,500 a year price tag. But underwriting has several conditions.
Certain Medicare requirements and new guidance on prescription labels for Leqembi could hurt the drug’s sales — at least in the short term, analysts believe.
“While logistical hurdles make obtaining the drug challenging over the next 6-12 months, we expect sales to pick up from mid-2024 onwards,” Guggenheim analyst Yatin Suneja wrote in a note Thursday. rise.”
Medicare will pay for Leqembi as long as patients find a health care provider that participates in a registry or database that tracks the drug’s benefits and risks.
The initial process of setting up a registry is a logistical hurdle that “will take time and may be somewhat burdensome early on,” Jefferies analyst Michael Yee said in a Thursday research note.
Yee added that the company’s channel checks indicated that physicians view the registration requirement as a “potentially real challenge — at least initially.” But he noted that could ease as the drug progresses toward the market.
Another hurdle may be related to testing requirements on drug prescription labels.
The FDA recommends that physicians test patients for the ApoE4 gene mutation before starting treatment. People with this mutation are at greater risk of swelling and bleeding in the brain if they take Leqembi.about 15% of people People with Alzheimer’s disease have ApoE4 in their bodies, according to the National Institute on Aging.
Stifel analyst Paul Matteis wrote Thursday that the testing requirement makes the drug “more difficult to prescribe.”
“For most clinicians, testing is strongly recommended, which would add another hurdle on top of other ‘substantial infrastructure requirements,'” he wrote.
That includes meeting Medicare registration requirements and coordinating PET scans and MRIs to screen for dangerous side effects of the drugs.
Jefferies’ Yee also highlighted MRI monitoring (a requirement on drug prescribing labels) as another near-term logistical challenge.
Patients should have multiple MRIs during the first year of treatment to check for signs of ARIA, a side effect that causes brain swelling or bleeding and can be fatal in rare cases, the label said.
Arranging MRI scheduling and reimbursement takes time, Yee said, noting that there is a fixed capacity for MRI equipment and scans.
SVB Securities analyst Marc Goodman wrote Thursday that the prescribing label requirement won’t affect overall use of Leqembi because “physicians already plan to treat patients accordingly,” SVB Securities analyst Marc Goodman wrote Thursday.
But Goodman, like other analysts, noted that “we still expect slow growth in 2023 and accelerated growth in 2024.”