Jay Reinstein, who suffers from Alzheimer’s disease, receives an injection so he can perform a PET scan at MedStar Georgetown University Hospital in Washington, D.C., June 20, 2023.
Michael Robinson Chavez | Washington Post | Getty’s paintings
Sales of Alzheimer’s drug Leqembi may be slow at first resulting from logistical requirements but could pick up in 2024, analysts say after breakthrough treatment won approval in United States
Wall Street chews on Thursday’s approval of Leqembi by the Food and Drug Administration – a milestone in history treatment of the diseasealthough the drug shouldn’t be a cure.
Leqembi, from drug manufacturers Eisai and Biogenis the primary drug proven to slow the progression of Alzheimer’s disease in people within the early stages of the disease causing memory loss.
On Thursday, Medicare announced it now covers antibody treatment for patients enrolled in its seniors insurance program, expanding access to those that cannot afford the drug’s massive cost. $26,500 per 12 months tag. But coverage comes with a couple of conditions.
Analysts consider that certain Medicare requirements and latest Leqembi prescription labeling guidelines could potentially affect sales of the drug – at least within the near future.
“While logistical obstacles hinder access to the drug in the approaching 6-12 months, we expect sales to begin picking up from mid-2024,” Guggenheim analyst Yatin Suneja wrote in a Thursday note.
Medicare can pay for Leqembi so long as patients find health professionals participating in a registry or database that tracks the advantages and risks of the drug.
The initial registry creation process is one of the logistical hurdles that “will take time and may be a bit disruptive within the early stages,” Jefferies analyst Michael Yee said in a Thursday research note.
Yee added that audits of the corporate’s channels suggest that doctors view the registration requirement “as a possible challenge in the actual world – at least within the initial phase.” Nevertheless, he noted that this may decrease because the drug is dropped at market.
One other hurdle may be the testing requirement on the drug label.
The FDA advises doctors to check patients for a genetic mutation often called ApoE4 before starting treatment. Individuals with this mutation usually tend to develop swelling and bleeding into the brain in the event that they take Leqembi. ABOUT 15% of people with Alzheimer’s have ApoE4, in keeping with the National Institute on Aging.
The testing requirement makes the drug “even harder to prescribe,” Stifel analyst Paul Matteis wrote on Thursday.
“The strong suggestion to check for many clinicians will add one other hurdle” to other “essential infrastructure requirements,” he wrote.
This includes navigating Medicare registry requirements and coordinating PET and MRI scans to detect dangerous drug negative effects.
Jefferies-based Yee also highlighted MRI monitoring – a requirement on the drug label – as one other logistical challenge within the near future.
The label says patients should get multiple MRI’s inside the first 12 months of treatment to ascertain for signs of ARIA, a side effect that causes brain swelling or bleeding and may be fatal in rare cases.
Yee said MRI scheduling and reimbursement takes time and noted that there may be a continuing capability for MRI equipment and scans.
Prescription label requirements is not going to affect Leqembi’s overall uptake, as “doctors were already planning appropriate treatment for patients anyway,” SVB Securities analyst Marc Goodman wrote on Thursday.
But Goodman, like other analysts, also noted that “we still expect slow growth in 2023 and acceleration in 2024.”