Jay Reinstein, who suffers from Alzheimer’s, receives an injection so he can have a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023.
Michael Robinson Chávez | The Washington Post | Getty Images
Sales of the Alzheimer’s drug Leqembi could also be slow initially as a result of logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval within the U.S.
Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone within the treatment of the disease, despite the fact that the drug is not a cure.
Leqembi, from drugmakers Eisai and Biogen, is the primary medicine proven to slow the progression of Alzheimer’s in people on the early stages of the memory-robbing disease.
Medicare on Thursday announced it’s now covering the antibody treatment for patients enrolled within the insurance program for seniors, broadening access for many who cannot afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions.
Analysts consider certain Medicare requirements and recent guidance on Leqembi’s prescription label could potentially weigh on sales of the drug – at the least within the near term.
“While logistic hurdles make accessibility to the drug difficult for the incoming 6-12 months, we do expect to begin seeing sales ticking up starting in mid-2024,” Guggenheim analyst Yatin Suneja wrote in a note Thursday.
Medicare can pay for Leqembi so long as patients find health-care providers participating in a registry or a database that tracks the drug’s advantages and risks.
The initial technique of constructing out a registry is one logistical hurdle that “will take time and could possibly be somewhat burdensome early on,” Jefferies analyst Michael Yee said in a research note Thursday.
Yee added that the firm’s channel checks suggest doctors see the registry requirement “as a possible real-world challenge – at the least within the initial phase.” But he noted that it could ease because the drug’s launch progresses.
One other hurdle could possibly be related to a testing requirement on the drug’s prescribing label.
The FDA recommends doctors test patients for a genetic mutation generally known as ApoE4 before starting treatment. Those with that mutation are at greater risk of swelling and brain bleeds in the event that they take Leqembi. About 15% of individuals with Alzheimer’s have ApoE4, in line with 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 check, for many clinicians, goes so as to add one other hurdle” on top of other “substantial infrastructure requirements,” he wrote.
That features navigating Medicare’s registry requirement and coordinating PET scans and MRIs to screen for dangerous unintended effects of the drug.
Jefferies’ Yee also highlighted MRI monitoring – a requirement on the drug’s prescribing label – as one other logistical challenge within the near term.
The label says patients should get multiple MRIs in the course of the first yr of treatment to examine for signs of ARIA, a side effect that causes brain swelling or bleeding and could be fatal in rare cases.
Yee said scheduling MRI scheduling and reimbursements take time and noted that there’s a fixed capability for MRI equipment and scans.
The prescription label requirements won’t impact the uptake of Leqembi overall because “physicians were already planning to treat patients accordingly anyway,” SVB Securities analyst Marc Goodman wrote Thursday.
But Goodman, like other analysts, also noted that “we proceed to expect a slow ramp in 2023 and acceleration moving into 2024.”
