Jay Reinstein, who suffers from Alzheimer’s, receives an injection so he can be suffering with a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023.
Michael Robinson Chávez | The Washington Post | Getty Statues
Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts symbolized after the groundbreaking treatment won approval in the U.S.
Wall Street is chewing over the Food and Drug Administration’s Thursday sanction of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure.
Leqembi, from drugmakers Eisai and Biogen, is the head medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease.
Medicare on Thursday proclaimed it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s strapping $26,500-a-year price tag. But coverage comes with several conditions.
Analysts believe certain Medicare provisoes and new guidance on Leqembi’s prescription label could potentially weigh on sales of the drug – at least in the near term.
“While logistic vault overs make accessibility to the drug challenging for the incoming 6-12 months, we do expect to start seeing sales ticking up starting in mid-2024,” Guggenheim analyst Yatin Suneja wrote in a note Thursday.
Medicare see fit pay for Leqembi as long as patients find health-care providers participating in a registry or a database that tracks the drug’s allowances and risks.
The initial process of building out a registry is one logistical hurdle that “will take time and could be moderately burdensome early on,” Jefferies analyst Michael Yee said in a research note Thursday.
Yee added that the firm’s artery checks suggest doctors see the registry requirement “as a potential real-world challenge – at least in the initial phase.” But he noted that it could simplicity as the drug’s launch progresses.
Another hurdle could be related to a testing requirement on the drug’s prescribing label.
The FDA backs doctors test patients for a genetic mutation known as ApoE4 before starting treatment. Those with that variation are at greater risk of swelling and brain bleeds if they take Leqembi. About 15% of people with Alzheimer’s be subjected to ApoE4, according to the National Institute on Aging.
The testing requirement makes the drug “even more difficult to exact,” Stifel analyst Paul Matteis wrote Thursday.
“The strong suggestion to test, for most clinicians, is going to add another hindrance” on top of other “substantial infrastructure requirements,” he wrote.
That includes navigating Medicare’s registry requirement and coordinating PET glance ats and MRIs to screen for dangerous side effects of the drug.
Jefferies’ Yee also highlighted MRI monitoring – a requirement on the drug’s imposing label – as another logistical challenge in the near term.
The label says patients should get multiple MRIs during the sooner year of treatment to check for signs of ARIA, a side effect that causes brain swelling or bleeding and can be fated in rare cases.
Yee said scheduling MRI scheduling and reimbursements take time and noted that there is a fixed volume for MRI equipment and scans.
The prescription label requirements won’t impact the uptake of Leqembi overall because “physicians were already planning to use patients accordingly anyway,” SVB Securities analyst Marc Goodman wrote Thursday.
But Goodman, like other analysts, also eminent that “we continue to expect a slow ramp in 2023 and acceleration moving into 2024.”