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 may be slow initially on account of logistical requirements but could pick up in 2024, analysts stated after the groundbreaking therapy won approval in the U.S.
Wall Street is chewing over the Food and Drug Administration‘s Thursday approval of Leqembi – a milestone in the treatment of the disease, regardless that the drug is not a remedy.
Leqembi, from drugmakers Eisai and Biogen, is the primary medication confirmed to slow the development of Alzheimer’s in folks on the early phases of the memory-robbing illness.
Medicare on Thursday introduced it’s now overlaying the antibody therapy for sufferers enrolled in the insurance coverage program for seniors, broadening entry for individuals who cannot afford the drug’s hefty $26,500-a-year price ticket. But protection comes with a number of situations.
Analysts imagine sure Medicare necessities and new steerage on Leqembi’s prescription label could probably weigh on gross sales of the drug – not less than in the close to time period.
“While logistic hurdles make accessibility to the drug difficult for the incoming 6-12 months, we do anticipate to begin seeing gross sales ticking up beginning in mid-2024,” Guggenheim analyst Yatin Suneja wrote in a be aware Thursday.
Medicare pays for Leqembi so long as sufferers discover health-care suppliers collaborating in a registry or a database that tracks the drug’s advantages and dangers.
The preliminary course of of constructing out a registry is one logistical hurdle that “will take time and could be considerably burdensome early on,” Jefferies analyst Michael Yee stated in a analysis be aware Thursday.
Yee added that the agency’s channel checks recommend docs see the registry requirement “as a possible real-world problem – not less than in the preliminary part.” But he famous that it could ease because the drug’s launch progresses.
Another hurdle could be associated to a testing requirement on the drug’s prescribing label.
The FDA recommends docs check sufferers for a genetic mutation referred to as ApoE4 earlier than beginning therapy. Those with that mutation are at larger danger of swelling and mind bleeds in the event that they take Leqembi. About 15% of people with Alzheimer’s have ApoE4, based on the National Institute on Aging.
The testing requirement makes the drug “much more tough to prescribe,” Stifel analyst Paul Matteis wrote Thursday.
“The robust suggestion to check, for many clinicians, goes so as to add one other hurdle” on high of different “substantial infrastructure necessities,” he wrote.
That consists of navigating Medicare’s registry requirement and coordinating PET scans and MRIs to display for harmful negative effects of the drug.
Jefferies’ Yee additionally highlighted MRI monitoring – a requirement on the drug’s prescribing label – as one other logistical problem in the close to time period.
The label says sufferers ought to get a number of MRIs throughout the first yr of therapy to examine for indicators of ARIA, a facet impact that causes mind swelling or bleeding and may be deadly in uncommon circumstances.
Yee stated scheduling MRI scheduling and reimbursements take time and famous that there’s a mounted capability for MRI tools and scans.
The prescription label necessities will not affect the uptake of Leqembi total as a result of “physicians have been already planning to deal with sufferers accordingly anyway,” SVB Securities analyst Marc Goodman wrote Thursday.
But Goodman, like different analysts, additionally famous that “we proceed to anticipate a slow ramp in 2023 and acceleration transferring into 2024.”