Jay Reinstein, who has Alzheimer’s, receives an injection so he can have a PET scan on June 20, 2023 at MedStar Georgetown University Hospital in Washington, DC.
Michael Robinson Chavez | The Washington Post | Getty Images
Sales of Alzheimer’s drug Leqembi could be slow at first due to logistical needs but could pick up in 2024, analysts said after the breakthrough treatment won approval in the US
Wall Street is mulling over the Food and Drug Administration’s Thursday approval of Leqembi — a milestone in treating the disease, even if the drug isn’t a cure.
Leqembi, by drug makers Eisai and biogenicis the first drug shown to slow the progression of Alzheimer’s disease in people with the early stages of the memory-wasting disease.
Medicare announced Thursday that it is now covering antibody treatment for patients enrolled in the seniors’ insurance program, expanding access for those who can’t afford the drug’s hefty $26,500-a-year price tag. However, the insurance cover is subject to several conditions.
Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially affect sales of the drug — at least in the short term.
“While logistical hurdles will hamper access to the drug over the next six to 12 months, we expect sales to pick up from mid-2024,” Guggenheim analyst Yatin Suneja wrote in a note Thursday.
Medicare will pay for Leqembi as long as patients find healthcare providers who participate in a registry or database that tracks the drug’s benefits and risks.
The initial process of building a registry is a logistical hurdle that “could take time and be a bit stressful at first,” Jefferies analyst Michael Yee said in a research note Thursday.
Yee added that the company’s channel reviews suggest doctors see the registration requirement “as a potential real-world challenge, at least in the early stages.” However, he did point out that it could taper off as the drug’s market launch progresses.
Another hurdle could be related to a testing requirement on the drug’s prescription label.
The FDA recommends doctors test patients for a genetic mutation called ApoE4 before starting treatment. People with this mutation have a higher risk of swelling and bleeding in the brain when taking Leqembi. According to the National Institute on Aging, about 15% of people with Alzheimer’s have ApoE4.
The requirement for testing makes prescribing the drug “even more difficult,” Stifel analyst Paul Matteis wrote on Thursday.
“The urgent proposition to conduct testing will present another hurdle for most doctors,” in addition to other “significant infrastructure requirements,” he wrote.
This includes complying with Medicare registration requirements and coordinating PET scans and MRIs to look for dangerous side effects of the drug.
Jefferies’ Yee also highlighted MRI scanning – a requirement on the drug’s prescription label – as another logistical challenge in the near future.
The label states that patients should have multiple MRI scans during the first year of treatment to check for signs of ARIA, a side effect that causes swelling or bleeding in the brain and can, in rare cases, be fatal.
Yee said planning MRI appointments and reimbursements takes time, noting that there is firm capacity for MRI machines and scans.
Prescription labeling requirements will not impact Leqembi’s overall acceptance as “doctors already planned to treat patients accordingly,” wrote Marc Goodman, an analyst at SVB Securities, on Thursday.
But Goodman also cautioned other analysts that “we continue to expect a slow increase in 2023 and an acceleration in 2024.”
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