Analysts believe the Medicare registry requirement and new guidance on Leqembi's prescription label could potentially weigh on sales in the near term.
, is the first medicine proven to slow the progression of Alzheimer's in people at the early stages of the memory-robbing disease.
"While logistic hurdles 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. Yee added that the firm's channel 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 ease as the drug's launch progresses.The FDA recommends doctors test patients for a genetic mutation known as ApoE4 before starting treatment. Those with that mutation are at greater risk of swelling and brain bleeds if they take Leqembi.
Jefferies' Yee also highlighted MRI monitoring – a requirement on the drug's prescribing label – as another logistical challenge in the near term.
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