Analysts predict slower initial sales for the Alzheimer’s medication Leqembi

Analysts predict that sales of the Alzheimer’s drug Leqembi may start off slow due to logistical requirements but could gain momentum in 2024. This comes after the groundbreaking treatment received approval in the U.S. from the Food and Drug Administration (FDA).

The approval of Leqembi by the FDA is a significant milestone in the treatment of Alzheimer’s disease, although it is important to note that the drug does not provide a cure.

Developed by Eisai and Biogen, Leqembi is the first medication with proven efficacy in slowing down the progression of Alzheimer’s in individuals at the early stages of the disease.

In a move to increase accessibility, Medicare announced that it will now cover the costs of Leqembi for patients enrolled in the insurance program for seniors. However, certain conditions must be met to be eligible for coverage.

Analysts believe that Medicare requirements and new guidance on Leqembi’s prescription label could impact the drug’s sales, at least in the short term. However, they anticipate sales to pick up starting in mid-2024.

To receive Medicare coverage, patients must seek healthcare providers who participate in a registry or database that tracks the benefits and risks of Leqembi.

Building this registry may pose a logistical challenge that could take time to overcome initially, according to analysts. However, it is expected to become smoother as the drug’s launch progresses.

Another potential hurdle is the testing requirement stated on the drug’s prescribing label. Before starting treatment with Leqembi, doctors are advised to test patients for a genetic mutation called ApoE4, which increases the risk of swelling and brain bleeds in some individuals. Approximately 15% of people with Alzheimer’s have this mutation.

This testing requirement adds complexity to the prescription process, on top of other infrastructure requirements such as Medicare’s registry and coordinating PET scans and MRIs to screen for side effects.

In the near term, the requirement for multiple MRIs during the first year of treatment to monitor for brain swelling or bleeding could also pose a challenge. Scheduling MRI appointments and handling reimbursements may take time, considering the fixed capacity for MRI equipment and scans.

Despite these challenges, analysts believe that the prescription label requirements will not significantly impact the overall adoption of Leqembi, as physicians were already planning to adjust their treatment approaches accordingly. However, they still expect a gradual increase in sales throughout 2023, with acceleration in 2024.