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Biogen and Eisai’s Alzheimer’s drug to be covered by US Veterans Health Administration

US veterans in the early stages of the disease who meet VHA criteria will be eligible for coverage


Biogen and Eisai have announced that their Alzheimer’s drug, Leqembi (lecanemab-irmb), will be covered by the US Veterans Health Administration (VHA).

The decision comes two months after the drug received accelerated approval in the US for patients with mild cognitive impairment or mild dementia stage of disease.

This was based on phase 2 data showing that Leqembi reduced the accumulation of amyloid beta plaque in the brain, a defining feature of Alzheimer’s disease.

Now, veterans in the early stages of the disease who meet VHA criteria will be eligible for coverage, contrasting with Medicare’s decision last month to decline coverage of the treatment except in very limited circumstances.

‘The VHA's careful consideration and timely action to make Leqembi available approximately two months after the US Food and Drug Administration (FDA) approved Leqembi under the accelerated approval pathway shows its continued commitment to veterans living with Alzheimer’s disease,’ Eisai said in a statement.

The drug has since been granted priority review for traditional approval in the US, with the application supported by data from the phase 3 confirmatory Clarity AD clinical trial.

The study met its primary endpoint, reducing clinical decline by 27% on the global cognitive and functional scale – Clinical Dementia Rating-Sum of Boxes – compared with placebo at 18 months.

All key secondary endpoints also showed highly statistically significant results compared with placebo, including other measures of cognition and daily function.

Eisai said it looks forward to ‘continuing discussions with the VHA as [it] prepares for the FDA's potential conversion of Leqembi 's accelerated approval to a traditional approval’.

Affecting more than 6.5 million Americans, Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.

While the specific causes of Alzheimer’s are not fully known, it is characterised by changes in the brain, including amyloid beta plaques, that result in loss of neurons and their connections.

Eisai and Biogen have been collaborating on the joint development and commercialisation of Alzheimer’s disease treatments since 2014.

For Leqembi, Eisai serves as lead of development and regulatory submissions globally, with both companies commercialising and promoting the product, and Eisai having final decision-making authority.

Article by
Emily Kimber

15th March 2023

From: Regulatory



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