Leqembi, an Alzheimer's drug from Biogen and Eisai, faces hurdles with respect to reimbursement and diagnostic uncertainties, diagnostic test requirements and the need for regular brain scans, CNBC reported Sept. 8.
Approved by the FDA in July 2023, Lequembi is a monoclonal antibody that does not offer a cure to the disease but has shown promise in slowing cognitive decline in early stage Alzheimer's patients.
The approval process and regimen include multiple diagnostic tests and insurance has been an significant obstacle, with some coverage denials and delays because of the drugs high cost and novelty.
Biogen and Eisai are working on more accessible forms of the drug, including a maintenance dose and a subcutaneous version to ease the burden on patients and broaden its use.