In a groundbreaking decision, the U.S. Food and Drug Administration (FDA) approved a new Alzheimer's drug on June 29th, 2023.
This drug is the first of its kind to be granted traditional full approval and is hailed as “the beginning of a new era” by Columbia University neurology professor Dr. Lawrence Honig.
The drug, Leqembi, was developed by pharmaceutical companies Eisai and Biogen and originally received accelerated approval in January 2023. It is administered to patients as an IV infusion given biweekly.
Infusion providers are now preparing for a boom of patients seeking Leqembi treatments; with Vivo Infusion, which provides infusions to roughly 50,000 American patients, projecting referral increases of 15 to 20 percent.
Research shows that Leqembi works by stripping away amyloid plaque buildups in the brain that are indicative of Alzheimer's.
While not a cure-all drug for Alzheimer’s, it offers promising results, slowing cognitive declines by 27% in 18-month clinical trials.
Alzheimer’s patients hoping to be prescribed Leqembi will need a treatment plan with a licensed physician and clinical team.
Currently, it is only approved for patients with early onset Alzheimer’s, mild cognitive impairments or dementia, who are diagnosed with amyloid plaque buildups. Those criteria, though, apply to an estimated one-sixth of the 6 million Americans with an Alzheimer’s diagnosis.
Dr. Honig notes the drug is not yet approved for patients with more advanced stages of Alzheimer’s and cognitive impairments. It is not a matter of the drug not being safe for later stage patients, rather that it has not been trialed with those patients and therefore researchers simply don’t know if it could be suitable.
Like most newly approved drugs, Leqembi is not without side effect warnings. Regular brain scans are necessary for Leqembi patients, as roughly 13% of patients experience brain swelling or bleeding, and the risks are increased for patients on blood-thinners.
Leqembi could give those suffering with Alzheimer’s more quality time with their loved ones.
The Centers for Medicare and Medicaid Services (CMS) has announced that they are expanding previously restrictive coverage of Leqembi, with the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, estimating that the drug will reach almost a million patients.
Due to previously restrictive coverage of Leqembi its annual cost, prior to insurance, is a staggering $26,500 per year. The widening approval will hopefully prompt insurance companies to examine their coverage of Leqembi and lower the out-of-pocket cost.
Early expanded coverage under Medicare are expected to run patients roughly 20% of coinsurance in out-of-pocket costs. However, each patient’s out-of-pocket costs will be determined by their specific policy plan.
While out-of-pocket co-pays hover around $5,300 annually are nothing to take lightly, the quality of life that Leqembi is found to give back to patients, may well be worth it for countless Alzheimer's patients and their families.
This may still be early days, but the results are extremely promising.