Is Leqembi used to treat Alzheimer's?

Official answer

by Drugs.com

Yes, Leqembi received traditional (full) approval to treat early Alzheimer’s disease in patients with mild cognitive impairment or a mild dementia stage of disease on July 6, 2023. The FDA granted a traditional approval to Leqembi based on the Phase 3 CLARITY AD results and Advisory Committee unanimous recommendations.

It is the second approved intravenous (IV) amyloid beta-directed monoclonal antibody, after Aduhelm (aducanumab), to treat patients with Alzheimer disease.

Initially, Eisai / Biogen’s Leqembi received accelerated approval by the FDA on January 6, 2023 and became available to patients on January 16th, 2023.

The accelerated approval was based on the surrogate endpoint of reduction in amyloid beta plaques in the brain in a Phase 2 dose-finding study. A surrogate endpoint is an indicator or sign used in place of another to tell if a treatment works.

In an accelerated approval, studies show an initial response, such as biomarker effect, but further clinical studies (effectiveness and safety) are needed before it can receive traditional (full) approval.

How does Leqembi work?

Leqembi (lecanemab-irmb) works in Alzheimer’s disease by neutralizing and eliminating amyloid-beta (Aβ) plaques in the brain of patients with Alzheimer’s disease. It is thought that this can slow down the progression of Alzheimer’s disease symptoms. The accumulation of amyloid plaques in the brain is a hallmark sign of Alzheimer’s disease.

Leqembi is classified as a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody and is given as a one hour intravenous (IV) infusion every two weeks.

Will Leqembi cure Alzheimer's?

Leqembi is not a cure for Alzheimer’s disease but may help to slow down the progression of the disease. About 6 million Americans live with Alzheimer’s disease, which affects memory and cognitive abilities, but there is no evidence it will reverse these impairments.

Does insurance pay for Leqembi?

Medicare

The Centers for Medicare and Medicaid Services (CMS) has stated they will cover the cost of anti-amyloid antibodies (which includes Aduhlem and Leqembi) when approved by the FDA. CMS has said anyone with Medicare Part B who meets the criteria will be covered.

However, CMS also stated that manufacturers will also have to gather and keep data in a registry showing how the drugs are working in the real world

Veterans

If you are a veteran seen at a VA hospital, you may be able to access Leqembi. On March 14, 2023, Eisai reported that the U.S. Veterans’ Health Administration (VHA) is now providing coverage to veterans living with early stage Alzheimer’s disease.

VHA healthcare professionals can prescribe Leqembi to veterans who fit the VHA’s criteria and the FDA current label.

Medicaid

Medicaid coverage and reimbursement for Leqembi varies from state to state. State Medicaid programs establish their own coverage and reimbursement policies. Contact the Medicaid office in your state for more information on formulary coverage of Leqembi.

Medicaid is a government insurance program that covers healthcare costs for low-income parents and children, people who are elderly, and people with disabilities.

Private / Commercial Health Insurance

Coverage for various commercial plans will vary based on formulary decisions for that plan. You or your doctor may contact your private health insurance plan to determine if Leqembi is covered by your plan.

Eisai, the manufacturer, may also be able to help you afford Leqembi if you qualify, or provide assistance in assessing the medication from your health insurance. You can contact them at 1-833-4-LEQEMBI (1-833-453-7362), M-F, 8AM-8PM ET, or access the information online.

This is not all the information you need to know about Leqembi (lecanemab-irmb) for safe and effective use and does not take the place of your doctor’s directions. Review the full Leqembi information and discuss this information and any questions you have with your doctor or other health care provider.

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