The Centers for Medicare & Medicaid Services (CMS) announced that Medicare Part B will cover treatments for Alzheimer’s disease that receive approval from the US Food and Drug Administration (FDA). The policy will provide coverage for new antibody treatments such as Leqembi, which slows cognitive decline, for patients who meet the eligibility criteria. Medicare Part B is an optional program for seniors that typically covers the cost of drugs that patients cannot self-administer, such as infusions. Patients will have to participate in a registry that collects real-world data on how the drugs work to obtain coverage under the policy. The expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment, which is expected to happen on July 6.
Alzheimer’s Association Lobbies for Dropping Restrictions on Leqembi
The Alzheimer’s Association has been lobbying for Medicare to drop restrictions on Leqembi and fully cover the drug for months. The FDA granted accelerated approval to Leqembi in January, but Medicare severely restricts coverage for Alzheimer’s antibody treatments that are cleared under that expedited pathway. Currently, seniors cannot access Leqembi unless they can afford the drug’s annual price of $26,500. The expanded coverage policy will apply to any other Alzheimer’s antibody treatment that receives full approval from the FDA. Eli Lilly is planning to submit such an application for its antibody donanemab. According to a study in a leading medical journal, Leqembi could cost Medicare up to $5 billion a year.
CMS Administrator Chiquita Brooks-LaSure told Congress in April that a registry “in no way limits people getting access to the drug.” She said that the goal is to set up the system when the FDA makes its decision on Leqembi on July 6. CMS will facilitate a nationwide portal in which clinicians can enter the required data. Brooks-LaSure stated that her agency is also in talks with multiple organizations planning to set up their own registries.
The policy change will provide broader access to Alzheimer’s treatments under Medicare Part B, benefitting patients who meet the eligibility criteria and participate in registries that collect real-world data on how the drugs work. The Alzheimer’s Association continues to lobby for the dropping of restrictions on Leqembi and full coverage of the drug. Medicare will apply the expanded coverage policy to any other Alzheimer’s antibody treatment that receives full approval from the FDA. Eli Lilly is planning to submit such an application for its antibody donanemab.