Medicare Expands Coverage for Fully Approved Alzheimer Agent Lecanemab

Chiquita Brooks-LaSure

Following the recent news of the full traditional approval of lecanemab (Leqembi; Eisai), the Centers for Medicare and Medicaid (CMS) announced that patients with Alzheimer disease (AD) under Medicare now have broader access to the treatment. This new coverage expansion also means that clinicians can access the CMS-facilitated registry along with further background information on how their patients can qualify.¹

In accordance with CMS' National Coverage Determination, Medicare will cover this drug when physicians and clinical teams actively participate in collecting real-world evidence through a registry. Researchers will have access to this information in order to conduct studies aimed at advancing the understanding of how these drugs can benefit Medicare beneficiaries, and addressing the research questions outlined in the National Coverage Determination.

"CMS today reaffirms our commitment to ensuring timely access to innovative treatments for individuals with AD, potentially leading to improved care and better outcomes. With the FDA's decision, CMS will now provide broad coverage for this medication while actively collecting data to enhance our understanding of its efficacy. This is encouraging news for the millions of individuals and families affected by this debilitating disease across the country,” Chiquita Brooks-LaSure, administrator at CMS, said in a statement.¹

The clinicians who participate in the registries will only be required to submit data that is concise and easy to use. These registries are tools that are widely used in clinical settings and have gathered patient outcome data successfully for several decades. The CMS-facilitated registry that clinicians have access to ensures ease of use as well as adheres to privacy and security protocols according to applicable federal laws and regulations, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA).¹

Patients can qualify for the coverage if they are enrolled in Medicare and have a diagnosis of mild cognitive impairment or mild AD that is supported by documentation of beta-amyloid plaque in the brain. The qualifying patients also must have a consultation with a provider who participates in an eligible registry and who can offer appropriate clinical team involvement and follow-up care. A recent statement from CMS noted that those who have Medicare should have a conversation with their providers to determine the suitability of the therapy for their care plan.¹

It was also noted that patients under the original Medicare will have a standard 20% coinsurance for the Medicare-approved amount of lecanemab that will be applied once Part B of their deductible is met. The expenses may be different for patients who have Medicare supplemental coverage including those under Medigap plans or other secondary insurance or enrolled in Medicare Advantage plans. Thus, patients should contact the respective plans they are under for more detailed information on the costs.

In other news, it was noted that additional registries might be available in the upcoming months, with their details being published on the CMS site. Based on the available options listed, providers will have flexibility in selecting the most suitable study. Additional news from the Medicare National Coverage Determination also noted that if the FDA grants traditional approval to other therapies in this drug class, Medicare will extend the coverage in the same framework.

“Medicare said they will cover it [for the patients] and are requiring these registries which is not uncommon. At least from what I understand of it, entering the data on patients into the registries will not be that difficult. I don't think [these registries set up by Medicare] will be a barrier to obtaining the antibodies or reimbursement as long as the doctors enter the necessary data,” Howard Fillit, MD, the cofounder and chief science officer of the Alzheimer's Drug Discovery Foundation, told NeurologyLive®. “I think it's important because we want to make sure that the appropriate patients get the drug, that [there are records] of amyloid in their brain on a PET scan and have prior authorization or utilization management strategies to make that happen and also to get more data on the safety signals that we have already,” Fillit told.

REFERENCES
1. Statement: Broader Medicare Coverage of Leqembi Available Following FDA Traditional Approval. News Release. Centers for Medicare & Medicaid Services. Published July 6, 2023. Accessed July 7, 2023. https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-following-fda-traditional-approval