Alzheimer’s Drug Leqembi Granted Full FDA Approval

— Offers Hope for Slowing Cognitive Decline

The Food and Drug Administration (FDA) has approved a new Alzheimer’s drug called Leqembi (pronounced le-KEM-bee), known by the generic name of lecanemab. This approval allows Medicare and other insurance plans to cover the treatment for individuals living with early Alzheimer’s disease and mild cognitive impairment.

Leqembi, developed by the Japanese company Eisai and co-marketed with Cambridge, Massachusetts-based Biogen, is the first medication to demonstrate modestly slowing the cognitive decline associated with Alzheimer’s. The drug works by clearing the sticky brain plaque, known as beta-amyloid, linked to the disease.

The approval process attracted significant attention due to concerns about the financial impact on Medicare, which provides healthcare for the majority of Americans living with Alzheimer’s disease. Medicare, which primarily serves adults age 65 and older, had previously announced that it would not cover drugs like Leqembi until they received full FDA approval. However, now that Leqembi has received full approval, Medicare will begin covering the treatment, albeit with additional requirements such as enrollment in a federal registry to monitor real-world safety and effectiveness.

Private insurers have also been withholding coverage for Leqembi and a similar drug called Aduhelm until they receive full FDA endorsement, which could still be years away for Aduhelm.

Leqembi’s prescribing information will carry a serious warning about potential side effects including that in rare cases, the drug can cause “serious and life-threatening events” and that there have been cases of brain bleeding, “some of which have been fatal.” Leqembi’s label says that “additional caution should be exercised” when considering whether to give blood thinners to people taking Leqembi.

The drug costs around $26,500 for a one-year supply of intravenous infusions administered every two weeks. While Medicare will cover 80 percent of the cost, patients may still be responsible for paying significant co-payments, potentially amounting to thousands of dollars. Taking into account expenses such as medical appointments and the necessary periodic brain scans, experts estimate that the overall cost of the treatment could amount to approximately $90,000 per year.

Approximately 1.5 million individuals in the United States are estimated to be in the early stages of Alzheimer’s disease, while a much larger group of about five million people have progressed to a stage where they are no longer eligible for treatment with Leqembi.

Despite the expanded coverage of Leqembi, it is anticipated that only a smaller fraction of Medicare patients will actually receive the drug in the near future. The risk of serious side effects in return for potentially little practical benefit may keep many people from wanting to try the medication. The unpreparedness of the U.S. healthcare system to effectively handle the diagnosis, treatment, and monitoring of such a large number of Alzheimer’s patients will also impact its availability.

Hospitals and medical clinics have highlighted the potentially time-consuming process of initiating patients on Leqembi. Confirming the presence of the specific brain plaque targeted by the drug requires doctors to conduct tests, and nurses need to undergo training to administer the treatment.

The administration of Leqembi involves an initial test to determine the presence of beta-amyloid, regular intravenous infusions every other week, and periodic brain scans to monitor potential side effects. There is, however, a shortage of knowledgeable specialists capable of providing this treatment and a lack of primary care physicians who feel confident enough to refer patients for such treatment.

Eisai conducted research on individuals with early or mild Alzheimer’s disease, assessing their memory, thinking abilities, and other fundamental skills. Over a span of a year and a half, those who received Leqembi exhibited a slower decline compared to participants who received a placebo infusion, with a difference of less than half a point on an 18-point scale.

While Leqembi cannot restore cognitive function, reverse the progression of the disease, or halt its worsening, it might slow the decline in individuals with mild symptoms by approximately five months within 18 months.

Although some Alzheimer’s experts believe the delay in cognitive decline caused by Leqembi may be too subtle for patients or their families to notice, federal health advisers deemed it meaningful and recommended full FDA approval in June.

“It’s not something that’s going to stop the disease or reverse it,” says Dr . Sanjeev Vaishnavi, director of clinical research at the Penn Memory Center. “But it may slow down the progression of the disease and may give people more meaningful time with their families.”

Following this approval, the importance of early detection and diagnosis has become even more crucial to ensure that individuals can receive maximum benefits from the treatment as early as possible.

“The full approval of this new Alzheimer’s drug is a significant milestone that brings hope to individuals and families living with Alzheimer’s disease,” said Lisa Sauder, Executive Director of Alzheimer’s Resource of Alaska. “We will continue to provide the daily educational, care coordination and referral services that so many Alaskans need. We hope for a future free from Alzheimer’s and related dementias.” 

If you or someone you care about is experiencing memory changes or other changes in thinking, Alzheimer’s Resource of Alaska strongly recommends that you consult a healthcare professional for a comprehensive evaluation, diagnosis, and discussion of available treatment options. For further information on diagnosis or to locate a local healthcare provider, reach out to Alzheimer’s Resource of Alaska at 907-561-3313.

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