Tag: Lecanemab

  • Who should take Leqembi, an Alzheimer’s drug?

    Who should take Leqembi, an Alzheimer’s drug?

    After years of review, the FDA approved Leqembi—lecanemab–for the treatment of Alzheimer’s. So, now, Medicare covers this drug. But, it’s not clear if any of the 6.5 million Americans with Alzheimer’s should take the drug, given that it can cause brain swelling and bleeding. Laurie McGinley reports for the Washington Post on the pros and cons of Leqembi.

    The clinical data indicate that, in some cases of individuals with early-stage dementia and a build-up of amyloid in their brains, Leqembi can slow cognitive decline for five months or so. But, Leqembi cannot stop the progression of Alzheimer’s disease, and it appears that it might not always be safe or effective.

    Medicare covers Leqembi under Medicare Part B for people with amyloid buildup in their brains. Patients who want the drug might have to pay out of pocket for a PET scan to demonstrate that building or get a spinal tap. They or their supplemental insurer is also responsible for the 20 percent coinsurance, more than $5,000.

    Medicare is requiring anyone administering the drug, which is injectable, to participate in a registry that documents Leqembi’s efficacy in the real world. And, people who take it will see a warning label that underscores the drug’s dangerous side effects, including brain bleeding and swelling.

    People on blood thinners are at extra risk of brain bleeds if they take Leqembi. So, the FDA has warned physicians to consider carefully whether to prescribe the drug to these people.

    To be clear, Leqembi does not improve memory or cognitive skills. It might help people be a little bit less forgetful. Patients who take Leqembi will need to undergo several brain scans and travel to receive the drug at an infusion center.

    Medicare’s registry will help scientists better understand the safety and efficacy of Leqembi. But, curiously, the Alzheimer’s Association is seemingly not interested and opposes the registry, claiming it will create a barrier to access.

    People with Alzheimer’s who are overweight or who smoke and people with hypertension or diabetes, could slow cognitive decline by losing weight, stopping smoking and/or treating their hypertension and diabetes.

    Leqembi comes with a price tag of $26,500 a year. The Medicare program is expected to spend $500 million on Leqembi this year and $3 billion on it next year. If so, Medicare Part B premiums will rise significantly because of this one drug over time, as will premiums for Medicare supplemental coverage.

    Here’s more from Just Care:

  • New Alzheimer’s drug shows promise at slowing cognitive decline

    New Alzheimer’s drug shows promise at slowing cognitive decline

    Damien Garde and Adam Feuerstein report for Stat News on likely FDA approval of a new drug to treat Alzheimer’s disease. In a clinical trial, the drug was shown to slow cognitive decline by 27 percent. Biogen and Eisai developed the drug, which they call lecanemab.

    Earlier this year, Biogen tried unsuccessfully to get FDA approval of Aduhelm to treat Alzheimer’s disease. But, Aduhelm showed limited at best clinical benefits and serious side effects.

    The clinical trial for lecanemab involved 1,800 patients with early-stage Alzheimer’s disease. It showed that patients fared better in terms of memory loss than patients who did not receive the drug. It also showed toxic plaque (amyloid) reduction in the brain and other benefits in terms of preserving memory and brain function.

    One in five patients who received lecanemab had brain swelling or bleeding. But fewer than three in one hundred showed symptoms.

    The FDA has said it will decide whether to conditionally approve lecanemab by Jan. 6. With new data, it could give full approval to lecanemab by the summer.

    The trial showed that patients who received lecanemab performed .45 points better on memory, problem-solving and personal care than patients who received the placebo, out of a total score of 18. The .45 point improvement is considered statistically significant, but this improvement may not be noticeable in a patient. Some experts believe the data available shows minimally significant positive results and want more data.

    Patients receive lecanemab twice a month through infusion.

    Here’s more from Just Care: