Biotech Values

[Biowatch]

NY Times on Leqembi for Alzheimer’s

https://www.nytimes.com/2023/01/06/health/alzheimers-drug-leqembi-lecanemab.html

By Pam Belluck

The drug, Leqembi, may modestly slow cognitive decline in early stages of the disease but carries some safety risks. Still, data suggests it is more promising than the small number of other available treatments...

… Studies of the drug — an intravenous infusion administered every two weeks — suggest it is more promising than the scant number of other treatments available. Still, several Alzheimer’s experts said it was unclear from the medical evidence whether Leqembi could slow cognitive decline enough to be noticeable to patients.

… the list price for Leqembi (pronounced le-KEM-bee) would be $26,500 per year. The price is slightly lower than Aduhelm’s, but higher than that recommended by some analysts.

“Based on our draft results, that price would not meet typical cost-effectiveness thresholds,” said Dr. David Rind, the chief medical officer for the Institute for Clinical and Economic Review, an independent nonprofit organization that assesses the value of medicines. In a preliminary report last month, the institute said that to be cost-effective for patients, the price should be set between $8,500 and $20,600 a year.

…The Leqembi label says the drug should be used only for patients in early and mild stages of Alzheimer’s disease, matching the status of patients in the clinical trials of the drug. It instructs doctors not to treat patients without doing tests to confirm that they have one of the hallmarks of Alzheimer’s: a buildup of the protein amyloid, which Leqembi (like Aduhelm) attacks.

…About 1.5 million of the six million people with Alzheimer’s in the United States are estimated to be in the beginning phases of the disease, with diagnoses of either mild cognitive impairment or early-stage Alzheimer’s. How many will be treated with Leqembi will depend significantly on whether Medicare covers the drug.

… Like Aduhelm’s label, Leqembi’s includes warnings about brain swelling and brain bleeding and notes that patients with a gene mutation that increases the risk of developing Alzheimer’s have a greater risk of brain swelling with the treatment. [So, the patient population most at risk of AD is also most at risk of adverse events?!?]

Leqembi’s label also includes cautionary language about taking blood thinners while on the treatment, which has been raised as a concern with anti-amyloid drugs but was not addressed on Aduhelm’s label. “Additional caution should be exercised” when considering whether to give blood thinners to a Leqembi patient, the label says.

Concerns about safety have been stoked by news reports of the deaths of three patients who experienced brain swelling and brain bleeding, two of whom were being treated with blood thinners. Those patients participated in a large Phase 3 trial of the drug, during which they were not told whether they received it or a placebo. But their deaths occurred after that phase of the trial, when they were knowingly being treated with lecanemab in what’s known as an open-label extension study.

In a published letter responding to the New England Journal of Medicine report, two researchers involved in Eisai’s Leqembi trial asserted that “t-PA appears to be the proximate cause of death,” not Leqembi, and noted that the woman had two copies of a gene mutation that increases brain swelling risk with anti-amyloid treatments. But, they said, “we agree that this case raises important management issues for patients with Alzheimer’s disease.”

Etc.