Latest Alzheimer’s drug needs to be cheaper than, watchdog says

Latest Alzheimer’s drug needs to be cheaper than, watchdog says

The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.

The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.

Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6.

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Hanging over the impending launch of lecanemab is the recent disaster of Aduhelm, an Alzheimer’s medicine developed by Eisai and Biogen but commercialized by the latter. In 2021, Biogen set a list price of $56,000 a year for the average patient and later cut that number in half after backlash from physicians and payers. Months later, amid doubts about the drug’s efficacy, Medicare implemented a policy that all but prohibits reimbursing for Aduhelm and any Alzheimer’s medicines that work by targeting toxic plaques in the brain, a category that includes lecanemab.

For lecanemab to succeed where Aduhelm failed, Eisai will need to persuade regulators that the drug’s clinical trial data, recently published in the New England Journal of Medicine, make it a worthwhile medicine for patients in the early stages of Alzheimer’s. And the company will need to set a price that doesn’t make that argument untenable.

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In its analysis, ICER considered a roughly 2,000-volunteer clinical trial in which lecanemab slowed the cognitive and functional decline of patients with early-stage Alzheimer’s by 27% relative to placebo. In the 18-month study, Eisai’s drug also dramatically reduced patients’ levels of beta-amyloid, a toxic protein in the brain thought to drive the advance of Alzheimer’s, and the drug showed statistically significant benefits on three backup measures of cognition and function.

About 20% of patients in the study experienced swelling or bleeding in the brain, a common side effect of amyloid-targeting medicines. Most of those cases resolved on their own, with about 4% resulting in symptoms.

Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds. The first, reported by STAT in October, was an 87-year-old patient taking the blood-thinner Eliquis. The second, revealed by Science in November, was a 65-year-old given a powerful anticoagulant after suffering a stroke, leading to concerns that the micro-hemorrhages tied to lecanemab could become dangerous bleeding episodes for patients taking blood thinners. A third, reported in Science on Wednesday, was a 79-year-old woman who received a course of the blood-thinner heparin after hospitalization.

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