Leqembi still too pricey, says ICER in updated review

Drug cost-effectiveness organisation ICER has revised its view of Eisai’s new Alzheimer’s disease therapy Leqembi, but has concluded that the price set by the pharma group is still too high.

The influential organisation said a fair price for the amyloid-busting drug would be between $8,900 and $21,500 per year, a little bit higher than its earlier range of $8,500 and $20,600, but still well below the $26,500 set by Eisai after it was approved in January.

ICER has also reiterated its position that the evidence that Leqembi (lecanemab) has a clinical benefit for patients over supportive care is “promising, but inconclusive,” with chief medical officer David Rind saying that current evidence is that the drug “mildly slows the loss of cognition in patients with early Alzheimer’s.”

He added that the first drug that shows definitively that it can halt or reverse dementia in Alzheimer’s will “warrant a very high price in the US health system.”

At the moment the cost-effectiveness deliberations are somewhat academic, as use of Leqembi remains restricted to subjects in clinical trials, under the limitations imposed by the US Centers for Medicare and Medicaid Services (CMS) for all amyloid-targeting Alzheimer’s therapies, which were slammed by patient organisations as “pernicious” last week.

That could change if the FDA decides to upgrade the current conditional approval of Leqembi to a full approval, which could follow the final results of the phase 3 CLARITY-AD study, which revealed a 27% reduction in cognitive decline compared to placebo at an interim readout.

Those results could be available within a few weeks, and then ICER’s number-crunching could have a bearing on discussions on Medicare reimbursement.

The broad price range reflects the difficulties in appraising new medicines for a complex disease like Alzheimer’s, where there is an incomplete understanding of the underlying molecular mechanisms that could be targeted with disease-modifying therapies.

One big reason for the range is the association between Leqembi and amyloid-related imaging abnormalities (ARIA), a group of side effects that can lead to brain swelling and bleeding, and in some cases has fatal consequences.

Rind said the risk of ARIA with Leqembi introduces “uncertainties as to whether the average benefits of lecanemab exceed its risks.”

ICER’s latest Evidence Report will be up for discussion at a virtual public meeting of the California Technology Assessment Forum (CTAF) on 17th March. It incorporated feedback from the earlier version that was published last year.

ICER also confirmed that it had removed Eli Lilly’s amyloid drug donanemab from its appraisal, after early approval was rejected by the FDA in January.