Influential U.S. drug pricing research group the Institute for Clinical and Economic Review (ICER) has updated its assessment of Eisai’s new Alzheimer’s disease drug Leqembi. In the wake of a rival drug’s rejection, the agency supports a slightly higher price tag for the Eisai medicine than it had previously proposed.
Leqembi, also known as lecanemab, should cost between $8,900 to $21,500 per year to be considered cost effective, ICER said Wednesday.
The new recommended price means Eisai should take 19% to 66% off of Leqembi’s current list price of $26,500, ICER contends. Still, the upper end of ICER’s new range marked a $900 increase from the group’s original report, which was published in December. Before finalizing the report, ICER will hold a virtual public meeting March 17 to review the analysis.
ICER’s recommended prices reference a drug’s net price after discounts and rebates. Net prices are negotiated behind closed doors and typically aren’t disclosed to the public.
The group’s updated Leqembi report comes after the FDA in January declined to approve a rival drug named donanemab from Eli Lilly. Both drugs, as well as Biogen’s FDA-approved Aduhelm, work by reducing beta amyloid plaques in the brain.
After Lilly’s FDA rejection, ICER slightly tweaked its Alzheimer’s patient characteristics analysis, leading to new suggested price levels for Leqembi, an ICER spokesperson said David Rind, M.D., ICER’s chief medical officer, gave Eisai credit for delivering an evidence package that “strongly suggests” the anti-amyloid antibody “mildly slows” cognition decline in patients with early Alzheimer’s. The first therapy that “effectively halts or reverses dementia will warrant a very high price in the U.S. health system,” he said in a Wednesday statement.
But ICER’s wide price range also reflects the difficulties in reaching a consensus for its appraisal committee. Most notably, patients who take Leqembi can sometimes develop a potentially fatal side effect called amyloid-related imaging abnormalities (ARIA). Death cases suspected to be related to Leqembi have been reported in Leqembi’s clinical trials, where patients have been closely monitored and carefully managed.
Rind expressed concern for the side effect in the real world.
Given the ARIA risks, “we have some uncertainties as to whether the average benefits of lecanemab exceed its risks,” he noted.
ICER isn’t a government entity that can directly determine a drug’s price. But its opinions are used by payers, insurance companies and sometimes lawmakers in their decision making.
That means ICER’s analysis could come into play as Eisai discusses Leqembi coverage on Medicare with the U.S. government. A few days ago, the Centers for Medicare & Medicaid Services (CMS) rejected a petition to immediately reconsider a restrictive reimbursement policy for Leqembi and other drugs in its class.
After the CMS announcement, Eisai said it had anticipated that the agency would only make coverage changes after a traditional FDA approval. The Japanese pharma said it’s “actively working with CMS to determine the most efficient path to appropriate access.”
Leqembi has been approved under the FDA’s accelerated approval pathway and is under consideration for a full approval.