The ICER (Institute for Clinical Economic Review) is an influential drug pricing group in the United States, and it has updated its evaluation of Leqembi, an Alzheimer’s drug by Eisai. The agency has suggested a comparatively higher price point that was agreed upon beforehand for the medication in light of a rival drug’s failure. ICER said that for the drug to be cost-effective it should be priced between $8,900 and $21,500.
The new price suggested by ICER means that Eisai should potentially decrease the current price of $26,500 by as low as 19% and as high as 66%. However, the upper bracket of the price range given by ICER is a $900 increase from the original report from back in December. A virtual public meeting will be held by ICER in mid-March before anything is finalized. The new recommended prices are the net prices of the drug after rebates and discounts. The net prices are generally not released to the public and are decided behind closed doors.
This updated report has come after the approval of a rival drug, Eli Lilly’s deonanemab was rejected by the FDA in January. Along with Biogen’s already approved Aduhelm, both these drugs cause a reduction in the beta-amyloid plaques found in the brain.
According to an ICER spokesperson, the agency changed the analysis of Alzheimer’s patient characteristics a little bit following the rejection of Eli Lilly’s drug, which is why the new prices were recommended for Leqembi.
ICER’s CMO (Chief Medical Officer) gave credit to Eisai for presenting evidence that suggests the slowing down of cognition decline by the use of the anti-amyloid antibody in early Alzheimer’s patients. The CMO also said that the first medication that is effective in stopping or reversing dementia will have a very high price in the United States market.
The wide range in the recommended price also shows that reaching a consensus was troublesome for the appraisal committee.
ICER’s opinions are of use to insurance companies, payers, and at times lawmakers for the purpose of decision-making, despite the agency not being a government body that can directly affect the drug’s pricing. ICER’s analysis could be of use when the Eisai talks to the U.S. government regarding coverage of Lecembi on Medicare. Not long ago, the CMS (Centers for Medicare and Medicaid Services) rejected an appeal to reconsider a reimbursement policy for the drug and other medicines in the same class.
The drug is being considered for full approval and has been approved by the FDA under the accelerated approval path.
Side effects/ risks associated with the drug:
- Patients who take Leqembu can, at times, develop a possibly fatal side effect called ARIA (amyloid-related imaging abnormalities).
- It is suspected that the death cases are connected to Leqembi, and it was reported in the clinical trials of the drug.
- The patients in the trial were carefully managed and strictly monitored. The CMO voiced concern about the impact of the side effect.
- Talking about the risks involved with ARIA, the CMO stated, “we have some uncertainties as to whether the average benefits of lecanemab exceed its risks.”
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