The Institute for Clinical and Economic Review (ICER) has released a revised report on Biogen’s Aduhelm, saying the Alzheimer’s disease drug should be offered at a much lower price than it current $56,000 per year price tag.
Following its surprise approval in June, Biogen announced that it would price its controversial Alzheimer’s disease drug at $56,000 per year of treatment.
The high list price for Aduhelm (aducanumab) has since been met with criticism, with ICER adding in its report that the $56,000 per year is ‘not a fair price’ for the treatment.
In its revised report, ICER said its cost-effectiveness analysis for Aduhelm brought the price of the drug down significantly – to around $3,000 to $8,400 per year of treatment. This reflects a 85-95% discount on the drug’s current list price.
The cost range for Aduhelm in the revised report is slightly higher than ICER’s preliminary report, due to the US Food and Drug Administration (FDA) requiring fewer MRIs than patients had received during clinical trials.
ICER feels that the evidence for Aduhelm is ‘insufficient’ to prove the drug has a net health benefit for patients with mild cognitive impairment due to Alzheimer’s disease, as well as patients with mild Alzheimer’s disease.
The watchdog added that evidence suggests Aduhelm’s side effects are common and ‘potentially serious’, with the two phase 3 trials of the drug producing ‘contradictory’ results as to whether it can slow the progression of the disease or improve cognition.
“Individuals and families dread Alzheimer’s disease, and the first therapy that effectively halts or reverses dementia will warrant a very high price in the US health system,” said David Rind, ICER’s chief medical officer.
“However, the clinical trial history and evidence regarding aducanumab are complex, and we agree with many independent experts that the current evidence is insufficient to know whether or not aducanumab slows the loss of cognition.
“After months of delving into the data, and working with patient groups, clinical experts, and the manufacturer to gain their perspectives, our judgment remains that the evidence on aducanumab is insufficient to be able to demonstrate that patients get benefits that would outweigh the risks and harms of this treatment,” he added.