The Institute for Clinical and Economic Review (ICER) released a draft evidence report assessing Biogen and Eisai's aducanumab for the treatment of Alzheimer's disease, suggesting that an annual price tag of $50,000, as predicted by some analysts, "would not be in reasonable alignment" with the anti-amyloid beta drug's clinical benefits. A decision on whether to approve aducanumab is expected from the FDA by June 7 following a negative advisory panel vote last year.
David Rind, ICER's chief medical officer, remarked "the clinical trial history and evidence regarding aducanumab are complex, and we believe that at the current time the evidence remains insufficient to determine whether the drug provides an overall health benefit." The application for aducanumab is primarily based on findings from the Phase III EMERGE and ENGAGE trials, which had initially failed a futility analysis. However, the companies released a subsequent analysis that they said backed the effectiveness of a high-dose of the drug given over a longer period in EMERGE, and while ENGAGE still failed, they considered that a subset of data from that trial supported the EMERGE findings.
Biogen and Eisai have argued that the different results for the two studies may be explained by rapid progressors and exposure to full-dose therapy. However, ICER said that "other explanations are equally or more likely," adding that "one alternative explanation is that the differences between the trials are due to chance."
ICER performed an analysis using combined results from the two contradictory trials, and determined that the price of aducanumab would need to be between $2500 and $8300 per patient per year in order to meet traditional cost effectiveness thresholds. In an "optimistic scenario" that only considers the favourable study, ICER said the health gains for patients could support an annual price of between $11,100 and $23,100 for aducanumab.
The group also calculated what a fair price would be for a potential chronic maintenance therapy that halted the progression of dementia, but did not cure Alzheimer's disease. Such a treatment, it said, would have a "considerable" budget impact for Medicare and other US payers due to the large patient population, but could be priced between $50,000 and $70,000 per year, and still meet long-term cost-effectiveness thresholds.
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