The Institute for Clinical and Economic Review (ICER) issued a revised evidence report Wednesday, now estimating that Biogen and Eisai's Aduhelm (aducanumab) should be priced between $3000 and $8400 annually for patients with early Alzheimer's disease in order to be cost-effective. The range works out at an 85% to 95% discount from the $56,000 price tag that the companies have set for the anti-amyloid antibody, an amount ICER considers "is not in reasonable alignment with its clinical benefits, even under a scenario with optimistic assumptions regarding…effectiveness."
The drug pricing watchdog, a vocal critic of the FDA's decision to grant Aduhelm an accelerated approval primarily based on findings from the conflicting Phase III EMERGE and ENGAGE trials, had previously calculated that treatment would have to be priced between $2500 and $8300 per patient per year in order to meet cost-effectiveness thresholds.
The draft ICER report was issued prior to the June 7 approval. ICER said the new one takes into account the breadth of the FDA's label and the announced treatment price, as well as comments from various stakeholders. "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 Aduhelm is insufficient to be able to demonstrate that patients get benefits that would outweigh the risks and harms of this treatment," commented David Rind, ICER's chief medical officer.
The group noted that the revised "health-benefit price benchmark" is slightly higher than the estimate it had proposed in its preliminary draft report, saying the difference is largely due to the FDA requiring fewer MRIs than what patients received during clinical trials. However, ICER said that the price range "would be lower" if patients with advanced dementia are also treated with Aduhelm, something that would be "consistent with the FDA's broader label."
Biogen and Eisai recently indicated that they would consider resetting the annual price of Aduhelm if it is prescribed to more people than anticipated, noting that the drug has so far only been studied in a subset of patients with early symptomatic Alzheimer's disease and confirmed amyloid pathology. ICER pointed out that while testing did not include patients with moderate or severe disease, "prior clinical trials of anti-amyloid drugs have suggested a lack of benefit in this population, and thus the potential that Aduhelm would benefit patients with severe forms of Alzheimer's disease is even less likely."
Meanwhile, ICER reiterated that a price range of $50,000 to $70,000 per year could still be considered cost-effective if a drug is used over the long term as chronic maintenance therapy to halt the progression of dementia in Alzheimer's patients, but Aduhelm "is not close to being this effective."
ICER's updated cost analysis comes shortly after two US House committees launched a joint investigation into the approval of Aduhelm, as well as its annual price tag. The announcement came hot on the heels of a call by two US Senators for a hearing looking into the potential budget impact of the product on the Medicare programme.
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