Even though Biogen’s Alzheimer’s disease drug Aduhelm scored a hotly debated, wide-labeled FDA nod earlier this month, the treatment still isn’t worth more than a mere 15% of the annual $56,000 list price the company is charging, a prominent U.S. drug cost watchdog argues.
The Institute for Clinical and Economic Review (ICER) said in a revised cost-effectiveness analysis Wednesday that Aduhelm’s controversial price tag is “not in reasonable alignment with its clinical benefits.” In ICER’s view, Aduhelm would need an 85% to 95% discount from its current list price to meet what the watchdog would consider fair.
That would be $3,000 per year on the low end and, potentially, as much as $8,400, ICER said, far below Biogen’s asking price. That’s slightly above the estimates of $2,500 to $8,300 the group previously set for the drug, but that change is mostly because the FDA is requiring fewer MRIs than patients had received during clinical trials.
RELATED: An Alzheimer's med for $2,500? Watchdog blasts Biogen's aducanumab data, suggests low price
Aduhelm’s cost would be justified if the treatment halted the progression of dementia in Alzheimer’s patients, ICER said. If that were the case, its fair price could go up to $70,000. But the antibody therapy “is not close to being this effective,” ICER said.
As reasoning, the group pointed to the two conflicting late-stage trials in patients with early-stage and mild Alzheimer’s that have been at the center of the controversy surrounding Aduhelm, also known as aducanumab.
In the EMERGE trial, patients who got the highest dose of aducanumab experienced a 22% improvement on a clinical dementia scale over placebo after 78 weeks, the company reported. Yet the same patient group in another study did worse than placebo on that same measure.
Even with the slight improvement shown in one study, the evidence is “insufficient to be able to demonstrate that patients get benefits that would outweigh the risks,” ICER said.
RELATED: A $57B drug? Medicare faces a massive bill for Biogen's Aduhelm—even if it limits coverage
That’s not to mention the cost the healthcare system stands to incur. The drug could cost an average of $39,600 per patient during their first year of treatment, which would then swell to roughly $176,200 by their fifth year, ICER estimates.
The nonprofit said it will meet with Biogen to discuss its findings July 15.
A Biogen spokesperson told Fierce Pharma that the company doesn't believe ICER's report "reflects the value of treatment or appropriately factors in the massive burden Alzheimer’s disease has on society." Biogen added that ICER "missed the mark on how much strain is placed on families who care for their loved ones."
Facing mounting criticism, Biogen recently issued a lengthy response promising to work with public and private insurers to ensure Aduhelm doesn't break their budgets. The company has vigorously defended Aduhelm’s list price for weeks, with CEO Michel Vounatsos saying it’s "substantiated by the value it is expected to bring to patients, caregivers and society.”
Not all have agreed. Even the Alzheimer's Association, a leading advocate for Aduhelm’s FDA approval, called the drug’s list price “simply unacceptable” and warned it will “pose an insurmountable barrier to access.”
Lawmakers were also quick to push back, and, over the last week, rumblings on Capitol Hill have been growing louder. The House Committee on Oversight and Reform said Friday that it will launch an investigation into what went on behind the company's pricing strategies, which “will have broader implications for seniors, providers, and taxpayers.”