Is there enough evidence to show Biogen’s new Alzheimer’s drug Aduhelm provides a benefit to patients, physicians and society beyond the current standard care? The answer from a group of ICER experts, perhaps unsurprisingly, was "no."
During a daylong meeting Thursday that featured debate over the drug's cost and more, experts voted 15 to 0 that Aduhelm doesn't provide benefits above routine care.
But ICER experts weren't the only ones to bring criticisms to the contentious meeting. In an equally-sharp rebuke, Biogen representatives blasted ICER's cost-effectiveness estimates, which value Aduhelm at $8,400 per year—at most.
Biogen’s top medical officer, Maha Radhakrishnan, M.D., argued that evaluating the med would require “innovative thinking” and a new framework to assess its potential value.
“We regret that the ICER assessment missed the mark on this,” Radhakrishnan told the group.
The experts' overwhelming rejection comes amid a bizarre and enduring saga of controversy following the FDA’s approval, issued just over a month ago. In just a matter of weeks, regulators have narrowed Aduhelm’s label and called for an independent investigation into the reportedly cozy dealings between Biogen execs and FDA personnel.
The company’s $56,000 price tag for a year’s worth of treatment has triggered its own squabbles, including a Capitol Hill probe. Aduhelm’s list price came in way above ICER’s suggestions and Wall Street estimates, and it doesn't include the PET scans and MRIs patients need alongside their infusions.
Once those ancillary diagnostics and monitoring expenses are included, payers are pegging Aduhelm’s cost closer to $100,000 annually, said Leslie Fish, vice president of clinical pharmacy at IPD Analytics.
Meanwhile, one pricing expert this week said the drug could trigger $2 billion in annual medical waste due to inefficient packaging.
“We’re talking about taking little bits of money from the average American through the healthcare system and transferring it to the stakeholders of Biogen,” said Annette Langer-Gould, M.D., a voting member of ICER’s California Technology Assessment Forum (CTAF) and neurologist at Kaiser Permanente.
Some major hospital systems are refusing to administer the drug, and insurers are delaying their coverage plans until Medicare makes a move. The government-run insurance plan opened a National Coverage Determination (NCD) analysis on Monday that will eventually decide whether Medicare will cover the pricey treatment.
The ICER experts based their unfavorable review mostly on Biogen’s conflicting late-stage clinical trials. While one trial showed a modest benefit in slowing disease progression, the other trial found the opposite. Frequent reports of brain swelling, or ARIA, were also a concern, although most cases were asymptomatic.
Biogen, for its part, slammed ICER for pooling data from the two trials together in its model, suggesting that only the positive phase 3 readout should be included. The drugmaker focused much of its rebuke on Aduhelm’s proven ability to remove amyloid plaque in the brain, a hallmark of Alzheimer’s disease.
“We can not lose sight that this is the first approved treatment that targets a defining disease pathology rather than just the symptoms,” Biogen’s Radhakrishnan said.
Above all, Thursday’s meeting was yet another display of the deeply emotional disagreements between physicians, patients and Biogen over Aduhelm’s prospects. While critics say the unproven drug could rack up billions in spending, patient advocacy groups and Biogen say millions of Alzheimer’s patients who have no other options stand to benefit.
https://www.fiercepharma.com/pharma/despite-biogen-s-sharp-rebuke-cost-watchdog-experts-unanimously-refute-aduhelm-s-benefits
