Is there ample proof that Biogen’s new Alzheimer’s med Aduhelm is beneficial to patients, physicians and society beyond the existing routine care? The response from a team of ICER experts, maybe unsurprisingly, was “no.”
During a daylong meeting Thursday involving debate over the drug’s costs and other issues, experts voted 15 to 0 that Aduhelm doesn’t offer benefits above standard care.
But ICER experts weren’t the only ones who brought criticisms to the controversial meeting. In an equally-sharp rebuke, Biogen reps hitted out at ICER’s cost-effectiveness values, which estimate Aduhelm at $8,400 annually-at most.
Biogen’s lead medical officer, Maha Radhakrishnan, M.D., was of the view that evaluating the drug would require “innovative thinking” and a new framework to determine its potential value.
“We regret that the ICER assessment missed the mark on this,” Radhakrishnan said to the group.
The experts’ unanimous rejections comes amid a weird and enduring saga of controversy following the FDA’s approval, announced just over a month ago. In only a matter of weeks, regulators have narrowed Aduhelm's label and urged for a private investigation into the allegedly cozy dealings between Biogen execs and FDA officials.
The company’s $56,000 price tag for a year’s worth of treatment has activated its own squabbles, including a Capitol Hill probe. Aduhelm’s list price came in way beyond ICER’s propositions and Wall Street estimates, and it doesn’t consider the MRIs patients and PET scans need together with their infusions.
Once those ancillary diagnostics and monitoring expenses are added, payers are putting Aduhelm’s price closer to $100,000 yearly, said Lesile Fish, vice president of clinical pharmacy at IPD Analytics.
In a related development, a pricing expert earlier this week noted that the drug could cause as much as $2 billion in annual medical waste as a result of 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.
A number of major hospital systems are refusing to administer the drug, and insurers are halting their coverage plans until Medicare makes a move. The government-run insurance plan launched a National Coverage Determination (NCD) analysis on Monday that will ultimately decide whether Medicare will cover the expensive treatment.
The ICER experts based their harsh review primarily on Biogen’s controversial late-stage clinical trials. While one trial found a modest benefit in slowing disease progression, the other trial showed the opposite. Widespread reports of brain swelling, or ARIA, were also an issue, although most cases were asymptomatic.
Biogen, for its part, criticized ICER for pooling data from the two trials together in its model, claiming that only the positive phase 3 readout should be used. The company relied much of its criticisms on Aduhelm’s proven ability to eliminate amyloid plaque in the brain, a major feature of Alzheimer’s disease.
“We cannot lose sight that this is the first approved treatment that targets a defining disease pathology rather than just the symptoms,” Biogen’s Radhakrishnan disclosed.
Above all, Thursday’s meeting was yet another show of the deeply emotional disunity between physicians, patients and Biogen over Aduhelm’s potentials. While critics fear the unproven drug could rack up billions in spending, patient advocacy associations and Biogen argue that millions of Alzheimer’s patients who have no alternatives stand to benefit.