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Is there enough evidence to show that Biogen’s new Alzheimer’s drug, Aduhelm, provides a benefit to patients, physicians and society beyond current standard care? The response from a group of ICER experts, perhaps unsurprisingly, was ‘no’.
During a day-long meeting Thursday that featured a debate on the cost of the drug and more, experts voted 15 to 0 that Aduhelm does not offer benefits greater than routine care.
But ICER experts were not the only ones criticizing the controversial meeting. In an equally scathing rebuke, Biogen representatives lashed out at ICER’s profitability estimates, which value Aduhelm at $ 8,400 per year, at most.
Biogen’s top medical official, Maha Radhakrishnan, MD, argued that evaluating the drug would require “innovative thinking” and a new framework to assess its potential value.
“We regret that the ICER evaluation missed the mark on this,” Radhakrishnan told the group.
The overwhelming rejection by experts comes amid a strange and enduring saga of controversy following the FDA approval, issued just over a month ago. In just weeks, regulators downgraded Aduhelm’s label and called for an independent investigation into the seemingly comfortable relationship between Biogen executives and FDA staff.
The company’s $ 56,000 price tag for a year of treatment has sparked its own bickering, including a Capitol Hill probe. Aduhelm’s list price was well above ICER suggestions and Wall Street estimates, and it does not include CT scans and MRIs that patients need in addition to their infusions.
Once those ancillary diagnostic and monitoring fees are included, payers estimate Aduhelm’s cost to be nearly $ 100,000 per year, said Leslie Fish, vice president of clinical pharmacy at IPD Analytics.
Meanwhile, a pricing expert this week said the drug could generate $ 2 billion in annual medical waste due to ineffective packaging.
“We’re talking about taking some money from the average American through the health care system and passing it on to stakeholders at Biogen,” said Annette Langer-Gould, MD, voting member of the California Technology Assessment Forum (CTAF). from ICER and neurologist at Kaiser Permanente.
RELATED: Biogen’s $ 56,000 Price on Aduhelm? Think again, says ICER, calling for discounts of around 90%
Some large 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 on Monday opened a National Coverage Determination Analysis (NCD) that will ultimately decide whether Medicare will cover the expensive treatment.
ICER experts based their unfavorable opinion primarily on the conflicting clinical trials of Biogen at an advanced stage. 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, criticized ICER for pooling data from both trials in its model, suggesting that only the positive reading from phase 3 should be included. The drugmaker focused much of its rebuke on Aduhelm’s proven ability to clear amyloid plaque in the brain, a hallmark of Alzheimer’s disease.
“We cannot lose sight of the fact that this is the first approved treatment that targets a defined pathology rather than just symptoms,” said Radhakrishnan of Biogen.
Importantly, Thursday’s meeting was yet another demonstration of the deeply emotional disagreements between doctors, patients and Biogen over Aduhelm’s outlook. 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 will benefit.
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