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An expert panel unanimously voted that Biogen’s controversial Alzheimer’s drug does not provide more benefit to patients than supportive care. The latest blow dealt to Aduhelm comes in the same week that two major health centers said they will not carry the drug.
The Institute for Clinical and Economic Review, a 15 member panel, met Thursday with Biogen representatives, patients and caregivers, and expert neurologists. The panel voted on whether the drug provides a net health benefit, if it has other potential benefits and important contextual considerations, and the long-term cost-effectiveness.
"Individuals and families dread Alzheimer’s disease, and the first therapy that effectively halts or reverses dementia will warrant a very high price in the U.S. health system" Dr. David Rind, ICER’s chief medical officer, said in a news release. "However, the clinical trial and evidence regarding aducanumab are complex, and we agree with many independent experts that the current evidence is insufficient to know whether or not aducanumab slows the loss of cognition."
Rind noted that many other drugs have been shown to remove amyloid from the brain, but did not necessarily improve the lives of Alzheimer’s patients and were not granted FDA approval.
COSTLY NEW ALZHEIMER'S DRUG COULD FORCE MEDICARE TO RESTRICT ACCESS
"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 aducanumab is insufficient to be able to demonstrate that patients get benefits that would outweigh the risks and harms of this treatment."
Earlier this month, the FDA revised the label to limit who it could be prescribed to, and FDA acting Commissioner Dr. Janet Woodcock called for an investigation into the agency’s staff communications with Biogen during the approval process.
The medication, which marked the first Alzheimer’s drug to enter the market in nearly 20 years, was granted accelerated approval by the FDA after an expert panel said data to consider the drug’s benefit was insufficient. Following the FDA’s decision to approve it, several panel members resigned.
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Endpoints News reported that Biogen’s chief medical officer blasted the ICER report on Thursday and called it "inappropriate" and "fundamentally flawed."
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