The Food and Drug Administration limited eligibility for the Alzheimer’s Disease treatment Aduhelm, an abrupt change in prescribing guidance linked to the sky-high price tag and dubious scientific evidence that it works.
“Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. … There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied,” the FDA announced Thursday.
IN COST-SAVING MOVE, MEDICARE COULD LIMIT PATIENT ACCESS TO ALZHEIMER’S TREATMENT
The FDA’s decision to narrow the pool of eligible patients from anyone with Alzheimer’s to only those with mild symptoms will ease the financial burden on the federal government. If prescribed to just 1 million Alzheimer’s patients, spending on Aduhelm alone would exceed $57 billion in a single year, according to a report from the Kaiser Family Foundation. The out-of-pocket cost to patients, when taking into consideration the costs of imaging and other related healthcare services that a patient would need throughout the course of treatment, would come to about $11,500.
The monthly IV treatment was first approved in early June for use in all Alzheimer’s patients in the United States. Roughly 6 million people would have been eligible to receive the treatment, most of whom are enrolled in Medicare, the government healthcare program for seniors. The manufacturer Biogen angered Alzheimer’s patient advocacy groups that had initially cheered on the approval, as well as federal lawmakers, when it announced the list price for the injections would come to $56,000 for a year’s supply.
The “accelerated approval” granted by the FDA stipulated that Biogen will have to continue trials of the treatment to prove efficacy to the FDA, but the timeline for those trials remains unclear.
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Aduhelm is a monoclonal antibody treatment that clears a “sticky” plaque in the brain made up of the protein beta-amyloid, which accumulates in the brains of Alzheimer’s patients and is believed to cause memory and cognition problems. But Biogen trial results did not provide proof of a clear benefit against the progression of the disease
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The FDA overruled neurologists on the panel of experts tasked with reviewing clinical trial data, which they argued did not provide enough proof that the monthly injections work to slow cognitive decline. Three scientists resigned from the panel in protest after the FDA’s decision to override the panel’s unanimous decision to recommend against approving the treatment.
