Biogen's experimental Alzheimer's drug, aducanumab, could be a game changer for millions of patients, but the U.S. healthcare system will likely struggle to get it to those who could benefit from it the most, Bloomberg reported May 24.
The FDA is expected to make a decision on whether to approve the drug by June 7. It would be the first drug authorized to alter the course of the most common type of dementia.
Aducanumab, which is given intravenously once a month, is believed to slow the progression of Alzheimer's in people who show early signs of cognitive impairment, Bloomberg reported.
A 2017 analysis by Rand Corp. estimated that 88 million Americans 55 years and older could be eligible for screening for a drug like aducanumab, and that 2.4 million people could ultimately be candidates for the drug.
But several bottlenecks stand in the way of the drug getting to those patients, according to Bloomberg. Patients must first be screened to determine if they have early signs of cognitive impairment that may be caused by Alzheimer's, and the U.S. has a limited number of dementia specialists needed to do so.
Patients must then be screened for amyloid plaques, which is a clear indicator of Alzheimer's in the brain, according to Bloomberg. That's typically done through a positron emission tomography, or PET, scan.
Patients who qualify for the drug would have to take monthly trips to infusion centers, and there are a limited number of seats at such facilities, Bloomberg reported. Patients would also need regular scans to monitor for side effects, such as brain swelling, a frequent side effect in clinical trials.
The Rand Corp. predicts that the average wait time for a patient to receive the drug could be 18 months, during which their disease could worsen to the point that they no longer qualify.
Steve Miller, chief clinical officer at Cigna, told Bloomberg he expects health plans will require patients receiving aducanumab strictly match the indication specified by the FDA, making it a very narrow use group.
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