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Latest From Biogen, Inc.
First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.
But premiums in future years made need to keep pace with accelerating Medicare spending on Alzheimer’s drugs.
With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?
Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.
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