Biogen is providing its much-debated Alzheimer's drug Aduhelm free of charge for some patients as it awaits claim reviews by Medicare, according to an Aug. 30 Barron's report.
The drugmaker has sent the drug to Medley-based Florida's First Choice Neurology for free. Biogen's giveaway will resemble a sample program and will allow Alzheimer's patients to begin taking the drug at the center, according to one of the clinic's neurologists.
The news comes after several large health systems — including Cleveland Clinic, the Department of Veterans Affairs, New York City-based Mount Sinai and Renton, Wash.-based Providence — said they will not include Aduhelm in their formulary.
Aduhelm was cleared by the FDA June 7 using the agency's accelerated approval pathway, marking the first Alzheimer's drug approved by the agency in two decades. The drug is the first treatment approved by the FDA intended to slow cognitive decline from Alzheimer's, as the Alzheimer's drugs the FDA previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.
The approval sparked an intense debate in the pharmaceutical and medical communities, with critics saying there was not enough evidence of clinical benefits to warrant an approval. Three members of the FDA's advisory committee resigned over the approval, and two House committees are investigating the drug's pricing and approval. On July 9, Janet Woodcock, MD, the FDA's acting commissioner, requested the HHS' Office of Inspector General conduct an independent review of the approval.