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Sen. Bill Cassidy, R-La., and Sen. Elizabeth Warren, D-Mass., are leading an effort to examine the Food and Drug Administration's (FDA's) recent approval of a drug to treat Alzheimer’s disease and its impact on Medicare.
The FDA on June 7 approved the drug called Aduhelm — the first FDA-approved medication to treat Alzheimer's — produced by Cambridge-based biotechnology company Biogen.
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Cassidy and Warren are concerned that the drug could "command" an estimated "$37 billion we currently spend on Medicare Part B and the $90 billion we currently spend on Medicare Part D," according to a Thursday letter addressed to Senate Finance Committee Chairman Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho.
"This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resilience," the senators wrote.
This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. (Biogen via AP)
The senators noted that Alzheimer's is one of the most "costly" diseases in the U.S.
It is expected that the disease may have cost the country $355 billion in 2021, "including $239 billion in Medicare and Medicaid payments," according to the senators. Aduhelm, meanwhile, will cost $56,000 per year per person and could treat as many as 6 million Americans with no limit on when people should stop taking the drug, they said.
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For those reasons, Warren and Cassidy are calling for a Senate hearing to examine the drug and its impact on the federal health care program.
Wyden tweeted his own concerns about the FDA's approval of Aduhelm on June 8.
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"It’s unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective," he tweeted at the time. "Medicare must be able to negotiate a fair price for prescription drugs."
The drug, which is the first approved for Alzheimer’s since 2003, works to remove sticky deposits of a protein called amyloid beta from the brain. Cavazzoni said in her statement that the clinical trials for Aduhelm were the first to show that a reduction in these plaques is expected to lead to a reduction in the clinical decline of patients.
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The Alzheimer's Association called the approval "the beginning of a completely new future for Alzheimer's treatments."
Fox News' Alexandria Hein contributed to this report.