The U.S. Food and Drug Administration’s (FDA) approval process of the controversial and costly new Alzheimer’s drug Aduhelm was “rife with irregularities” and “highly atypical,” according to a report released on Dec. 29 by the House Oversight and Energy and Commerce committees. The report (pdf) is the result of an 18-month investigation conducted by the Committee on Oversight and Reform, and Committee…
Biden Touts Reduction of 2023 Medicare Fees, Due Largely to Limiting of Alzheimer’s Drug
President Joe Biden on Tuesday touted a decline in costs for tens of millions of Americans covered by the Medicare health program as the country continues to battle with soaring inflation, stating that the “American people won, and Big Pharma lost.” Monthly premiums for Medicare Part B will drop by $5.20 for an annual savings of…
FDA Finally Approved an Alzheimer’s Drug—But Everything Surrounding It Is Controversial
August 20, 2022
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Analysis Aduhelm is the brand name under which the Alzheimer’s drug Aducanumab is marketed. It is developed by the U.S. company Biogen. The drug is to be administered as an intra-venous infusion every four weeks. The Food and Drug Administration (FDA) approved Aducanumab in June 2021, making it the first Alzheimer’s disease medication approved by the…
Fixed Packaging of Alzheimer’s Drug May Waste $605 Million a Year for Medicare, Experts Warn
July 6, 2022
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Medicare could potentially waste up to $605 million annually from the packaging of controversial Alzheimer’s drug aducanumab if it is approved for widespread use, according to a University of California Los Angeles (UCLA) study. “Given Medicare’s premium increase in 2022 partly due to aducanumab, greater focus on efficient vial packaging could improve the value of…
Biogen CEO to Step Down, Drugmaker Pulls Back on Alzheimer’s Drug Aduhelm
Biogen Inc said on Tuesday that Chief Executive Michel Vounatsos will step down and that the company is pulling back on selling its Alzheimer’s drug Aduhelm after the U.S. government’s Medicare program restricted coverage of the controversial treatment to patients in clinical trials. Vounatsos, who was named as the CEO in 2016, will continue in…
Medicare Officially Limits Coverage of Alzheimer’s Drug to Those in Clinical Trials
Medicare will only cover a drug for Alzheimer’s disease for patients in clinical trials, President Joe Biden’s administration announced on April 7. The drug, Aduhelm, is made by Biogen. The government said in January that it planned to limit coverage of the drug, which costs $28,000 a year, to trial enrollees. But the announcement was…
Biden Administration Decides to Limit Medicare Coverage of New Alzheimer’s Drug
Medicare will only cover a new Alzheimer’s drug that costs $28,000 a year for patients who are enrolled in clinical trials, President Joe Biden’s administration announced preliminarily Tuesday. Aduhelm, made by Biogen, was approved by drug regulators last year. Since then, the Centers for Medicare & Medicaid Services (CMS) has been assessing whether to cover…
CMS May Review Medicare Premium In Light of Aduhelm Price Drop
President Joe Biden’s administration is considering a reassessment of Medicare Part B premiums after the drugmaker behind a new Alzheimer’s drug cut its price. The administration announced in November 2021 that the monthly premium would rise by nearly $22 and attributed the rise in part to the potential use of Aduhelm, an Alzheimer’s drug from…
Biogen Halves Price of Alzheimer’s Drug to $28,200
Biogen Inc. on Monday cut the price of its Alzheimer’s drug by about half to $28,200 for an average weight person after facing slower-than-expected U.S. sales on complaints from hospitals that its high cost was not worth its benefits. The U.S. Food and Drug Administration (FDA) approved the drug, Aduhelm, in June to treat the…
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