Shares in Biogen fell on Wednesday, a day after federal regulators imposed coverage restrictions on the drugmaker’s new treatment for Alzheimer’s disease.
The Centers for Medicare and Medicaid Services said Tuesday after market closing time that patients taking Biogens Aduhelm should also participate in clinical trials to assess the drug’s efficacy in order for Medicare to cover costs.
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This is an important warning because Medicare is expected to cover most of the patients who choose Aduhelm, and the drug can cost as much as $ 28,000 annually, not including the cost of brain scans and other care that patients need while taking it. .
Biogen had cut those costs down from more than $ 50,000 annually last month after taking months of criticism over the expense.
The original Medicare coverage decision will significantly restrict access to Aduhelm, said Mizuho Securities U.S. analyst Salim Syed. He had previously estimated about $ 3.5 billion to $ 4 billion in peak annual sales for the drug.
But he said Wednesday that he now assumes less than $ 100 million.
Medicare’s national coverage provision will become final on 11 April following a public comment period and further evaluation by the Agency.
The U.S. Food and Drug Administration had approved Aduhelm in June last year and later said it was appropriate for patients with mild symptoms or early stage of Alzheimer’s.
Aduhelm removes cerebral palsy, which is thought to play a role in Alzheimer’s disease, and regulators made their appeal based on research showing that the drug appeared to benefit patients. But they have asked for another inquiry.
Biogen said last month that it would submit final plans for this study to the Food and Drug Administration in March. It then plans to have the first patient screened for the research in May.
Researchers will aim to enroll about 1,300 people with Alzheimer’s at an early stage and expect to complete the research about four years after the study begins.
Aduhelm has been hailed as a promising treatment by some researchers because it has the potential to slow down the deadly Alzheimer’s. No medicine on the market is doing that at the moment.
But concerns about cost and effectiveness have slowed the drug’s debut.
Biogen CEO Michel Vounatsos said Monday that the company now has about 220 sites that treat patients with Aduhelm.
Biogen said in June, shortly after FDA approval, that about 900 sites in the United States have the equipment and expertise to immediately begin administering the drug, which requires monthly IVs.
The shares in Cambridge, Massachusetts-based Biogen Inc. fell $ 16.18, or 6.7%, to close Wednesday at $ 225.34.
The stock had risen above $ 400 following the FDA decision in June.
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