US Lawmakers Move to Strip CMS of Some Market Access Influence

A bipartisan group of lawmakers in the US House of Representatives have put forward legislation to curb the Center for Medicare & Medicaid Services’ (CMS) ability to dictate market access for new biologics. The legislation is spearheaded by Rep Vern Buchanan (R-FL) and Nanette Barragan (D-CA). The move comes in response to the agency’s response to the controversial Alzheimer’s drug Aduhelm, wherein it refused to reimburse the drug unless patients were registered in a randomized controlled clinical trial (RCT).

According to Robert King, “Back in April, CMS finalized a national coverage determination that targets not only Aduhelm but the entire class of treatments. CMS ruled that only Medicare patients in eligible clinical trials would get coverage for the monoclonal antibodies directed against amyloid plaques. So far, the Food and Drug Administration has only approved Biogen’s Aduhelm in the class. However, more such drugs are in the pipeline, and their clinical efficacy has been disputed.”

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(Source: Fierce Pharma, October 6^th, 2022)