Medicare said Tuesday it will limit coverage of a $28,000-a-year Alzheimer’s drug whose benefits have been widely questioned, a major development in the nation’s tug-of-war over the fair value of new medicines that offer tantalizing possibilities but come with prohibitive prices.
The initial determination from the Centers for Medicare and Medicaid Services means that for Medicare to pay, patients taking Biogen’s Aduhelm medication will have to be part of clinical trials to assess the drug’s effectiveness in slowing the progression of early-stage dementia as well as its safety.
Medicare’s national coverage determination would become final by April 11, following a public comment period and further evaluation by the agency.
“Alzheimer’s disease is a devastating illness that has touched the lives of millions of American families,” Medicare administrator Chiquita Brooks-LaSure said in a statement. “CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”
The requirement for clinical studies applies to the entire class of drugs of which Aduhelm is a pioneer, monoclonal antibodies that work against amyloid, a kind of protein that forms plaques characteristic of Alzheimer’s disease.
Cambridge-based Biogen sharply disapproved of Medicare’s decision. The company said in a statement that the decision “denies the daily burden of people living with Alzheimer’s disease.”