The CMS issued its statement late Wednesday following a request from the Alzheimer’s Association to reconsider its coverage policy on amyloid-clearing antibody drugs. The agency said its standards for coverage, that a drug is “reasonable and necessary,” differ from the FDA’s “safe and effective” requirements for approval, and the data its top officials have seen so far haven’t changed their views.
“We are aware that additional publications may be forthcoming that include information relevant to the questions included in the current [policy],” the statement said. “CMS will expeditiously review any new evidence that becomes available that could lead to a reconsideration.”
