With personal stories of the effects that Alzheimer’s disease has had on them, lawmakers in a Senate Finance Committee hearing on Wednesday called for the federal government to speed up access to treatments. The topic of the hearing was the 2024 Health and Human Services budget.
The proclamations came in response to the Centers for Medicare & Medicaid Services denying a request from the Alzheimer’s Association and other advocates to reconsider its restrictive national coverage determination policy for Alzheimer’s drugs. CMS issued the coverage decision in April for aducanumab (Aduhelm), applying it to all future monoclonal antibody treatments.
Senate Finance Committee ranking member Mike Crapo (R-ID) said that the Food and Drug Administration’s accelerated approval pathway has provided a “lifeline” to advancing access to safe and effective medicines for conditions such as Alzheimer’s disease years before those treatments can come to the market.
But he said during the hearing that the administration is eroding that pathway, “deterring life-saving innovation and delaying access to care.” He said the move has “grave implications” for Alzheimer’s coverage decisions.
“This troubling trend began with CMS’ coverage restrictions for an entire class of Alzheimer’s therapies, and it seems set to continue with the recently announced accelerating clinical evidence model, which would slash payments for treatments that rely on accelerated approval,” Crapo said, adding that he signed his name to a letter urging the administration to “abandon this misguided model.”
In response to HHS Sec. Xavier Becerra’s comment during the hearing that CMS ”wants to be there” for people living with Alzheimer’s, Alzheimer’s Association Chief Public Policy Officer Robert Egge said that easily can be done.
“Reverse the decision and provide access now,” Egge said in a statement. “Every day matters. Each day CMS blocks access, more than 2,000 people transition to a more advanced stage of Alzheimer’s where they are no longer eligible for treatment.”
During a hearing of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, also on Wednesday and focused on the HHS budget, Sen. Susan Collins (R-ME) said that CMS is “acting as a roadblock for patient access” to the drugs, particularly in the early stages of the disease.
Egge said that comments during the Senate budget hearings capture the sentiment of millions of Americans.
“Access to FDA-approved Alzheimer’s treatment is indeed urgent, urgent business,” Egge said.
In February, 72 lawmakers signed a letter to Becerra and CMS Administrator Chiquita Brooks-LaSure emphasizing the importance of access to FDA-approved Alzheimer’s treatments. Senators sent a similar letter signed by 20 bipartisan colleagues.