Health and Human Services Secretary Xavier Becerra came under fire Wednesday during a Senate Finance Committee meeting regarding the Centers for Medicare & Medicaid Services’ restrictive national coverage determination (NCD) policy for new drugs to treat Alzheimer’s disease.
Last month, CMS said it would not reconsider its policy for monoclonal antibody drugs that target amyloid brain plaques, despite a formal request from the Alzheimer’s Association and pressure from lawmakers. CMS’ NCD for anti-amyloid drugs restricts coverage for those approved via FDA’s accelerated approval pathway to clinical trials and for drugs that received full approval to registry-based studies.
The senators on Wednesday questioned the coverage restrictions in two hearings on the 2024 fiscal budget. At the Senate Finance Committee hearing, ranking member Mike Crapo (R-ID) said the administration is eroding the accelerated approval process.
“This troubling trend began with CMS’ coverage restrictions for an entire class of Alzheimer’s therapies and it seems to set to continue with the recently announced accelerating clinical evidence model, which would slash payments for treatments that rely on accelerated approval,” Crapo said.
At the appropriations subcommittee hearing, ranking member Shelley Moore-Capito (R-WV) and Appropriations Vice Chair Susan Collins (R-ME) argued that access to Alzheimer’s drugs through clinical trials isn’t enough, especially for people living in rural areas.
“I just do not understand CMS’s misguided and outright unprecedented decision to not cover a whole class of Alzheimer’s drugs,” Collins said, according to prepared remarks. “It is not CMS’s job to second-guess the drug approvals of the FDA. That’s not what CMS is supposed to do,” Collins said.
Senate Finance Chair Ron Wyden (D-OR), in closing out the Senate Finance Committee hearing, told Becerra that soon he personally would be urging CMS to speed up access to Alzheimer’s treatments and services and expects to be working closely with HHS — a statement that drew cheers from patient advocates.
“I think, Mr. Secretary, seriously, we’ve seen how strongly the committee feels. We’ve seen how strongly the country feels. This is urgent, urgent business,” Wyden said.
