The U.S. Centers for Medicare and Medicaid Services (CMS) will take another look at its recent national coverage determination (NCD) that limits Alzheimer’s disease patients eligible for monoclonal antibody treatments to a single PET scan.
The potential revision of the NCD is based on stakeholder feedback and was "internally generated," CMS said in a post announcing the reconsideration.
"Clinical study protocols may involve more than one beta-amyloid PET scan per patient," CMS said.
CMS received a record 10,000 stakeholder comments and more than 250 peer-reviewed documents during the process to finalize the NCD, which was announced in April.
Currently, CMS payments cover approved drugs such as aducanumab (Aduhelm, Biogen) for Alzheimer's disease if patients are enrolled in clinical studies approved by the U.S. Food and Drug Administration (FDA). It limits patients eligible for these trials to one beta-amyloid PET scan per lifetime.
The Society for Nuclear Medicine and Molecular Imaging (SNMMI) encouraged members to submit comments and noted it voiced strong opposition to the current NCD during the last round of public input.
"Beta-amyloid PET is the standard of care -- and, in fact, the only test approved by the FDA -- for detecting beta amyloid," SNMMI said in a news release.
In stark contrast to amyloid PET scans, the current NCD explicitly covers other tests for detection of beta amyloid (e.g., cerebral spinal fluid) without limitation, SNMMI added.
The public comment period associated with the reconsideration of this NCD ends July 15. The proposed decision by CMS is expected by December 16, with the final decision to be made by March 16, 2023.