CMS Proposes New Rule for Coverage of PET Scan Needed for Alzheimer’s Drug Leqembi

CMS has proposed removing the national coverage determination for the positron emission tomography (PET) beta amyloid imaging needed to diagnose the onset of Alzheimer's disease and prescribe the newly approved antiamyloid antibody drug Leqembi (lecanemab-irmb).

Eisai, the maker of Leqembi, sought and acquired FDA full approval on July 6, making the drug eligible for CMS coverage under the Medicare program after CMS stated that it would cover the drug if it achieved full approval.

CMS has covered PET scans to diagnose the presence of beta amyloids in the brain since 2013, but only one scan per patient “in the context of clinical studies,” CMS explained.

Comment period on the proposed decision is open until Aug. 16.

Read the proposed decision here.

To read the full story, click here to subscribe.

Related Topics