The Medical Imaging and Technology Alliance (MITA) is praising the U.S. Food and Drug Administration (FDA) for its traditional approval of Eisai and Biogen's Alzheimer's disease drug Leqembi (lecanemab).
But the alliance is also urging the Centers for Medicare & Medicaid Services (CMS) to issue a proposed decision memorandum so that the one scan limit for beta-amyloid PET can be reconsidered -- and to remove the coverage with evidence development requirement for beta-amyloid PET.
"While traditional approval of Leqembi is a milestone for Alzheimer's patients, we remain concerned that access may be limited because beta-amyloid scans remain under Medicare's coverage with evidence development policy, which creates access barriers to this cutting-edge technology," said MITA executive director Patrick Hope in a statement released by the alliance. "In addition to removing the one-time limit on PET scans, it's essential that CMS remove beta-amyloid PET from the coverage with evidence policy to ensure that Alzheimer's patients receive an accurate diagnosis in order to benefit from Leqembi."
