MITA Applauds FDA’s Decision to Approve Leqembi (lecanemab-irmb) – Urges Swift CMS Reconsiderations

Jan 10, 2023, 11:10 AM

MITA, the premier trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices, is pleased that the Food and Drug Administration has approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway, giving hope to those who suffer from Alzheimer’s Disease. We now call on CMS to formally open a reconsideration of the national coverage determination to remove the onerous coverage barriers for Alzheimer’s disease modifying therapies and PET diagnostics to estimate the brain levels of amyloid beta plaque.

There is now a decade of widely accepted clinical data sufficient for CMS to cover beta amyloid PET imaging to support or exclude a diagnosis of Alzheimer’s disease outside of limited Coverage with Evidence Development (CED) studies. Patients deserve access to treatments that could impact their lives. Considering the extensive clinical data, MITA urges CMS to immediately reconsider the National Non-Coverage Determination for beta amyloid PET drugs and provide coverage.