FDA Fully Approves Leqembi for Alzheimer’s; CMS Unclear on PET Reimbursement

July 10, 2023

Reston, VA—The U.S. Food and Drug Administration (FDA) has granted full approval to Leqembi (lecanemab), which has been shown to slow the progression of Alzheimer’s in patients with mild cognitive impairment or mild dementia; however, the Centers for Medicare & Medicaid Services (CMS) has not committed to reimbursement of the needed PET scans.

Alzheimer’s disease affects more than six million Americans and ranks as the sixth leading cause of death among U.S. adults. In 2022, the economic impact of Alzheimer’s disease on the American economy was estimated at $321 billion.

Leqembi (lecanemab), a monoclonal antibody, targets and helps eliminate beta amyloid, a protein that builds up in the brains of individuals with Alzheimer’s disease. Initially approved under the FDA’s Accelerated Approval Pathway in January, Leqembi’s full approval was supported by the results of a large clinical trial in which the drug slowed the rate of cognitive and functional decline by 27% compared to a placebo. The drug necessitates preliminary testing to assess amyloid plaque presence, intravenous infusions administered every other week, and periodic brain scans to monitor potential side effects.

Although the FDA requires pretreatment amyloid testing, it has provided no guidance about the specific test to be used. In clinical studies, amyloid PET scans have been the gold standard for detecting amyloid plaques in the brain. Lumbar punctures are an alternative; however, they are less accurate, can be painful, and are not feasible for a significant number of patients. According to a 2020 study in The Lancet, approximately 35 percent of patients refuse or are unable to undergo a lumbar puncture.

Although CMS will cover Leqembi and other drugs to treat Alzheimer’s, the agency has not committed to covering the ongoing scans and may not cover the preliminary PET scan needed to confirm the presence of amyloid. CMS currently covers only one amyloid PET scan per patient per lifetime.

“Leqembi can slow cognitive decline for eligible patients,” said Helen Nadel, MD, FRCPC, FSNMMI, SNMMI president. “But we need to ensure that it is accessible to all patients who can benefit from it. Amyloid PET scans are an essential tool that will allow physicians to identify appropriate candidates for Leqembi. PET scans should also be performed on patients after they begin taking lecanemab to ensure that the amount of amyloid plaque has decreased.”

SNMMI will continue to engage with CMS to secure coverage reimbursement of amyloid PET. Medicare reimbursement of amyloid PET is currently well below the cost of the radiopharmaceutical used in the scan, raising serious concerns about equitable patient access to non-invasive testing and to the therapies for which testing is required. SNMMI urges Congress to pass the FIND Act, bi-partisan legislation that will improve access to innovative radiopharmaceuticals for Medicare beneficiaries.

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About the Society of Nuclear Medicine and Molecular Imaging
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to advancing nuclear medicine and molecular imaging—vital elements of precision medicine that allow diagnosis and treatment to be tailored to individual patients in order to achieve the best possible outcomes.

SNMMI’s members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit www.snmmi.org.