WASHINGTON (AP) — The Centers for Medicare & Medicaid Services (CMS) says it needs more information before it will agree to pay for routine use of Amyvid, an imaging chemical that may help doctors screen for Alzheimer’s disease-related brain plaque.
Eli Lilly & Co., the company that is developing the first-of-a-kind imaging chemical, says it will forge ahead with efforts to introduce the product.
Through Medicare, CMS provides health coverage for more than 47 million seniors. Medicare is the largest payer for prescription drugs in the United States.
In decision posted online, CMS said more trials are needed to prove that the imaging agent works.
The government will pay for patients enrolled in future Amyvid studies, but not for general use.
The radioactive imaging agent works by binding to beta-amyloid plaques and causing them to show up on positron emission tomography, or PET, scans of the patient’s brain. The presence of these plaques may help indicate that a patient with cognitive problems has Alzheimer’s disease, although such a scan does not definitively show that.
Eli Lilly, which is based in Indianapolis, has said Amyvid is one tool intended to help find the cause of a patient’s cognitive decline.
The ruling is an unexpected setback for the product after European Union regulators endorsed the chemical in January.