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Alzheimer’s PET Imaging Agent Hits Roadblock

January 31, 2013
Written by: , Filed in: Diagnostic Imaging, Neuroradiology
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Remember last week, when we reported on a survey indicating that neurologists would likely use a newly approved brain scan imaging agent to evaluate their patients for Alzheimer’s Disease—if health insurance covered the procedure?

Well, it probably won’t. On Wednesday, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) said there wasn’t enough evidence to determine whether the agent could help improve outcomes for patients with early signs of cognitive impairment.

As DOTmed News reports, MEDCAC has no authority to determine Medicare coverage. However, the Centers for Medicare & Medicaid Services (CMS) does, and it relies on the committee’s advice to help it determine what procedures for which it will authorize coverage. Private insurers usually, but not always, follow suit.

The agent in question is florbetapir, marketed by Eli Lilly under the name Amyvid. The Food and Drug Administration approved it last April as a PET imaging agent to detect beta-amyloid deposits in the brain. Such deposits are associated with Alzheimer’s disease. A positive scan doesn’t necessarily indicate Alzheimer’s, but a negative scan probably rules it out—although other types of dementia could still be present.

MEDCAC consists of radiologists, neurologists, and psychiatrists. The majority wanted more evidence. Steve Gutman, MD, an adviser to the in vitro diagnostic company Myraqa, Inc., said:

I just can’t connect the dots between the current state of knowledge of the way the test performs and the outcome. I don’t think you can create a chain of evidence here that works.

Skeptics wanted more studies of patients with mild cognitive impairment and more proof that the drug changed patient management. They also expressed concern about possible overuse of the drug and needless worry caused by false positives.

Art Sedrakyan, MD, PhD, an associate professor of public health at Weill Cornell Medical College in New York and vice chair of the committee, said, “I’m not sure I have enough data to be able to weigh the benefits and harms of this particular technology in terms of that false-positive aspect.”

Even some of the skeptics did, however, suggest that Medicare pay for the use of the drug in clinical trials.

The next move is up to the CMS. We’ll keep a eye out for developments.

Related seminar: UCSF Neuro and Musculoskeletal Imaging

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