Magazine article Clinical Psychiatry News

Study Seeks to Make Case for Early Amyloid Imaging

Magazine article Clinical Psychiatry News

Study Seeks to Make Case for Early Amyloid Imaging

Article excerpt

A $100 million study may decide the financial fate of amyloid PET imaging and thus potentially the frequency with which it is used to help rule out Alzheimer's disease as a cause of dementia.

If the study finds that amyloid imaging improves patient outcomes, hopes are high that Medicare may reverse a 2013 decision that severely limited reimbursement for the procedure and start covering the scan for patients being evaluated for cognitive decline or progressive dementia of unknown etiology.

Medicare officials said extant data do not confirm improved patient outcomes with amyloid PET imaging, but they promised to revisit the issue should new information emerge. The IDEAS study is designed to provide that information, said Maria C. Carrillo, Ph.D., chief science officer of the Alzheimer's Association and a cochair of the study.

"One aim of the IDEAS study is to clearly demonstrate that an early and accurate Alzheimer's disease (AD) diagnosis is aided by the use of brain amyloid PET scans--in appropriate cases where there is substantial diagnostic uncertainty. Also, we hope to show that this novel technology can improve health outcomes," she said in an interview. "I am confident that, at the end of this study, we will have amassed sufficient data to assess whether amyloid imaging has a positive impact on patient outcomes leading to expansion of beneficiary access to this important procedure beyond the IDEAS study."

The Alzheimer's Association worked with the Centers for Medicare & Medicaid Services to design the trial, which is expected to cost about $100 million. CMS will pay for the PET scans--estimated at $80 million--under its Coverage with Evidence Development program. The rest of the money is expected to come from industry and philanthropic sources.

IDEAS seeks to examine how amyloid imaging might affect the clinical management of patients with symptoms suggestive of AD and how it might affect 12-month major medical outcomes for those patients, compared with a control group.

Positive findings could be used to support another plea for Medicare to cover the scans in clinical practice. Reimbursement is now limited to one scan per patient, and only for those enrolled in an approved randomized trial.

The root of CMS's reluctance to full endorse amyloid scanning is its clinical utility - or lack thereof. …

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