dismiss

Be DOTmed’s Guest at FIME 2014 in Miami Beach Aug 6th-8th -- Get your Free Pass here

SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment

Never Miss a Story

Sign up for email alerts

 

More Industry Headlines

New catheter improves stroke treatment Enhances visualization with MR

July's New Product Showcase This month's roundup of the latest industry products.

Obstacles in the way of value-based relationships Providers don't trust payors

Genomic test personalizes prostate cancer treatment Predicts radiotherapy benefits for patients

Global surgical equipment market will hit $12.1 billion Electrosurgical and robotic devices spur growth

Surgery better than endoscopy for some early esophageal cancers Newly published study provides insight

Medtronic acquires Visualase Expands neuroscience offerings

No anxiety over false positive CT lung cancer results May influence CMS's coverage decision

FDA approves Philips' mobile ultrasound Product for the globe

ACR calls for tomo coverage CMS will decide in October

CMS panel says evidence lacking for Amyvid

By Brendon Nafziger and Loren Bonner

A Medicare advisory panel voted Wednesday there wasn't enough evidence to determine whether the PET amyloid drug Amyvid could help improve outcomes for patients with early signs of cognitive dysfunction. The decision by the panel, called the Medicare Evidence Development & Coverage Advisory Committee, could represent a setback in efforts to get national Medicare coverage for the drug, and potentially others that will be coming down the pipeline for amyloid PET imaging.

Story Continues Below Advertisement

SIUI introduces two ULTRACLOUD color Doppler systems - click for more info

The two new models provide premium imaging performance. Apogee 5500 is equipped with new 4D imaging tools which contribute to lifelike images and more reliable diagnosis while Apogee 1000 features lightweight laptop design



The MEDCAC panel only judged evidence for the drug and has no authority to determine if Amyvid should be covered. However, the Center for Medicare and Medicaid Services relies on its advice to inform coverage decisions for new technology or procedures — in this case, with Amyvid for PET beta-amyloid imaging.

The Eli Lilly & Co. drug received FDA approval last spring. It's used in PET scans to help doctors measure beta-amyloid plaque load in the brain, which is associated with Alzheimer's disease.

According to the language of Amyvid's FDA approval, a positive scan is not diagnostic for Alzheimer's, but a negative scan could help physicians rule out the brain-wasting disease in favor of other types of dementia.

Backers of the agent say it can help change management of patients, but a majority of the expert panelists, made up of radiologists, neurologists and psychiatrists, thought the jury was still out on the drug.

"I just can't connect the dots between the current state of knowledge of the way the test performs and the outcome," Dr. Steve Gutman, a panelist and strategic advisor with Myraqa Inc., said at the meeting. "I don't think you can create a chain of evidence here that works."

In the vote, the panelists gave their confidence rating on the evidence an average of 2.2 on a five point scale, indicating lower levels of confidence. The panel also voted that the uncertainty applied to Medicare-aged populations, too.

"I think it's incredibly important to our patients and our physicians to have a biomarker like this available," said Dr. Jerrold Rosenbaum, the psychiatrist-in-chief at Massachusetts General Hospital. "The question is, this one and now, not whether we need it (in general)."

Skeptics on the panel said they wanted more studies that include enough patients with unexplained mild cognitive impairment, thought to benefit most from the scans, and they also wanted proof that the drug actually changed patient management.

The panel also expressed concern about potential overuse of the scans and the danger that false positives — positive scans of actually healthy people — could needlessly worry patients. "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," Dr. Art Sedrakyan, an associate professor at Weill Cornell Medical School and vice-chair of the panel, said.

Continue reading CMS panel says evidence lacking for Amyvid ...
  Pages: 1 - 2 >>

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.

You Must Be Logged In To Post A Comment

Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2014 DOTmed.com, Inc.
ALL RIGHTS RESERVED