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

Olympus facing suits for infection and death of patients at UCLA Olympus Corp. of the Americas is facing suits of infections allegedly stemming from use of its duodenoscopes

DoD is homing in on a suitor for its $11 billion EHR contract Interested parties emphasize "fee for value" in selection process

Patient satisfaction little moved by fancy hospital design: study $200 billion spent on renovation projects, but is it worth it?

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

Young child is first fatality in Germany's measles outbreak Berlin has recorded more than 570 measles diagnoses since October

Toshiba to unveil Aquilion Lightning CT at ECR 2015 16-row helical CT with 0.5mm element for isotropic imaging

Medical identity fraud affected two million American adults last year Increased use of EHRs contributing to the problem

Medical World Americas announces sponsorship from major industry players GE, and others, are backing the second annual conference and expo

Comparing options for stereotactic radiosurgery Comparing options for stereotactic radiosurgery

Neuronetrix scores FDA approval for portable EEG device Primary care physicians can now evaluate neurological problems in office

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

OiHealthcare - ISO 9001 & 13485 Certified - Call 888-673-5151

Oxford Instruments Healthcare, is a leading ISO 9001 & 13485-certified organization, that specializes in providing quality after-market GE CT and MRI systems, service and parts - at prices you can afford.



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

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Center
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
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 ©2001-2015 DOTmed.com, Inc.
ALL RIGHTS RESERVED