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

Cerner wins highly sought Department of Defense EHR contract Military Health System contract worth at least $4.3 billion

Pantheon acquires IBSL, expands into biomedical service segment Will significantly increase footprint in Italian market

Strength in numbers: The microbiome versus 'superbugs' New insight into how bacteria fight invasion could inform probiotic development

GE invests $1 billion to improve global training over next five years Over 300 million patients globally could benefit

Genetic test predicts sensitivity of tumors to radiation therapy Customizing dose to a particular tumor instead of standard uniform dose

Certain cardiovascular factors may predict Alzheimer’s Alcohol, smoking, diabetes and obesity all increase risk

Is China the new frontier for medical equipment manufacturers? 'Made in China 2015' initiative aims to boost quality — and competitiveness

Guerbet to acquire Mallinckrodt's contrast agent business Deal valued at $270 million will be paid in cash

Family members of ICU patients may be at risk for PTSD New research indicates active decision-making reduces psychological distress

Study finds cardiac CT scans damage cells No damage detected in doses under 7.5 milliSieverts, however

Amyvid backers respond to MEDCAC meeting

by Loren Bonner , DOTmed News Online Editor
Despite a lack of support from an advisory panel, backers of the PET amyloid imaging drug Amyvid are urging the Centers for Medicare and Medicaid Services to evaluate the evidence and provide coverage for the U.S. Food and Drug Administration-approved indication.

On Wednesday, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC ) — a panel that has the ability to influence Medicare coverage decisions — heard testimony from several experts about how Amyvid was able to increase physician confidence in diagnosing Alzheimer's disease and change the management of patients experiencing cognitive impairment. However, the MEDCAC panel was not convinced that there was enough evidence to determine whether the drug could change health outcomes for Medicare beneficiaries.

Story Continues Below Advertisement

We want to buy your Siemens Symphony or Avanto MRI -- today!

Top Dollar Paid, Fixed or Mobile. Call our Siemens Specialist for a Quote today -- 212-558-6600 Ext. 250 DOTmed Certified



While disappointed, backers of the drug remain steadfast in their belief that the Eli Lilly & Co. drug, which received FDA approval last spring, provides significant value to clinicians and patients.

"We encourage CMS to weigh the totality of evidence and make a positive coverage decision," Wei-Li Shao, senior director of Alzheimer's Business at Lilly, told DOTmed News.

In a statement from the Medical Imaging & Technology Alliance (MITA), the OEM lobby encouraged CMS to consider diagnostic endpoints — not therapeutic ones — as the basis for its coverage decision, which is expected to be drafted in July.

"Thanks to PET imaging procedures, diseases that once eluded the medical community can now be better understood and detected earlier than ever before, which gives us hope of eventually finding an effective treatment," said Gail Rodriguez, executive director of MITA.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) said in a statement that they believe the evidence, together with FDA approval, "supports the ability of beta-amyloid imaging to change patient management, leading to better outcomes for patients."

SNMMI and the Alzheimer's Association co-released appropriate use criteria for brain amyloid imaging earlier this week, which CMS might consider in their decision since many of the criteria address some of the concerns from the MEDCAC panelists.

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 Central
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