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

Companies develop pediatric medical devices to compete for $50,000 prize Will the smallest of patients finally have more options?

New imaging method may detect cancer earlier Will shortwave infrared be a bright spot?

Siemens AAMI 2014 CMS debate video released See a video of the debate on CMS's imaging equipment maintenance edict from December 2013

Technology uses extremely cold temperatures to treat breast cancer Multi-center trial enrolls first patients

Samsung's tablet ultrasound can diagnose patients en route to hospital The technology can prove crucial when seconds matter

Ultrasound-powered chip monitors diseases and delivers therapies May be able to study nervous system and treat Parkinson's symptoms

Celgene invests in Sequenta's MRD test Test will participate in trials to create blood cancer medicine

AFT calls for improved Ebola hospital protocols Meanwhile, 43 people in Texas are removed from Ebola watch list

Americans with insurance still not going to doctor Will making cost and quality information transparent be the solution?

Mass. health care cost transparency law underperforming Pricing still murky after transparency law introduced

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

How to Get the Most Out of Your Service Providers

(and Add Value to Your Facility). Knowing where and how to add value greatly benefits your facility-- and your personal career. Read more and get a comparison tool to help you make smart decisions



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

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