This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Lilly Supports The Medical Community's Testimony On The Clinical Utility Of Beta-Amyloid Imaging Agents, Such As Amyvid™ (Florbetapir F 18 Injection), During CMS Public Hearing

INDIANAPOLIS, Jan. 30, 2013 /PRNewswire/ -- Leading medical experts in the fields of imaging, neurology and dementia came together today to present evidence supporting the clinical utility of beta-amyloid imaging agents, such as Amyvid™ (Florbetapir F 18 Injection), during a public hearing held by the Centers for Medicare & Medicaid Services (CMS), known as a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.

The CMS panel voted "low to intermediate confidence" in response to whether there is adequate evidence available to determine whether or not positron emission tomography (PET) imaging of brain beta-amyloid changes health outcomes (improved, equivalent or worsened) in patients who display early symptoms or signs of cognitive dysfunction. Additionally, the panel voted "high confidence" that these conclusions are generalizable to the Medicare beneficiary population. The MEDCAC vote may impact future Medicare coverage decisions for beta-amyloid imaging agents.

Amyvid is indicated for PET imaging of the brain to estimate beta-amyloid plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. Amyvid is an adjunct to other diagnostic evaluations. Amyvid for intravenous use is a radioactive diagnostic agent that is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18. 1

"The overwhelmingly positive testimony presented by the medical experts around the clinical utility of beta-amyloid imaging agents reinforces that these tools should be a Medicare covered benefit for patients with cognitive impairment being evaluated for Alzheimer's Disease and other causes of cognitive decline," said Wei-Li Shao, senior director, Alzheimer's Business Division, Eli Lilly and Company. "When making a final coverage decision, we encourage the Centers for Medicare & Medicaid Services to heavily consider the real-world medical experience presented today, and the appropriate use criteria recently released by the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association supporting the use of these imaging agents."

The new guidelines state that amyloid imaging could potentially be helpful in the diagnosis of people with cognitive impairment when considered along with other clinical information, and when performed according to standardized protocols by trained staff. The guidelines also indicate that, although published data is extremely limited, amyloid PET is likely to contribute to better patient care under specific circumstances. 2

The panel voted on two questions, giving a score from one to five – one being low confidence, five being high confidence. The questions focused on whether there is adequate evidence to determine if PET imaging of brain beta-amyloid changes health outcomes in patients who display early symptoms or signs of cognitive dysfunction, and if the evidence can be generalized to the Medicare beneficiary population.

1 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,677.90 +216.58 1.32%
S&P 500 1,950.82 +23.71 1.23%
NASDAQ 4,452.7920 +69.9450 1.60%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs