Lilly Disappointed in Draft Medicare Coverage Decision for Beta-Amyloid
Continued insufficient Medicare coverage would be a significant setback for
patients and the Alzheimer's Disease community
INDIANAPOLIS, July 8, 2013
INDIANAPOLIS, July 8, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
today announced that the Centers for Medicare & Medicaid Services (CMS) has
issued a draft decision proposing Coverage with Evidence Development for the
use of beta-amyloid positron emission tomography (PET) imaging agents.
Beta-amyloid imaging agents are used to evaluate patients with cognitive
impairment for Alzheimer's Disease and other causes of cognitive decline.^
An Amyvid™ (Florbetapir F 18 Injection) beta-amyloid scan is for use in adults
with thinking or memory problems who are being assessed for Alzheimer's
Disease or other causes of these symptoms. Amyvid is used by doctors in
combination with other tests. A positive Amyvid scan does not diagnose
Alzheimer's Disease or other thinking or memory disorders. Amyvid is not
approved to predict the development of dementia or other brain conditions in
the future or for monitoring the effectiveness of treatments. Amyvid for
intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials
containing 500-1900 MBq/mL Florbetapir F 18.^
"CMS appears to be challenging the value of an adjunctive tool that can assist
physicians in making a more informed diagnosis for patients with cognitive
impairment. Restricting coverage could hinder a timely and accurate diagnosis,
which is in conflict with the advice of Alzheimer's Disease experts and with
the administration's National Alzheimer's Project Act," said Daniel
Skovronsky, M.D., Ph.D., president and CEO, Avid Radiopharmaceuticals, Inc., a
wholly owned subsidiary of Eli Lilly and Company, and vice president, Tailored
Therapeutics at Eli Lilly and Company. "In addition, it may stifle future
innovation aimed at improving diagnosis."
A decision for Coverage with Evidence Development proposes that there are
still evidentiary gaps necessary to reconcile prior to reevaluating coverage.
CMS would require additional trial(s) to address these gaps, and only those
patients taking part in the trials would be eligible for coverage.^ Once
those studies are complete, CMS can conduct another national analysis and
render a decision on coverage.
"Lilly remains steadfast in our request for Medicare coverage of beta-amyloid
imaging agents for the appropriate patient population without Coverage with
Evidence Development, as recommended by the Alzheimer's Association and the
Society of Nuclear Medicine and Molecular Imaging," said Wei-Li Shao, senior
director, Alzheimer's Business Division, Eli Lilly and Company.
A task force of experts organized by the Alzheimer's Association and the
Society of Nuclear Medicine and Molecular Imaging has developed the
Appropriate Use Criteria, which outline the appropriate and inappropriate use
of amyloid PET imaging.^
The decision is currently in draft form and is subject to change before the
final decision is expected in October. For now, there is a 30-day comment
period in which interested parties can post their reactions to the decision at
Alzheimer's Disease is one of many possible causes of cognitive impairment,
which can make diagnosis challenging.^, In fact, it is estimated that up
to one in five patients clinically diagnosed with probable Alzheimer's Disease
during life do not exhibit Alzheimer's Disease pathology upon autopsy.^,
If determined through clinical assessment and scan results that Alzheimer's
Disease is not the cause of a patient's cognitive impairment, their physician
can avoid or discontinue unnecessary or potentially harmful treatments and
investigate other possible causes.^,,
Amyvid is an FDA-approved radioactive diagnostic agent that is injected into
the bloodstream, where it crosses the blood-brain barrier and selectively
binds to amyloid plaques. The fluorine 18 (F 18) isotope produces a positron
signal, which is detected by a PET scanner. Physicians who read Amyvid PET
scans should complete a comprehensive training program available through live
events or online at AmyvidTraining.com.
For more information about Amyvid, please see the Full Prescribing Information
INDICATIONS AND USAGE:^
Amyvid is approved for use in adults with thinking or memory problems who are
being assessed for Alzheimer's Disease (AD) or other causes of these symptoms.
Amyvid is used by doctors in combination with other tests.
Amyvid is used with a positron emission tomography (PET) scanner to show
whether high levels of plaques, which are a buildup of a protein called
beta-amyloid, are in the brain.
A negative Amyvid scan means that there are few to no plaques in the brain and
makes it unlikely that AD is the cause of symptoms at the time of the scan.
A positive Amyvid scan means that the amount of plaque in the brain is similar
to the amount seen in people with AD. This amount of plaque may also be seen
in people with other conditions of the brain that cause thinking or memory
problems, as well as in older people with normal thinking and memory.
A positive Amyvid scan does not diagnose AD or other thinking or memory
disorders. Amyvid is not approved to predict the development of dementia or
other brain conditions in the future or for monitoring the effectiveness of
IMPORTANT SAFETY INFORMATION:^
What is the most important information I should know about Amyvid?
oRisk for Misreading Scans and Other Errors
oErrors may happen when Amyvid scan images are read. In clinical
studies, a scan read as negative, when it was actually positive,
accounted for most of these errors. An Amyvid scan only indicates
whether beta-amyloid plaques, which are a buildup of proteins in the
brain, are present at the time of the scan. Even if the scan is
negative, it is possible to develop plaques in the future
oAmyvid, like other radioactive diagnostic agents, adds to overall,
long-term combined radiation exposure. Long-term combined radiation
exposure may increase risk of cancer
IMPORTANT SAFETY INFORMATION:
What are the most common side effects of Amyvid?
oMuscle or joint pain
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
What should I tell my doctor before taking Amyvid?
oTell your doctor if you are pregnant or breast-feeding
oTell your doctor about any prescription or over-the-counter medicines you
Amyvid is available by prescription only.
See Prescribing Information.
AM CON ISI 28MAR2013
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers—through medicines and information—for some of the world's most urgent
medical needs. Additional information about Lilly is available at
This press release contains certain forward-looking statements about Amyvid™
(Florbetapir F 18 Injection), a radioactive diagnostic agent indicated for
brain imaging of beta-amyloid plaques in patients with cognitive impairment
who are being evaluated for Alzheimer's Disease and other causes of cognitive
decline. This release reflects Lilly's current beliefs; however, as with any
pharmaceutical product, there are substantial risks and uncertainties in the
process of development and commercialization. There is no guarantee that
future study results and patient experience will be consistent with study
findings to date or that Amyvid will prove to be commercially successful. For
further discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
©Lilly USA, LLC 2013. All rights reserved. AM85491 07/2013
Amyvid™ is a trademark of Eli Lilly and Company.
^ Centers for Medicare & Medicaid Services. Proposed decision memo for beta amyloid positron emission tomography in dementia and neurodegenerative disease (CAG-00431N).
Published July 3, 2013. Accessed July 3, 2013.
^ Amyvid™ (Florbetapir F 18 Injection) [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012.
^ Centers for Medicare & Medicaid Services. Draft guidance for the public, industry, and CMS staff coverage with evidence development in the context of coverage decisions. http://www.cms.gov/medicare‐coverage‐database/details/medicare‐coveragedocument‐details.aspx?MCDId=23. Published November 29,
2012. Accessed June 17, 2013.
^ Johnson KA, Minoshima S, Bohnen NI, et al. Appropriate use criteria for amyloid PET: a report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer's Association [published online ahead of print January 28, 2013]. Alzheimers Dement.
^ Balasa M, Gelpi E, Antonell A, et al; for the Neurological Tissue Bank/University of Barcelona/Hospital Clínic NTB/UB/HC Collaborative Group. Clinical features and APOE genotype of pathologically proven early-onset Alzheimer disease. Neurology. 2011;76(20):1720–1725.
^ Alzheimer's Association. 2012 Alzheimer's disease facts and figures. Alzheimers Dement. 2012;8(2):131–168.
^ Lim A, Tsuang D, Kukull W, et al. Clinico-neuropathological correlation of Alzheimer's disease in a community-based case series. J Am Geriatr Soc. 1999;47(5):564–569.
^ Petrovitch H, White LR, Ross GW, et al. Accuracy of clinical criteria for AD in the Honolulu-Asia Aging Study, a population-based study. Neurology. 2001;57(2):226–234.
^ Alzheimer's Association. 2011 Alzheimer's disease facts and figures. Alzheimers Dement. 2011;7(2):208–244.
^ Boise L, Neal MB, Kaye J. Dementia assessment in primary care: results from a study in three managed care systems. J Gerontol A Biol Sci Med Sci. 2004;59(6):621–626.
^ Mendez MF, Shapira JS, McMurtray A, et al. Preliminary findings: behavioral worsening on donepezil in patients with frontotemporal dementia. Am J Geriatr Psychiatry. 2007;15(1):84–87.
Refer to: (317) 478-0263, firstname.lastname@example.org – Celeste Stanley
SOURCE Eli Lilly and Company
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