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
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
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
"These diagnostic imaging agents allow physicians to determine – for the first
time – whether living patients have beta-amyloid plaques in their brain," said
Mark Mintun, M.D., chief medical officer, Avid Radiopharmaceuticals, Inc., a
wholly owned subsidiary of Lilly. "This information may impact how physicians
ultimately treat their patients by helping inform diagnostic decisions.
However, patient outcomes are largely due to the physician's ability to make
an accurate diagnosis and recommend an appropriate treatment plan."
About Alzheimer's Disease
By 2030, the total number of Americans aged 65 and over with Alzheimer's
Disease is expected to reach 7.7 million.^3 In response to this mounting
national health threat, the National Alzheimer's Project Act has brought about
renewed urgency and focus on developing new and innovative ways to diagnose,
support and treat patients suffering from Alzheimer's Disease.^4
Alzheimer's Disease is one of many possible causes of cognitive impairment,
which can make diagnosis challenging. Alzheimer's Disease and other causes of
cognitive impairment share many overlapping symptoms, including deficiencies
in memory, visuospatial ability, executive function, behavior and
language.^5,6 Furthermore, it is estimated that up to one in five patients
clinically diagnosed with probable Alzheimer's Disease during life and do not
exhibit Alzheimer's Disease pathology upon autopsy.^7,8
Amyvid is a 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.
Indications and Usage^1
Amyvid is indicated for Positron Emission Tomography (PET) imaging of the
brain to estimate beta-amyloid neuritic plaque density in adult patients with
cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and
other causes of cognitive decline.
A negative Amyvid scan indicates sparse to no neuritic plaques and is
inconsistent with a neuropathological diagnosis of AD at the time of image
acquisition; a negative scan result reduces the likelihood that a patient's
cognitive impairment is due to AD. A positive Amyvid scan indicates moderate
to frequent amyloid neuritic plaques; neuropathological examination has shown
this amount of amyloid neuritic plaque is present in patients with AD, but may
also be present in patients with other types of neurologic conditions as well
as older people with normal cognition. Amyvid is an adjunct to other
Limitations of Use:
A positive Amyvid scan does not establish a diagnosis of AD or other cognitive
disorder. Additionally, the safety and effectiveness of Amyvid have not been
established for predicting development of dementia or other neurologic
condition, or monitoring responses to therapies.
Important Safety Information^1
WARNINGS AND PRECAUTIONS
Risk for Image Misinterpretation and Other Errors
oErrors may occur in the Amyvid estimation of brain neuritic plaque density
during image interpretation
oImage interpretation should be performed independently of the patient's
clinical information. The use of clinical information in the
interpretation of Amyvid images has not been evaluated and may lead to
errors. Other errors may be due to extensive brain atrophy that limits the
ability to distinguish gray and white matter on the Amyvid scan as well as
motion artifacts that distort the image
oAmyvid scan results are indicative of the brain neuritic amyloid plaque
content only at the time of image acquisition and a negative scan result
does not preclude the development of brain amyloid in the future
oAmyvid, similar to other radiopharmaceuticals, contributes to a patient's
overall long-term cumulative radiation exposure. Long-term cumulative
radiation exposure is associated with an increased risk of cancer. Ensure
safe handling to protect patients and health care workers from
unintentional radiation exposure
MOST COMMON ADVERSE REACTIONS
oThe most common adverse reactions reported in clinical trials were
headache (1.8%), musculoskeletal pain (0.8%), fatigue (0.6%), nausea
For Full Prescribing Information for Amyvid, visit
AM HCP ISI 05OCT2012
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. AM81786 01/2013
Amyvid™ is a trademark of Eli Lilly and Company.
^1 Amyvid [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012.
^2 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.
Alzheimers Dement. 2013; doi:10.1016/j.jalz.2013.01.002.
^3 Hebert LE, Scherr PA, Bienias JL, et al. Alzheimer disease in the US
population: prevalence estimates using the 2000 census. Arch Neurol.
^4 US Department of Health and Human Services. National plan to address
Alzheimer's disease. http://aspe.hhs.gov/daltcp/napa/NatlPlan.pdf. Published
May 15, 2012. Accessed January 22, 2013.
^5 Balasa M, Gelpi E, Antonell A, et al; for the Neurological Tissue
Bank/University of Barcelona/Hospital Clinic NTB/UB/HC Collaborative Group.
Clinical features and APOE genotype of pathologically proven early-onset
Alzheimer disease. Neurology. 2011;76(20):1720–1725.
^6 Thies W, Bleiler L; Alzheimer's Association. Alzheimer's Association
report: 2012 Alzheimer's disease facts and figures. Alzheimers Dement.
^7 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.
^8 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.
Refer to: Celeste Stanley, + 317-478-0263, firstname.lastname@example.org
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
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