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FOR US HEALTH CARE PROFESSIONALS ONLY

The information contained at AmyvidHCP.com is technical in nature and was specifically created for US Health Care Professionals.

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If you have additional questions about Amyvid, call the Lilly Answers Center at 1-800-LillyRx (1-800-545-5979). This toll-free number will connect you with a Health Care Professional who can provide additional information. This is an information service provided by Eli Lilly and Company.

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REFERENCES

1. 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. 2. Alzheimer’s Association. 2013 Alzheimer’s disease facts and figures. Alzheimers Dement. 2013;9(2):208–245. 3. Boise L, Morgan DL, Kaye J, et al. Delays in the diagnosis of dementia: perspectives of family caregivers. Am J Alzheimers Dis Other Demen. 1999;14(1):20–26. 4. 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. 5. 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. 6. Mok W, Chow TW, Zheng L, et al. Clinicopathological concordance of dementia diagnoses by community versus tertiary care clinicians. Am J Alzheimers Dis Other Demen. 2004;19(3):161–165. 7. Jack CR Jr, Albert MS, Knopman DS, et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):257–262. 8. Sperling RA, Aisen PS, Beckett LA, et al. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):280–292. 9. Jack CR Jr, Knopman DS, Jagust WJ, et al. Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade. Lancet Neurol. 2010;9(1):119–128. 10. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):263–269. 11. Forlenza OV, Diniz BS, Gattaz WF. Diagnosis and biomarkers of predementia in Alzheimer's disease. BMC Med. 2010;8:89. 12. Data on file, Lilly Research Laboratories: a: AMY20120725; b: AMY20121001A; c: AMY20121001B; d: AMY20121001Q. 13. Hyman BT, Trojanowski JQ. Editorial on consensus recommendations for the postmortem diagnosis of Alzheimer disease from the National Institute on Aging and the Reagan Institute Working Group on diagnostic criteria for the neuropathological assessment of Alzheimer disease. J Neuropathol Exp Neurol. 1997;56(10):1095–1097. 14. Ammonia N 13 Injection [package insert]. Manhasset, NY: Feinstein Institute for Medical Research; 2011. 15. CardioGen-82 [package insert]. Princeton, NJ: Bracco Diagnostics Inc; 2012. 16. Sodium Fluoride F 18 Injection [package insert]. Knoxville, TN: Siemens Molecular Imaging; 2011.

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REFERENCES

1. Data on file, Lilly Research Laboratories: a: AMY20121001B; b: AMY20121001A. 2. Alzheimer's Association. 2011 Alzheimer's disease facts and figures. Alzheimers Dement. 2011;7(2):208–244. 3. 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. 4. 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.

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REFERENCE

1. Jack CR Jr, Albert MS, Knopman DS, et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):257–262.

FOR PATIENTS AND CAREGIVERS

IMPORTANT SAFETY INFORMATION:

WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid estimation of brain neuritic plaque density during
    image interpretation.
  • Image 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.
  • Amyvid 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.

Radiation Risk

  • Amyvid, 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

  • The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%).

Please see Full Prescribing Information for Amyvid.

AM HCP ISI 10JAN2014

This site is intended for US Health Care Professionals only.

AMYVID REIMBURSEMENT INFORMATION

AMYVID REIMBURSEMENT SUPPORT PROGRAM

Coverage, coding, and payment policies vary significantly by payer and can present increasingly complex administrative challenges. Please see the information below related to reimbursement for beta-amyloid imaging.

In addition, Lilly is pleased to offer the Reimbursement Support Program, which consists of a call center and Web-based resources to assist with Amyvid reimbursement for your patients.

The Reimbursement Call Center can assist with reimbursement for your patients:
  • General coverage inquiries
  • Benefits Investigations
  • Billing and coding information
  • Assistance with prior authorization and precertification

Please contact our knowledgeable support personnel
at 1-877-9-AMYVID (1-877-926-9843), Monday to Friday, 8 AM to 8 PM ET

MEDICARE COVERAGE

On September 27, 2013, the Centers for Medicare & Medicaid
Services (CMS) issued a National Coverage Decision (NCD) for
beta-amyloid imaging. The NCD declares coverage for one PET
beta-amyloid scan per patient through coverage with evidence
development (CED) in clinical studies that meet a number of
specific criteria. These clinical studies must be approved by CMS.
Clinical studies are not approved by CMS at this time. Please
check back for updates, as this Web site will communicate the
latest information regarding Medicare coverage. You may also
contact the Reimbursement Call Center at 1-877-9-AMYVID
(1-877-926-9843).

COMMERCIAL INSURANCE

Commercial insurance coverage will vary by plan. Effective
January 1, 2013, the following A code can be used for administrative
and billing purposes specific to Amyvid: A9586 Florbetapir F 18,
Diagnostic, Per Study Dose, Up To 10 Millicuries. Billing and
coding information is intended to provide guidance, and the
use of this code does not guarantee coverage, which will vary
according to the policies of the insurer. Providers will need
to determine the medical necessity of the services provided and
consult with individual insurers for accurate and appropriate
coding information. The provision of this coding information
should not be read as making any claim, expressed or implied,
regarding the safety and efficacy of any product(s) and/or the
interchangeability or comparative effectiveness of any product(s)
or procedure(s). Coding information provided here was updated on
November 28, 2012, and is subject to change. Specific decisions
for the coding of a particular procedure are made by the provider
of care after considering medical need and applicable regulations.

If you require any assistance with reimbursement-related
questions, including Benefits Investigations, please contact the
Reimbursement Call Center at 1-877-9-AMYVID (1-877-926-9843)
or contact the payer directly.

INDICATIONS AND USAGE:

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 diagnostic evaluations.

Limitations of Use:
  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder
  • Safety and effectiveness of Amyvid have not been
    established for:
    • Predicting development of dementia or other
      neurologic condition
    • Monitoring responses to therapies

Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

IMPORTANT SAFETY INFORMATION:

WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation
  • Image 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
  • Amyvid 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

Radiation Risk

  • Amyvid, 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

  • The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%)