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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 (0.8%), fatigue (0.6%), nausea (0.6%).

Please see Full Prescribing Information for Amyvid. »

AM HCP ISI 05OCT2012

You have requested to download the Billing and Coding Resource. The 4 page Prescribing Information will be included with your print out.

        

You have requested to download the Reimbursement Call Center Program Application and Patient Authorization Form. The 4 page Prescribing Information will be included with your print out.

        

AMYVID REIMBURSEMENT INFORMATION

Reimbursement Call Center

Support offered to assist with reimbursement for your patients includes:

  • 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-Friday, 8 AM to 8 PM ET

Online Resources

Amyvid A Code

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

Note: Amyvid third-party coverage will vary by plan and is not covered under Medicare, based on National Coverage Determination (NCD) 220.6. 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 11/28/2012, 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.

INDICATIONS AND USAGE:

Amyvid™ (Florbetapir F 18 Injection) 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 (0.8%), fatigue (0.6%), nausea (0.6%)