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Woman with text "repeating stories, memory issues, losing things" and It's hard to see from the outside. AMYVID can help

IT'S HARD TO SEE FROM THE OUTSIDE. AMYVID CAN HELP.1

Amyvid is used 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. Amyvid is an adjunct to other diagnostic evaluations.4

In 2023, the Centers for Medicare & Medicaid Services (CMS) removed the national coverage determination (NCD) for beta amyloid PET (§220.6.20). This ends the requirement of coverage with evidence development (CED) for beta amyloid PET imaging. Removal of the NCD from §220.6.20 permits Medicare coverage determinations to be made by Medicare Administrative Contractors (MACs).5

With new therapies focusing on earlier stages in the disease continuum, confirming the presence of Alzheimer’s disease (AD) pathology to aid in determining an AD diagnosis as early as possible is essential.6,7

ACT EARLY

Learn more about accuracy with Amyvid.

WHY AMYVID

Learn more about Amyvid's procedure time and image center scheduling.

AMYVID PROCEDURE TIME

PET=positron emission tomography.

Learn which patients may be right for Amyvid

References:

  1. Clark CM, Schneider JA, Bedell BJ, et al; for AV45-A07 Study Group. Use of florbetapir-PET for imaging β-amyloid pathology. JAMA. 2011;305(3):275-283.
  2. Gauthier S, Rosa-Neto P, Morais JA, et al. World Alzheimer Report 2021: Journey Through the Diagnosis of Dementia. London, England: Alzheimer’s Disease International; 2021. Accessed January 25, 2023. https://www.alzint.org/u/World-Alzheimer-Report-2021.pdf
  3. DiBenedetti DB, Slota C, Wronski SL, et al. Assessing what matters most to patients with or at risk for Alzheimer’s and care partners: a qualitative study evaluating symptoms, impacts, and outcomes. Alzheimers Res Ther. 2020;12(1):90. doi: 10.1186/s13195-020-00659-6
  4. Amyvid (florbetapir F 18 injection). Prescribing Information. Lilly USA, LLC.
  5. CMS.gov. Beta amyloid positron emission tomography in dementia and neurodegenerative disease (CAG-00431R). Accessed October 13, 2023. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=308
  6. Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of early Alzheimer’s disease: clinical practice in 2021. J Prev Alzheimers Dis. 2021;8:371-386.
  7. Aisen PS, Cummings J, Jack CR Jr, et al. On the path to 2025: understanding the Alzheimer’s disease continuum. Alzheimers Res Ther. 2017;9(1):60. doi:10.1186/s13195-017-0283-5

Important Safety Information

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

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 14SEP2022

Indication

Amyvid is a radioactive diagnostic agent 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.

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

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