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Effective January 1, 2025, the Centers for Medicare & Medicaid Services (CMS) will reimburse separately for Amyvid® (florbetapir F18 injection) in the hospital outpatient setting, resulting in a higher payment rate than pre-2025. Payment rates will be calculated using mean unit cost (MUC).1,2
IT'S HARD TO SEE FROM THE OUTSIDE. AMYVID CAN HELP.1
Amyvid is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:
Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline
Selection of patients who are indicated for amyloid beta–directed therapy as described in the prescribing information of the therapeutic products
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).4
With approved 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.5,6
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. doi:10.1001/jama.2010.2008
Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of early Alzheimer’s disease: clinical practice in 2021. J Prev Alzheimer’s Dis. 2021;8:371-386
Aisen PS, Cummings J, Jack CR Jr, et al. On the path to 2025: understanding the Alzheimer’s disease continuum. Alzheimer’s 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 estimation of brain amyloid beta neuritic plaque density during Amyvid image interpretation.
The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to an inaccurate assessment. Extensive brain atrophy as well as motion artifacts that distort the image may limit the ability to distinguish gray and white matter on an Amyvid scan.
Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal.
Radiation Risk
Amyvid 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. Advise patients to hydrate before and after administration and to void frequently after administration.
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%), injection site reaction (0.5%), anxiety (0.4%), back pain (0.4%), claustrophobia (0.4%), dizziness (0.4%), feeling cold (0.4%), insomnia (0.4%) and neck pain (0.4%).
Amyvid (florbetapir F 18 injection) for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL.
Amyvid is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:
Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline
Selection of patients who are indicated for amyloid beta–directed therapy as described in the prescribing information of the therapeutic products
