The Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the Alzheimer’s Association have released new appropriate use criteria for brain PET imaging of amyloid and tau pathology related to cognitive impairment and Alzheimer’s disease.
The update is the first revision since the initial guidance for amyloid PET was introduced in 2013, noted the two organizations in a January 8 announcement.
“Since then, the U.S. Centers for Medicare and Medicaid Services has announced key changes to reimbursement that make advanced imaging more accessible, lifting its one-scan-per-patient restriction in 2023 and unbundling payment for high-cost diagnostic radiopharmaceuticals in 2024,” the groups stated.
There are three PET radiotracers labeled with F-18 approved by the U.S. Food and Drug Administration (FDA) for clinical imaging of beta amyloid: Florbetapir (Amyvid, Avid Radiopharmaceuticals), florbetaben (Neuraceq, Life Molecular Imaging), and flutemetamol (Vizamyl, GE HealthCare).
In addition, the updated appropriate use criteria introduces guidelines for tau PET imaging, which could pave the way for its broader clinical use following the FDA’s approval of the tau radiotracer F-18 flortaucipir (Tauvid, Eli Lilly) in 2020, the groups noted.
To develop the new criteria, a multidisciplinary task force studied clinical literature to date on amyloid and tau PET imaging. The experts considered factors such as age, prognosis, how symptoms manifest, cerebrospinal fluid biomarker results, and whether patients are at-risk, and then defined 17 clinical scenarios for which imaging would be either “appropriate,” “uncertain,” or “rarely appropriate.”
For amyloid PET, seven scenarios were deemed appropriate, two were deemed uncertain, and eight were determined to be rarely appropriate. For tau PET, the group rated five scenarios as appropriate, six as uncertain, and six as rarely appropriate.
In addition, the appropriate use criteria discuss PET imaging for determining eligibility for new treatments such as Leqembi and Kisunla and for following treated patients to assess their response to therapy. It is also expected the new criteria will reduce the need for less specific diagnostic testing and provide guidance for safety considerations, noted Kevin Donohoe, MD, chair of SNMMI’s Committee on Guidance Document Oversight.
“[These appropriate use criteria] will help providers determine the most effective use of these important PET tracers as well as describe clinical scenarios that are not likely to benefit from PET imaging,” Donohoe stated.
The updated appropriate use criteria for amyloid and tau PET are available on the websites of the Journal of Nuclear Medicine, the SNMMI, and Alzheimer’s & Dementia.