The Medicare Evidence Development and Coverage Advisory Committee has expressed its opinion that PET scans that scan for beta-amyloid protein in the brain is not beneficial for patients as an early Alzheimer’s diagnosis tool.
Using a scale of 1 for “low confidence” and 5 for “high confidence,” the 12-member panel responded with an average vote of 2.1667. The MEDCAC panelists expressed their concerns that the benefits of a Medicare patient knowing that they tested positive for beta-amyloid were outweighed by possible false-positive results and other issues that come with that knowledge.
The vote does not reflect the accuracy of such tests as neuroimaging is among the most promising areas of research focused on early detection per the Alzheimer’s Association. The concern, rather, is how a clinician can use the information to positively impact outcomes and the course of care for a patient.
"I think there's not enough research at all on the quality-of-life outcomes in these patients," panelist Paula Hartman-Stein, PhD, professor of psychiatry at the Center for Healthy Aging in Kent, Ohio, said.
Functional imaging tests, such as the positron emission tomography (PET) and other such methods locates areas of reduced brain cell activity in within the brain. Amyvid (Florbetapir F 18 injection) is an FDA-approved radioactive agent used in PET imaging scans to estimate beta-amyloid neuritic plaque density. However, a positive Amyvid scan does not establish a diagnosis of Alzheimer’s or other cognitive disorder.
The Alzheimer’s Association agrees that detection of shrinkage by structural imaging does not yet provide enough information to translate these general patterns of reduced activity into diagnostic information about individuals. However, the organization does recommend that the test be used as part of a comprehensive workup of patients with persistent or progressive and unexplained mild cognitive impairment, those with a clinical diagnosis of “possible” Alzheimer’s disease, or those with progressive dementia beginning at age 65 or younger.
William Thies, MD, chief medical and scientific officer of the Alzheimer's Association, said a positive diagnosis for Alzheimer's disease could better a patient's care later in life. It would allow doctors to build a care plan and team, while improving documentation and communication among healthcare providers and payers.
The wholesale price of Amyvid (florbetapir) is $1,600. The price of the entire PET scan could come to more than $3,000, depending on the imaging center.
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Alzheimer’s & Dementia, and The Journal of Nuclear Medicine, © 2013 by the Alzheimer’s Association, and the Society for Nuclear Medicine and Molecular Imaging.