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DESCRIPTIONThree radioactive tracers (florbetapir F18, flutemetamol F18, florbetaben F18) that bind to beta amyloid and can be detected in vivo with positron emission tomography (PET) have been developed. This technology is being evaluated to detect beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer disease (AD) and/or other causes of cognitive decline.
The diagnosis of AD is divided into three categories: possible, probable, and definite AD. A diagnosis of definite AD requires post-mortem confirmation of AD pathology, including the presence of extracellular beta amyloid plaques and intraneuronal neurofibrillary tangles in the cerebral cortex. Probable AD dementia is diagnosed clinically when the patient meets core clinical criteria for dementia and has a typical clinical course for AD. A typical clinical course is defined as an insidious onset, with the initial and most prominent cognitive deficits being either amnestic or non-amnestic (e.g., language, visuospatial, or executive function deficits) and a history of progressively worsening cognition over time. A diagnosis of possible AD dementia is made when the patient meets the core clinical criteria for AD dementia but has an atypical course or an etiologically mixed presentation.
Mild cognitive impairment (MCI) may be diagnosed when there is a change in cognition, but impairment is insufficient for the diagnosis of dementia. Features of MCI are evidence of impairment in one or more cognitive domains, and preservation of independence in functional abilities. In some patients, MCI may be a predementia phase of AD. Patients with MCI may undergo ancillary testing (e.g., neuroimaging, laboratory studies, and neuropsychological assessment) to rule out vascular, traumatic, and medical causes of cognitive decline and to evaluate genetic factors. Because clinical diagnosis can be difficult, particularly early in the course of disease, there has been considerable interest in developing biomarkers for AD (see Biochemical Markers of Alzheimer's Disease medical policy). One biomarker that is being evaluated is beta amyloid plaque density in the brain detected in vivo by PET. However, beta amyloid is present in individuals without dementia, in patients with mild or subjective cognitive impairment who may or may not progress to dementia, and in patients with other types of dementia, and may be absent in a substantial proportion of patients with clinical features of AD.
PET images biochemical and physiological functions by measuring concentrations of positron-emitting chemicals in the body region of interest. Radiopharmaceuticals used for beta amyloid imaging may be generated in a cyclotron or nuclear generator and introduced into the body by intravenous injection. A number of 11C and 18F-labeled PET radiopharmaceuticals have been investigated for imaging brain beta amyloid. However, due to the short half-life (20 minutes), 11C radiotracers are not convenient for commercialization. Several 18F beta amyloid radiotracers are currently in phase II and III clinical trials.
In 2012, the FDA approved florbetapir F18 (Amyvid™, Avid Radiopharmaceuticals, [a subsidiary of Eli Lilly], Philadelphia, PA) as a radioactive agent for visualizing amyloid plaque in the brain. The FDA document prepared for the advisory committee meeting indicated that while florbetapir may detect pathology, there could be no claim of disease detection because beta amyloid aggregates can be found in cognitively normal elderly patients, as well as patients with AD.
In October 2013 and March 2014, FDA approved 2 other radioactive diagnostic imaging agents for detecting beta-amyloid plaque, flutemetamol F18 (Vizamyl™; GE Healthcare) and florbetaben F18 (Neuraceq™; Piramal Life Sciences, Matran, Switzerland), respectively.
Amyvid™, Vizamyl™, and Neuraceq™ are indicated “for PET imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer disease and other causes of cognitive decline.” Prescribing information for all 3 agents states:
POLICYBeta amyloid imaging with positron emission tomography (PET) is investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/15/2012: Approved by Medical Policy Advisory Committee.
10/23/2013: Policy reviewed; no changes.
02/26/2014: Added the following new 2014 HCPCS code(s) to the Code Reference section: A9599.
08/06/2014: Policy reviewed; description updated regarding radioactive diagnostic imaging agents and prescribing information. Policy statement revised to remove "considered." It previously stated: Beta amyloid imaging with positron emission tomography (PET) is considered investigational.
07/08/2015: Code Reference section updated for ICD-10.
10/30/2015: Policy description updated regarding the presence of beta amyloid in individuals. Policy statement unchanged. Investigative definition updated in policy guidelines section.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 6.01.55
This may not be a comprehensive list of procedure codes applicable to this policy.