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Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DAT-SPECT)

Policy Number: MP-504

Latest Review Date: November 2024

Category: Radiology                                                

POLICY:

Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) may be considered medically necessary when used for individuals with:

  • clinically uncertain Parkinson disease(PD); or
  • clinically uncertain dementia with Lewy bodies

Use of dopamine transporter imaging with single-photon emission computed tomography is considered investigational for all other indications not included above.

Note: In July 2021, aducanumab (Aduhelm™; Biogen), received U.S. Food and Drug Administration (FDA) accelerated approval and in July 2023, lecanemab-irmb- (Leqembi; Esai) received FDA approval as amyloid beta-targeted antibodies was approved for the treatment of mild cognitive impairment or mild dementia due to Alzheimer disease. A third anti-amyloid antibody product, donanemab-azbt, was approved by the FDA in July 2024. Aducanumab was subsequently discontinued by the manufacturer in 2024. The safety and efficacy of aducanumab, lecanemab or donanemab in individuals with dementia with Lewy bodies has not been established as participants with any medical or neurological condition other than Alzheimer disease that might be a contributing cause to the subject's cognitive impairment were excluded from trials. The use of dopamine transporter imaging with single-photon emission computed tomography for the diagnosis, management, or surveillance of Alzheimer disease is considered out of scope for this policy.

DESCRIPTION OF PROCEDURE OR SERVICE:

Dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT), using radiopharmaceutical ioflupane injection, is a neuro-imaging modality being evaluated to improve the differential diagnosis of parkinsonian syndromes from non-parkinsonian tremor, as well as dementia with Lewy bodies from Alzheimer disease.

Parkinsonian Syndromes

Parkinsonian Syndromes are a group of diseases that share similar cardinal signs, characterized by bradykinesia, rigidity, resting tremor, and gait disturbance. Parkinson disease (PD) is the most common cause of Parkinsonism.

Despite the well-known symptoms of PD, diagnosis is challenging even for experienced clinicians, particularly in early stages of the disease. In addition, other etiologies such as essential tremor, corticobasal degeneration, multisystem atrophy, progressive supranuclear palsy, vascular parkinsonism, and drug-induced parkinsonism can lead to a similar set of symptoms.

One recent approach to improve the accuracry of clinical diagnosis of PD and other parkinsonian syndromes is to evaluate the integrity of dopaminergic pathways in the brain using DaT-SPECT imaging.

Dementia with Lewy Bodies

Dementia with Lewy Bodies (DLB) is a type of dementia characterized by Parkinsonism, visual hallucinations, cognitive fluctuation, sleep disorders, and severe neuroleptic sensitivity. DLB is the second most common form of degenerative dementia; Alzheimer disease, which can have similar symptoms at onset, is the most common.

Diagnosis can be challenging, particularly when individuals have multiple comorbidities including cerebrovascular disease and/or Alzheimer disease. As with PD, DLB is characterized by the degeneration of nigrostriatal neurons; as such, DaT-SPECT is also proposed to differentiate DLB from Alzheimer disease.

Dopamine Transporter Imaging With Single-Photon Emission Computed Tomography (DaT-SPECT)

Dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT) is based on the selective affinity of dopamine transporter ligands for dopamine synthesizing neurons, which allows visualization of deficits in the nigrostriatal dopaminergic pathway.

Dopamine transporter ligands include iodine 123 2β-carbomethoxy-3β-(4-iodophenyl) tropane    (123 I-β-CIT), which is a cocaine analogue with affinity for both dopamine transporter and serotonin transporters. Intravenous 123I-β-CIT requires a delay between injection and scan of about 24 hours. Iodine 123 N-(3-fluoropropyl)-2β-carbomethoxy-3β-(4-iodophenyl) nortropane (123I-FP-CIT) is a fluoropropyl derivate of β-CIT that is selective for brain striatal dopamine transporter, but can also bind to the serotonin transporter. Intravenous 123I-FP-CIT can be injected three to six hours before the scan (DaTscan). Other ligands with affinity for dopamine transporter include technetium 99m (2β ((N, N`-bis (2-mercaptoethyl) ethylene diamino) methyl) and 3β-(4-chlorophenyl) tropane (99mTc-TRODAT-1).

Binding of ligands with an affinity for DaT ligands in the striatum is, in general, reduced in PD, genetic parkinsonism, DLB, corticobasal degeneration, progressive supranuclear palsy, and multiple system atrophy. In contrast, striatal DaT ligand binding is expected to be within the normal range of Alzheimer disease, essential tremor, dystonic tremor, orthostatic tremor, drug-induced parkinsonism, and psychogenic parkinsonism.

Visualization of striatal dopamine transporter binding, through DaT-SPECT, permits assessment of presynaptic dopaminergic deficit. It is proposed that an abnormal DaT-SPECT scan supports the diagnosis of PD, DLB, or other neurodegenerative parkinsonian syndromes, while a normal DaT-SPECT scan in a symptomatic individual supports the diagnosis of a disease not affecting the nigrostriatal dopaminergic pathway.

Analysis of DaT-SPECT images can be visual, semiquantitative, or quantitative. In individuals with PD, physical symptoms start after 30% to 50% of dopaminergic neurons have degenerated. Symptomatic individuals with would be thus expected to have sufficient abnormality on DaT-SPECT for visual analysis to be adequate for interpretation.  A variety of methods are being tested to improve the validity and reliability of ratings, including commercially available software to define the region of interest for analysis and the development of an atlas for visual interpretation. Several research centers are developing quantitative and semiquantitative classification methods for the evaluation of DaT-SPECT images.

Anatomic variation in the brain, including vascular lesions, may impede the distribution of the iodine123 tracer and could result in an abnormal scan. Dopamine agonists and levodopa may also affect DaT expression, which could influence the ability of DaT-SPECT to monitor the progression of disease unless these agents are discontinued prior to imaging. Individuals with clinically diagnosed PD or DLB, who present with a normal DaT-SPECT scan, are referred to in the literature as having “scans without evidence of dopaminergic deficit.” While many of these individuals are ultimately diagnosed with non-PD syndromes, a portion of individuals with normal DaT-SPECT imaging are confirmed to have PD or DLB by the reference standard. In studies where clinical diagnosis is used as an end point, scans without evidence of dopaminergic deficit are present in 3% to 20% of PD individuals. In a study of individuals clinically diagnosed with DLB, van der Zande et al (2016) found that 10% of these individuals had normal scans. Further research may shed light on these cases.

KEY POINTS:

The most recent literature review was updated through August 26, 2024.

Summary of Evidence

For individuals who have clinically uncertain Parkinson disease (PD) who receive dopamine transporter imaging with single-photon emission computed tomography (DaT-SPECT), the published evidence includes randomized controlled trials (RCTs), cohort studies, and case series. Relevant outcomes are symptoms, functional outcomes, and treatment related mortality and morbidity. In populations with clinically apparent PD, studies of diagnostic accuracy have reported high sensitivity and specificity for PD. Studies of clinical validity in the target population of clinically uncertain PD are limited by gaps in study design, conduct, and relevance. Evidence on clinical utility in the target population includes an RCT showing no significant difference in outcomes over time between individuals who received a DaT-SPECT scan and those who did not. 

For individuals who have clinically uncertain dementia with Lewy bodies who receive DaT-SPECT, the published evidence includes RCTs, cohort studies, and case series. Relevant outcomes are symptoms, functional outcomes, and treatment-related mortality and morbidity. No such studies with the optimal reference standard to assess clinical validity have been performed in the target population of clinically uncertain dementia with Lewy bodies. No studies have directly evaluated the effect of DaT-SPECT on health outcomes in the target population. 

Clinical Input From Physician Specialty Societies and Academic Medical Centers

2018 Input

Clinical input was sought to help determine whether the use of DaT-SPECT in individuals with clinically uncertain Parkinson disease or clinically uncertain dementia with Lewy bodies would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from three respondents, including one specialty society-level response and two physician-level responses identified through specialty societies.

In individuals who have clinically uncertain PD who receive DaT-SPECT, clinical input supports that DaT-SPECT is clinically useful when a negative result on DaT-SPECT is used to inform treatment decisions by reducing or avoiding unnecessary dopaminergic therapy. Clinical input highlights that the published RCT also reported changes in management following DaT-SPECT imaging that may translate to improvements in health outcomes over time, and the one-year study follow-up may be too short to demonstrate significant improvement in quality of life in a slowly progressive disease such as PD. Clinical input further supports that DaT-SPECT offers clinically valid diagnostic information about the presence or absence of functional loss in the dopamine system (ie, nigrostriatal degeneration) and is clinically useful for clinically uncertain Parkinson syndrome when a negative result on DaT-SPECT is used to inform treatment decisions by reducing or avoiding unnecessary dopaminergic therapy in individuals who have clinically uncertain dementia with Lewy bodies who receive DaT-SPECT, clinical input supports that DaT-SPECT is clinically useful when a positive result on DaT-SPECT is used to inform treatment decisions by avoiding potentially harmful use of neuroleptics which may be used in dementia individuals. Clinical input noted that DaT-SPECT offers clinically valid diagnostic information about the presence or absence of functional loss in the dopamine system (i.e., nigrostriatal degeneration) and is clinically useful for clinically uncertain dementia with Lewy bodies using a chain of evidence where a positive result on DaT-SPECT is used to inform treatment decisions by avoiding potentially harmful use of neuroleptics typically used in dementia individuals.

Practice Guidelines and Position Statements

American College of Radiology

In 2019, the American College of Radiology updated the appropriateness criteria for movement disorders and neurodegenerative diseases. The College categorized Ioflupane SPECT/CT as 'may be appropriate' for initial imaging of Parkinsonian syndrome. A strength of evidence rating was not given for this statement.

The American College of Radiology (2019) updated the appropriateness criteria for dementia.The College categorized Ioflupane SPECT or SPECT/CT brain as 'may be appropriate' for initial imaging for suspected dementia with Lewy bodies. A strength of evidence rating was not given for this statement.

Dementia of Lewy Bodies Consortium

In 2017, the Dementia of Lewy Bodies Consortium published clinical guidelines on diagnosis and management based on American expert opinion. The guidelines stated that reduced DaT uptake in basal ganglia demonstrated by SPECT is an indicative biomarker. As such, dementia with abnormal DaT-SPECT imaging would be classified as possible dementia with Lewy bodies. The presence of another core clinical feature (fluctuating cognition, recurrent visual hallucinations, rapid-eye-movement sleep disorder, parkinsonism motor abnormalities) in addition to dementia and abnormal DaT-SPECT imaging would allow classification as probable dementia with Lewy bodies. It was noted that individuals with autopsy-confirmed dementia with Lewy bodies may have normal DaT-SPECT imaging.

Movement Disorder Society

In 2015, the Movement Disorder Society’s (MDS) published diagnostic criteria for PD intended for use in clinical research but also commonly used to guide clinical diagnosis. The MDS considers the clinical expert opinion to be the criterion standard to diagnose PD and that diagnoses are usually made clinically without need for ancillary diagnostic testing. Methods that may become available as knowledge advances are diagnostic biochemical markers, anatomic neuroimaging, and methods to detect alpha-synuclein deposition. MDS noted that, although dopaminergic neuroimaging can help to distinguish parkinsonism from PD mimics like essential tremor, “it does not qualify as a criterion for the differentiation of PD from other parkinsonian conditions like atypical parkinsonian syndromes.”In 2023, the MDS published a statement on the biological definition, staging and classification of PD. The document mentions dopamine imaging but states that its use is not widespread enough to be included in a staging or classification schema.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence published guidance on the diagnosis and management of PD in 2006, which was updated in 2017. The 2006 guidance stated that 123I-FP-CIT SPECT should be considered for people with tremor where essential tremor cannot be clinically differentiated from parkinsonism (based on studies with level of evidence 1a or 1b); this guidance is continued in 2017 recommendations. In addition, the 2006 guidance stated that 123I-FP-CIT SPECT should be available to specialists with expertise in its use and interpretation (based on level of evidence IV, expert opinion).

The Institute updated its guidance on dementia in 2018. It recommended that 123I-FP-CIT SPECT be used to help establish the diagnosis in those with suspected DLB {dementia with Lewy bodies] if the diagnosis is uncertain.

Society of Nuclear Medicine and Molecular Imaging et al

In 2020, the Society of Nuclear Medicine and Imaging and the European Association of Nuclear Medicine published a joint practice guideline and procedure standard for dopaminergic imaging in Parkinsonian syndromes. The guideline indicated presynaptic dopaminergic imaging for "detecting loss of nigrostriatal dopaminergic neuron terminals of individuals with parkinsonian syndromes, especially:

  • To support the differential diagnosis between essential tremor and neurodegenerative parkinsonian syndromes. Note that presynaptic dopaminergic imaging is unable to distinguish IPD [idiopathic Parkinson disease] and DLB from PSP [progressive supranuclear palsy], CBD [corticobasal degeneration], or putaminal variant of MSA [multiple system atrophy];
  • To help distinguish between dementia with Lewy bodies and other dementias (in particular, Alzheimer’s disease, AD);
  • To support the differential diagnosis between parkinsonism due to presynaptic degenerative dopamine deficiency and other forms of parkinsonism, e.g., between IPD and drug-induced, psychogenic, or vascular parkinsonism;
  • To detect early presynaptic parkinsonian syndromes."

In 2011, the Society of Nuclear Medicine, now called the Society of Nuclear Medicine and Molecular Imaging, provided practice guidelines for DaT-SPECT, The guidelines stated that the main indication for DaT-SPECT is striatal DaT visualization in the evaluation of adults with suspected parkinsonian syndromes to help differentiate essential tremor from tremor due to presynaptic parkinsonian syndromes (PD, multisystem atrophy, progressive supranuclear palsy). Other indications are the early diagnosis of presynaptic parkinsonian syndromes, differentiation of presynaptic parkinsonian syndromes from parkinsonism without a presynaptic dopaminergic loss (e.g., drug-induced parkinsonism, psychogenic parkinsonism), and differentiation of dementia with Lewy bodies from AD. The guidance stated that visual interpretation of the scan is usually sufficient for clinical evaluation, where the striatal shape, extent, symmetry, and intensity differentiate normal from abnormal. For semiquantitative analysis, each site should establish its own reference range by scanning a population of healthy controls or by calibrating its procedure with another center that has a reference database.

U.S. Preventative Service Task Force Recommendations

Not applicable

KEY WORDS:

DaTscan, DAT-SPECT, 123I-Ioflupane, Iodine I-123 ioflupane diagnostic study, dopamine transporter SPECT using 123I-Ioflupane, FP-CIT SPECT, [123I]-FP-CIT SPECT imaging

APPROVED BY GOVERNING BODIES:

In 2011, DaTscan™ (GE Healthcare, Chicago, IL) was approved by the U.S. Food Drug Administration through a new drug application and is “indicated for striatal dopamine transporter visualization using single photon emission computed tomography brain imaging to assist in the evaluation of adult individuals with suspected parkinsonian syndromes. In these individuals, DaTscan may be used to help differentiate ET [essential tremor] from tremor due to parkinsonian syndromes (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations.” In 2022, DaTscan was approved for use in individuals with suspected dementia with Lewy bodies.

In July 2021, aducanumab (Aduhelm™; Biogen), an amyloid beta-targeted antibody, was approved for the treatment of mild cognitive impairment or mild dementia due to Alzheimer disease. In July 2023, lecanemab-irmb (Leqembi®; Esai) received FDA approval as amyloid beta-targeted antibodies for the treatment of mild cognitive impairment or mild dementia due to Alzheimer disease. A third anti-amyloid antibody product, donanemab-azbt, was approved by the FDA in July 2024. Aducanumab was subsequently discontinued by the manufacturer in 2024. The safety and efficacy of aducanumab, lecanemab, or donanemab in individuals with dementia with Lewy bodies has not been established as individuals with any medical or neurological condition other than Alzheimer disease that might be a contributing cause to the subject's cognitive impairment were excluded from trials. The use of DaT-SPECT for the diagnosis, management, or surveillance of Alzheimer disease is considered out of scope for this policy.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:  

78803 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); tomographic (SPECT)

HCPCS Codes:   

A9584 Iodine I-123 ioflupane, diagnostic, per study dose, up to 5 millicuries

 

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POLICY HISTORY:

Medical Policy Panel, August 2012

Medical Policy Group, August 2012 (2); New Policy

Medical Policy Administration Committee, September 2012

Available for comment September 18 through November 1, 2012

Medical Policy Panel, July 2013

Medical Policy Group, July 2013 (2):  2013 Updates to Key Points and References; no change in policy statement

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (3):  2014 Updates to Key Points & References; no change in policy statement

Medical Policy Panel, November 2015

Medical Policy Panel, November 2015 (3): 2015 Updates to Description, Policy Statement, Key Points and References; no change to policy intent.

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (3): 2016 Updates to Description, Key Point & References. No change to policy statement.

Medical Policy Panel, October 2017

Medical Policy Group, November 2017 (3): 2017 Updates to Description, Key Points & References; No change to policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (3): Updates to Description, Key Points, Practice Guidelines and Position Statements and References. No changes to policy statement or intent.

Medical Policy Panel, September 2019

Medical Policy Group, October 2019 (3): 2019 Updates to Key Points. No changes to policy statement or intent.

Medical Policy Group, December 2019: 2020 Annual Coding Update. Added CPT Code 78803 to Current Coding Section. Created Previous Coding section to include code 78607.

Medical Policy Group, October 2020 (2): Updates to  Key Points; Policy Statement updated to allow coverage of dopamine transporter imaging with single photon emission computed tomography when used for individuals with clinically uncertain Parkinson disease or clinically uncertain dementia with Lewy bodies; considered investigational for all other indications; (effective 10/9/2020).

Medical Policy Panel, November 2020

Medical Policy Group, November 2020 (2): Updates to Key Points and References; No change to policy statement.

Medical Policy Panel, October 2021

Meidcal Policy Group, October 2021 (2): Updates to Key Points, Approved by Governing Bodies, and References. Policy statement updated to remove “not medically necessary,” no change in intent. Note added to policy section stating “The use of DaT-SPECT for the diagnosis, management, or surveillance of Alzheimer disease is considered out of scope for this policy;” no change in intent.

Medical Policy Panel, October 2022

Medical Policy Group, October 2022 (2): Updates to Description and References; no change to policy intent. 

Medical Policy Panel, October 2023

Medical Policy Group, November 2023 (2): Updates to Description, Key Points, Benefit Application and References. Previous coding section removed; no change to policy statement.

Medical Policy Panel, October 2024

Medical Policy Group, November 2024 (9): Updates to Description, Key Points, Practice Guidelines, Governing Bodies and References; no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.