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PET or PET/CT for Small Cell Lung Cancer | |
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Description: |
Neuroendocrine tumors account for approximately 20% of lung cancers; most are small cell lung cancer (SCLC). Nearly all cases of SCLC are attributed to cigarette smoking. Although the incidence of SCLS has been decreasing, the incidence in women is increasing and the male-to-female ratio is now 1:1.
Positron emission tomography/computed tomography (PET/CT) is increasingly used for disease staging and evaluation of treatment effectiveness in limited-stage small cell lung cancer (LS-SCLC). However, the prognostic value of PET/CT metrics in LS-SCLC is not clear.
Definitions
Screening – testing in the absence of an established or clinically suspected diagnosis
Diagnosis - testing based on a reasonable clinical suspicion of a particular condition or disorder
Diagnostic Workup – initial staging of documented malignancy
Management – testing to direct therapy of an established condition, which may include preoperative or postoperative imaging, or imaging performed to evaluate the response to nonsurgical intervention. In oncologic imaging, management applies to patients with measurable disease and to imaging performed before or after planned treatment intervention, therapy response, restaging or clinically suspected recurrence.
Surveillance – periodic assessment following completion of therapy. In oncologic imaging, surveillance applies to asymptomatic patients in remission and/or without measurable disease
Cannot be performed or is nondiagnostic – applies when the test:
Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending
on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
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Policy/ Coverage: |
Act 583 applies to all contracts subject to AR state law (this includes fully insured contracts, self-funded church sponsored health plans, and self-funded state and local government sponsored health plans except the Arkansas State and Public School Employees program). For a list of the plans subject to AR state law, please see policy guidelines below.
As required by Act 583 of the Arkansas Legislature, positron emission tomography to screen for or to diagnose cancer in a patient upon the recommendation of the patient's physician when the patient has a prior history of cancer is covered when the following criteria are met:
a) Documentation of the malignancy by pathologic or equivalent report, and
b) Performed no more often than every 6 months, and
c) Ordered by or in consultation with a specialist trained in pediatric oncology for an individual under the age of 18 (given the enhanced risk of radiation exposure in young).
Special Note regarding “prior history of cancer”: In applying Act 583 to any PET scan prior approval or coverage decision for those fully-insured contracts and self-funded church or government plans to which Act 583 applies, the patient-member will be considered to have a “prior history of cancer” as referenced in Act 583 if the patient-member either (a) has active cancer at the time a prior approval request is submitted, as documented by a pathologic or equivalent report or (b) previously had cancer, whether or not in remission at the time the prior approval request is submitted, as documented by a pathologic or equivalent report.
For additional information, please see policy 2021004 (PET or PET/CT for Cancer Surveillance and Other Oncologic Applications)
Policy Guidelines
List of Plans subject to Act 583:
As stated above, this does not apply to Arkansas State and Public School Employee health plan participants and beneficiaries. For Arkansas State and Public School Employee health plan participants and beneficiaries, please see policy 2023025 (PET or PET/CT for Oncologic Applications for ASE/PSE Contracts) for additional information.
For Federal Employee Health Benefit Program and Medicare Advantage plan participants please use the appropriate policy set to review.
For other requests for PET or PET/CT scans, the following policy/coverage criteria applies:
Effective April 14, 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
FDG-PET/CT for patients with Small Cell Lung Cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for: (may be considered medically necessary) for:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
PET/CT for patients with for patients with Small Cell Lung Cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any indication or any circumstance other than those listed above including but not limited to:
For contracts without primary coverage criteria, PET/CT for patients with for patients with Small Cell Lung Cancer is considered investigational and is not covered for any indication or any circumstance other than those listed above including but not limited to:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Note: Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy
Effective March 13, 2022 - April 13, 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
FDG-PET/CT for patients with Small Cell Lung Cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
PET/CT for patients with for patients with Small Cell Lung Cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any indication or any circumstance other than those listed above including but not limited to:
For contracts without primary coverage criteria, PET/CT for patients with for patients with Small Cell Lung Cancer is considered investigational and is not covered for any indication or any circumstance other than those listed above including but not limited to:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
*For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
Note: Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy
Effective Prior to March 13, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
FDG-PET/CT for small cell lung cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
Diagnostic Workup
Indicated prior to definitive therapy when standard imaging suggests limited stage disease.
Management
As clinically indicated prior to initiation of radiation therapy.
For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
PET/CT for patients with Small Cell Lung Cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for improving health outcomes for:
For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
For members with contracts without primary coverage criteria, PET/CT for patients with Small Cell Lung Cancer is considered investigational for:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective October 2018 to May 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
PET or PET/CT for small cell lung cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
PET or PET/CT for small cell lung cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following:
For members with contracts without primary coverage criteria, PET or PET/CT for small cell lung cancer is considered investigational for the following:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective prior to October 2018
PET or PET/CT meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
PET or PET/CT does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
For members with contracts without primary coverage criteria, PET or PET/CT is considered investigational if performed for the indications listed above as not meeting primary coverage criteria. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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Rationale: |
PET or PET/CT for small cell lung cancer is controversial, and when recommended, is recommended in limited situations. The following are statements from expert panels and systematic reviews:
Expert Panel Review (Fletcher JW, 2008):
Technology Assessment – Agency for Healthcare Research & Quality (McEwan AJ, 2008):
Technology Assessment - Canadian Agency for Drugs & Technologies in Health (Mujoomdar M, 2010):
NCCN Task Force Report (Podoloff DA, 2009):
PET scanning may have a clinical role in patients with solitary pulmonary lung nodules in whom the diagnosis is uncertain after prior CT scan and chest x-ray. Patients who are relatively young and have no smoking history are at a relatively low risk for lung cancer, and in this setting the negative predictive value of a PET scan is relatively high. If presented with a negative PET scan and information about the very low probability of undetected malignancy, it is quite likely that some patients would choose to avoid the harms of an invasive sampling procedure (i.e., biopsy).
An NCCN report on the use of PET scanning (Podoloff, 2007)) supports an indication for patients who are suspected to have solitary metastases who may be candidates for surgical resection. In such patients the test may detect additional metastases, which would rule out or change the extent of planned surgery.
Six studies of patients with small cell lung cancer (SCLC) reported evidence suggesting that for non-brain metastases, PET added to conventional staging is more sensitive in detecting disease than conventional staging alone. (Seidenfeld, 2006) PET may correctly upstage and downstage disease, and studies reported very high occurrence of patient management changes that were attributed to PET. However, the quality of these studies is consistently poor, and insufficient detail in reporting was the norm, especially with respect to the reference standard. It is not possible from the limited and poor quality evidence that is available to determine whether the use of PET adds value relative to conventional staging tests for SCLC.
Gomez DR, Gladish GW, Wei X, et al. (2012) reported on a retrospective study with 50 patients with LS-SCLC who had had PET/CT before definitive chemoradiation therapy over a 6 year period was reviewed with the conclusions that pretreatment PET/CT metrics had no prognostic significance for patients with LS-SCLC, perhaps because of the rapid proliferation of SCLC or other confounding factors affecting survival.
Sohn and colleagues (2012) performed a study to evaluate whether PET-CT could be used as part of the staging work-up in patients with limited-stage disease (LD) small cell lung cancer (SCLC). A total of 73 patients with presumed LD on CT, who underwent a PET-CT scan, were included in the study.
Conventional work-up revealed distant metastases in 12 patients. Out of 61 patients diagnosed as LD SCLC, PET-CT found unexpected distant metastases in 15 (24.6%) patients (LD/extensive-stage disease (ED)) of whom 13 (21.3%) were upstaged as a consequence. In 10 (76.9%) of the 13 upstaged patients, treatment was changed. The authors concluded that the addition of PET-CT seems to allow more accurate staging and may thus protect a percentage of SCLC patients from potentially futile and toxic radiotherapy.
NCCN Guidelines for SCLC – Version 2.2013
ACR Appropriateness Guidelines for Non-invasive Clinical Staging of Bronchogenic Carcinoma
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement.
2015 Update
A literature search conducted through August 2015 did not reveal any new information that would prompt a change in the coverage statement.
A 2014 meta-analysis included 12 studies (total N=369) of FDGPET/ CT for staging SCLC (Lu, 2014). Although estimated pooled sensitivity and pooled specificity were 0.98 (95% CI, 0.94 to 0.99) and 0.98 (95% CI, 0.95 to 1.00), included studies were small (median sample size, 22 patients); of primarily fair to moderate quality; and heterogeneous in design (retrospective, prospective), PET parameter assessed, indication for PET, and reference standard used.
2017 Update
A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement.
October 2018 Update
A literature search was conducted through September 2018. The key identified literature is summarized below.
Small-Cell Lung Cancer
Approximately 15% of all lung cancers are small-cell lung cancer (SCLC). Patients with SCLC are typically defined as having either limited stage or extensive stage disease. Most patients diagnosed with SCLC have extensive stage disease, which is characterized by distant metastases, malignant pericardial or pleural effusions, and/or contralateral hilar lymph node involvement. Limited stage SCLC is limited to the ipsilateral hemithorax and regional or mediastinal lymph nodes and can be encompassed in a safe radiotherapy field.
Guidelines
Current NCCN guidelines for SCLC indicate PET/CT can be used in the staging of disease if limited stage is suspected. If extensive stage is established, brain imaging, MRI (preferred), or CT with contrast is recommended. PET/CT “is not recommended for routine follow-up” (NCCN, 2018).
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through February 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
DIAGNOSTIC WORKUP
Asymptomatic metastatic central nervous system disease is seen in up to 15% of patients and MRI brain with contrast is indicated regardless of stage (1,2). Most of the available data regarding PET in lung cancer is for non-small cell lung cancer, but limited data does suggest that PET/CT can increase staging accuracy in small cell lung cancer. In a small prospective trial (N =24) evaluating PET versus CT in limited stage small cell lung cancer, FDG-PET had a lesionbased sensitivity relative to CT of 100% and upstaged 2/24 (8.3%) patients. In addition, 25% of patients (6/24) were discovered to have unsuspected regional nodal metastasis. (3) Survival benefit was seen in a retrospective study using pre-treatment PET in patients with limited stage small cell lung cancer. Three-year overall survival was 47% for PET versus 19% for CT (P =.03). The authors attributed the difference in survival to improved radiation field planning and disease upstaging.4Another review found an 84% concordance between PET and CT for staging; however, 19% were upstaged to extensive stage small cell lung cancer and 8% were downstaged to limited stage small cell lung cancer when PET was performed.(1) In studies where PET/CT was used for staging and targeting of lymph nodes for radiation, the local recurrence rates have been reported to be less than 3%.(5, 6) Pathologic staging is still required for PET/CTdetected lesions that would result in upstaging.(7)
MANAGEMENT
The NCCN recommends assessment of treatment response following systemic therapy with or without subsequent radiation therapy using chest/abdomen/pelvis CT (level of evidence category 2A); NCCN does not recommend PET/CT for routine follow-up. (7) Three small prospective trials (N =36) evaluated the use of PET for response assessment in small cell lung cancer. Although metabolic response was associated with better prognosis, no patient benefit was observed. (2)
SURVEILLANCE
National Comprehensive Cancer Network Guidelines for Small Cell Lung Cancer recommend imaging surveillance with a CT of the chest and abdomen every 3 to 4 months as clinically indicated. There is no role for PET/CT in surveillance of treated small cell lung cancer. (7)
Current References
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
NCCN Guidelines for Small Cell Lung Cancer (Version 2022) were reviewed with no change from Version 2021 with regard to PET applications.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement.
NCCN Guidelines for Small Cell Lung Cancer (Version 1.2024) were reviewed with no change from Version 2022 with regard to PET applications.
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CPT/HCPCS: | |
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References: |
American College of Radiolgy(2010) CR Appropriateness Criteria for Small-cell lung carcinoma. www.acr.org; last accessed 1/29/2013. Fletcher JW, Djulbegovic B, Soares HP, et al.(2008) Recommendations on the use of 18F-FDG PET in oncology. J of Nucl Med, 2008; 49:480-508. Gomez DR, Gladish GW, Wei X, et al.(2012) Prognostic Value of Positron Emission Tomography/Computed Tomography Findings in Limited-stage Small Cell Lung Cancer Before Chemoradiation Therapy. Am J Clin Oncol. 2012 Oct 29. [Epub ahead of print] McEwan AJ, Gulenchyn K, Oprina MB, et al.(2008) Positron emission tomography for nine cancers (bladder, brain, cervical, kidney, ovarian, pancreatic, prostate, small cell lung, testicular). University of Alberta Evidence-based Practice Center, Edmonton, Canada. AHRQ Technology Assessment Program, December 1, 2008; pp136-144. Mjuoomdar M, Moulton K, Nkansah E.(2010) Positron emission tomography in oncology: A systematic review of clinical effectiveness and indications for use. Ottawa: Canadian Agency for Drugs & Technologies in Health, 2010; pp 144. National Comprehensive Cancer Network (NCCN).(2018) NCCN Clinical Practice Guidelines in Oncology: Small Cell Lung Cancer. Version 2.2018. https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed August 2, 2018. National Comprehensive Cancer Network(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer (Version 2.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022. National Comprehensive Cancer Network.(2024) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer (Version 1.2024). Available at http://www.nccn.org. National Comprehensive Cancer Network®.((2012) Small cell lung cancer. NCCN Guidelines, version 2.2013. Available at www.nccn.org.; last accessed 1/29/2013. Podoloff DA, Advani RH, Allred C et al.(2007) NCCN task force report: positron emission tomography (PET)/computed tomography (CT) scanning in cancer. J Natl Compr Canc Netw 2007; 5(suppl 1):S1-22. Podoloff DA, Ball DW, en-Josef E, et al.(2009) NCCN task force report: Clinical utility of PET in a variety of tumor types. JNCCN, 2009; 7 (Suppl 2):S-14. Samson DJ, Seidenfeld J, Simon GR, et al.(2007) Evidence for management of small cell lung cancer: ACCP evidence-based clinical practice guidelines. Chest, 2008; 132 (Suppl 3):314S-323S. Seidenfeld J, Samson D, Aronson N.(2006) Management of Small Cell Lung Cancer. Evidence Report. Evidence Report. Evidence Report. Publication No. 06-E016. Rockville, MD: Agency for Healthcare Research and Quality. July 2006. Sohn BS, Lee DH, Kim EK, et al.(2012) The role of integrated 18F-FDG PET-CT as a staging tool for limited-stage small cell lung cancer: a retrospective study. Onkologie. 2012;35(7-8):432-8. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |