Medical Policy: 02.04.77
Original Effective Date: September 2019
Reviewed: September 2020
Revised: September 2020
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This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Lung cancer is the leading cause of cancer death in the United States. In 2020, an estimated 228,820 new cases (116,300 in men and 112,520 in women) of lung and bronchial cancer will be diagnosed, and 135,720 deaths (72,500 in men and 63,220 in women) are estimated to occur because of the disease. Only 19% of all patients with lung cancer are alive 5 years or more after diagnosis. However, much progress has been made recently for lung cancer such as screening, minimally invasive techniques for diagnosis and treatment, and advances in radiation therapy (RT) including stereotactic ablative radiotherapy (SABR), targeted therapies, and immunotherapies. Patients with metastatic lung cancer who are eligible for targeted therapies or immunotherapies are now surviving longer; 5-year survival rates range from 15% to 50%, depending on the biomarker. Thus, death rates from lung cancer have been declining although there are still more deaths from lung cancer than from breast, prostate, colorectal and brain cancers combined together. (NCCN Version 8.2020)
The term proteome refers to the entire complement of proteins produced by an organism, or cellular system and proteomics refers to the large-scale comprehensive study of a specific proteome. The proteome may differ from cell to cell and may vary over time and in response to selected stressors.
Proteomic testing has been proposed as a way to predict survival outcomes, as well as the response to and selection of targeted therapy for patients with non-small cell lung cancer (NSCLC). One commercially available test, the VeriStrat assay has been investigated to assess prognosis for outcomes in advanced non-small cell lung cancer (NSCLC) and predictive survival benefit between epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and single agent chemotherapy.
The VeriStrat assay uses an 8-peak proteomic signature; 4 of the 8 have been identified as fragments of serum amyloid A protein 1. This protein has been found to be elevated in individuals with a variety of conditions associated with acute and chronic inflammation. The VeriStrat assay measures acute phase proteins and the acute phase response which indicates chronic inflammation and more aggressive cancer. This assay is intended to impact treatment strategy and facilitate disease state monitoring. The VeriStrat results are reported as good or poor: VeriStrat Good results indicate a disease state that is more likely to respond to standard of care treatment; VeriStrat Poor results indicate a chronic inflammatory disease state and these patients may benefit from an alternative treatment strategy including clinical trial, broad genomic profiling for rare mutations, faster time to treatment if active therapy is being considered or palliative care.
Clinical Context and Test Purpose
The purpose of proteomic testing in individuals with non-small-cell lung cancer (NSCLC) who are epidermal growth factor receptor (EGFR)-negative or EGFR-status unknown NSCLC is to predict expected survival when receiving standard therapies for the treatment of NSCLC. More specifically, the testing could impact the decision point for the selection of treatment based on a prediction of response to EGFR tyrosine kinase inhibitors (TKIs). That is, the VeriStrat classification might be predictive of a differential response to EGFR TKIs.
The relevant populations of interest are patients with EGFR-negative or EGFR-status unknown NSCLC who are newly diagnosed or who have progressed after first-line treatment.
The test being considered is management with a serum proteomic test to predict survival and select systemic therapy.
The following practice is currently being used to manage NSCLC: standard medical management to include predictive and prognostic biomarkers in patients with metastatic NSCLC through technical advances using next generation sequencing for NSCLC by testing solid tumor specimen for EGFR mutations, BRAF mutations, ALK fusions, ROS1 fusions, METext14 skipping mutations, RET rearrangements and PD-L1 expression levels. to asses whether patients are eligible for targeted therapies or immunotherapies (NCCN Version 8.2020 Non-Small Cell Lung Cancer).
The outcomes of interest are overall survival (OS) and progression-free survival (PFS).
In patients with NSCLC, the most commonly found EGFR mutations are deletions in exon 19 (Exon19del [with conserved deletion of the LREA sequence] in 45% of patients with EGFR mutations) and a point mutations in exon 21 (L858R in 40%). Both mutations result in activation of the tyrosine kinase domain, and both are associated with sensitivity to the small-molecule EGFR TKIs, such as erlotinib, gefitinib, afatinib, osimertinib, and dacomitinib. Thus, these drug-sensitive EGFR mutations are referred to as sensitizing EGFR mutations. Other less common mutations (10%) that are also sensitive to EGFR TKIs include exon 19 insertions, p.L861Q, p.G719X, and p.S768I. Data suggest that patients harboring tumors without sensitizing EGFR mutations should not be treated with EGFR TKIs in any line of therapy. These sensitizing EGFR mutations are found in approximately 10% of Caucasian patients with NSCLC and up to 50% of Asian patients.
The predictive effects of the drug-sensitive EGFR mutations are well defined. Patients with these mutations have a significantly better response to erlotinib, gefitinib, afatinib, osimertinib or dacomitinib. Data show that EGFR TKI therapy should be used as first-line monotherapy in patients advanced NSCLC and sensitizing EGFR mutations documented before first-line systemic therapy (e.g. carboplatin/paclitaxel). Progression-free survival (PFS) is longer with use of EGFR TKI monotherapy in patients with sensitizing EGFR mutations when compared with cytotoxic systemic therapy, although overall survival is not statistically different.
Non-responsiveness to EGFR TKI therapy is associated with KRAS and BRAF mutations and ALK or ROS1 gene fusions. Patients with EGFR exon 20 insertion mutations are usually resistant to erlotinib, gefitinib, afatinib, or dacomitinib, although there are rare exceptions. Patients typically progress after first-line EGFR TKI monotherapy. EGFR p.Thr790Met (T790M) is a mutations associated with acquired resistance to EGFR TKI therapy and has been reported in about 60% of patients with disease progression after initial response to erlotinib, gefitinib or afatinib. Most patients with sensitizing EGFR mutations become resistant to erlotinib, gefitinib or afatinib; PFS is about 9.7 to 13 months. Studies suggest T790M may rarely occur in patients who have previously received erlotinib, gefitinib or afatinib. Genetic counseling is recommended for patients with pre-treatment p.T790M, because this suggest the possibility of germline mutations and is associated with predisposition to familial lung cancer. Acquired resistance to EGFR TKIs may also be associated with histologic transformation from NSCLC to SCLC and with epithelial to mesenchymal transition. Acquired resistance can also be mediated by other molecular events, such as acquisition of ALK rearrangement, MET or ERBB2 amplification.
The current NCCN Guideline Version 8.2020 Non-Small Cell Lung Cancer states the following:
- "The NCCN NSCLC Panel recommends testing for sensitizing EBFR mutations in patients with metastatic nonsquamous NSCLC or NSCLC NOS based on data showing the efficacy of osimertinib, erlotinib, gefitinib, afatinib or dacomitinib and on DFA approval. DNA mutational analysis is the preferred method to assess for EGFR status; IHC is not recommended for detecting EGFR mutations. Real-time PCR, Sanger sequencing (paired with tumor enrichment), and NGS are the most commonly used methods to assess EGFR mutation status. Direct sequencing of DNA corresponding to exons 18 to 21 (or just testing for exons 19 and 21) is a reasonable approach; however, more sensitive methods are available. Mutation screening assays using multiplex PCR (e.g. Sequenom’s MassARRAY system, SNaPshot Multiplex system) can simultaneously detect more than 50- point mutations. NGS can also be used to detect EGFR mutations."
- "To minimize tissue use and potential wastage, the NCCN NSCLC Panel recommends that broad molecular profiling be done as part of biomarker testing using a validated test(s) that assess a minimum of following potential genetic variants: EGFR mutations, BRAF mutations, METex14 skipping mutations, RET rearrangements, ALK fusions, and ROS1 fusions. Both FDA and laboratory developed test platforms are available that address the need to evaluate these and other analytes. Broad molecular profiling is also recommended to identify rare driver mutations for which effective therapy may be available, such NTRK gene fusion, high level MET amplification, ERBB2 mutations and TMB. Although clinicopathologic features such as smoking status, ethnicity and histology are associated with specific genetic variants (e.g. EGFR mutations), these features should not be used to select patients for testing. Although the NCCN guidelines for NSCLC provide recommendations for individual markers that should be tested and recommend testing techniques, the guidelines do not endorse any specific commercially available biomarkers assays."
Previous NCCN guidelines for the treatment of NSCLC supported the use of proteomic tests to evaluate potential therapies in advanced NSCLC. However. likely due to technical advances, availability of next generation sequencing (NGS) testing for solid tumors, and treatment options, the current NCCN guideline Version 8.2020 Non-Small Cell Lung Cancer no longer incorporates these proteomic tests to include VeriStrat into their NSCLC evaluation algorithms.
The available peer-reviewed clinical validity studies assess the predictive performance of VeriStrat-directed erlotinib therapy compared with chemotherapy in patients who were either EGFR wild type or had an unknown EGFR mutation status and had progressed after first-line treatment. The overall evidence base for predictive use is characterized by several study design limitations. For example, VeriStrat was not used to determine treatment in the available studies and the majority of the study authors reported that treatment selection was based on standard of care. In addition, a “VSGood” result claims to identify NSCLC patients who are EGFR wild-type but still likely to benefit from EGFR-TKI therapy. Yet the clinical validity studies did not consistently test for EGFR variants and, consequently, the true relationship between VeriStrat results, EGFR status, and survival cannot be definitively understood. For VeriStrat to demonstrate clinical validity in patients with NSCLC in light of the NCCN guideline changes and some of the original design limitations, additional studies supporting its performance are required.
Direct clinical utility studies were not identified in the scientific literature. Examples of these would include prospective studies comparing survival outcomes in patients who had EGFR-TKI treatment selected either by VeriStrat classification or through other standard EGFR variant analysis methods (such as next-generation sequencing).
Regarding the prognostic ability of VeriStrat, the majority of the available evidence predicting disease outcomes included retrospective clinical validity studies which evaluated the test in patients with advanced NSCLC who were treatment-naïve or had either failed first-line treatment or had a recurrence. To infer how well VeriStrat performed as a prognostic test, these studies examined the degree of association between VSGood or VSPoor scores and survival outcomes. Overall, this evidence base demonstrating the performance of VeriStrat as a prognostic test is of low quality.
Summary of Evidence
Previous NCCN guidelines for the treatment of NSCLC supported the use of proteomic tests to evaluate potential therapies in advanced NSCLC. However. likely due to technical advances, availability of next generation sequencing (NGS) testing for solid tumors, and treatment options, the current NCCN guideline Version 8.2020 Non-Small Cell Lung Cancer no longer incorporates these proteomic tests to include VeriStrat into their NSCLC evaluation algorithms. Given that VeriStrat testing is not currently supported in clinical practice guidelines for the treatment of advanced NSCLC and the published evidence does not independently meet the criteria for this indication, the use of proteomic testing to include VeriStrat is considered not medically necessary.
Practice Guideline and Position Statements
National Comprehensive Cancer Network (NCCN)
Non-Small Cell Lung Cancer Version 8.2020 current NCCN guideline does not include or indicate specific recommendations for proteomic testing; there is no mention of proteomic testing or the use of Veristrat in the management of non-small cell lung cancer.
American Society of Clinical Oncology (ASCO)
In 2018, the American Society of Clinical Oncology (ASCO) updated their guideline on molecular testing guideline for the selection of patients with lung cancer for treatment with targeted tyrosine kinase inhibitors in which they endorsed the molecular testing guidelines from the College of American Pathologists (CAP)/International Association for the Study of Lung Cancer (IASCL) and the Association for Molecular Pathology (AMP) molecular testing guideline with minor modifications. Their recommendation does not include or indicate the use of proteomic testing or the use of Veristrat in the management of non-small cell lung cancer.
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments (CLIA). The commercially available proteomic test (VeriStrat®; Biodesix) is available under the Clinical Laboratory Improvement Amendments (CLIA). Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of these tests.
See related medical policies
- 02.04.16 Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy)
- 02.04.79 Circulating Tumor DNA for Management of Non-Small Cell Lung Cancer (Liquid Biopsy)
- 02.04.78 Molecular Analysis for Targeted Therapy of Non-Small Cell Lung Cancer
- 02.04.55 Epidermal Growth Factor Receptor (EGFR) Testing
- 02.04.63 Expanded Genetic Panels to Identify Targeted Cancer Therapy
The use of proteomic testing, including but not limited to the VeriStrat assay, is considered not medically necessary for all uses in the management of non-small cell lung cancer (NSCLC).
Previous NCCN guidelines for the treatment of NSCLC supported the use of proteomic tests to evaluate potential therapies in advanced NSCLC. However. likely due to technical advances, availability of next generation sequencing (NGS) testing for solid tumors, and treatment options, the current NCCN guideline Version 8.2020 Non-Small Cell Lung Cancer no longer incorporates these proteomic tests to include VeriStrat into their NSCLC evaluation algorithms. Given that VeriStrat testing is not currently supported in clinical practice guidelines for the treatment of advanced NSCL and the published evidence does not independently meet the criteria for this indication, the use of proteomic testing to include VeriStrat is considered not medically necessary.
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
- 81538 Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival
- National Comprehensive Cancer Network (NCCN) Non-Small Cell Lung Cancer Version 8.2020.
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- September 2020 - Annual Review, Policy Revised
- September 2019 - New Policy Created
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