Medical Policy: 02.04.77 

Original Effective Date: September 2019 

Reviewed: September 2020 

Revised: September 2020 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

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.

 

Description:

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.

 

Patients

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.

 

Intervention

The test being considered is management with a serum proteomic test to predict survival and select systemic therapy.

 

Comparator

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).  

 

Outcomes

The outcomes of interest are overall survival (OS) and progression-free survival (PFS).

 

EGFR Mutations

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.

 

Regulatory Status

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.

 

Prior Approval:

Not applicable

 

Policy:

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

 

Selected References:

  • National Comprehensive Cancer Network (NCCN) Non-Small Cell Lung Cancer Version 8.2020. 
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  • Jacot W, Lhermitte L, Dossat N, et al. Serum proteomic profiling of lung cancer in high-risk groups and determination of clinical outcomes. J Thorac Oncol. Aug 2008;3(8):840-850. PMID 18670301
  • Abbatiello S, Ackermann BL, Borchers C, et al. New guidelines for publication of manuscripts describing development and application of targeted mass spectrometry measurements of peptides and proteins. Mol Cell Proteomics. Mar 2017;16(3):327-328. PMID 28183812
  • Amann JM, Lee JW, Roder H, et al. Genetic and proteomic features associated with survival after treatment with erlotinib in first-line therapy of non-small cell lung cancer in Eastern Cooperative Oncology Group 3503. J Thorac Oncol. Feb 2010;5(2):169-178. PMID 20035238
  • Kuiper JL, Lind JS, Groen HJ, et al. VeriStrat((R)) has prognostic value in advanced stage NSCLC patients treated with erlotinib and sorafenib. Br J Cancer. Nov 20 2012;107(11):1820-1825. PMID 23079575
  • Akerley W, Boucher K, Rich N, et al. A phase II study of bevacizumab and erlotinib as initial treatment for metastatic non-squamous, non-small cell lung cancer with serum proteomic evaluation. Lung Cancer. Mar 2013;79(3):307-311. PMID 23273522
  • Gautschi O, Dingemans AM, Crowe S, et al. VeriStrat(R) has a prognostic value for patients with advanced non-small cell lung cancer treated with erlotinib and bevacizumab in the first line: pooled analysis of SAKK19/05 and NTR528. Lung Cancer. Jan 2013;79(1):59-64. PMID 23122759
  • Stinchcombe TE, Roder J, Peterman AH, et al. A retrospective analysis of VeriStrat status on outcome of a randomized phase II trial of first-line therapy with gemcitabine, erlotinib, or the combination in elderly patients (age 70 years or older) with stage IIIB/IV non-small-cell lung cancer. J Thorac Oncol. Apr 2013;8(4):443-451. PMID 23370367
  • Grossi F, Rijavec E, Genova C, et al. Serum proteomic test in advanced non-squamous non-small cell lung cancer treated in first line with standard chemotherapy. Br J Cancer. Jan 3 2017;116(1):36-43. PMID 27898657
  • Carbone DP, Salmon JS, Billheimer D, et al. VeriStrat classifier for survival and time to progression in non-small cell lung cancer (NSCLC) patients treated with erlotinib and bevacizumab. Lung Cancer. Sep 2010;69(3):337-340. PMID 20036440
  • Spigel DR, Burris HA, 3rd, Greco FA, et al. Erlotinib plus either pazopanib or placebo in patients with previously treated advanced non-small cell lung cancer: A randomized, placebo-controlled phase 2 trial with correlated serum proteomic signatures. Cancer. Jun 1 2018;124(11):2355-2364. PMID 29645086
  • Grossi F, Genova C, Rijavec E, et al. Prognostic role of the VeriStrat test in first line patients with non-small cell lung cancer treated with platinum-based chemotherapy. Lung Cancer. Mar 2018;117:64-69. PMID 29395121
  • Herbst RS, Johnson DH, Mininberg E, et al. Phase I/II trial evaluating the anti-vascular endothelial growth factor monoclonal antibody bevacizumab in combination with the HER-1/epidermal growth factor receptor tyrosine kinase inhibitor erlotinib for patients with recurrent non-small-cell lung cancer. J Clin Oncol. Apr 10 2005;23(11):2544-2555. PMID 15753462
  • Salmon S, Chen H, Chen S, et al. Classification by mass spectrometry can accurately and reliably predict outcome in patients with non-small cell lung cancer treated with erlotinib-containing regimen. J Thorac Oncol. Jun 2009;4(6):689-696. PMID 19404214
  • Wu X, Liang W, Hou X, et al. Serum proteomic study on EGFR-TKIs target treatment for patients with NSCLC. Onco Targets Ther. Nov 2013;6:1481-1491. PMID 24204163
  • Yang L, Tang C, Xu B, et al. Classification of epidermal growth factor receptor gene mutation status using serum proteomic profiling predicts tumor response in patients with stage IIIB or IV non-small-cell lung cancer. PLoS One. Jun 2015;10(6):e0128970. PMID 26047516
  • Gregorc V, Novello S, Lazzari C, et al. Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomised phase 3 trial. Lancet Oncol. Jun 2014;15(7):713-721. PMID 24831979
  • Peters S, Stahel RA, Dafni U, et al. Randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer failing first-line platinum-based doublet chemotherapy stratified by VeriStrat good versus VeriStrat poor. The European Thoracic Oncology Platform (ETOP) EMPHASIS-lung Trial. J Thorac Oncol. Apr 2017;12(4):752-762. PMID 28017787
  • Carbone DP, Ding K, Roder H, et al. Prognostic and predictive role of the VeriStrat plasma test in patients with advanced non-small-cell lung cancer treated with erlotinib or placebo in the NCIC Clinical Trials Group BR.21 trial. J Thorac Oncol. Nov 2012;7(11):1653-1660. PMID 23059783
  • Gadgeel S, Goss G, Soria JC, et al. Evaluation of the VeriStrat(R) serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study. Lung Cancer. Jul 2017;109:101-108. PMID 28577938
  • Buttigliero C, Shepherd FA, Barlesi F, et al. Retrospective assessment of a serum proteomic test in a phase III study comparing erlotinib plus placebo with erlotinib plus tivantinib (MARQUEE) in previously treated patients with advanced non-small cell lung cancer. Oncologist. Aug 23 2018. PMID 30139835
  • Scagliotti G, von Pawel J, Novello S, et al. Phase III multinational, randomized, double-blind, placebo-controlled study of tivantinib (ARQ 197) plus erlotinib versus erlotinib alone in previously treated patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer. J Clin Oncol. Aug 20 2015;33(24):2667-2674. PMID 26169611
  • Akerley WL, Nelson RE, Cowie RH, et al. The impact of a serum based proteomic mass spectrometry test on treatment recommendations in advanced non-small-cell lung cancer. Curr Med Res Opin. May 2013;29(5):517-525. PMID 23452275
  • Akerley WL, Arnaud AM, Reddy B, et al. Impact of a multivariate serum-based proteomic test on physician treatment recommendations for advanced non-small-cell lung cancer. Curr Med Res Opin. Jun 2017;33(6):1091-1097. PMID 28277859
  • Hanna N, Johnson D, Temin S, et al. Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. Oct 20 2017;35(30):3484-3515. PMID 28806116
  • Kalemkerian GP, Narula N, Kennedy EB, et al. Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted tyrosine kinase inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Clinical Practice Guideline Update. J Clin Oncol. Mar 20 2018;36(9):911-919. PMID 29401004
  • Socinski MA, Evans T, Gettinger S, et al. Treatment of stage IV non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. May 2013;143(5 Suppl):e341S-368S. PMID 23649446
  • Fidler MJ, Fhied CL, Roder J, et . al. The serum based VeriStgrat test is associated with proinflammatory reactants and clinical outcome in non-small cell lung cancer patients. BMC Cancer Volume 18 article number 310 (2018)
  • Lee SM, Upadhyay S, Lewanski C, et. al. The clinical role of VeriStrat testing in patients with advanced non-small cell lung cancer considered unfit for first line platinum- based chemotherapy. Clinical Trial Volume 120 P86-96 October 2019
  • My Cancer Genome. 
  • Maejm M, Juan O, Reguarta N, et. al. SEOM Clinical Guidelines for the Treatment of Non-Small Cell Lung Cancer. Clinical and Translational Oncology (2019) 21:3-17
  • National Cancer Institute. Non-Small Cell Lung Cancer Treatment (PDQ) – Health Professional Version.

 

Policy History:

  • September 2020 - Annual Review, Policy Revised
  • September 2019 - New Policy Created

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

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