Proteomic testing (e.g.. VeriStrat) is proposed as a blood-based predictive and prognostic test for individuals with non-small-cell lung cancer (NSCLC) who test negative for EGFR mutations (EGFR wild-type) or whose EGFR mutation status is unknown and for individuals who have not responded to first line therapies. The test relies on a predictive algorithm analysis of pretreatment serum to generate a good or poor assessment for response to tyrokinase inhibitors (TKIs).
Proteomic testing for targeted therapy in the management of non-small-cell lung cancer (NSCLC) is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
The evidence for the use of serum proteomic testing to select targeted therapy in individuals with non-small-cell lung cancer (NSCLC) who are EGFR wild-type or have unknown EGFR status who have disease progression after first-line treatment is limited. The evidence is insufficient to determine the effects of the technology on health outcomes.
American College of Chest Physicians. (2013). 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. Retrieved March 3, 2016 from http://www.ncbi.nlm.nih.gov.
American Society of Clinical Oncology. (2015). Systemic therapy for Stage IV non-small cell lung cancer: American Society of Clinical Oncology clinical practice guideline update. Retrieved March 3, 2016 from www.jco.ascopubs.org.
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2017). Proteomic testing for targeted therapy in non-small-cell lung cancer (2.04.125). Retrieved January 5, 2018 from BlueWeb. (36 articles and/or guidelines reviewed)
Grossi, F., Rijavec, E., Genova, C., Barletta, G., Biello, F., Maggioni, C., et.al. (2016). Serum proteomic test in advanced non-squamous non-small cell lung cancer treated in first line with standard chemotherapy. British Journal of Cancer, 116, 36-43. (Level 2 evidence)
Hornberger, J., Hirsch, F., Q, Li., & Page, R. (2015). Outcome and economic implications of proteomic test-guided second-or third-line treatment for advanced non-small cell lung cancer: extended analysis of the PROSE trial. Lung Cancer, 88 (2), 223-230, Abstract retrieved March 3, 2016 from PubMed database.
National Comprehensive Cancer Network. (2016). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-small cell lung cancer. Version 2.2018. Retrieved January 5, 2018 from the National Comprehensive Cancer Network.
Peters, S., Stahel, R.A., Dafni, U., Ponce, A., Massuti, B., Gautschi, O, et al. (2017). 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. Journal of Thoracic Oncology, 12 (4), 752-762. Abstract retrieved January 5, 2018 from PubMed database.
Tanvetyanon, T., Creelan, B., Chiappori, A. (2014). Current clinical application of genomic and proteomic profiling in non-small-cell lung cancer. Cancer Control, 21 (1), 32-39. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 4/9/2015
MOST RECENT REVIEW DATE: 2/8/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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