VeriStrat® proteomic testing may be considered medically necessary for patients with advanced non-small cell lung cancer (NSCLC) to determine second-line treatment when BOTH of the following criteria are met:

• Failed previous first line doublet platinum-based therapy;
• Initial genomic EGFR mutation testing is wild-type (no mutation detected) or unknown (e.g., if tumor tissue might not be available for initial EGFR testing)

All other uses of VeriStrat proteomic testing are considered experimental/investigational other than advanced non-small cell lung cancer (NSCLC).

A participating preferred, or network provider can bill the member for the denied service.

Note: It is expected that this test will be performed once per patient lifetime.

Place of Service: Outpatient

VeriStrat assay is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Description

VeriStrat® assay (Biodesix, Inc.) is a mass spectrophotometric, serum-based predictive proteomics assay for patients with non-small-cell lung cancer (NSCLS) where "first line" EGFR mutation testing is either wild-type, or the patient is not able to be tested (e.g., if tumor tissue might not be available).

The test is designed to identify which patients with advanced non-small cell lung cancer (NSCLC) who are likely to receive clinical benefit from an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) such as erlotinib. Erlotinib is approved by the Food and Drug Administration (FDA) for use in first-line for NSCLC patients with an EGFR activating mutation and in maintenance, second-line, and third-line therapy for all NSCLC patients.

VeriStrat results: The test separates patients into two groups with differential survival outcomes. VeriStrat GOOD (VSGood) identifies patients that may benefit from EGRF-TKI and should be considered for alternate approaches. VSGood have a significantly longer overall survival rate following treatment with EGFR-TKI (i.e., erlotinib) therapy versus VeriStrat POOR (VSPoor). VeriStrat classification is a significant predictor of outcomes independent of patient clinical characteristics traditionally used to help inform treatment decisions such as histology, gender, ethnicity, smoking history, performance status, other comorbidities, and genetic mutational status (EGFR and KRAS). Most patients with advanced NSCLC with wild-type EGFR or “status unknown” receive platinum-doublet chemotherapy in first line.

VeriStrat requires a standard blood draw and the typical turnaround time is less than 72 hours. 

Lung cancer is the third most commonly diagnosed cancer in the United States and leading cause of death from cancer. NSCLC, comprising about 85% of lung cancer, is diagnosed after the patient has already reached an advanced stage that displays regional distant metastatic disease.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

08/2014, Coverage criteria established for VeriStrat®
08/2014, Place of service designation included on additional medical policies

Carbone D, 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. 2012;7(11):1653-1660.

Kuiper JL, Lind JS, Groen, et al. VeriStrat® has prognostic value in advanced stage NSCLC patients treated with erlotinib and sorafenib. Br J Cancer. 2012;107(11):1820-1825.

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 or Older) with stage IIIB/IV non-small-cell lung cancer. J Thorac Oncol. 2013;8:443-451.

Polychronidou G, Papakotoulas P. Long-term treatment with erlotinib for EGRF wild-type non-small lung Cancer: A case report. Karger. 2013;(6)1:189-196.