CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

VeriStrat serum proteomic test for non-small cell lung cancer — Coverage Criteria

Policy references and supporting literature for use of the VeriStrat serum proteomic classification test in patients with advanced non-small cell lung cancer; affects providers ordering or interpreting VeriStrat testing for BCBSRI members. (This file contains reference list and policy footer material.)

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyVeriStrat serum proteomic test for non-small cell lung cancer — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionVerify member benefits and prior authorization requirements with BCBSRI before ordering or billing for VeriStrat testing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~33Reference items

multipleVeriStrat-specific refs

ASCO 2023Recent guideline cited

Coverage Criteria

Benefits and eligibility for services are determined by the member's subscriber agreement, member certificate, and/or the employer agreement; those documents supersede this medical policy. For member-specific benefit and eligibility information, contact the provider call center. If services provided to a member are determined to be not medically necessary or are non-covered benefits, the provider may not charge the member unless the member was informed and agreed in writing in advance to accept financial responsibility. Blue Cross & Blue Shield of Rhode Island reserves the right to review and revise this policy at any time.

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Regimen	Study / Evidence notes
Erlotinib ± Bevacizumab
Pooled analyses and individual studies report VeriStrat has prognostic value in patients treated with erlotinib plus bevacizumab in first-line settings (SAKK19/05 and NTR528 pooled analysis; Carbone et al. classifier evaluation). References include Gautschi et al. (pooled analysis) and Carbone et al.

Required Provider Actions

Prior Authorization

Verify benefits / prior authorization

This medical policy is provided for informational purposes only and is not a guarantee of payment or a substitute for clinical judgment.

Benefits and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement; those documents supersede this policy.
For information on member-specific benefits and to verify coverage or prior authorization requirements, contact Blue Cross Blue Shield of Rhode Island (BCBSRI) Provider Call Center before rendering services.
If services are determined to be not medically necessary or are non-covered benefits, the provider may not charge the member unless the member was informed in advance and provided written agreement to pay out-of-pocket.

Note

Provider action required

Contact the BCBSRI Provider Call Center to confirm any member-specific benefit limits, prior authorization requirements, and eligibility before scheduling or performing services.

Note

Policy informational notice

This policy is current at the time of publication; BCBSRI reserves the right to review and revise the policy at any time, with or without notice. The policy is informational and does not replace the member's plan documents or participation agreements.

Background and Bibliography

This section lists bibliographic references related to the VeriStrat serum proteomic classifier, a serum-based mass spectrometry classifier that has been evaluated as a prognostic and predictive biomarker in multiple studies of advanced non-small cell lung cancer (NSCLC). The source literature includes clinical investigations of VeriStrat performance in patients treated with EGFR-targeted agents (for example, erlotinib, afatinib), combinations with agents such as bevacizumab and tivantinib, and with cytotoxic regimens (including platinum-doublet and gemcitabine-containing chemotherapy), as well as guideline citations relevant to molecular testing in NSCLC.

Definitions

inv-07: VeriStrat — definition

Test typeSerum-based proteomic mass spectrometry classifier (VeriStrat)

Clinical roleEvaluated as a prognostic and predictive biomarker in multiple clinical studies of advanced non-small cell lung cancer (NSCLC)

Analyte/sourceCirculating serum proteins measured by mass spectrometry

Validated contextsStudies include first-line and second-line settings and trials with agents such as erlotinib, bevacizumab, afatinib, and chemotherapy

Supporting evidenceMultiple peer-reviewed studies and clinical trials document association with survival, time to progression, and treatment outcomes in NSCLC

Line of Therapy

first-line | second-line

Applies to use of the VeriStrat proteomic classifier in advanced non‑small cell lung cancer; coverage considerations depend on line of therapy.

Lines referenced: References include studies in first-line and second-line therapy settings (first-line platinum-based chemotherapy and first-line regimens including erlotinib ± bevacizumab; second-line erlotinib or afatinib versus chemotherapy).

Biomarker / Test Requirements

inv-09: VeriStrat proteomic signature (prognostic/predictive classifier)

Classifier outputProteomic signature that stratifies patients (commonly reported as VeriStrat 'Good' vs 'Poor')

Test-specific requirementPerformed on serum samples using the VeriStrat mass spectrometry platform described in cited clinical studies

Associated treatments in studiesAssessed in trials of erlotinib (± bevacizumab or sorafenib), afatinib, platinum-doublet chemotherapy, gemcitabine (± erlotinib), and other regimens

Prognostic vs predictiveReported as both prognostic for survival and predictive of differential benefit in biomarker-stratified trials (e.g., PROSE, pooled analyses)

Key supporting trials/publicationsIncludes PROSE (Lancet Oncol 2014), pooled SAKK19/05 and NTR528 analyses, LUX-Lung 8 analysis, and multiple retrospective and prospective studies

Covered Regimens and Evidence

Regimen	Study / Evidence notes
Erlotinib ± Bevacizumab
Multiple reports evaluate VeriStrat performance with erlotinib plus bevacizumab, including pooled analyses (Gautschi et al.) and classifier evaluations (Carbone et al.).
Erlotinib ± Tivantinib
Studies of proteomic signatures in previously treated advanced NSCLC include randomized trials assessing erlotinib with other agents (eg, tivantinib or pazopanib) with correlated serum proteomic signatures (Spigel et al.).
Afatinib
VeriStrat was evaluated in the second-line afatinib versus erlotinib setting (LUX-Lung 8 analysis) reporting the test's performance in squamous cell NSCLC (Goss et al.).
Platinum-doublet chemotherapy
Prognostic role of VeriStrat in first-line patients treated with platinum-based chemotherapy has been reported (Grossi et al.; randomized trials stratified by VeriStrat status such as Peters et al.).
Gemcitabine ± Erlotinib
Retrospective and randomized trials in elderly patients evaluated VeriStrat status in outcomes for gemcitabine, erlotinib, or combination regimens (Stinchcombe et al.; PROSE and other trials include proteomic evaluations).