Circulating Tumor DNA Management of Non-Small Cell Lung Cancer (Liquid Biopsy)

Effective 1-15-2021

• Updated Description Section
• Updated Medical Policy Section
• Revised Item I.A., with the following changes:
• (Content that is underlined was added, content with a strikethrough was removed.)

“At diagnosis, Except as noted below, analysis of 2 types of somatic sensitizing variants within the epidermal growth factor receptor (EGFR) gene¾small deletions in exons 18 through 21 (e.g., G719X, L858R, T790M, S6781, L861Q) within the epidermal growth factor receptor (EGFR), 19 and a point mutation in exon 21 (L858R)-using for example the cobas EGFR Mutation Test v2, Guardant360 test, or OncoBEAM, or InVisionFirst-Lung test with plasma specimens to detect circulating tumor DNA (ctDNA) may be considered medically necessary as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to an EGFR tyrosine kinase inhibitor (TKI) therapy (eg, erlotinib [Tarceva], gefitinib [Iressa], afatinib [Gilotrif], or osimertinib [Tagrisso]) in patients with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell non-small-cell lung cancer, and non-small-cell lung cancer not otherwise specified. stage III or IV non-small-cell lung cancer (NSCLC) when tissue biopsy is medically contraindicated or the quantity is not sufficient for testing. The cobas test is a companion diagnostic for erlotinib and gefitinib.”

• Added Item I.B.
• Item I.C., removed “sensitizing” “18” and “using ctDNA for” and added “22” and “or other” to read “Analysis of other EGFR variants within exons 22 to 24 or other applications related to NSCLC is considered experimental / investigational.”
• Removed Items I.D, “Analysis of the EGFR T790M resistance variant for targeted therapy with osimertinib using ctDNA or for other applications related to NSCLC is considered experimental / investigational.”
• Removed Item I.E., “Analysis of 2 types of somatic variants within the EGFR genesmall deletions in exon 19 and a point mutation in exon 21 (L858R)-using ctDNA is considered experimental / investigational for patients with advanced NSCLC of squamous cell type.”
• In Items II.A, III.A, and IV.A, replaced “stage III or IV NSCLC” with “advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell non-small-cell lung cancer, and non-small-cell lung cancer not otherwise specified.”
• In Policy guidelines, Replaced “advanced (stage III or IV) non-small-cell lung cancer” and “stage III or IV NSCLC” with “advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell non-small-cell lung cancer, and non-small-cell lung cancer not otherwise specified” to read “The tests discussed herein are intended for use in patients with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell non-small-cell lung cancer, and non-small-cell lung cancer not otherwise specified.”
• Updated Code Section Added CPT 81210, 81445, 81455

Source: https://www.bcbsks.com/CustomerService/Providers/MedicalPolicies/policies/policies/CirculatingTumorDNAManagement_Non-SmallCellLungCancer_2021-01-15.pdf