Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Stage II adenocarcinoma of the lung.
Treatment:  Circulating tumor DNA test/liquid biopsy.

The insurer denied coverage for Circulating tumor DNA test/liquid biopsy.  The denial is upheld.

This patient is a female with a stage II adenocarcinoma of the lung diagnosed.  The patient underwent a left lower lobectomy with mediastinal lymph node dissection.  The patient underwent Next Generation Sequencing (NGS) at that time of her tumor.  The patient was treated with four cycles of chemotherapy.  The patient did well until when she was found to have a recurrent disease.  The patient then underwent a repeat biopsy.  The patient was found to have a recurrent tumor.  Guardant360 was requested to help determine therapy.

The Guardant360 is a liquid biopsy.  When not enough tissue is available to run the Next Generation Sequencing (NGS), then a circulating tumor DNA test/liquid biopsy (like Guardant360) is done to detect any mutations present to help guide treatment.  However, this approach does not result in improvement in health outcomes.      

Per National Comprehensive Cancer Network (NCCN) guidelines, "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 assesses a minimum of the 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 as NTRK gene fusions, high-level MET amplification, ERBB2 mutations, and TMB.  Although the NCCN Guidelines for non-small cell lung cancer (NSCLC) provide recommendations for individual biomarkers that should be tested and recommend testing techniques, the guidelines do not endorse any specific commercially available biomarker assays."

Based on the review of the medical record and literature, the patient is not a good candidate for genetic testing (circulating tumor DNA test/liquid biopsy).  Per the visit note, the patient had a supraclavicular lymph node biopsy that came back as adenocarcinoma, and Next Generation Sequencing (NGS) from the biopsy was still pending.  Peripheral blood NGS was ordered as well and performed showing EGFR exon-19 deletion.  EGFR exon-19 deletion was found on the tumor testing completed.  Per testing, there is no change in mutation, which does not establish an improvement in health outcome and does not change treatment. 

Literature supports that using tumor tissue for testing is the best available treatment.  Even with the patient's biopsy, if there was not enough tissue, then the original tumor could have been retested.  Per the pathology report of the tumor, tumor markers that were identified were EGFR exon-19 deletion.  Per the patient's visit note, the peripheral blood NGS revealed EGFR exon-19 deletion, which was the same information as the patient's tissue biopsy.  No new information was obtained with this testing.  Therefore, the requested treatment was not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of Circulating tumor DNA test/liquid biopsy should be upheld.