Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Stage IV (four) non-small cell lung cancer (NSCLC)

Treatment is Guardant 360 (0242U)	

The insurer denied coverage for Guardant 360 (0242U)
 
The denial is upheld

This is a patient who is diagnosed with stage IV (four) non-small cell lung cancer (NSCLC) with metastases to the liver, bone, and pleural fluid. A computed tomography (CT) of the chest, abdomen and pelvis showed an increase in the size of a mass to the posterior medial right upper lobe. Per the physician there is also a left sided nodule that has slightly increased in size. The patient was returning for cycle nine of trastuzumab-deruxtecan and had unexplained neurological symptoms. Per the physician's note, Guardant 360 testing was drawn to reveal helpful information, and if it did not, a biopsy of the right upper lobe mass would be considered. The treating provider is requesting approval for Guardant 360 (0242U).

In metastatic disease, a sign of progression should not require a repeat biopsy of previously established and defined lesions. More relevant to the question, it is not clear how Guardant 360 would provide information that a repeat biopsy could then be avoided. Guardant is one of several panels of tumor markers designed to give the oncologist an option of treating in a personalized manner, directed to the specific markers that the patient's cancer expresses. It is a clinical diagnostic test based on sequencing 72 genes and Guardant claims to be highly accurate in identifying genomic alterations. It is not a diagnostic test that can replace a biopsy.      

"The advent of "precision" medicine has been characterized by improvements in diagnostic, prognostic, and therapeutic approaches. The "liquid biopsy" has recently and rapidly emerged (Figure 1) as a method to minimize the amount of tissue needed for testing, as a less invasive and safer alternative to more traditional procedures. While definitions vary on the precise meaning of this term, it can broadly be thought of as collection of a body fluid sample to test for relevant biomarkers to inform patient management. A "liquid biopsy" does not replace a tissue-based diagnosis, but rather provides alternate sampling for (typically) molecular testing purposes." (College of American Pathologists, n.d.).

"Furthermore, although accuracy in obtaining a precise tumor profile has improved, liquid biopsy tests still carry the risk for false-positive or false-negative results, prompting the FDA (food and drug administration) to recommend confirmation of a negative result from Guardant360 and FoundationOne Liquid with a tissue biopsy test. The 2021 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for molecular and biomarker analysis of NSCLC also specify that cell-free/circulating tumor DNA (Deoxyribonucleic acid) testing should not replace a histologic tissue diagnosis unless a patient is medically unfit for invasive tissue sampling." (Cavallo, J. 2021).

The provider did not adequately describe how this test would positively effect health outcomes. In metastatic disease, a sign of progression should not require a repeat biopsy of previously established and defined lesions. It is not a diagnostic test that can replace a biopsy on available tissue.                                                         

The insurer's denial of coverage for Genetic testing: Guardant 360 (0242U) is upheld. Medical Necessity is not substantiated.