Appeal type: Medical necessity
Decision: Upheld

Diagnosis: ALK positive metastatic lung cancer

Treatment: Cancer Screening

The insurer denied coverage for genetic testing. The denial is upheld.

This patient is a male who had a history of ALK positive metastatic lung cancer diagnosed several years prior. He was originally treated with Xalkori. He was seen and at that time a Positron Emission Tomography and Computed Tomography (PET CT) scan showed disease progression in the right scapula and mediastinum. Guardant 360 assay was done and showed a variant of uncertain significance.

There is limited high-grade clinical trial data that shows the efficacy of the Guardant 360 assay for the treatment of lung cancer. Schwaederle, et al. (2017) performed Guardant360 testing in 88 lung cancer patients and found 82% with at least one genomic alteration of which 75% were "potentially actionable." At the moment though, there are no high-grade trials such as randomized controlled trials which show that the use of this information to direct patient care results in improvement in health outcomes.

Although NCCN guidelines (2020) Non-small Cell Lung Cancer 3.2020 states that for stage IV lung cancer, molecular testing with EGFR, ALK, BRAF, PDL1 should be considered as part of a broad molecular profiling (2). It should be noted that the purpose would be to identify driver mutations for which drugs have been noted to be useful in other malignancies and for which patients would be counseled regarding the availability of clinical trials. The utility of this information is debatable as again, the targeted agents advised by such results would have not been conclusively proven to be useful for the diagnosis of non-small cell lung cancer. There is also no indication which specific molecular profiling would be appropriate considering that there are several available types including tumor tissue profiling versus liquid biopsy profiling. The NCCN guidelines indicate that "briefly, the panel feels that plasma cell free/circulating tumor DNA testing should not be used to diagnose NSCLC; tissue should be used to diagnose NSCLC... There is up to a 30% false-negative rate, and variance can be detected that are not related to the tumor".  In addition, there is no recommendation for the use of any molecular testing following failure of first-line ALK directed therapy. 

Similarly, ASCO guidelines (2016) also recommend testing for EGFR, ALK, and ROS1 as molecular testing for metastatic non-small cell lung cancer.  There is no specific recommendation for "liquid biopsy" testing in patients who have previously had tumor tissue testing.

In this clinical setting, the use of broad mutational testing by liquid biopsy testing such as Guardant360 has not been shown to be superior or improve health outcomes and thus would not be considered medically necessary.

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.

The use of Guardant 360 assay testing has not been shown to improve health outcomes for the restaging of treated metastatic lung cancer. In that setting, the health plan did act reasonably upon denial.      

Based on the above, the medical necessity for the genetic testing for lung squamous cell carcinoma is not substantiated.  The insurer's denial is upheld.