Diagnosis: Lung cancer
Treatment: Guardant 360 testing
The insurer denied Guardant 360 testing. The health plan's determination is upheld.

The patient is a woman diagnosed with stage IV non-small cell lung cancer. She has metastases to brain, liver and left supraclavicular lymph nodes. The diagnosis was established via EBUS (endobronchial ultrasound) with + (positive) 4 lymph node for adenocarcinoma as well as level 7 at subcarina. Liver biopsy also confirmed the diagnosis. Treatment with carboplatin/alimta/Keytruda was started.

The Guardant360 laboratory testing is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The National Comprehensive Cancer Network (NCCN) guidelines recommend molecular testing for advanced cases of non-small cell lung cancer to assist in determining systemic therapy options. Tissue based testing is recommended.

The use of cell-free/circulating tumor deoxyribonucleic acid (DNA) testing should not be used in lieu of a tissue diagnosis. Studies have revealed false negative rates up to 30% with such assays. Standard of analytical performance characteristics of cell-free tumor DNA have not been established and no guidelines exist regarding the recommended performance characteristics of this type of testing. This sort of testing can identify alterations that are unrelated to a lesion of interest.

The use of this type of testing may be used if the patient is medically unfit for invasive tissue sampling or if there is insufficient material for molecular analysis. These scenarios are not present in this case.
There are no data from randomized, controlled clinical trials that demonstrate a survival benefit when such testing is used for selecting molecularly targeted agents based on such testing compared to the agents as recommended by NCCN by standard molecular markers outlined above.
Therefore, the use of this assay is not likely to be more beneficial than standard treatment in this case.