Diagnosis: Cancer.
Treatment: Guardant360 testing (Cancer Screening).

The insurer denied the Guardant360 testing (Cancer Screening). The denial is overturned in whole.

The patient is a male diagnosed with stage IV lung cancer four years ago with epidermal growth factor receptor (EGFR) mutation. He was initially treated with Erlotinib (Tarceva) and upon progression three years ago therapy was switched to Osimertinib. Scan in last year showed progression of disease, which was treated with radiation therapy. Cell free deoxyribonucleic acid (DNA) testing (Guardant360) was performed by treating physician. Mutation in KRAS K117N was identified.

The subject under review is whether this testing is likely to be more beneficial for the patient than standard care.

The health plan's determination is overturned in whole.

Yes. The Guardant360 testing is likely to be more beneficial than any standard treatment for the patient's disease. Molecular profiling is a standard practice for patient with metastatic cancer. National Comprehensive Cancer Network (NCCN) guidelines recommend comprehensive molecular profiling to identify driver mutations for patients with metastatic lung cancer, particularly patients who are progressing on standard therapies. In this case, the patient is progressing after receiving two standard therapies, Erlotinib and Osimertinib. Testing for cell free DNA, such as Guardent360, would help identify acquired mutations leading to resistance to the standard therapy. Identifying such mutations and molecular alternation would allow the patient to receive effective targeted therapies already available (such as BRAF mutation, certain type of KRAS), and also allow patient to identify available clinical trials (clinicaltrials.gov).