Metastatic Non-small Cell Lung Cancer: when insurers say no, reviewers often say yes

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee’s representative has requested reimbursement for Guardant360 liquid biopsy gene assays. Molecular diagnostic studies in non-small cell lung cancer are considered within the standard of care based on current publications and guidelines. In addition, numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network (NCCN) strongly advises broader molecular profiling with the goal of identifying driver mutations for effective therapies, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is key for the improvement of care in patients with non-small cell lung cancer.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Guardant360 testing provided on 2/15/17 for evaluation of the enrollee’s non-small cell carcinoma. The patient presents with biopsy proven metastatic non-small cell lung cancer. In this clinical setting molecular diagnostic studies are considered the standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network (NCCN) guidelines for non-small cell lung cancer strongly advises broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with non-small cell lung cancer.

Where the denial was upheld

Physician 1: The patient is a 53-year-old man with metastatic squamous cancer to the lung. He progressed after carboplatin and Taxol, Gemzar and Taxotere, and Alimta and Tarceva. He now wishes to be treated with Velcade, carboplatin and gemcitabine. The Health Plan has denied coverage for the requested therapy on the basis that it is considered experimental in this setting.The submitted literature reports are irrelevant to this patient and in any case provide weak support even for the specific setting in which the phase II trial was reported. It appears the patient’s primary cancer is from the head and neck. The proposed therapy is fourth-line treatment. Based upon the scientific evidence available to date, there is insufficient data that the proposed therapy will benefit this patient.

Nature of Statutory Criteria/ Case Summary: The enrollee requested reimbursement for Guardant360 Liquid Biopsy for a diagnosis of metastatic non-small cell lung cancer. His physician ordered the Guardant360 test to determine if his current treatment regimen was optimized to manage his care. The Guardant360 report indicated somatic alterations were detected in the circulating cell-free DNA isolated from the enrollee’s blood specimen. The genomic alterations were cancer-associated somatic variants, some of which have been associated with either increased or reduced clinical response to specific treatments. Epidermal growth factor receptor (EGFR) amplification was detected in the circulating cell-free DNA isolated from this enrollee’s blood specimen for the annotated gene(s). Other alterations found in the report are MET, TP53 and NF1.

These outcomes come from California’s external review program — an independent physician panel whose decision binds the insurer. Every state has an equivalent, and internal appeals succeed even more often. If your care for metastatic non-small cell lung cancer was denied, the published record says the denial is worth fighting.