Guardant 360 denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic testing service, Guardant360. Pancreatic cancer has a poor prognosis and is fatal in most patients. While inoperable advanced pancreatic cancer is an incurable disease, chemotherapy may prolong survival but not induce a cure. In all cases, the genetic mutations present within the pancreatic cancer may be of prognostic significance and help direct therapy. The National Comprehensive Cancer Network (NCCN) guidelines include mutational analysis as part of its algorithms, although this is restricted to testing on the primary tumor samples. The NCCN notes that germline testing is recommended for any patient with confirmed pancreatic cancer, using comprehensive gene panels for hereditary cancer syndromes.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the gene test using a panel of genes (molecular profiling) provided. Findings: The physician reviewer found that the patient is with metastatic non-small cell adenocarcinoma of the lung. He was diagnosed over 2 years ago. He is currently being treated with Opdivo with possible progression. Multiplex genotyping with Guardant360 was for testing help guide further therapy decision making. The patient has requested reimbursement for gene test using a panel of genes (molecular profiling) provided. The Health Plan denied reimbursement for the services at issue noting that the gene testing was investigational for the evaluation of this patient’s medical condition. The medical evidence supports the superior efficacy of the services at issue in this clinical setting.

Where the denial was upheld

Nature of Statutory Criteria/ Case Summary: The enrollee requested coverage for Guardant Health Laboratory Tests. The enrollee has breast carcinoma originally diagnosed as multifocal infiltrating lobular cancer node negative classic type. She had aggressive chemotherapy at that time, went into menopause and then developed a local recurrence in her late 50s. Lymph nodes were removed, she had radiation therapy to her axilla and she has been on tamoxifen with no evidence of systemic relapse. Her tumor DNA has been non-detectable after she was started on tamoxifen. Her routine bloodwork indicated a normal CA 15-3 but the circulating tumor DNA showed a re-appearance of the BRCA mutation shown initially on her first test. Thus, the DNA test was repeated.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Guardant360 genetic test. Guardant360 is a liquid biopsy that analyzes patient plasma for mutations in a panel of cancer-causing genes. Analyses of tumors that have progressed on therapy for actionable mutations are recommended to help guide the next therapy or determine eligibility for a clinical trial. As noted in the current guidelines and medical literature, this tumor analysis can be especially beneficial for patients with stage IV disease. There are active clinical trials that are testing targeted therapies based on actionable mutations present in a given tumor. guidelines recommend mutational testing for metastatic tumors based on this medical evidence. However, in most instances of visceral disease or lymph node involvement, testing should be performed on the excised tissue.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Guardant 360, then check the rights and deadlines that apply to your plan.