Foundation One Gene Testing denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for FoundationOne gene testing for evaluation of the enrollee’s thyroid cancer. Findings: two of three physician reviewers found that The testing at issue was likely to be more beneficial for evaluation of the patient’s medical condition than any available standard therapy. According to the documentation submitted for review, the patient has metastatic medullary thyroid cancer that has been treated with multiple tyrosine kinase inhibitors as well as immunotherapy. The patient has exhausted available standard therapies. Next generation sequencing with FoundationOne can provide possible targets for which clinical trials may be available.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Foundation One gene testing for evaluation of the enrollee's pigmented villonodular synovitis (PVNS). Findings: Three reviewers found that PVNS is a rare disease which results in proliferation of the synovial tissue. It is a result of hypervascular proliferative synovium containing multi-nucleated giant cells, macrophages, and hemosiderin. Since the giant cells express osteoclasts, the abnormal proliferation of the synovial tissue results in destruction of adjacent bone. The optimal treatment option is surgical resection but there is a high risk of recurrence. Since PVNS is a rare disease treatment options are in limited. Due to the high risk of recurrence, radiation therapy is also considered a treatment option and is associated with a decrease in the rate of recurrence.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has reimbursement for FoundationOne gene testing services for treatment of the enrollee’s breast cancer. Findings: The physician reviewer found that molecular assay that explores the mutations of an individual’s cancer cells. The hope is that the assay will identify a specific mutation or target, which could inform the clinician as to which chemotherapeutic drug would be useful. However, there is a lack of convincing evidence that the assay adds to the decision making ability of the clinician, nor yields a result that is reliably clinically beneficial to the patient. There are various nonrandomized studies exploring the value of molecular profiling but these studies are not convincing. A randomized study by Le Tourneau and colleagues did not demonstrate significant clinical benefit from choosing therapy based on molecular targets.

Nature of Statutory Criteria/Case Summary: A female enrollee has requested reimbursement for Foundation One gene testing for evaluation of the enrollee’s endometrial cancer. Findings: The physician reviewer found that Foundation One assay explores the mutations of an individual’s cancer cells. The hope is that the assay will identify a specific target which could inform the clinician as to what chemotherapeutic agent would be useful. Thus far, however, there is a lack of convincing evidence that the assay adds to the decision-making ability or yields a result that is reliably clinically beneficial. There are a variety of non-randomized studies exploring the value of molecular profiling, none of which have offered convincing evidence of the efficacy of this approach.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Foundation One Gene Testingwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.