Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Breast Cancer

Treatment: FoundationOne CDx (broad companion diagnostic) molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment)

The insurer denied coverage for FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment).

The denial is upheld.

This patient is a female with history of metastatic breast cancer as well as diagnoses including, but not limited to hypothyroidism, migraines, and osteoarthritis. She presented to the Oncologist's office for a follow up for breast cancer. Over the years, she was treated with chemotherapy and radiation. At the time of the evaluation, she was treated with Abraxane and Xgeva. The treating provider performed FoundationOne testing to further guide the course of treatment, and its use is under medical necessity review.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health. The testing completed has not been shown to improve outcomes.

The FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment) does have final approval from the appropriate regulatory bodies for this diagnosis. This has regulatory approval, where applicable.   

This patient is not a good candidate for FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment).

The FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment), is not the best available treatment for this patient at this time. As previously stated, the patient is not a candidate for this testing, based on current literature and guidelines.     

"Although Frampton, G.M., et al. (2013), noted with the use of this assay across the broad spectrum of cancer cell line types resulted in 'clinically actionable alterations' in 76% (percent) of tumors, at the moment there are no prospective or controlled trials showing that the use of this information to direct therapy improves health outcomes for patients with the diagnosis of cancer. In fact, the SHIVA (conventional therapy for advance cancer) study showed that the use of broad molecular mutation testing to direct therapy resulted in no improvement in progression free survival and the conclusion was that 'off label use of molecularly targeted agent should be discouraged.'"

Per Le Tourneau, C., et al (2015), "The use of molecularly targeted agents outside their indications does not improve progression-free survival compared with treatment at physician's choice in heavily pretreated patients with cancer. Off-label use of molecularly targeted agents should be discouraged, but enrolment in clinical trials should be encouraged to assess predictive biomarkers of efficacy."

Finally, as per National Comprehensive Cancer Network (NCCN), they do not recommend the use of FoundationOne testing for either prognosis or determining chemotherapy. In the patient with metastatic disease, they note the value of germline testing; namely, "Breast Cancer 1/2 (BRCA1/2) have proven clinical utility and therapeutic impact." 

The testing completed is not likely to be more beneficial than any of the standard treatments/procedures for this patient, as it is more likely to lead to harm than benefit, in this scenario.                                                    

The carrier's denial of FoundationOne CDx molecular panel testing (genetic testing of tumor tissue to identify targeted cancer treatment) performed should be upheld.