Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Breast Cancer

Treatment: FoundationOne CDx testing

The insurer denied coverage for FoundationOne CDx testing.

The denial is upheld.

Per the medical records, the patient has recurrent breast cancer in the same breast where a lumpectomy was performed with radiation. Mastectomy was not performed. Oncotype was 23. Chemotherapy was not recommended and Anastrozole was recommended.

All available medical documentation was reviewed.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

The setting is not proven for FoundationOne testing. There was no metastatic disease and the decision was already made to treat with hormonal therapy. FoundationOne results can be obtained, when and if, there is a metastatic progression, when it becomes a consideration in choosing therapy. No first line chemo had ever been given.      

The FoundationOne CDx testing does have final approval from the appropriate regulatory bodies for this diagnosis. It is Food and Drug Administration (FDA) approved.     

This patient is not a good candidate for FoundationOne CDx testing.     

FoundationOne CDx testing is not the best available treatment for this patient at this time.     
  
If treatment decisions are made based on this test, there are adverse risks increased over standard treatment/services.      

The requested service is not likely to be more beneficial than any of the standard treatments / procedures for this patient.

"We used data obtained by Caris Life Sciences, to evaluate the benefits of tailoring treatments for a breast carcinoma cohort by using tumor molecular profiles to inform decisions. Data for 92 breast cancer patients from the commercial Caris Molecular Intelligence database was retrospectively divided into two groups, so that the first always followed treatment recommendations, whereas in the second group all patients received at least one drug after profiling that was predicted to lack benefit. The biomarker and drug associations were based on tests including fluorescent in situ hybridization and deoxyribonucleic acid (DNA) sequencing, although immunohistochemistry was the main test used. Patients whose drugs matched those recommended according to their tumor profile had an average overall survival of 667 days, compared to 510 days for patients that did not (P=0.0316). In the matched treatment group, 26% (percent) of patients were deceased by the last time of monitoring, whereas this was 41% (percent) in the unmatched group (P=0.1257). We therefore confirm the ability of tumor molecular profiling to improve survival of breast cancer patients. Immunohistochemistry biomarkers for the androgen, estrogen and progesterone receptors were found to be prognostic for survival" (Carter, P. et al. 2018).

"The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer address all aspects of management for breast cancer. The treatment landscape of metastatic breast cancer is evolving constantly. The therapeutic strategy takes into consideration tumor biology, biomarkers, and other clinical factors. Due to the growing number of treatment options, if one option fails, there is usually another line of therapy available, providing meaningful improvements in survival. This NCCN Guidelines Insights report focuses on recent updates specific to systemic therapy recommendations for patients with stage IV disease" (Gradishar, W. J. et al. 2023). 

In summary, the denial of FoundationOne CDx testing provided and coverage for the requested service should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.