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.

This is a patient with a new diagnosis of infiltrating ductal carcinoma who had a prior history of lobular carcinoma who has been placed on hormonal therapy. A FoundationOne next generation sequencing has been performed.

All available medical documentation was reviewed.

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

FoundationOne CDx testing has final approval from the appropriate regulatory bodies for this diagnosis. This is a Food and Drug Administration (FDA) approved test.     

No, FoundationOne CDx testing is not the best available treatment for this patient at this time. This is not indicated at this time.     
  
The adverse risks are not increased over standard treatment/services. 

This is a patient with a new diagnosis of breast cancer who has been placed on hormonal therapy and having difficulties tolerating the side effects. There is no indication for next generation sequencing at this time, just the need to change to a more tolerable hormonal therapy. The use of next generation sequencing could be indicated if the patient was failing hormonal therapy where the detection of a Estrogen Receptor 1 (ESR1) mutation might suggest the change to a different form of hormonal therapy. However, in this patient the change of hormonal therapy is not due to lack of efficacy but to the side effects of the drug.

"Conclusion: Premature discontinuation of initial aromatase inhibitor (AI) therapy as a result of symptoms is common, although more than one third of patients may be able to tolerate a different AI medication. Additional research is needed to identify predictive tools and interventions for AI-associated treatment-emergent symptoms" (Henry, N. L. et al. 2012).

"Interpretation: 5 years of treatment with aromatase inhibitors was not superior to 2 years of tamoxifen followed by 3 years of aromatase inhibitors. None of the three aromatase inhibitors was superior to the others in terms of efficacy. Therefore, patient preference, tolerability, and financial constraints should be considered when deciding the optimal treatment approach in this setting" (De Placido, S. 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 not substantially increased over standard treatments.