Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Endometrial cancer.
Treatment: Genetic testing regarding endometrial cancer.
The insurer denied coverage for the genetic testing regarding endometrial cancer.
The denial is upheld. 

This is a female patient with a diagnosis of endometrial cancer. As per attending physician referral, the patient underwent a Foundation One Companion Diagnostic (CDx) testing.

Per the National Comprehensive Cancer Network (NCCN) Guidelines for Uterine Neoplasms, "New biologic and molecular therapies for the treatment of recurrent or metastatic endometrial carcinoma are being assessed in clinical trials." The NCCN Guidelines do not discuss the use of molecular testing in endometrial cancer. It is thus, not recommended.

As per Frampton et al. (2013), the use of this genetic assay across the broad spectrum of cancer cell line types resulted in clinically actionable alterations in 76% of tumors. However, 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 renal cell cancer. 

As per Le Tourneau 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."

As per Singh et al. (2020), this study "identified multiple reasons for the relatively smaller clinical impact of [comprehensive genomic profiling (CGP)] in other tumor types, despite a much larger proportion of patients with actionable genomic alterations reported. The impact however is anticipated to be increasing in light of new advances, e.g., recent studies do suggest expanding impact in breast...nd pancreatic malignancies...Although issues, such as optimal timing, access to clinical trials, and consolidating genomic testing need to be addressed at an institutional level, reports from testing platforms need to be carefully interpreted and ideally discussed in molecular tumor boards to provide the best treatment option possible. More prospective trials are needed that would better inform our choices for personalized treatment by providing assessments of overall survival and quality of life with choosing targeted therapies that are based on CGP when compared to conventional therapies."	

The use of next-generation sequencing (NGS) panel testing as a means to select anti-cancer therapy in advanced cancer remains an area of active research with ongoing studies. The concept of this approach is that all cancers are unique and each cancer has a specific individual molecular driver which can be identified using this testing. Once identified specific therapy can be given to the patient directly treating their tumor. The majority of studies of this approach are fraught with methodological design issues such as lack of randomization and inclusion of large numbers of patients with established molecular drivers (i.e. breast cancer with estrogen receptor (ER) and human epidermal growth factor receptor (HER2) and then claiming that the identification and targeting of said known drivers contributes to benefit. There has been only one well designed trial of this approach, which demonstrated that this testing approach does not improve clinical outcomes for patients with advanced cancer (Le Tourneau et al. 2015).

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

The carrier's denial of coverage for the genetic testing regarding endometrial cancer should be upheld. The medical necessity is not substantiated.