Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Uterine cancer

Treatment: genetic testing (0037U x 1)

The insurer denied coverage for genetic testing (0037U x 1)

The denial is upheld

 
This is an adult female with a diagnosis of uterine cancer underwent surgery. Stage four (IVB). Treated with carboplatin and Abraxane. Also treated with vaginal brachytherapy. The treating provider performed genetic testing (0037U x 1), which is under review.
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 Er and 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, SHIVA, which demonstrated that this testing approach does not improve clinical outcomes for patients with advanced cancer.  

"Although Frampton, G.M., and others (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 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."

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."

"Tumor sequencing frequently occurs in the setting of advanced cancer to identify potential therapeutic targets. Use of such testing has rapidly increased, with further growth anticipated.1 Mutations identified on tumor sequencing may be acquired somatically, caused by postzygotic mosaicism, or inherited through the germline. Identification of germline mutations potentially influences treatment of the current cancer, may provide prognostic information about the potential development of future cancers, and has important implications for family members in terms of risk and prevention of disease. However, guidelines on both how to determine which somatic findings may be potentially germline and the optimal clinical practice for referral and germline testing of patients undergoing tumor sequencing are not widely available, and there is no established standard of care." (Clark, D. F. et al. 2019).                                           

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for genetic testing (0037U x 1) is not substantiated.