Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 59-year-old woman diagnosed with progressive breast cancer, metastatic to bone and liver. She has apparently been treated in the past with multiple chemotherapeutic agents, most recently Avastin, Xeloda and Faslodex. It has now been proposed that the patient be treated with Sutent. The Health Plan has denied coverage for Sutent on the basis that it is considered experimental in this clinical setting.Sutent is a new drug that has been approved for use in renal cell cancer and a rare form of gastrointestinal stromal tumor. The submitted ASCO abstract reports the use of Sutent in 24 patients with metastatic breast cancer. Details about these patients are very limited and it is impossible to determine how they might relate to the patient in this case. It is noted that two patients have achieved some sort of partial response. The data from the abstract is not sufficient justification for the use of Sutent in metastatic breast cancer. Therefore, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  The patient is a 59-year-old woman with metastatic breast cancer who requests coverage for the use of Sutent.  Her provider reports the patient has received extensive chemotherapy including Avastin, Xeloda and Faslodex. The patients provider has recommended the patient receive Sutent. The Health Plan has determined Sutent is experimental for patients such as this patient and therefore not a covered benefit.Sutent  (sunitinib malate) is a highly potent, selective inhibitor of several protein tyrosine kinases, and has demonstrated activity (and FDA approval) in the treatment of renal cell and gastrointestinal stromal tumors. Although there is some pre-clinical data and a single institution Phase II trial (presented only in abstract form) that indicate promise for this oral inhibitor in patients with Stage IV breast cancer, there is no body of peer-reviewed literature, nor adequate follow-up of the cohort treated in the Phase II trial to support the use of Sutent in a setting outside of a clinical trial. Review of the peer-reviewed literature contains scant primary data and no recommendations for the empiric use of this drug outside of a clinical research setting, and therefore, there is inadequate data establishing that the medication is likely to be superior to available standard treatment.Based upon the information set forth above, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3:  The patient is a 59-year-old woman diagnosed with metastatic breast cancer to her spine and liver. The patients provider indicates the patient has exhausted available chemotherapy regimens. In light of the patients rising tumors markers her provider has proposed that she begin taking Sutent. The Health Plan has denied authorization for the proposed drug based on a lack of scientific evidence supporting its use in this setting.There is inadequate support in the medical literature for the proposed therapy. Sutent has FDA-approval for use in cases of gastrointestinal stromal tumors and renal cell carcinoma. Though there is growing interest in the use of the drug in the context of breast cancer, there is no peer-reviewed scientific data currently available to support the proposed usage. In the absence of data demonstrating the potential benefits of Sutent in this clinical setting, it cannot be said that the drug is likely to be of greater benefit than standard treatment. For the reasons set forth above, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.