Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician #1:  The patient is a 44-year-old female with recurrent glioblastoma. She is status post two resections followed by radiotherapy and Temodar. Her oncologist has now recommended Avastin and irinotecan J9206 combination therapy. The Health Plan has denied authorization and coverage for the requested therapy on the basis that the use of Avastin in this setting has not been shown to be effective.Review of the scientific literature reveals no peer-reviewed studies supporting the use of the proposed therapy in the treatment of recurrent glioblastoma. Although the patients provider states early clinical trials with the proposed combination indicate a response rate of 50 to 60 percent, no documentation has been provided to substantiate this statement. Furthermore, it is notoriously difficult to objectify responses in tumors of this type. Finally, there are numerous safety concerns associated with the use of these drugs. For these reasons, I have determined that the requested therapy 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 44-year-old woman first diagnosed with glioblastoma multiforme in September 2005. She underwent subtotal resection, followed by radiation therapy and Temodar chemotherapy. Further excision was attempted in January 2006, but there was a residual tumor after the surgery.Multiple options of chemotherapy have been considered, with a recommendation for a combination of Avastin and irinotecan J9206. The Health Plan indicates Avastin in this setting is considered experimental.There has been increasing interest in the use of epithelial growth receptor inhibitors such as Avastin in the treatment of brain tumors. As yet, however, there is no convincing data to indicate that such drugs prolong survival or offer significant clinical benefit in this setting. Accordingly, the use of Avastin in the treatment of brain tumors must be considered investigational and of no proven clinical benefit. Therefore, I have determined that the requested therapy 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 44-year-old woman with glioblastoma multiforme (GBM), recurrent after standard therapy. She is requesting authorization for off-label use of Avastin in combination with irinotecan. The Health Plan has classified this approach as investigational.  At issue is whether the requested therapy is likely to be more beneficial for this patient than any available standard therapy.Review of the relevant scientific literature including NCCN guidelines reveals that standard therapy for recurrent disease involves a nitrosourea-based  (e.g., BCNU, CCNU) regimen. Although the data concerning the role of Avastin/immunotherapy-based regimens is intriguing, the data is sparse, considered investigational, and cannot yet be considered more beneficial than available standard therapy.  Since standard therapy options have not been exhausted in this case, I have determined that the requested therapy is not likely to be more beneficial in this clinical setting. Therefore, the Health Plans denial should be upheld.