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

Physician 1: The patient is a 51-year-old man diagnosed with glioblastoma in July 2004. He was treated with surgery, radiation therapy, and chemotherapy. The patient underwent further surgery in January 2005 followed by treatment with interleukin-13 pseudomonas exotoxin. An MRI performed in September 2005 demonstrated progressive disease and it has been recommended that the patient be treated with CPT-11 and Avastin. The Health Plan has denied authorization for Avastin on the basis the therapy is considered investigational in this clinical setting.The included evidence includes two abstracts/papers that have been submitted for publication. One of these papers noted that in 21 patients treated with CPT-11 and Avastin, 9 had some sort of response. This was suggestive of an improved response to the combination when compared to CPT-11 alone. The second paper (from Duke) demonstrated a number of partial responses in patients treated with the combination. Neither study could comment on whether it appeared that survival was benefited by the use of CPT-11 with Avastin.Given the limited data available, the proposed combination of CPT-11 and Avastin for the treatment of glioblastoma is of unproven efficacy and remains investigational. 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 2: The patient is a 51-year-old male with progressive glioblastoma. He underwent surgical resection in July 2004 followed by brain irradiation and adjuvant chemotherapy. A second surgical resection was performed in January 2005 followed by treatment with interleukin-13 pseudomonas exotoxin. After an MRI revealed progression in September 2005, the patient underwent a third resection that revealed pathology of recurrent glioblastoma. The combination of Avastin and CPT-11 was proposed and the patient received his first Avastin treatment in October 2005. The Health Plan has denied coverage for Avastin on the basis that it is considered experimental/investigational.Upon review of the submitted evidence, there is no indication for Avastin therapy in this case. The available literature consists of small reported series without evidence of independent radiographic response assessment or even the traditional confirmation of response with a second scan. There is no randomized data to suggest that the combination of CPT-11 and Avastin is superior to CPT-11 alone. To date, it has not been established that the proposed regimen is effective for patients such as this patient. 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 51-year-old male with recurrent, resected, radiated, glioblastoma multiforme (GBM), which is the most-virulent form of adult malignant brain tumors. He has failed standard chemotherapy and one investigational systemic therapy. The patient remains in good clinical condition. His provider has recommended treatment with CPT-11 and Avastin. The Health Plan indicates the efficacy of Avastin for the treatment of glioblastoma has not been established.GBM is an extremely aggressive brain tumor. There have been modest improvements in treatments over the years but better systemic and local therapies are needed. Following progression after standard therapies, responses to subsequent second and third line chemotherapies are infrequent and generally short-lived. CPT-11 alone is one such agent. Avastin has been anecdotally shown to induce occasional remarkable meaningful responses in GBM. Furthermore, the combination of these agents has been associated with remarkable activity in GBM patients with an otherwise poor prognosis. This patient is an excellent candidate for the proposed therapy and given the lack of available alternatives, Avastin is medically reasonable and appropriate.Based upon the information set forth above, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.