Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: This patient is a 57-year-old female apparently first diagnosed with breast cancer in 1989 and treated with surgery, radiation, and chemotherapy of unknown types. In 2000, she had a local recurrence and was treated with mastectomy and hormonal therapy. In 2003, she was found to have bone metastases. Additional chemotherapy of unknown type was given. The patient was seen in June 2005 by another oncologist who noted that she was stable on a combination of two chemotherapy drugs, Abraxane and Xeloda. The extent of her disease and its responsiveness to the combination therapy are unclear.It has been recommended that Avastin be added to her current regimen. This has been denied by the Health Plan as investigational.The patient is a 57-year-old woman with reported bone-only metastatic breast cancer.  Her current treatment regimen is Abraxane and Xeloda, and there is presumably progression of the disease.  A full history of her prior chemotherapy exposures is not provided. The patient is now being offered Avastin. The Health Plan has denied coverage for Avastin on the basis it is considered experimental for treatment of patients such as this patient.The data supporting the efficacy of Avastin is only with Taxol and only as a first line treatment for metastatic disease.  Data from studies with Avastin as a single agent or in combination with drugs other than Taxol did not indicate there was a benefit to the therapy.  The patient has already been treated with a taxane drug, Abraxane, and there is no clinical rationale for treatment with Taxol and the proposed Avastin at this point.  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 57-year-old woman with reported bone-only metastatic breast cancer.  Her current treatment regimen is Abraxane and Xeloda, and there is presumably progression of the disease.  A full history of her prior chemotherapy exposures is not provided. The patient is now being offered Avastin. The Health Plan has denied coverage for Avastin on the basis it is considered experimental for treatment of patients such as this patient.The data supporting the efficacy of Avastin is only with Taxol and only as a first line treatment for metastatic disease.  Data from studies with Avastin as a single agent or in combination with drugs other than Taxol did not indicate there was a benefit to the therapy.  The patient has already been treated with a taxane drug, Abraxane, and there is no clinical rationale for treatment with Taxol and the proposed Avastin at this point.  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: This patient is a 57-year-old female with T2 (3.5cm) poorly differentiated breast cancer post lumpectomy in 2002, treated with chemotherapy followed by hormonal therapy with subsequent bony progression. She apparently has exhausted hormonal treatments, the last being Faslodex. Currently, she is post mastectomy for local recurrence and is being treated with Abraxane (a second generation taxane that is superior to Taxol) and Xeloda and is stable.A request has been made for the addition of Avastin to the patients regimen. The Health Plan has denied this request on the basis Avastin is investigational in this clinical setting.The patient is of good performance status four to five years from adjuvant chemotherapy. She has failed hormone treatment for breast cancer and has been started on Abraxane and Xeloda, which is being tolerated well and on which she is apparently stable. Avastin has been demonstrated to add to Taxol therapy when given as first line therapy for metastatic disease. It has also shown an increased response rate with Xeloda and chemotherapy given as a second line of chemotherapy. At this juncture it appears the patient is on her first chemotherapy for metastatic disease with Abraxane as well as Xeloda with which Avastin has previously shown synergism. Adding Avastin to this regimen would be medically reasonable and appropriate. This patient should have her HER-2/NEU status confirmed with FISH.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.