Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: This patient is a 62-year-old female who was diagnosed with a right upper lobe 5 cm mass in February 2004. First-line treatment was surgery. This was followed by adjuvant treatment consisting of chemotherapy, DDP and navelbine with radiation therapy.  The patient experienced a relapse one year out and received second-line chemotherapy with gemcitabine and Taxotere. This was followed with Iressa and then Tarceva. The patient has requested authorization and coverage to add Avastin to her treatment plan. The Health Plan has denied this request indicating Avastin has not been shown to be effective for treatment of the patients condition.The Health Plans denial should be upheld. The data for the combination of therapies involved in this case are very sparse and are not based on randomized controlled trials. The efficacy of adding Avastin to this patients regimen is not supported by the literature. There is no data demonstrating Avastin is beneficial for patients such as this patient. 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: This patient has the diagnosis of non-small cell lung cancer, stage IV, poorly differentiated adenocarcinoma, with progressive pulmonary metastases. She is status post lobectomy, which revealed lymph node involvement. Following surgery the patient underwent adjuvant chemotherapy with cisplatin and navelbine, which was followed by radiotherapy. Bilateral pulmonary metastases were discovered in December 2004. The patient then began treatment with Iressa followed by Gemzar and Taxotere. A CT scan in August 2005 revealed worsening pulmonary metastases. Tarceva was initiated. It has now been recommended that the patient receive Avastin. The Health Plan has denied authorization and coverage for Avastin on the basis that its use in this setting is considered experimental. Although Avastin has not been approved by the Food and Drug Administration for the treatment of lung cancer, the off-label use of the drug is medically appropriate in this case. Avastin is listed in the USP-DI in combination with paclitaxel and carboplatin. It appears there is no significant medical difference between the accepted listing and the combination involved in this case (i.e., Avastin with erlotinib). This is particularly true in light of the Journal of Clinical Oncology article from April 2005. As such, I have determined that the requested medication 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.Physician 3: The patient is a 62-year-old woman who was initially diagnosed with non-small cell lung cancer in early 2004. She underwent a right upper lobectomy and biopsy, which revealed a poorly differentiated adenocarcinoma with involvement of one of twelve level IV nodes and one of four hilar nodes. The patient was then treated with radiation along with cisplatin-navelbine chemotherapy. In December 2004, she was noted to have bilateral pulmonary metastases along with possible bone metastases. She was treated with Iressa, but had progressive disease. The patient then received chemotherapy with Taxotere-Gemzar, but was noted to have progressive disease in August 2005. She was then treated with Tarceva. It is now proposed that she be treated with Avastin. The Health Plan has denied authorization for Avastin indicating it has not been established as efficacious for patients such as this patient.Certainly there is a great deal of interest in the use of epithelial growth inhibitors, which have generally been used in combination with chemotherapy. These drugs, including Avastin, are being very actively studied in a wide variety of cancers.In lung cancer, the paper with the best data appeared in June 2004. In this study, 99 patients with non-small cell lung cancer, previously untreated with chemotherapy, were treated with either carboplatinum-Taxol alone or with Avastin. The patients who received Avastin did indeed have a higher response rate, a longer median time to progression, and perhaps a slight increase in survival. Such a study cannot be used to support the use of Avastin in this patients case, as she has been heavily pre-treated, not only with chemotherapy, but also with other epithelial growth inhibitors. The Journal of Clinical Oncology article by Herbst reported a Phase I/II trial wherein 40 patients with previously treated, advanced, non-small cell lung cancer, were treated with the combination of Tarceva and Avastin. The median survival for the 34 patients treated at full dose was 12.6 months, with progression-free survival of 6.2 months. This was a dose and toxicity study and no effort was made to compare this treatment with, for example, Tarceva alone. Thus, it is very early data and not sufficient to suggest that this proposed combination of therapies is of proven clinical benefit. As set forth above, there is no data to support the use of Avastin for treatment of this patients 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.