Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 53-year-old man with metastatic squamous cancer to the lung. He progressed after carboplatin and Taxol, Gemzar and Taxotere, and Alimta and Tarceva. He now wishes to be treated with Velcade, carboplatin and gemcitabine. The Health Plan has denied coverage for the requested therapy on the basis that it is considered experimental in this setting.The submitted literature reports are irrelevant to this patient and in any case provide weak support even for the specific setting in which the phase II trial was reported. It appears the patients primary cancer is from the head and neck. The proposed therapy is fourth-line treatment. Based upon the scientific evidence available to date, there is insufficient data that the proposed therapy will benefit this patient. Furthermore, there is no evidence that the effects of the proposed therapy would be better than standard treatment. 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 53-year-old man with progression of stage IV non-small cell lung cancer (squamous cell in histology). His past regimens have included Gemzar with Taxotere, and Alimta combined with Tarceva. It is now recommended that he be treated with Velcade, carboplatinum, and Gemzar. The Health Plan has denied coverage for the requested therapy citing a lack of proven efficacy.The combination of carboplatinum-Gemzar is a commonly used chemotherapy program in metastatic non-small cell lung cancer. The submitted materials include two abstracts wherein Velcade was added to this combination. Subsequent to these abstracts is a published report of one of them, which is more complete.The first of these abstracts was a phase II (dose-finding) study, which gave no real indication as to whether the addition of Velcade improved results expected from the carboplatinum-Gemzar. The second study reported the use of the combination of carboplatinum-Gemzar-Velcade in 113 patients with metastatic non-small cell lung cancer. Comparing the results to historical expectations suggested there might have been some increased efficacy with the addition of Velcade. However, most of these patients had adenocarcinoma, not squamous cell carcinoma, and all were previously untreated. This patient has been treated with multiple chemotherapeutic drugs already.Neither of these studies provides sufficient data to demonstrate that the use of Velcade in this situation is anything but investigational; it has 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 53-year-old male with metastatic non-small cell lung cancer. His treating physician has recommended treatment with gemcitabine, carboplatin and Velcade. The Health Plan has denied authorization for the requested therapy on the basis that it is considered experimental/investigational.Velcade is a small molecule proteasome inhibitor approved for the treatment of multiple myeloma. Pre-clinical studies have suggested the possibility of activity in other tumor types including lung cancer. Two studies have been reported adding Velcade to standard chemotherapy in non-small cell lung cancer. Davies et. al., (ASCO 2006) reported a 20% response rate and 11-month median survival for Velcade given in combination with gemcitabine and carboplatin. A phase I study has also been reported (ASCO 2004, Davies et. al.). A phase III study is underway.Although the results of the phase II study are promising, they are not clearly better than standard chemotherapy. The combination of gemcitabine and cisplatin, which is standard in this setting, has published results of 35% response and median survival of 10.4 months in a phase II study (Paz-Ares, et. al.). In light of these results, the patient is likely to receive greater benefit from standard therapy than the proposed regimen.For the reasons set forth above, 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.