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

Physician 1The patient is a 37-year-old woman first diagnosed with renal cell carcinoma in January 2001. At that time she underwent nephrectomy. She was then well until mid-2003 when she developed left groin pain. Evaluation in September 2003 revealed a solitary lytic bone metastasis in her left superior pubic ramus. This was resected and the patient was treated with radiation therapy following surgery. As yet, the patient has not experienced any further recurrence or evidence of metastasis. Because of the patients high risk of further recurrence, the patients provider has proposed that the patient undergo nonmyeloablative allergenic transplant if an HLA-matched sibling can be found. The Health Plan has denied authorization and coverage for the requested procedure on the basis that it is considered experimental.As documented in the submitted literature, nonmyeloablative allergenic transplant from a matched sibling is being studied in a variety of cancer types, including renal cell carcinoma. All studies have been quite small but there have been responses noted, a few of which appear to be long-lasting. There has also been a fair degree of morbidity and even mortality from the treatment itself.At present it is not clear whether allergenic stem cell transplant is a viable form of treatment since there are many unknown variables including how often the procedure will benefit patients, which patients the procedure will benefit (most responses have been in patients with lung metastases), what is the best preparatory regimen, and how the procedure compares to other available treatments. Renal cell carcinoma can be a very unpredictable disease. Thus, it is very difficult to be sure of the role of a specific therapy in anecdotal cases. The protocol that has been proposed for this patient is a pilot study and is of unknown efficacy. Furthermore, there is no data involving the use of the requested procedure to prevent further recurrence rather than to treat known metastases.Based upon the information set forth above, I have determined that the requested procedure 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 2The patient is a 37-year-old woman who underwent a nephrectomy approximately 3.5 years ago for cancer (presumed conventional clear cell). The submitted records indicate that four months ago the patient relapsed with solitary bone metastasis that was resected and irradiated to no evidence of disease status. The patient has requested authorization and coverage for nonmyeloablative allogeneic transplant. The Health Plan has denied the request on the basis that the requested procedure is considered experimental.There is insufficient published evidence that the patient is likely to receive greater benefit from allogeneic stem cell transplant than from standard treatment. Standard treatment would be high dose interleukin-2 (IL-2) at the first sign of new metastatic disease, which provides a 15-25% objective response rate and a 5-7% chance of durable complete remission. In addition, the patient does not appear eligible for the proposed protocol. Furthermore, the patients risk of regimen mortality may be as high as 15% or more. Moreover, results of the proposed protocol have been very poor outside of NIH, probably due to patient selection. Finally, the patient has not undergone treatment with IL-2 or interferon alpha, the standard treatments for the patients disease. Although they are not active adjuvantly, they have routinely been used before consideration of allogeneic transplant because of their superior risk/benefit. Based upon the information set forth above, I have determined that the requested procedure is likely not to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3The patient is a 37-year-old female with a history of renal cell cancer who underwent radical nephrectomy in January 2001. The patients cancer has recurred with a single bony metastasis, which was resected and radiated in the fall of 2003. The patient is presumed to be without evidence of active disease currently, but is recognized to have an extreme likelihood of residual cancer to become evident eventually. A request has been made for nonmyeloablative allogeneic transplant. Nonmyeloablative allogeneic transplantation is a reasonable and acceptable treatment for non-rapidly progressing metastatic renal cell cancer that may have failed interferon- alpha and/or IL-2 treatment. There is not sufficient evidence demonstrating the efficacy of nonmyeloablative allogeneic transplantation for patients without evidence of active disease. Proceeding with such a transplant as an adjuvant therapy now in the absence of identifiable further metastatic disease is not medically indicated. Therefore, I have determined that the requested procedure is not likely to be more beneficial for treatment of the enrollees medical condition than any available standard therapy. The Health Plans denial should be upheld.