Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 49-year-old woman who was discovered upon routine laboratory testing to have an elevated globulin level in mid 2003. Further workup revealed a monoclonal IgG gammopathy. Bone marrow analysis performed in August 2003 demonstrated that plasma cells comprised 40% to 50% of the cellular marrow elements. Bone series and beta2-microglobulin assay were normal, which were good prognostic factors. The patient was seen in oncologic consultation in August 2003, at which time various options were apparently discussed including the possibility of allogeneic or autologous stem cell transplant. Based upon the records submitted it does not appear that the patient has undergone treatment. It has been proposed that the patient enter a phase I/II clinical trial evaluating the usefulness of celecoxib in smoldering or low stage myeloma.The purpose of the proposed use of celecoxib is to ascertain if it will block the progression of low stage myeloma to more advanced stages. At present, there is no real data to suggest that celecoxib might be successful in this regard. Accordingly, this clinical trial is properly labeled a phase I/II trial, which indicates that the primary goals are to determine dose and toxicity, as well as the impact of any possible symptoms from the myeloma. There is no scientific data to suggest that such therapy is likely to be of 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 2The patient is a 49-year-old woman who was diagnosed with multiple myeloma in August 2003. The patient is requesting authorization and coverage for an industry-sponsored clinical trial assessing the impact of celecoxib use in early stage multiple myeloma. The Health Plan states that this approach is considered experimental.Although the activities of COX-2 inhibitors may yet prove to be useful as anti-tumor agents, there is a paucity of both pre-clinical and clinical literature that would support use of celecoxib in this clinical setting. No compelling arguments or literature-based evidence for the choice of participation has been provided. The purpose of phase I/II studies is indeed to establish such a basis. At this time, there is no evidence that participation in the proposed trial would benefit the patient over standard/accepted therapeutic approaches.Based upon the information 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.Physician 3The patient is a 49-year-old woman with early stage asymptomatic IgG multiple myeloma. It does not appear the patient has been treated to date; she is in excellent clinical condition. It has been proposed that the patient participate in a phase I/II clinical trial involving celecoxib. The Health Plan has denied authorization for the patients participation in the clinical trial on the basis that it is considered experimental.Standard treatment for this patient would be bisphosphonate therapy only with initiation of chemotherapy or thalidomide/Decadron treatment upon progressive disease. Though angiogenesis approaches are theoretically attractive, the role of celecoxib here is unclear. To date, there is no scientific data to support the conclusion that the proposed trial will benefit 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.