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

Physician 1The patient is a 62-year-old woman who was diagnosed with extensive cancer of the pancreas in September 2002. She had bilateral pulmonary metastases. Her condition was that of an unresectable cancer of the pancreas, stage IV. The patient was treated with 14 cycles of chemotherapy, which after 16 months is failing to be effective. On 4/23/04, CT scans showed progression of pulmonary metastases to 7mm in diameter. The pancreatic mass has increased and so has the lateral hepatic mass extending to the right intercostal space. The patients medical oncologist wishes to enroll the patient in a phase I clinical trial involving a Cytoxan-Celebrex combination. The Health Plan has denied authorization for the requested therapy on the basis that it is considered experimental.Since September 2002 the patient has had stage IV pancreatic cancer, which has a poor prognosis. To date, there is no evidence to demonstrate the efficacy of the combination of Cytoxan and Celebrex in the treatment of metastatic pancreatic cancer. Thus, there is no evidence that the proposed trial will be of any benefit to the patient.For this patients condition, chemotherapy can be used to palliate the symptoms of the patient if the side effects are acceptable to the patient. In addition, there are many non-chemotherapeutic agents available for palliation (e.g., analgesics, radiation therapy, antiemetics), which have minimal to no side effects. These therapies are more clinically appropriate than the requested therapy and are likely to be more beneficial for purposes of palliation.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 2The patient is a 62-year-old woman with locally advanced pancreatic cancer with lung metastases. In the past she has been treated with radiation therapy and gemzar chemotherapy. She was then treated with a combination of Celebrex and etoposide, but a CT scan of April 2004 has shown progression of her lung metastases. It is now suggested she be treated on a phase I trial of Celebrex combined with oral Cytoxan. The Health Plan has denied authorization for the requested therapy on the basis that it is considered experimental.There is indeed much interest in the use of Celebrex in the treatment of a variety of cancer types. Purportedly, it has anti-angiogenic and other properties. As yet, there is no valuable data to suggest that there is any usefulness to the combination of Celebrex with chemotherapy, and specifically the combination of Celebrex and Cytoxan in pancreatic cancer. Indeed, this is a phase I trial, the goal of which is primarily to determine toxicity and safe dosage. As such, this is an investigational approach of no proven value. There is no reason to believe it will be of clinical benefit to 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.Physician 3The patient is a 62-year-old woman with advanced pancreatic cancer that is refractory to conventional chemotherapy and radiation approaches. She has requested authorization for participation in a phase I clinical trial involving two oral agents, Celebrex and Cytoxan. The Health Plan has denied authorization for the requested therapy on the basis that it is considered experimental.The clinical experience with these two well-tolerated agents is extensive in terms of safety profile. The National Comprehensive Cancer Network guidelines as well as widely accepted standard of care would be participation in a clinical trial of palliative chemotherapy, sponsored or institutional, or palliative supportive care. In light of the poor prognosis in this clinical setting the proposed phase I trial is likely to be more beneficial than standard therapy, with acceptable risks. Therefore, 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.