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

Physician 1The patient is a 74-year-old man who was initially diagnosed with colon cancer in 1999. His initial treatment is unknown. He has recently been found to have three very small lung nodules, which have not been biopsied. The patients oncologist believes they represent metastases to the lung, but feels that there is no advantage to instituting chemotherapy at this point in time. He has recommended the use of high dose Celebrex in an effort to control the metastases. The Health Plan has denied authorization for Celebrex indicating that its use is considered investigational for treatment of the patients medical condition.Celebrex is a COX-2 inhibitor, which has found wide use in many rheumatologic conditions. It also purportedly has anti-angiogenic properties; therefore, there is interest in its potential usefulness in cancer. Indeed there is some data to suggest that Celebrex might be of use in decreasing the development of polyps in the colon. However, there is no evidence to date that Celebrex is useful in the treatment of ongoing cancer. While there are ongoing protocols exploring the usefulness of Celebrex in conjunction with chemotherapy in the treatment of several cancer types, there is no scientifically reliable data that would be useful in the patients situation.Based upon the information set forth above, 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 2The patient is a 74-year-old man with colon cancer. Recently, three pulmonary lesions were found. It is not known if these in fact represent metastatic disease. The patients provider has recommended the use of Celebrex. The Health Plan indicates that the use of Celebrex is considered experimental for treatment of the patients diagnosis.Current scientific evidence does not demonstrate that Celebrex is beneficial in the treatment of metastatic colon cancer. Celebrex may be useful in the chemoprevention of gastrointestinal polyps for patients with familial adenomatous polyposis. There is also some very early experimental evidence that Celebrex may have some utility in the treatment of colon cancer, though there is no clinical information available. However, there is also a great deal of uncertainty of the mechanism of Celebrex in the treatment of colon cancer, that is, whether it is a direct or indirect effect and whether it is COX-2 mediated. There is no clinical data on the utility of Celebrex in colon cancer for any phase of treatment.There are chemotherapies that have accepted efficacy in the treatment of metastatic colon cancer. It is likely the patient still has several options in the treatment of his metastatic colon cancer that have demonstrated efficacy. 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. Thus, the Health Plans denial should be upheld.Physician 3The patient is a 74-year-old male with presumed metastatic colon cancer to the lung (presumed because not biopsy proven). Whether he has an elevated CEA or a positive PET scan is unknown. According to the submitted information, the patient is asymptomatic. No other sites of metastasis have been documented. The patients provider has recommended Celebrex. The Health Plan indicates Celebrex is considered investigational for patients such as this patient.COX-2 inhibitors such as Celebrex have a potential role in cancer management. They clearly can prevent polyp formation and are useful in familiar adenomatous polyp syndromes. However, the role of COX-2 inhibitors in overt, invasive cancers, colon or otherwise is still being investigated. There is clear scientific basis and rationale for their use. Several ASCD abstracts have been published illustrating COX-2 inhibitor use in metastatic colon cancer. However, these have been in conjunction with chemotherapy. No randomized trials have demonstrated additive benefit to chemotherapy for COX-2 inhibitors. With the recent release of Avastin, an anti-VEGF antibody used in conjunction with chemotherapy, the use of Celebrex here would appear moot. Moreover, given the patients disease free interval, surgical resection should be considered if he has only limited pulmonary metastatic disease.Based upon the information set forth above, 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.