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

Physician #1:  The patient is a 53-year-old woman with ovarian cancer. She had her initial surgery in September 2004, with the findings of Stage III papillary serous ovarian cancer. She had extensive peritoneal and omental seeding as well as positive lymph nodes. She was apparently treated with chemotherapy and underwent second-look surgery in March 2005. It appears she was free of cancer at that time.Since that time she has had a rising CA-125 and a recent PET scan has demonstrated new areas of uptake consistent with recurrent cancer. She has been started on Doxil chemotherapy and has requested authorization and coverage for intraperitoneal chemotherapy. At issue is whether the requested therapy is likely to be more beneficial for treatment of the patients condition than any available standard therapy.Intraperitoneal chemotherapy for ovarian cancer has been studied for many years. Though the data has been conflicted, a recent review of published, randomized studies indicated that intraperitoneal chemotherapy, when combined with intravenous chemotherapy, prolongs survival; this has however only been demonstrated when such therapy is used in the primary chemotherapeutic treatment for ovarian cancer. There has also been great concern regarding relatively severe toxicity seen with such combined therapy.There is no convincing data that combining intravenous with intraperitoneal chemotherapy offer superior survival in the treatment of recurrent ovarian cancer. In the recent review article by Markman, et. al., the author refers to randomized studies in primary therapy of ovarian cancer. He does not note nor recommend the use of intraperitoneal therapy in recurrent disease. In the PDQ analysis from the NCI addressing recurrent ovarian cancer, the only mention of intraperitoneal chemotherapy is at the very end, quoting two Phase I studies that are 10 years old. This is not an endorsement of such therapy as a possible option. A thorough review of the relevant scientific literature did not reveal any data demonstrating superior efficacy of intraperitoneal chemotherapy, with or without intravenous chemotherapy, in recurrent ovarian cancer. Accordingly, 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 female with metastatic ovarian cancer. She is requesting approval for chemotherapy administered intraperitoneally as part of a treatment plan for her advanced stage ovarian cancer.  She is currently receiving intravenous Doxil chemotherapy, and apparently has a rising CA-125. The Health Plan has denied authorization for the requested therapy indicating it is considered experimental in this clinical setting.  In contrast to intravenous administration of chemotherapy, the intraperitoneal route is capable of achieving high local concentrations of therapeutic drugs with acceptable systemic side effects, particularly in the treatment of ovarian cancer. The patients treating physician proposes to follow the chemotherapy regimen dosing published recently in the New England Journal of Medicine (2006). The PET scan in January 2006 detected two small serosal lesions suggestive of tumor implants in the peritoneal cavity, but no evidence of disease elsewhere. This clinical presentation is similar to the patients described in the article; that study demonstrated an increase in survival in the patients that received intraperitoneal chemotherapy as part of their treatment. Other references provided further support the use of intraperitoneal chemotherapy. 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.Physician #3:  The patient is a 53-year-old female with recurrent ovarian cancer. In September 2004 she was found to have Stage IIIC poorly differentiated adenocarcinoma of the ovary. In March 2005, she underwent second look surgery, which was negative. She subsequently received Doxil chemotherapy. In January 2006 a PET scan revealed two moderately FDG-avid foci adjacent to the spleen. A CT of the abdomen performed on the same date showed a 1.5cm density in the para-aortic region. In January 2006 a chest CT revealed tiny subpleural pulmonary nodules. In February 2006, a rising CA-125 was noted. Office notes from February and March 2006 indicate the patient has Stage IV ovarian cancer. The patients provider has recommended intraperitoneal chemotherapy. The Health Plan has denied authorization and coverage for this therapy on the basis that it has not been shown to be efficacious in the treatment of recurrent ovarian cancer.Intraperitoneal chemotherapy has been used in the management of ovarian cancer as evidenced by multiple publications including a recent article by Armstrong and colleagues in the New England Journal of Medicine, involving first-line therapy. Intraperitoneal chemotherapy is utilized in only small volume doses; otherwise its usefulness is tempered by limited penetration of cytotoxic agents into the tissue. There is also the issue of the limitations of intraperitoneal therapy such as limited distribution of agents into the peritoneum. In the case of this patient she has recurrent disease as evidenced by a rising CA-125 as well as by radiographical studies. Several of the submitted notes indicate the patient has Stage IV disease and subpleural nodules of possible significance. The use of intraperitoneal chemotherapy in a patient with what appears to be Stage IV disease is not likely to result in a superior outcome over standard chemotherapy. However, if it is established that the patient has Stage III rather than Stage IV disease, her request should be reconsidered.  Based upon the information provided at this time, 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.