Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 59-year-old female diagnosed with ovarian cancer in October 2003.  She was initially treated with cytoreductive surgery and chemotherapy.  She was found to have recurrent disease and underwent splenectomy in October 2004.  The patient has had additional chemotherapy since that time, but as of January 2006 she has been found to have progressive and strongly symptomatic disease.  The patients clinician has requested authorization for intra-peritoneal hyperthermic chemotherapy. The Health Plan has denied authorization citing the investigational nature of the procedure in the treatment of recurrent ovarian cancer.Intra-peritoneal chemotherapy for ovarian cancer has been studied for many years.  Though the data has been conflicting, a recent review of published, randomized studies has indicated that as primary treatment for ovarian cancer, intra-peritoneal chemotherapy combined with intravenous chemotherapy, prolongs and improves survival.  There is no convincing data however, that intra-peritoneal chemotherapy is superior to intravenous chemotherapy alone in the treatment of advanced, recurrent and extensively treated ovarian cancer.  Furthermore, though there has also been interest in hyperthermic intra-peritoneal chemotherapy, no randomized study suggests that this would offer the patient any benefit.  For these reasons, I have determined that intra-peritoneal hyperthermic chemotherapy 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 59-year old female diagnosed with ovarian cancer in late 2003.  She has been treated aggressively, but in January 2006 CT scan confirmed progression of the disease.  The patients provider indicates that intra-peritoneal hyperthermic chemotherapy is the only remaining treatment option and has requested authorization. The Health Plan denied the request based upon a determination that the procedure is experimental/ investigational in this clinical setting.The patient has requested authorization for hyperthermic therapy used intra-peritoneally as part of a treatment plan called Cytoreductive Surgery with Intra-peritoneal Hyperthermic Chemotherapy.  There is a Level I clinical study that demonstrates stage 4 ovarian cancer can be appropriately treated with surgery to reduce the tumor burden and intra-peritoneal chemotherapy with or without systemic chemotherapy.  Yet there is no evidence to support the premise that hyperthermic therapy in combination with surgery and intra-peritoneal chemotherapy is a superior treatment approach.  Further randomized, prospective, controlled clinical trials are needed before hyperthermic therapy can be considered the standard of care.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 3: The patient is a 59-year-old female with advanced refractory mixed Mullerian tumor, abdominal pain and obstructive symptoms. She has failed various treatments with platinum salts, taxanes, Adriamycin, gemcitabine, topotecan and VP16.  The patient now requests authorization and coverage intra-peritoneal hyperthermic chemotherapy.  The Health Plan considers the procedure experimental/investigational and has denied her request.The patient appears to have a completely refractory cancer. The data to support the proposed treatment approach does not come from prospective Phase III or even well designed Phase II clinical trials. The protocol submitted does not have the elements of an NIH or FDA-approved study with a consent form and IRB approval. The treatment plan is more of a procedural guide than an actual protocol. As such, the procedure is clearly experimental and at this stage 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.