Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 57-year-old woman first diagnosed with breast cancer in October 2003, at Stage II. She was initially treated with adjuvant FAC and Taxotere, but was found to have progressive disease in her left axilla and liver in June 2004. The patient was subsequently treated with Xeloda-Taxotere with progression of disease. She was then treated with another therapy, epotholone, again with progression of disease. It has now been proposed that the patient be treated with halichondrin B analog (E7389) on a Phase II trial. The Health Plan has denied coverage for the requested therapy on the basis it is considered experimental.E7389 is an investigational agent being studied in a Phase II drug-company sponsored trial in breast cancer. There is no data as yet as to the possible efficacy of the agent and therefore, there is no reason to believe it is likely to offer this patient significant clinical 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 2: The patient is a 57-year-old woman with advanced disease who has received several agents including anthracyclines, taxanes, and capecitabine. It has been proposed the patient participate in a clinical trial of halichondrin B analog since she has proved refractory to several agents. The Health Plan has denied coverage for the requested therapy on the basis that it is considered experimental. Upon review of the information provided, it appears there are several agents that have not been explored. Such agents include Gemzar, Navelbine, carboplatin and Taxotere, Abraxane (recently FDA-approved), GEM Taxol, and GEM Taxotere. There is no evidence that a trial involving halichondrin analog B is likely to result in a better outcome than these agents. 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 3: The patient is a 57-year-old woman with refractory Stage IV breast cancer, ER/PR negative, Her-2 negative. She is requesting coverage for participation in an industry-sponsored open label Phase II clinical trial with halichondrin B analog. The patient has a clinically aggressive disease that has progressed through two different conventional regimens and one experimental protocol. The two conventional regimens were Adriamycin-based and Taxotere based. The NCCN guidelines for therapy of Stage IV breast cancer recommends a palliative care regimen if breast cancer has progressed through three successive regimens. However, most practitioners, as standard practice would consider participation in another clinical trial in a highly motivated patient with a relatively good performance status. The Health Plan has denied coverage for the patients participation in the halichondrin B analog trial indicating it is not likely to be more effective than standard therapy. Although the patient has aggressive cancer she has not had a trial of several chemotherapy agents with documented activity in breast cancer, namely, gemcitabine, cisplatin or carboplatin, liposomal Adriamycin, vinblastine, mitomycin-C, and vinorelbine. Under these circumstances, standard of care would be either participation in an NCI-sponsored clinical trial or a regimen that incorporates some of the agents that have documented activity in this disease to which the patient has not yet been exposed. Consideration of a cisplatin-gemcitabine combination or single agent vinorelbine (widely used) would be considered standard approaches at this point. No evidence has been presented that the proposed agent, halichondrin B analog, is likely to be more beneficial for this patient than these other available standard therapies. 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.