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

Physician 1: The patient is a 35-year old male found to have an extensive and inoperable carcinoma of the stomach in October 2005.  He was started on chemotherapy with Xeloda and Oxaliplatin. The latter drug was denied by the Health Plan as experimental/ investigational for treatment of the patients gastric cancer.It is true that Oxaliplatin has only been approved by the Food and Drug Administration (FDA) for treatment of colon cancer. However, the submitted materials include five studies documenting the usefulness of Oxaliplatin in the treatment of gastric cancer.  The patient is likely to experience less nausea with Oxaliplatin than with the alternative, Cisplatin. In view of current studies, Oxaliplatin is a reasonable drug for treatment of this patients gastric cancer and is likely to be less toxic than Cisplatin. 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 2: The patient is a 35-year old man who presented with epigastric pain and linitis plastica.  He was diagnosed with metastatic gastric cancer and his current chemotherapy regimen consists of Xeloda and Oxaliplatin.  He has not used any other chemotherapy regimens to treat his gastric cancer. The Health Plan considers Oxaliplatin investigational for the treatment of gastric cancer and has denied the patients request for coverage.There have been several phase II studies on the use of Oxaliplatin for the treatment of gastric cancer, which appear encouraging in terms of efficacy and decreased toxicity.  There is also an on-going phase III study with patients who have advanced esophagogastric cancer.  However, before a new chemotherapy agent is used in a specific clinical application, its efficacy should be confirmed in phase III studies. Treatment with Oxaliplatin for metastatic gastric cancer remains unproven at this time. There is insufficient data to warrant its use outside of a clinical study.  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 3: The patient is a 35-year old male who has been diagnosed with an unresectable gastric cancer. Chemotherapy is his only treatment option.  He has been started on a combination chemotherapy regimen using Xeloda and Oxaliplatin. The Health Plan has denied coverage for the Oxaliplatin as an unproven chemotherapeutic agent for the treatment of gastric cancer.The literature submitted supports the use of Oxaliplatin in combination with infusional 5-FU, Leucovorin, or Xeloda for the treatment of metastatic/recurrent gastrointestinal cancers. The studies show a 40-55% response rate, which are at least as good as any existing alternative regimens. Additionally, the toxicity from Oxaliplatin is more manageable and clearly less than would be experienced with any Cisplatin containing regimen.  The patient should be allowed to continue on this regimen because it is equal to more standard approaches in terms of efficacy, and superior in terms of toxicity.  Based upon the information set forth above, 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.