Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 44-year-old man with a long and complex medical history. He was first diagnosed with testicular cancer in 1994, with a recurrence in 2005. He was treated with conventional chemotherapy (cisplatin-etoposide) without success. He was then treated on a clinical trial including oxaliplatin, gemzar, and Taxol. The patient apparently experienced a good response to this therapy, and then underwent surgical resection of residual disease. Post-operatively he was given further cycles of chemotherapy with the same drugs, though no longer on a clinical trial. It is recommended that he continue such treatment. The Health Plan has denied coverage for the oxaliplatin chemotherapy treatments on the basis that the therapy is considered experimental/investigational.Submitted with the appeal are several journal articles demonstrating that oxaliplatin is of some usefulness in cis-platinum refractory testicular cancer. In addition, several other articles have reached essentially the same conclusion. In particular, the article by Fizazi suggests the use of oxaliplatin in this setting is useful. Thus, there is sufficient scientific data to support the use of oxaliplatin chemotherapy for patients such as this patient. Accordingly, I have determined that the therapy at issue is likely to be of clinical benefit and 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 44-year-old male with recurrent germ cell testicular cancer (GCT). He has requested coverage for oxaliplatin chemotherapy treatments. The patient has a complicated medical history with the pertinent facts of recurrent disease and lung involvement following initial chemotherapy with a CisPlat-based standard regimen (poorly tolerated). Subsequent therapy involving oxaliplatin, gemzar and paclitaxel was administered as part of a clinical trial, with a good serological response, but the patient then experienced significant post-operative complications from abdominal resection.  Monitoring revealed rising serum tumor markers and new lung lesions post-operatively.  The patient was re-started on the previous chemotherapy regimen, but was now off-trial given his post-operative recovery time.  The plan is to resect the lung disease after several more cycles of chemotherapy.The Health Plan has denied coverage for the post-operative chemotherapy, as the patient is no longer participating in the clinical trial, and oxaliplatin is being used off-label.  At issue is whether the therapy at issue is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Refractory GCT is a rare disease with a poor prognosis. Active agents in the salvage setting include gemcitabine and Taxol.  According to the relevant peer-reviewed literature, a recurring theme in the management of this disease is the need for clinical trial participation and therapy through a tertiary referral center. In the case of this patient, available standard therapy has been largely exhausted or is in use with the disputed agent.  Given the German study included in the submitted materials as well as the known activity and tolerability of oxaliplatin in cisplatin failures, the rarity of this disease, the efforts to participate in a clinical trial, and the strong recommendation and supervision of a physician appropriately associated with a comprehensive cancer center, the therapy at issue is clearly more beneficial than any other standard regimen.For the reasons set forth above, I have determined that the therapy at issue 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 has a history of germ cell tumor, originally diagnosed in 1994. He experienced a recurrence in 2005.  The patient received cisplatin and etoposide and was then treated with oxliplatin/gemcitabine and paclitaxel as part of a clinical trial. The patient responded to the therapy. He then underwent surgery, sustaining complications. Recently, his markers have increased. His provider has recommended a return to oxaliplatin chemotherapy given its initial efficacy. The Health Plan has denied coverage for the therapy indicating it remains unproven in this clinical setting.The patient has refractory germ tumor and has exhausted conventional combinations. He has clearly benefited from oxaliplatin chemotherapy. The literature submitted by the referring physicians provides sufficient evidence of the benefit of this agent in the patients disease. As such, the therapy at issue is likely to result in a superior outcome over standard therapeutic regimens. Therefore, I have determined that the therapy at issue 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.