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

Physician 1:  The patient is a 53-year-old male diagnosed with an ocular melanoma in November 2002 and treated with surgical excision and radiation therapy. The patient was then well until he developed pain in his shoulder in the fall of 2006. He was found to have a lytic lesion in his distal clavicle, and staging CT revealed extensive metastatic disease. The patient began treatment with Nexavar and his provider recommends the addition of Abraxane to his chemotherapy regimen. The request for authorization was denied by the Health Plan on the basis that Abraxane has not been shown to be efficacious in the treatment of ocular melanoma.Abraxane is a protein-bound form of a Taxol and is approved for the treatment of metastatic breast cancer. Although there are anecdotal reports of responses when used to treat other cancers, there is no convincing data to indicate that Abraxane therapy will prolong survival or offer significant clinical benefit in this setting. Accordingly, the use of Abraxane in the treatment of metastatic ocular melanoma must be considered investigational and of no proven 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 53-year-old male recently diagnosed with metastatic ocular melanoma involving several sites, including bone. He is status post radiation therapy in 2002 when originally diagnosed. The patients provider has researched available treatment options and proposes that Abraxane be combined with the Nexavar chemotherapy the patient is now receiving. The Health Plan denied the request for authorization and coverage for this therapy on the basis that it is experimental/investigational for the treatment of metastatic ocular melanoma. Taxanes are used only occasionally for the treatment of melanoma with rare transient responses. The literature is very sparse on this subject; however a Phase III registration trial for breast cancer found that Abraxane offered no advantage in terms of survival. Cytotoxics are generally not effective in the treatment of ocular melanoma and do not reduce bone-related pain. Bone metastases are more resistant to treatment than other sites and the impact of the treatment is more difficult to assess. 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 3:  The patient is a 53-year-old male with a primary ocular melanoma who now has widely metastatic bone disease. A consulting oncologist from a major cancer center recommended the administration of Abraxane chemotherapy, and a request for authorization was submitted. The Health Plan denied the request based on a determination that the therapy is experimental/investigational for the treatment of patients such as this one.A review of the NCCN guidelines for metastatic melanoma, ASCO abstracts and scholarly journals did not reveal a consensus of support for the off-label use for Abraxane in this setting. Internet articles are often pharmaceutical or industrial bulletins reporting only small series of cases with impressive response rates. Overall, the safety, efficacy, and durability of responses cannot be evaluated from single-arm, early phase studies. Other active agents such as Temozolomide have already met a reasonable burden-of-proof for patients such as this one. The off-label use of Abraxane without participation in a clinical trial cannot be recommended for this patient.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.