Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 59-year-old female with metastatic ocular melanoma diagnosed January 2004.  She is status post right enucleation and guided biopsy in February 2006.  It appears the patient has explored available treatment options, and wishes to proceed with Abraxane chemotherapy. The Health Plan has denied authorization and coverage for this chemotherapy on the basis that it is experimental/investigational for the treatment of metastatic ocular melanoma. The data in support of Abraxane are limited and of questionable applicability to this patient.  The abstract submitted had only 13 chemo-naive patients, only 11 evaluable, and only 8 with visceral involvement.  The two partial responses cited in the abstract have no information as to confirmation with follow-up scans or validation by an independent reviewer.  Furthermore, there are data supporting paclitaxel in the treatment of melanoma suggesting it has some slight activity, although also in unselected patients.  This data is also of questionable applicability to this patient with ocular melanoma primary.  Breast cancer studies suggest an advantage with Abraxane over paclitaxel in terms of a higher response rate in minimally treated, advanced breast cancer.  However, there is simply not enough data to extrapolate the results from the breast cancer studies to this clinical situation.  Therefore, I have determined that the requested 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 with a primary ocular melanoma who now has widely metastatic (Stage IV) disease.  The oncologist at a tertiary referral center requested authorization for the administration of Abraxane. The Health Plan has denied authorization for the chemotherapy citing the investigational nature of Abraxane in this clinical context.Abraxane is a new generation paclitaxel that has shown some promising results in a multi-institutional Phase II trial in comparison to the historical data for this poor-prognosis disease.  The standard, FDA approved therapy is admittedly either highly toxic with a low, although potentially durable, response rate with IL-2 based regimens, or other chemotherapy regimens that have equally low response rates without a sustained response (DTIC, temozolomide).  The patients oncologist makes valid points regarding the unknown characteristics of this unusual form of primary melanoma (ocular) and the historically disappointing results of standard treatment approaches.  However, single arm Phase II trials in difficult-to-treat oncologic problems do not often stand up to the closer scrutiny of Phase III studies designed to test standard versus these investigational agents.  There is no convincing data in the peer-reviewed literature or recommendations in the consensus treatment algorithms (NCCN guidelines) that would argue there is a benefit to Abraxane over standard first and second line systemic therapies for metastatic melanoma of any origin, outside of the clinical trial setting.  Having fully considered the available data, I have determined that the requested 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 3: The patient is a 59-year-old female who has recurrent ocular melanoma with liver, bone and subcutaneous metastases. She has not had either of the two FDA approved therapies for metastatic melanoma.  The patient has requested authorization for treatment with Abraxane.   The Health Plan denied authorization and coverage for this chemotherapy on the basis that it has not been shown to be efficacious in the treatment of recurrent ocular melanoma.To date, there are no studies of Abraxane for the treatment of ocular melanoma and only Phase II, uncontrolled clinical studies that pertain to use of Abraxane in metastatic melanoma.  This chemotherapy is still experimental and the use of Abraxane outside of proper clinical trials cannot be recommended. Accordingly, I have determined that the requested 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.