Uveal Melanoma denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the DecisionDx-UM uveal melanoma gene expression profile assay for evaluation of the enrollee’s uveal melanoma. Findings: 2/3 of the physician reviewers found that DecisionDx assay is a study of 15-31 genes in an individual patient’s melanoma cells. DecisionDx has been used to classify the melanoma as either a high or low risk of metastasis. While DecisionDx remains controversial for use in cutaneous melanoma, it does appear to be useful in the analysis of uveal melanoma as noted by the American Joint Committee on Cancer (AJCC) and in clinical studies from colleagues. Specifically, a Class 1 category carries with it a less than 20% chance of metastasis, whereas Class 2 has a greater than 70% chance of metastasis.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for DecisionDx-UM genetic testing. There is solid scientific evidence in current medical literature that genetic testing of uveal melanoma tumor can stratify the tumors into high-risk and low-risk for systemic metastasis. Researchers found that gene expression profiling provides a highly accurate and biologically informative gold standard for molecular prognostication. The authors further note that molecular prognostic testing and enrollment of high-risk patients into clinical trials of targeted molecular therapy are rapidly becoming the standard of care in the management of uveal melanoma.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary:An enrollee has requested reimbursement for Decision DX UM melanoma assay for evaluation of the enrollee’s uveal melanoma (UM).Findings: Two physician reviewers found that Uveal melanomas arise from melanocytes in the uvea, as was the situation in this case. Uveal melanomas tend to present with visual symptoms and are diagnosed upon funduscopic evaluation. The literature reports that local treatment is effective in preventing local recurrence in over 95% of cases, but 50% treated with enucleation developed metastatic disease over a five year follow up period. Clinical factors associated with poor prognosis include large tumor size, involvement of the ciliary body, increased age, and extrascleral extension.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Sutent. This patient has a uveal melanoma classified as high risk based on a class 2 genetic profiling. His uveal melanoma involves the choroid. At this time, no standard adjuvant treatment options have been established for use in this clinical setting. However, new data suggests that Sutent may provide benefit in uveal melanoma. A multi-institutional study of 128 patients of which 54 received Sutent showed a significant improvement with a statistically significant overall survival. Given the published peer-reviewed medical literature to support the use of Sutent, the requested Sutent 25 mg daily for 12 month is likely to be more beneficial than any available standard therapy for treatment of this patient’s medical condition.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving uveal melanoma, then check the rights and deadlines that apply to your plan.