Prosigna Coverage with BCBS FL

• February 15, 2017
• News

This morning BCBS FL published an updated policy for Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer.  Prosigna now has the same coverage criteria as Oncotype Dx.  Below is the coverage criteria.  The full policy can be found at www.bcbsfl.com, go under the provider tab, select tools and resources, select medical policies, select pathology and laboratory and lastly select Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer.

POSITION STATEMENT:

The use of the 21-gene reverse transcriptase-polymerase chain reaction (PT-PCR) assay (i.e., Oncotype DX™) to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy meets the definition of medical necessity in members with newly diagnosed (6 months or less) primary, invasive breast cancer meeting ALL of the following criteria:

• Unilateral tumor AND
• Node-negative (lymph nodes with micrometastases (< 2 mm in size) are considered node negative) OR with 1-3 involved ipsilateral axillary lymph nodes AND
• Hormone-receptor-positive (that is ER-positive or PR-positive) AND
• HER2-negative AND
• Tumor size > 0.5 cm AND
• Who will be treated with hormonal therapy AND
• Who are candidates for chemotherapy AND
• Who have had surgery and full pathological examination of the tumor completed AND
• The test result will determine if adjuvant chemotherapy will be used AND
• The test is ordered by the treating physician.

Use of EndoPredict™, the Breast Cancer Index^sm, and Prosigna™ to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy meets the definition of medical necessity in members with primary, invasive breast cancer that meet the above criteria for for Oncotype DX.

Other than its use related to newly diagnosed (6 months or less) breast cancer as outlined above, all other uses of the 21-gene reverse transcriptase-polymerase chain reaction (PT-PCR) assay (i.e., Oncotype DX), EndoPredict, the Breast Cancer Index, and Prosigna, including determination of recurrence risk in invasive breast cancer members with positive lymph nodes, members with bilateral disease, or to consider length of treatment with tamoxifen are considered experimental or investigational. There is a lack of clinical data in peer-reviewed literature to permit conclusions on safety, efficacy and net health outcomes.

Use of a subset of genes from the 21-gene RT-PCR assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ (i.e., Oncotype DX DCIS) to inform treatment planning following excisional surgery is considered experimental or investigational. The evidence is insufficient to permit conclusions on efficacy and net health outcomes.

All other gene expression assays (e.g., MammaPrint^®, Mammostrat^®, BreastOncPx^™, Insight^® DX Breast Cancer Profile, NexCourse^® Breast IHC4, PAM50 Breast Cancer Intrinsic Classifier^™, BreastPRS™, MapQuant Dx™, and BreastOncPx™.) are considered experimental or investigational, as there is insufficient clinical evidence to support the use of these tests to predict the baseline risk of breast cancer recurrence after surgery, radiation therapy or hormonal therapy. The evidence is insufficient to permit conclusions on efficacy and net health outcomes.

The following is considered experimental or investigational as the evidence is insufficient to permit conclusions on efficacy and net health outcomes:

• The use of gene expression assays to molecularly subclassify breast cancer (eg, BluePrint®)
• The use of gene expression assays for quantitative assessment of ER, PR and HER2 overexpression (eg, TargetPrint®).

BILLING/CODING INFORMATION:

CPT Coding: