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Breast Cancer Recurrence Assay (Mammaprint®) Hs-197

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Breast Cancer Recurrence Assay (Mammaprint®) Hs-197 BREAST CANCER RECURRENCE ASSAY (MAMMAPRINT®) HS-197 Easy Choice Health Plan, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Inc. ‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc. WellCare Health Insurance of Illinois, Inc. WellCare Health Plans of New Jersey, Inc. WellCare Health Insurance of Arizona, Inc. WellCare of Florida, Inc. WellCare of Connecticut, Inc. WellCare of Georgia, Inc. WellCare of Kentucky, Inc. Breast Cancer Recurrence WellCare of Louisiana, Inc. Assay (MammaPrint®) WellCare of New York, Inc. (Medicaid Only) WellCare of South Carolina, Inc. Policy Number: HS-197 WellCare of Texas, Inc. WellCare Prescription Insurance, Inc. Original Effective Date: 12/1/2011 Windsor Health Plan Revised Date(s): 8/2/2012; 10/4/2012; Windsor Rx Medicare Prescription Drug Plan 5/2/2013; 4/3/2014; 4/2/2015 APPLICATION STATEMENT The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. BREAST CANCER RECURRENCE ASSAY (MAMMAPRINT®) HS-197 DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs. BACKGROUND In 2010, over 207,000 new cases of breast cancer among women in the United States while 39,840 died from the disease. With early detection, the 5-year survival rate for women with breast cancer is 98.6%; if the cancer spreads to the lymph nodes the 5-year survival drops to 83.8% and decreases drastically to 23.4% when the cancer metastasizes (NCI, 2011b). Due to the high rate of early detection prior to metastasis (93%), the overall 5-year survival rate is 89.1%; the number is 12% lower among black women.1 MammaPrint (Agendia, BV, Amsterdam, Holland; also referred to as the "Amsterdam signature"), in 2010 became the only FDA-approved test for stage 1 and 2 breast cancer patients of all ages and is a predictor of disease outcome, especially in early stage breast cancer. The test identifies patients with early metastasis risk which is likely within 5 years following surgery; MammaPrint provides practitioners with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests. (“FDA Expands Approval for MammaPrint Test,” 2010). A benefit of Mammaprint is the ability to influence the usage, or non-usage, of chemotherapy.2 The test measures the activity of 70 genes, providing information about the likelihood that cancer will recur. It measures each of these genes in a sample of a woman's breast-cancer tumor and then uses a specific formula to produce a score that determines if the patient is deemed low-risk or high-risk for metastasis. In clinical trials, 1 in 4 women found to be at high risk by Mammaprint had recurrence of their cancer within 5 years. However, there are questions regarding the accuracy of this test. The positive predictive values at 5 and 10 years were 23% and 29%, respectively, while the corresponding negative predictive values were 95% and 90%, respectively.2 Mammaprint was tested on 307 patients under the age of 61 years who underwent surgery for stage I or stage II breast cancer, and who have tumor size equal to or less than 5 cm, and lymph node-negative. The study found that Mammaprint more than doubled physicians' ability to predict breast cancer recurrence. Furthermore, a major clinical study is now underway to determine the tests efficacy in helping patients avoid needless chemotherapy; the European study will recruit 6,000 patients with early-stage breast cancer.2 Position and Policy Statements Centers for Medicare and Medicaid Services (CMS). Patients with high risk of relapse need to be identified and treated with a systematic adjuvant therapy. However, while adjuvant therapies, such as chemotherapy and hormonal therapy, can reduce the risk of distant metastases by approximately one-third, it is estimated that many patients receiving chemotherapy may have survived without it and also avoided often unpleasant side-effects. MammaPrint, in addition to other tests and clinical factors, helps to classify the tumors into high and low risk for recurrence. Chemotherapy itself has inherent risk of morbidity, particularly in patients with comorbid conditions. When physicians make treatment decisions that chemotherapy can be safely avoided and alternative therapy (hormonal manipulation, radiation therapy) used, there can be patient benefit.4 National Comprehensive Cancer Network (NCCN). The NCCN guidelines for systemic adjuvant treatment for invasive breast cancer discussed the availability and some of the clinical data behind the MammaPrint assay, but declined to include the assay in its clinical guidelines. In contrast, the Oncotype Dx 21-gene assay was included as an option for some patients to aid in estimating the likelihood of cancer recurrence and potential benefit from chemotherapy.4 Clinical Coverage Guideline page 2 Original Effective Date: 12/1/2011 - Revised: 8/2/2012, 10/4/2012, 5/2/2013, 4/3/2014, 4/2/2015 BREAST CANCER RECURRENCE ASSAY (MAMMAPRINT®) HS-197 Evaluation of Genomic Applications in Practice (EGAPP) Working Group. In January 2009, the EGAPP Working Group published a report on the ability of tumor gene expression profiling to improve the outcomes of patients with breast cancer. This report was based on an earlier systematic review of the literature. The MammaPrint assay was included in the review and the conclusions were as follows: 5 Analytical Validity: Some data were available for the MammaPrint assay, although estimates of analytical sensitivity and specificity could not be made. Overall, there was inadequate evidence of the analytical validity for the MammaPrint assay. Clinical Validity: Data were found to be adequate that characterized the association of MammaPrint with future metastases, but inadequate evidence was identified to assess the added value to standard risk stratification, and finally, the population to which the test applied could not be determined. Clinical Utility: No evidence was found with regards to the clinical utility of the MammaPrint assay. Overall, although use of the MammaPrint assay could plausibly improve patient outcomes, there was insufficient evidence to assess the balance of risks and harms. American Society of Clinical Oncology (ASCO). In 2007, ASCO published an update to the recommendations of the use of tumor markers in the treatment and management of breast cancer. The recommendation for the MammaPrint assay was that the precise clinical utility and appropriate application remain to be determined and are 6 under investigation. POSITION STATEMENT Applicable To: Medicaid Medicare Use of the Breast Cancer Recurrent Assay (MammaPrint™) is considered medically necessary when the criteria below are met. Claims for MammaPrint are subject to medical necessity review by a WellCare medical director and is reviewed on a case-by-case basis. Medical necessity criteria may include: 1. Characteristics of the Disease Tumor size <5.0 cm Lymph node negative Stage 1 and Stage 2 invasive breast cancer ER+ or ER­ Tamoxifen independent Nodal micrometastases (< 2.0 mm) No more than three positive lymph nodes 2. Medical Necessity of the Test. Medical tests are covered only when ordered by the treating physician, when necessary for diagnosis or treatment decisions, and when used in patient care. Documentation on file with the treating physician should indicate that results of the MammaPrint test are expected to play a significant role (along with other clinical findings) in the prognosis of the patient. For example, a patient with a large, high grade stage 3 invasive carcinoma who in agreement with the oncologist and patient, has decided to have adjuvant chemotherapy regardless of the results of the test would not be an appropriate candidate for this test. 3. Timeliness of the Test. MammaPrint is FDA approved for assisting in the prognosis of patients with breast cancer of non-metastatic or stage 1 and 2 invasive breast carcinoma. In addition, more recent clinical data supports its use for micrometastases and for 1-3 positive lymph nodes. Usual chemotherapies have been studied for effectiveness based on initiation within 3 months of diagnosis. MammaPrint test is not Clinical Coverage Guideline page 3 Original Effective Date: 12/1/2011 - Revised: 8/2/2012, 10/4/2012, 5/2/2013, 4/3/2014, 4/2/2015 BREAST CANCER RECURRENCE ASSAY (MAMMAPRINT®) HS-197 considered reasonable and necessary for care when more than six months have elapsed since diagnosis, or if chemotherapy has been initiated, since the value of the test for highly delayed chemotherapy is not established. NOTE: Applies to claims payable by Medicare Part B. CLINICAL EVIDENCE In a study by Deck, Sinha, Kerlin, Barone, Rivera, Garcia, & et al., MammaPrint was measured in a prospective U.S. breast cancer patient cohort to determine how it compares to treatment advice according to National Comprehensive Cancer Network (NCCN) consensus guidelines.7 MammaPrint results were evaluated in fresh tumor samples from 111 breast cancer patients (median age 62) in 7 U.S.
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