LCD Reference Article Response To Comments Article

Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

A55876

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A55876

Article Title
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

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Response to Comments

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01/18/2018

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The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression Test Local Coverage Determination (LCD) began on 06/21/17 and ended on 08/06/17. The notice period will begin on 1/18/2018 and will end on 03/05/18. The LCD will become effective on 03/06/2018. The following comments were received from the provider community:

Response To Comments

Number	Comment	Response
1	From Johnathan M. Lancaster, MD, PhD; Chief Medical Officer, Myriad Genetic Laboratories “Myriad Genetic Laboratories, Inc. appreciates the opportunity to comment on Draft Local Coverage Determination (LCD) MolDX: EndoPredict Breast Cancer Gene Expression Test. We are writing to express our support for the content of the Draft LCD and to reiterate the importance of the proposed coverage for women with breast cancer. As described in the Draft LCD, determining which patients with ER+/Her2- breast cancer will have a low enough risk of distant recurrence after 5 years of endocrine therapy to forgo adjuvant chemotherapy is a priority for physicians who manage these patients. The Endopredict 12 gene molecular score is combined with clinicopathologic features (tumor size and lymph node status) to produce the EndoPredict (EPclin) score, which is reported as low- or high-risk and includes a personalized risk of 10- year distant recurrence (DR) based on each patient’s result. The prognostic ability of EndoPredict has been validated by prospectively designed-retrospective studies in three different cohorts from phase III trials involving more than 2,600 patients.1,2 These studies collectively demonstrate the ability of EndoPredict to predict the primary endpoint of DR in both early and late time periods, to accurately classify patients into a low or high risk group, and to identify a low risk group with excellent 10 year outcomes after treatment with 5 years of endocrine therapy only. Among patients in the validation studies: 73-78% of node-negative patients fell into the Endopredict ‘low-risk’ category with 10-year risk of distant recurrence of 5-5.9%, compared to 16-20% for the ‘high-risk’ patients. 19-30% of node-positive patients fell into the Endopredict ‘low-risk’ category with 10-year risk of distant recurrence of 5-5.2%, compared to 28-36.9% for the ‘high risk’ patients. In summary, Endopredict is a second-generation test for highly accurate assessment of 10-year risk ofdistant recurrence. Coverage of Endopredict for Medicare beneficiaries meeting the criteria outlined in the Draft LCD provides the opportunity for physicians to identify those patients with a low-risk EPClin score, for whom the absolute benefit of adjuvant chemotherapy is unlikely to outweigh the risks. References Filipits M, Rudas M, Jakesz R, et al. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors. Clin Cancer Res. 2011;17(18):6012– 6020. https://www.ncbi.nlm.nih.gov/pubmed/21807638 Buus R, Sestak I, Kronenwett R, et al. Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016 Jul 10;108(11). Print 2016 Nov. https://www.ncbi.nlm.nih.gov/pubmed/27400969”	Comment acknowledged.
2	From Jack Spicer, MD, Medical Director, Managed Care Medical Affairs, Genomic Health “On behalf of Genomic Health, Inc., we are pleased to submit comments in response to the Proposed/Draft Local Coverage Determination for the Endopredict® Breast Cancer Assay. Our comments are not directed at the decision to cover the Endopredict Breast Cancer Assay or the scope of coverage, but rather, are limited to addressing the accuracy of the comparison table shown at the beginning of the LCD. Requested Change: Remove the comparison table (first table in the LCD) and the statement on page 5 that “the observed change in treatment recommendations …after the use of Endopredict is therefore consistent with the expected clinical utility of similar established tests.” Rationale: The Endopredict Breast Cancer Assay should be assessed based on the analytical validation, clinical validation, and clinical utility data specifically generated for the Endopredict test in the targeted patient population. It is inappropriate to infer or assume clinical utility for Endopredict based on the performance of other tests with unique evidentiary portfolios. Specifically, inferring utility for Endopredict because of performance relative to Oncotype DX Recurrence Score based on one single study in post-menopausal patients is inappropriate. Importantly, the study upon which this comparison was made included women with more than three axillary nodes which is outside the intended use population of Oncotype DX. The focus on this single study fails to reflect that the Oncotype DX Recurrence Score is distinguished from Endopredict not only by its proven ability to predict chemotherapy benefit but also by the reporting of prospective outcomes from multiple datasets, including the Level IA evidence from the RS th edition of the AJCC is now exclusively utilizing the 21-gene RT-PCR assay to downstage patients with T1/T2, N0, M0, ER+, HER2-negative EBC as high as Prognostic Stage IIIA to Prognostic Stage IA if they have RS.”	The commenter is absolutely correct that inferring utility for one assay because of performance relative to another assay is inappropriate. The table has been removed.
3	From Alessandra Cesano, MD, PhD; Chief Medical Officer, NanoString Inc. “On behalf of the NanoString Inc., I respectfully ask to consider the following comments related to the recent Draft MolDX LCD: EndoPredict Breast Cancer Gene Expression Test. The published draft contains a misleading cross-trial comparison with the Prosigna Breast Cancer Gene Signature Assay and other minor inaccuracies. While we respectfully acknowledge the evidence evaluation performed by Palmetto, we assert that the presentation of the information in this manner may create confusion in the interpretation of comparative information between genomic tests for hormone receptor-positive early stage breast cancer for the following reasons: In the table comparing Myriad’s EndoPredict test with Prosigna, the comparative information is derived from different clinical trial cohorts (TransATAC for EndoPredict and ABCSG.8 for Prosigna). This is an inappropriate comparison due to the differences in clinical and pathological characteristics of the patients within each cohort which produces differing risk group distributions and group estimates of survival. The presentation of this information in the table creates an impression that the results are representative of those that would be observed if utilizing the tests on an identical set of patients. The table could be construed as encouraging the inappropriate comparison as it includes a comparison of two tests within the same cohort (EndoPredict and OncotypeDX) with Prosigna which was tested in a separate cohort. The risk score cutoff value to define the low risk group for reporting survival and percentage of patients for Prosigna in node-positive (1-3 positive nodes) patients in the table is not the same as the cutoff value utilized by the FDA-cleared product in the United States. The low risk cutoff value for node-positive patients in the United States is 40 ROR score units. The values in the table do not reflect the results that would be obtained in the United States on those same patients. We respectfully request removal of the information regarding Prosigna from the table in the Draft MolDX LCD: EndoPredict Breast Cancer Gene Expression Test based on the points stated above. If determined that it is necessary to include Prosigna in the table, we would like to respectfully request the following changes be made to the table in order to provide accurate information consistent with the FDA 510(k)-cleared package insert: Under the ‘Low Risk Scores’ heading, the value for ‘% of Node-pos pts with Low Risk Score’ should be changed to 41.4%. The draft LCD indicated a value 4.1% which is associated with the European product labeling (CE mark) Under the ‘DR in Pts with Low Risk Score’ heading, the value for ‘Node-pos, Low Risk Score- 10yr DR risk’ should be changed to 5.8% (2.8-11.9%). The draft LCD indicated a value of 0% (0-21.8%), which is associated with the European product labeling (CE mark). Under the ‘High/Non-Low Risk Scores’ heading, the value for ‘% of Node-neg pts with High/Non-Low Risk Score’ should be changed to 53.5%. The draft LCD separates this field into two separate fields for Prosigna (Int and High), which is inconsistent with the reporting convention for the other tests. Removal of the ‘Int and High’ values and replacement with a single value of 53.5% reflects a fair comparison between the tests. Under the ‘High/Non-Low Risk Scores’ heading, the value for ‘% of Node-pos pts with Non-Low Risk Score’ should be changed to 58.6%. The draft LCD separates this field into two separate fields for Prosigna (Int and High), which is inconsistent with the reporting convention for the other tests. Removal of the ‘Int and High’ values and replacement with a single value of 58.6% reflects a fair comparison between the tests and the appropriate risk cutoffs for US patients. Under the ‘DR in Pts with High/Non-Low Risk Score’ heading, the value for ‘Node-pos, Non-Low Risk Score- 10yr DR risk’ should be changed to 24.2% (18.6–31.1%). The draft LCD separates this field into two separate fields for Prosigna (Int and High), which is inconsistent with the reporting convention for the other tests. Removal of the ‘Int and High’ values and replacement with a single value of 24.2% (18.6–31.1%) reflects a fair comparison between the tests and the appropriate risk cutoffs for US patients. Under the ‘DR in Pts with High/Non-Low Risk Score’ heading, the value for ‘% of Patients in Intermediate Risk Group’ should be changed to 23.4%. The draft LCD indicated a value of 33.5% which is associated with the European product labeling (CE mark). In summary, we are primarily seeking removal of Prosigna from the table in the Draft MolDX LCD: EndoPredict Breast Cancer Gene Expression Test as it inappropriately compares results between trial populations with differing patient characteristics. Alternatively, at a minimum, we request an update to the Prosigna portion of the table to be consistent with the US product labeling cleared for marketing during FDA 510(k) review.	The table has been removed.

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Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

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