LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Breast Cancer Assay: Prosigna (L36811).

A55401

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Article ID
A55401
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Article Title
Response to Comments: MolDX: Breast Cancer Assay: Prosigna (L36811).
Article Type
Response to Comments
Original Effective Date
02/16/2017
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) MolDX: Breast Cancer Assay: Prosigna (L36811). Thank you for the comments.

Response To Comments

Number Comment Response
1 An oral presentation at WPS GHA’s open meeting provided a recap of their validation and decision impact studies by a representative of one of the tests. Commenter requested an expansion of the coverage criteria. Power-point presentation included as a comment. No new information was included to support expansion request.
2 Commenter stated that a head to head study in which Oncotype DX and Prosigna were performed on the same specimens found significant discordance and poor correlation between the two assays. Only the Oncotype DX assay has prospective outcomes in over 50, 000 patients (including the Level 1A evidence Tailorx study) showing excellent results when the assay is used prospectively to guide treatment decisions. Decision impact studies show that using Prosigna in clinical practice would cause more patients to be placed on unnecessary chemotherapy when compared to Oncotype. Prosigna has been validated only in postmenopausal patients as indicated by its 510k clearance. Most studies of the PAM50 signature used quantitative RT-PCR but the Prosigna assay uses the nCounter digital gene expression platform performed in local pathology labs. Prosigna’s ATAC validation study was run on RNA extracted by Genomic Health whereas in current practice this extraction is done by the local laboratory that may have different quality control standards. Comments noted.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36811 - MolDX: Breast Cancer Assay: Prosigna®
Related National Coverage Documents
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