LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Breast Cancer Index® (BCI) Gene Expression Test

A58670

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A58670
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Article Title
Response to Comments: MolDX: Breast Cancer Index® (BCI) Gene Expression Test
Article Type
Response to Comments
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05/10/2021
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The comment period for the: MolDX: Breast Cancer Index® (BCI) Gene Expression Test DL37824 Local Coverage Determination (LCD) began on 05/28/2020 and ended on 07/12/2020. The notice period for L37824 begins on 3/25/21 and will become effective on 5/10/21. The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

The following comment was submitted to Noridian:

I am writing in support of the draft update to the Medicare policy for Breast Cancer Index (BCI). As a medical oncologist who has focused my career on the advancement of care for Breast Cancer patients, my professional opinion is that the proposed coverage is aligned with the published evidence and clinical utility of the assay in the management of patients with hormone receptor positive, early stage breast cancer who have been prescribed adjuvant systemic hormonal therapy.

Extending endocrine therapy beyond the standard 5 years has been an approach long considered to help address the long horizon of recurrence and metastatic relapse that is inherent to HR+ breast cancer. A number of trials have explored extended endocrine therapy, often comparing the standard 5 years of therapy to 10 years. These trials have consistently shown modest recurrence prevention benefit from extending therapy, with the expected tradeoff of side effects from longer duration anti-estrogen blockade. Selecting patients based on higher perceived risk of recurrence as judged by clinicopathologic features such as number of positive nodes or tumor size has been a common approach but this approach unfortunately misses tailoring therapy to those who would respond to additional therapy versus just those at potentially higher risk.

The Breast Cancer Index is distinct as an assay in providing both prognostic information for overall and late recurrence risk as well as prediction of extended endocrine therapy benefit. In particular this predictive ability for extended endocrine therapy benefit is unique and has been extensively studies in a number of validation trials. With regards to clinical utility in N1 patients, BCI has demonstrated consistent predictive ability in both the MA.17, which a significant number of node positive patients, as well as the trans-aTTom, which was a study looking exclusively at patients with node-positive disease. Across both studies, the BCI predictive component has shown remarkably consistent performance, demonstrating that it could stratify patients into those who would have significant and clinically meaningful benefit from longer duration endocrine therapy and those who, despite their node-positive status could expect no significant benefit from longer therapy (but would still be exposed to the side effects if treated). The strength and consistency of the evidence supporting BCI are why I am writing in with my support for the proposed update the CMS Medicare policy covering BCI.

Thank you for your support of the policy.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
03/16/2021 05/10/2021 - N/A Currently in Effect You are here

Keywords

  • BCI
  • Breast Cancer Index
  • Breast Cancer Index Gene Expression Test