Retired Local Coverage Article Response to Comments

Response to Comments: MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease (DL37911)

A56403

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Article ID
A56403
Article Title
Response to Comments: MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease (DL37911)
Article Type
Response to Comments
Original Effective Date
05/13/2019
Retirement Date
10/27/2022
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Response To Comments

NumberCommentResponse
1

As described in the Draft LCD, Decipher Biopsy has been demonstrated, across multiple studies, to provide accurate predictions of critical clinical end points such as metastasis, prostate cancer specific mortality and high-grade disease.

Decipher Biopsy measures risk of disease progression, independent of clinical and pathologic-al risk factors using the gene expression profile of biopsy prostate cancer tissue samples. The Decipher Biopsy 22-biomarker expression signature reports a continuous risk score between O and 1, with higher risk scores indicating a greater probability of developing metastasis, prostate cancer mortality or high-grade disease.

Decipher Biopsy is used by physicians and patients to determine which patients with early prostate cancer are candidates for active surveillance or observation, who are more likely to have good outcome without needing to undergo surgery or receive radiation. We sincerely appreciate the opportunity to provide comments on the Draft LCD. We strongly believe with the positive body of evidence that Decipher Biopsy will significantly improve the health and well-being of Medicare beneficiaries diagnosed with prostate cancer.

Thank you for the comment. We attempt to ensure Medicare beneficiaries have access to reasonable and necessary services which can improve outcomes.

2

I have been a practicing urologist for over 20 years at Urology Associates, a 16 –physician practice that is a division of Minnesota Urology. I also served as chairman of the Department of Urology at Abbott Northwestern Hospital.

Decipher has been a tremendous help to me and my colleagues for making the most informed treatment decisions for our prostate cancer patients. We routinely use Decipher Biopsy to help identify which newly diagnosed prostate cancer patients qualify for active surveillance or active treatment for the most optima l outcome. The independent Decipher Biopsy risk scores based solely on a patient’s individualized genomics have been valuable as additional piece of critical information for our patients.

I have also used Decipher RP to make radiation treatment decisions for patients with adverse risk features after surgery. I am confident that GenomeDx develops and markets well-validated and clinically valuable genomic tests that help improve patient outcomes.

Thank you for the comment about Decipher RP (covered in a prior LCD) and Decipher testing more generally . We attempt to ensure Medicare beneficiaries have access to reasonable and necessary services which can improve outcomes.

3

Prostate Conditions Education Council (PCEC) is a non-profit organization comprised of a consortium of leading physicians, health educators, scientists and prostate cancer advocates. We are the nation’s leading resource for information on prostate health.

PCEC wants to increase awareness about prostate cancer biomarkers and make them accessible to all men. We want to thank Palmetto/MolDx for their recent coverage recommendation for Decipher Biopsy Prostate Cancer Classifier Assay for men with very low and low risk disease.

Active surveillance (AS) is currently offered for men with NCCN very low, low and favorable intermediate risk disease at diagnosis; however, it is not entirely clear which men can be safely monitored. Better risk stratification biomarkers are needed to inform physicians and patients choosing between AS and treatment. Patient access to biomarkers, such as Decipher Biopsy, will help determine which patients with early prostate cancer are candidates for AS, and are more likely to have a good outcome without needing to receive treatment.

PCEC appreciates the opportunity to comment on the proposed Local Coverage Determination for Decipher Biopsy.

Thank you for the comment. We attempt to ensure Medicare beneficiaries have access to reasonable and necessary services which can improve outcomes.

4

Comment about draft LCD on MolDx Decipher biopsy assay. I would extend indications to use Decipher with patients who have favorable pathology, intermediate grade cancer (Gleason 3+4), analogous to policy recently revised on Oncotype Dx. The use is similar helping to stratify cancer into that with low risk that can be safely followed with Active Surveillance or high risk that demands active treatment. The policy can be left intact with changes limited to 1. the name to include favorable histology, intermediate grade disease, 2. add to indications Favorable histology, intermediate risk cancer (Gleason 3+4) throughout the policy. This change is supported by literature and clinical practice and already reflects common use across the country.

Thank you for the comment. We attempt to ensure Medicare beneficiaries have access to reasonable and necessary services which can improve outcomes.

5

A CAC member for WPS spoke positively about this test; it banks an entire genome. The CAC member prefers this test for the genome results and the genome specific database, which will be very important in the future. Banked data allows for continued improvement for the research community and for practicing radiologists.

The input is appreciated.

6

A CAC member for WPS expressed that the test helps to confirm that patients are low enough risk for surveillance and prevents more costly and/or risky treatments.

The input is appreciated.

Associated Documents

Related Local Coverage Documents
LCDs
DL37911 - (MCD Archive Site)
L37911 - (MCD Archive Site)
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
10/27/2022 05/13/2019 - 10/27/2022 Retired You are here
03/20/2019 05/13/2019 - N/A Superseded View

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