LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Prolaris Prostate Cancer Genomic Assay, L36340

A54589

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A54589
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Article Title
Response to Comments: MolDX: Prolaris Prostate Cancer Genomic Assay, L36340
Article Type
Response to Comments
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10/15/2015
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Noridian’s Response to Provider Recommendations (for comment period ending 03/30/2015):

Response To Comments

Number Comment Response
1 Expand coverage to subset of intermediate risk patients defined as those with Gleason 3+4 disease and <50% of biopsy cores positive for cancer, and no more than one NCCN intermediate risk determinant. Preliminary published data does not include this group of patients and no nationally recognized professional organization includes this group of patients in their AS recommendations. When published data support inclusion of this group of patients and national guidelines recommend AS in their guidelines, the policy can be amended.
2 Expand coverage to all intermediate and high-risk patients. The cornerstone of the literature validating the Prolaris assay is from UK men, diagnosed with prostate cancer (at varied PSA and clinical stages) and managed conservatively. The frequency or method of follow up is unknown. And, in these patients, the 10-year mortality for prostate cancer for even the lowest CCP numbers was close to 20% (Cuzik 2011). In multiple other studies, the Prolaris assay provides additional prognostic information beyond clinicopathological characteristics, but no author suggests that the test can replace these factors especially since all reported outcomes were analyzed retrospectively. Some comments extrapolate that the Prolaris assay can override the clinicopathologic stage in patients with intermediate and high-risk disease category. This is in direct conflict with the NCCN 2015 v1 guidelines, which state, “Active surveillance of intermediate and high-risk clinically localized cancers is not recommended in patients with a life expectancy > 10 years.” (NCCN Prostate 2015.1). The NCCN suggests, “Men with clinically localized disease could consider use of a tumor-based molecular assay to stratify better risk of adverse pathology AT RADICAL PROSTATECTOMY or chance of biochemical recurrence or disease-specific mortality after radical prostatectomy.“ (NCCN Prostate 2015.1 Pros-1; Capitalization added). Regarding the Prolaris assay, NCCN comments that “clinical utility awaits evaluation by prospective, randomized clinical trials, which are unlikely to be done. The marketplace and comparative effective research may be the only means . . .to gain proper place for better risk stratification for men with clinically localized prostate cancer.” Based the literature, subject matter experts and NCCN, the MolDX Contractor believes that outside of a well designed prospective clinical trial, extension of testing to intermediate and high grade patients would likely increase morbidity and mortality and strongly recommends a prospective “comparative effectiveness” trial before wholesale expansion into these groups.
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Keywords

  • prolaris
  • genomic
  • assay
  • myriad
  • MolDX
  • malignant
  • neoplasm
  • prostate