Transparency Submission

Miller, Ann
amiller@myriad.com
5705617201_____
03/07/2024
Company: Myriad Genetics
Guideline: Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate
Panel: Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic Panel

Algorithm Page Number: CRIT-6
Specific Change Requested: 

We request that the following criteria be added to the Testing Criteria for Prostate Cancer to make them consistent with the prior testing criteria in the NCCN Prostate Cancer guideline v4.2023 (page PROS-C 2 of 3):

 

On page CRIT-6, under the second arrow (“By family history and ancestry”) please add:

  • >1 close relative with:
    • Colorectal or endometrial cancer at age <50y
  • >1 first-degree relative with:
    • Prostate cancer at age <60 y
  • A known family history of a familial cancer risk mutation (pathogenic/likely pathogenic variant).
FDA Clearance: not applicable
Rationale for Requested Change: Inconsistencies between NCCN guidelines create confusion among payors and clinicians alike and ultimately may lead to denial of insurance coverage and discrepancies in care for at-risk patients.
Citation of Literature
Schaeffer EM, Srinivas S, Adra N, et al. Prostate Cancer, Version 4.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023 Oct;21(10):1067-1096. doi: 10.6004/jnccn.2023.0050. PMID: 37856213.