What information is available?
Health Technology Assessment (HTA) by managed care payers and public payers is important for establishing coverage and reimbursement of diagnostics. Models for the development of technology assessment reports are varied by groups such as the Blue Cross Blue Shield Association, California Technology Assessment Forum (CTAF) and the government-sponsored Agency for Healthcare Research and Quality (AHRQ). These groups systematically review the published evidence and comment on various aspects of the development, validation and clinical utility of molecular classifiers. The groups vary in the criteria they cite in the reviews and the definitions of specific criteria, hence, there is a need in the payer community for a consistent format to present updated clinical and economic data for HTA agencies that is provided by the manufacturer. To satisfy that need, in this portion of the Oncotype DX®
website, key elements from the recently developed Genomic Health Oncotype DX Assay Genomic Dossier are provided. For this genomic dossier, all criteria that were mentioned by technology assessment groups and the evidence that has been published on the Oncotype DX assay that specifically address such questions are summarized. A complete dossier for managed care or CMS is available upon request from your Managed Care Account Executive.