Perceived Barriers to NGS-Based Molecular Profiling Among US Metastatic Breast Cancer Patients.

Background/Objectives: Next-generation sequencing (NGS)-based molecular profiling has revolutionized personalized medicine and unlocked new treatment options for cancer patients. Clinical guideline bodies agree that patients diagnosed with HR+/HER2- metastatic breast cancer (mBC) may benefit from comprehensive somatic genomic profiling to identify candidates for established targeted therapies and clinical trials, yet many patients are not receiving it due to a lack of widespread access to NGS. Methods: To better understand the perceived barriers (if any) to NGS tests in mBC, a study was conducted across multiple stakeholders including medical oncologists, nurses, physician assistants, lab directors, pathologists, payers, and patients. Results: This study revealed that despite the awareness and recognition of the value proposition of NGS-based molecular profiling in mBC, inconsistent payer coverage, high out of pocket costs for patients, and challenges in managing reimbursement and prior authorization processes can lead to suboptimal utilization of NGS, which can subsequently lead to suboptimal treatment decisions where approved therapies exist. Interestingly, many payers (33%) were not aware of the current somatic biomarker testing recommendations from NCCN guidelines. As a result, payers identified the lack of clear clinical guidelines (74% ranked as top 3), the lack of internal consensus on which NGS tests to cover (45%), and the absence of internal expertise on NGS (39%) as the primary hurdles for broader NGS access. Conclusions: The results suggest that widespread HCP and payer education on clinical guidelines (e.g., NCCN) and utility for targeted therapy selection is crucial for enhanced adoption of NGS-based molecular profiling in mBC.