Perceived barriers to NGS-based molecular profiling in metastatic breast cancer.

35 Background: Next generation sequencing (NGS)-based molecular profiling has revolutionized personalized medicine and unlocked new treatment options for patients with cancer. Clinical guideline bodies agree that patients diagnosed with HR+/HER2- metastatic breast cancer (mBC) may benefit from comprehensive genomic profiling to identify candidates for targeted therapies, yet many patients are not receiving it due to a lack of widespread access to NGS. Methods: To better understand the perceived barriers to NGS in mBC, a study was conducted across multiple stakeholders including medical oncologists, nurses, physician assistants, lab directors, pathologists, payers, and patients. We conducted five individual online quantitative surveys with United States-based medical oncologists (n = 109), nurses and physician assistants (n = 50), pathologists and lab directors (n = 40), payers (n = 31), as well as patients diagnosed with mBC (n = 137). Results: Despite a strong rationale, HCPs report testing 70% of their eligible patients today, leaving 30% of eligible patients without comprehensive NGS panel results after metastatic diagnosis that could be used to guide targeted therapy selection and improve patient outcomes. While all stakeholders claim to have awareness of testing guidelines, 25% of medical oncologists and 33% of payers are unaware of NCCN guidelines recommending patients diagnosed with metastatic breast cancer receive NGS testing upon metastatic diagnosis. The 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 can lead to suboptimal utilization of NGS. Interestingly, payers’ unawareness on updated clinical guidelines, the lack of understanding of targeted therapy related molecular biomarker testing, and internal expertise on NGS have appeared as the primary hurdles for broader NGS access. Conclusions: The results suggest that widespread education on clinical guidelines and utility for targeted therapy selection is crucial for enhanced adoption of NGS-based molecular profiling, as well as future biomarker regimen, in mBC. Enhanced educational efforts across stakeholders in support of guideline concordant NGS testing will allow patients to more fully realize the benefits of personalized medicine.