Barriers to implementing primary HER2 FISH testing.

Abstract

e16642 Background: Two HER2/neu testing protocols are recommended by guidelines—primary Fluorescence In Situ Hybridization (FISH) and primary Immunohistochemistry (IHC) with reflex to FISH. FISH testing is recognized as more accurate at 4% error rate versus IHC at 20% (Wolf et al, J Clin Oncol. 2007). Transition to primary FISH should improve quality (Sauter et al, J Clin Oncol. 2009) but is hampered by factors of familiarity, cost, and convenience (Ross et al, Oncologist. 2009). Our goal is to further characterize the barriers to adopting primary HER2 FISH testing. Methods: 49 multi-disciplinary interviews with clinicians (n=13), executives (n=11) from 5 insurers, lab management (n=8) and pathologists (n=17) on barriers impacting a move to primary HER2 FISH testing protocol. We analyzed the interviews using the framework approach of qualitative research. Results: We identified themes impacting a move to primary HER2 FISH testing. Many care organizations lack a consistent comprehensive process to evaluate impact of a new testing protocol (Table). There are conflicting views on the impacts of primary FISH implementation: IHC pathologists and lab managers perceived it will cause ineffective workflow, clinician dissatisfaction from increased turn-around time and negative financial impact. However, FISH pathologists and lab managers reported effective workflow, clinician satisfaction, and positive/neutral financial impact (Table). Clinicians in ‘IHC primary’ centers did not express concerns regarding primary FISH, and reported preference for adopting it (Table). Most payers are concerned with HER2 quality issues but lack mechanisms to address them (82%). Conclusions: Organizational factors impact implementation of HER2 primary FISH testing. The dichotomy between expected and actual impact suggests lack of consistent framework and information available for decision making. Future studies assessing actual impacts of adopting primary FISH, and other testing protocols, are needed to inform diagnostic protocol evaluation and decision making. Factors Pathologists and lab managers – IHC Pathologists and lab managers – FISH Clinicians in IHC centers Payers Lack of process to evaluate 75% 78% 85% 64% Negative workflow, clinical, financial impact 88% 0% 8% 27%