Deconstructing implementation of reflex biomarker testing in non–small cell lung cancer (NSCLC): Diverse strategies to overcome barriers.

Abstract

e13542 Background: Comprehensive tumor biomarker testing (CBT) is critical and time sensitive for newly diagnosed advanced NSCLC and increasingly for earlier stages. To avoid delays and variability in ordering at the point of oncology visit, reflex CBT (requested by pathology at diagnosis) is recommended (Gosney ESMO Open 2023). However, implementation is challenging due to delays in staging and uncertainty in reimbursement policy, such as CMS 14-day rule and pathologist ordering authority. Literature on reflex CBT mostly describes practices of single large academic institutions. To inform a broad range of institutions, we examined reflex CBT practices and strategies to address challenges across diverse settings. Methods: We interviewed 6 diverse centers (Table) that implemented reflex CBT and achieved ≥80% of reflex CBT for advanced stage patients with results returned ≤ 21 days of diagnosis. Results: Four centers use a 2-step CBT order process with diagnosing pathologists initiating the process and a centralized function placing the order (Table). Two centers use 1-step ordering by diagnosing pathologist or centralized oncology function. To authorize orders, centers proactively identify a treating physician, or use stand-in oncologist or physician ordering biopsy. Three centers test all stages due to economy of scale, expanding indications and patient assistance programs if tested externally. Others use proxy staging based on initial imaging and clinical data. Inpatient orders are delayed at 3 centers due to 14-day rule. Conclusions: Our findings enable reflex CBT implementation in diverse settings by flexibly mixing and matching practices to tailor to institutional operational contexts. Barriers are addressable and should not impede adoption. CENTER CHARACTERISTICS C1 C2 C3 C4 C5 C6 # cases a year ≥500 100 300 250 500 ≥500 # hospitals served 7 1 3 1 3 1 Academic No Yes No No Yes No Where CBT done Send out Send out Send out Send out Inhouse Inhouse CBT ORDER PROCESS Who initiates order process Diagnosing pathologist Diagnosing pathologist Diagnosing pathologist No initiation step No initiation step Diagnosing pathologist Who places order Central function in oncology Central function in oncology Central function in pathology Central function in oncology Diagnosing pathologist Central function in oncology Physician on order Treating or stand-in physician Treating physician Treating physician Treating physician Physician on biopsy Stand-in physician NSCLC stages tested All All Proxy stage III, IV Proxy stage IB, II resectable, III, IV All Proxy stage III, IV Who determines proxy stage N/A N/A Diagnosing pathologist Central function N/A Central function Does 14-day rule Impact inpatient CBT No, ordered same as outpatient Ordered for stage III, IV, others delayed No, ordered same as outpatient Orders delayed No, ordered same as outpatient Orders delayed C1-6, Center 1-6.