Frameworks for improving comprehensive biomarker testing in NSCLC: A multi-stakeholder consensus.

Abstract

e23121 Background: Despite the availability of numerous targeted therapies for NSCLC, significant barriers persist in ensuring timely comprehensive biomarker testing, leading to suboptimal patient outcomes and inequitable care. To better understand system-level barriers and develop actionable solutions, multidisciplinary experts from four stakeholder perspectives were convened in a structured two-day workshop in the United States: clinicians (oncology, pathology, surgery), laboratory diagnostics, payers, and manufacturers. Methods: A validated, stepwise consensus process with 30 experts was conducted to qualitatively and quantitatively identify barriers and solutions across the NSCLC patient journey. World Café-style small group discussions were used, with participants rotating across thematic care-stage tables (diagnosis through survivorship). Synthesized results were prioritized via iterative digital voting based on impact, relevance, and feasibility. Prioritized solutions were consolidated into idea profiles and translated through a standardized concept development process into pilot-ready concepts. Results: Key barriers to comprehensive biomarker testing in NSCLC included delayed or inconsistent NGS testing and result reporting, tissue inadequacy, non-standardized biomarker reporting, payer coverage and authorization barriers, and fragmented multispecialty care coordination. A total of 26 solutions were generated and consolidated into 8 idea profiles. Expert voting prioritized 3 of these profiles (Table 1), which informed development of 2 minimum viable products (MVPs) addressing upstream and downstream gaps in comprehensive biomarker testing and treatment initiation. MVP 1 focuses on accelerating availability of biomarker results through automated, concurrent reflex NGS testing using tissue and plasma (ctDNA) at diagnosis, supported by standardized pathology workflows. MVP 2 addresses downstream delays by integrating molecular results with therapy authorization and payer approval within a single digital workflow, reducing administrative friction and enabling timely guideline-based treatment decisions. Conclusions: This structured, multi-stakeholder consensus process identified key cross-system barriers to timely and comprehensive biomarker testing in NSCLC and generated feasible, high-impact solutions, including automated reflex testing and integrated access workflows. These findings highlight actionable opportunities to improve delivery of the right therapy to the right patient at the right time, with potential applicability beyond NSCLC. Selected Top 3 Idea Profiles Mean Rank Votes (clinician / payer / lab / manufacturer)* Reflex Biomarker Testing Pathway 1.7 2.2; 2.3; 1.0; 1.2 PA Fast-Track & Coverage Clarity 3.1 4.0; 1.7; 2.5; 4.2 Value-Based Testing & Therapy Bundle 3.9 5.1; 3.0; 4.5; 3.0 *Scale 1 (highest) – 8 (lowest).