Relevant factors for policy concerning comprehensive genomic profiling in oncology: stakeholder perspectives.

Abstract

Background: Comprehensive genomic profiling (CGP) can identify targets beyond standard of care, potentially revolutionizing personalized cancer management. However, conducting well designed studies in this rapidly evolving field is complex and demands time and investments. Consequently, the total added value of CGP remains uncertain. Clinical benefit and costs often are driving factors in coverage decisions. Recently, five additional factors were identified in the literature that can influence the choice for targeted profiling vs. CGP, specifically: "feasibility", "test journey patient/physician", "wider implications of diagnostic results", "organization of laboratories", and "scientific spillover". The objective of the current study is to examine the role and importance assigned to these five additional factors for a comprehensive technology assessment by different stakeholders.

Methods: Purposive sampling was used to identify respondents from 4 stakeholder groups (i.e., medical specialists, molecular specialists, patient representatives, and policymakers) from different regions and hospital types (academic vs. non-academic) in the Netherlands. In semi-structured interviews, respondents scored the importance to decision-making of the five factors on a 0 (not important) to 5 (essential) scale. Reasoning behind the scores were elicited using open-ended follow-up questions. Transcripts were independently double-coded by two researchers using thematic analysis.

Results: Nineteen stakeholders (100% response rate; medical specialists (n = 7), molecular specialists (n = 7), patient representatives (n = 2), and policymakers (n = 3)) were interviewed. We observed differences between stakeholders in the relative importance assigned to the factors (range of median importance scores: 2-5). Overall, "wider implications of diagnostic results", primarily CGP's potential to identify additional treatment options, was deemed the most important factor alongside clinical benefit and costs in decision-making about CGP (median range: 3-5). While the "organization of laboratories" was considered less important (median range: 3-4), opposing arguments and preferences regarding the organization of laboratories were identified, with participants from academic centers preferring a centralized approach whilst non-academics preferred a decentralized approach.

Conclusions: Stakeholders deemed "wider implications of diagnostic results", "feasibility", and "test journey" the most important considerations for decision-making about targeted profiling vs. CGP alongside clinical benefit and costs. For policy decision-making, it is important to understand the arguments behind the heterogeneous opinions, often related to the setting they originate from.