(146) Implementation of a Multigene Pharmacogenomic Testing Pilot within a GI Oncology Clinic

Poster Abstract: Background/Rationale: Pharmacogenomic (PGx) testing plays a crucial role in guiding appropriate chemotherapy selection, dosing, and monitoring for treatment-related toxicities. PGx testing leads to a reduction in costly hospitalizations/emergency department visits and enhances patient clinical outcomes and satisfaction. Despite its benefits, clinical implementation of multigene PGx testing is lacking due to patient/provider education gaps, testing reimbursement issues, and insufficient clinical expertise to interpret and apply the results. An implementation science approach could provide a structure in which institutions could identify and address barriers to implementation of PGx testing.

Objective: The objective of this study is to utilize Lean Methodology to develop a scalable pilot for multigene PGx testing at UNC Health Medical Center within the gastrointestinal (GI) oncology clinic.

Methods: We applied the DMADV method to begin implementation of multigene PGx testing in a single clinic. The phases are: Define, Measure, Analyze, Design and Verify.

Results: In the Define and Measure phases, we determined the necessity of implementing PGx testing and obtained support from external/internal stakeholders. We identified the GI oncology population as the target population based on a 100-patient simulation study to predict the number of drug-gene interactions we would observe. We determined project metrics that will be used to monitor success and prompt improvement of the proposed process. In the Analyze phase, we determined genes of interest and developed an assessment to compare and select reference laboratories based on nine factors. In response to reimbursement challenges, we worked with laboratory colleagues to pursue a flexible approach that allows for the use of two reference laboratories and two billing approaches to better assess feasibility at scale. In the Design phase, we developed a clinical workflow and education documents that will be used to train new and existing team members. We built clinical decision support within our EPIC EHR for all CPIC level A drug-gene interactions, with an emphasis on formatting consistency. To support the workflow, we have developed a PGx e-consult service that will provide additional clinical expertise if needed. Project implementation (Verify phase) is scheduled for March 2024.

Discussion/conclusion: Application of the Lean Methodology, specifically the DMADV method allowed for a structured approach to our implementation of multigene PGx testing. While each institution is different, we feel that dissemination of our approach could assist others and thereby expand utilization of PGx testing in oncology patients.

References (must also be included in final poster): 1. Kabbani D, Akika R, Wahid A, et al. Pharmacogenomics in practice: a review and implementation guide. Frontiers in Pharmacology. 14:1189976. doi:10.3389/fphar.2023.1189976
2. Making things better by advancing lean thinking and practice. Lean Enterprise Institute. Last accessed January 8, 2024. https://www.lean.org/