Integrated Radiology, Pathology, and Pharmacy Program to Accelerate Access to Osimertinib

Abstract

Purpose: Targeted therapy yields superior outcomes relative to genotype-agnostic therapy for patients with epidermal growth factor receptor (EGFR)-mutant lung cancer. Workflows that facilitate timely detection of EGFR mutations and early dispensation of osimertinib can improve management of this disease.

Methods: We developed an Integrated Radiology, Pathology, and Pharmacy Program to minimize delays in initiating osimertinib. The intervention consisted of parallel workflows coupling interventional radiology, surgical pathology, and analysis of nucleic acids from frozen tissue with early pharmacy engagement. We compared time to EGFR testing results and time to treatment for participating patients with those of historical cohorts.

Results: Between January 2020 and December 2021, 222 patients participated in the intervention. The median turnaround time from biopsy to EGFR results was 1 workday. Forty-nine (22%) tumors harbored EGFR exon 19 deletions or EGFR L858R. Thirty-one (63%) patients were prescribed osimertinib via the intervention. The median interval between osimertinib prescription and osimertinib dispensation was 3 days; dispensation occurred within 48 hours for 42% of patients. The median interval between biopsy and osimertinib dispensation was 5 days. Three patients received osimertinib within 24 hours of EGFR results. Compared with patients with EGFR-mutant non-small-cell lung cancer who were diagnosed through routine workflows, the intervention led to a significant reduction in median time between biopsy and EGFR results (1 v 7 days; P < .01) and median time to treatment initiation (5 v 23 days; P < .01).

Conclusion: Combining radiology and pathology workflows with early parallel pharmacy engagement leads to a significant reduction in time to initiating osimertinib. Multidisciplinary integration programs are essential to maximize clinical utility of rapid testing.

FIG 1.

Integrated Radiology, Pathology, and Pharmacy Program. (A) Simplified workflow depicting the two parallel workflow components. (B) Detailed process map of the different tasks. Briefly, the program optimizes total turnaround time using interdisciplinary alignment. The top workflow optimized turnaround time by coordinating interventional radiology, fine-needle aspiration-based tumor confirmation, and obtaining frozen tumor sections for subsequent rapid molecular diagnostics. Simultaneously, the bottom workflow is composed of a specialty pharmacy benefits review and a test claim process that ensures–should an actionable mutation be identified–streamlined benefits review and alignment with cost coverage programs, and dispense tracking. (C) Density plot of cases processed through the integrated pharmacy workflow (sorted by EGFR mutation status); note the decrease in volumes during the peak of the COVID-19 pandemic in early 2020 (laboratory volume for reference). auth, authorization; Dx, diagnosis; EGFR, epidermal growth factor receptor; FNA, fine-needle aspiration; MDx, molecular diagnostics; min, minimal; MUT, mutation; Neg., negative; NGS, next-generation sequencing; NSCLC, non–small-cell lung cancer; PAP, patient assistance program; PHSP, Partners Health specialty pharmacy; Pos., positive; pt, patient; S/O, sign-out; SpP, specialty pharmacy; WT, wildtype.

FIG 2.

Patient disposition and drug cost coverage analysis by payor factors. (A) The composition of the study cohort according to EGFR mutation status and histology, as well as osimertinib dispensation rate among patients with canonical EGFR mutations. (B) The pie chart summarizes factors contributing to failure to prescribe osimertinib. (C) Overview of the n = 31 patients with canonical EGFR mutation who received osimertinib through the workflow as sorted by time to dispense osimertinib; 0 = same day dispensation. The heatmap illustrates other relevant factors including prior authorization requirements (approval rate ∼97%), payor type, necessity of financial assistance, and dispensing pharmacy. Time to dispense did not differ by payor types, and financial assistance was associated with longer time to dispensation. del, deletion; EGFR, epidermal growth factor receptor; ext, externally; rad/onc, referred for radiation.

FIG 3.

Clinical utility of the Integrated Radiology, Pathology, and Pharmacy Program. (A) Event curves depict rapid EGFR test reporting times alongside historic comparators (eg, Dagogo-Jack et al). (B) Event curves show tyrosine kinase inhibitor initiation times relative to the diagnosis for patients in the integrated pharmacy program, the previously reported rapid program, and historical cohorts (see the study by Dagogo-Jack et al). All P values are obtained using the log-rank test. (C) Next-day initiation of osimertinib. The figure demonstrates one of the patients where EGFR results were available within 24 hours of biopsy and osimertinib was initiated within 24 hours of EGFR results. Serial imaging demonstrates significant response to osimertinib 48 days after commencing osimertinib. EGFR, epidermal growth factor receptor; FNA, fine-needle aspirate; mut, mutation; NA, not applicable; Pat., patient; TKI, tyrosine kinase inhibitor.