Costs to healthcare payers associated with clinical trial (CT) participation in metastatic non-small cell lung cancer (NSCLC).

Abstract

3 Background: To assess the financial implications of therapeutic CT participation for healthcare payers, we compared first-line (1L) and second-line (2L) total direct medical costs between patients enrolled in 2L CT vs non-CT participants receiving 2L therapy for metastatic NSCLC. Methods: We linked electronic health records from a single academic center with tumor registry and claims data to identify patients with metastatic NSCLC diagnosed from 1/1/2007-12/31/2015. Eligibility criteria included 60 day minimum survival, receipt of ≥ 1 anti-cancer drug within 180 days of diagnosis, insurance enrollment for ≥ 12 months after diagnosis and receipt of ≥ 2 therapy lines. Patients on 1L trials were excluded. We calculated mean per-patient-per-month (PPPM) total direct medical costs from the payer perspective for 1L and 2L. We performed a difference-of-difference analysis to estimate the effect of trial enrollment on costs by calculating the mean PPPM difference between 2L and 1L in trial (Diff trial) and non-trial enrollees (Diff non-trial). Then we calculated the difference between Diff trial and Diff non-trial. We used paired and non-paired t-tests for statistical comparisons and report all costs in 2019 US dollars. Results: Of 63 patients, 22 (35%) enrolled in a 2L CT. CT enrollees were younger (mean age 63.5 vs 66.7 years), female (73% vs 41%), had commercial insurance (36% vs 32%), were never smokers (36% vs 32%), had EGFR mutations (27% vs 22%) and fewer had brain metastases (14% vs 29%). The mean PPPM total direct medical costs decreased between 2L and 1L for patients enrolled in 2L CTs but increased in non-trial participants (Diff trial = -$5,585, SD ± $6,541; Diff non-trial = $1,532, SD ± $14,739). The mean difference of difference (Diff trial - Diff non-trial) was -$7,117 (p = 0.01; Table). Conclusions: This small observational study suggests that CT enrollment results in substantial cost-savings to payers. If confirmed in larger studies, our findings suggest that insurers support trial participation for patients with NSCLC. [Table: see text]