Cost implications of clinical trial (CT) participation in metastatic non-small cell lung cancer (NSCLC).

Abstract

7084 Background: To assess the value of CTs in advanced NSCLC from the payer perspective, we compared insurance-related total direct medical costs for NSCLC patients who enrolled in CTs vs. those who did not. Methods: After linking electronic health records with tumor registry and claims data, we identified 101 patients with metastatic NSCLC diagnosed between 1/1/2007 and 12/31/2015 and treated at the Seattle Cancer Care Alliance. Eligibility criteria included 60-day minimum survival, claims for ≥ 1 anti-cancer drug within 180 days of diagnosis and insurance enrollment for the first 12 months after diagnosis. We abstracted patient sociodemographic, disease and treatment data, and obtained death dates from the Washington State Cancer Registry, censoring patients alive on 3/7/2019.We used the Kaplan-Meier sample-average (KMSA) estimator with bootstrapped 95% confidence intervals to describe direct medical costs and compared costs in CT enrollees vs. non-enrollees by applying a generalized linear model (Gamma distribution, log link) adjusted for confounding covariates. Results: Of 101 patients, 39 (39%) enrolled in CTs. Compared with non-enrollees, CT enrollees were younger (mean age 61.6 vs. 66.5 years), female (67% vs. 47%), Asian (18% vs. 11%), never smokers (41% vs.32%), had commercial insurance (44% vs. 35%), resided in metropolitan areas (90% vs. 79%) and had a higher median income ($81,149 vs. $76,844). Table shows KMSA estimates of total direct medical costs and adjusted mean lifetime total direct medical costs by CT participation. After adjusting for sex, smoking status, residence, income, insurance payer, ECOG and mutation status, CT enrollment was associated with an increase in lifetime total direct medical costs compared with no enrollment (adjusted cost ratio=1.39; 95% CI: 1.01, 1.90; p=0.043). Conclusions: CT participation is associated with increased total direct medical costs in patients with metastatic NSCLC. Our results may inform partnerships between trial sponsors, oncology centers and payers to sustain treatment innovation through CTs. [Table: see text]