Abstract
Introduction: CAR T cell therapies are a pivotal advancement in the treatment of R/R LBCL that offer the potential for long-lasting deep remissions. However, real-world access to CAR T cell therapy remains fragmented, with systemic and logistical barriers limiting equitable access for eligible patients. This retrospective cohort study used US-based real-world claims data to assess CAR T cell therapy referral patterns and characteristics of patients with R/R LBCL in the US stratified by referral status.
Methods: Data from the Komodo Health® claims database from October 2016 to May 2025 were used to identify patients in the US with ≥2 diagnoses of LBCL recorded ≥30 days apart. Eligible patients had continuous claims enrollment, initiated ≥2 lines of LBCL therapy after initial diagnosis, and had no evidence of prior LBCL-approved treatment before first recorded diagnosis. Patients with ≥1 line of therapy (LOT) between January 2021 and May 2025 were included. Referral rates were evaluated among patients who received treatment at non-CAR T sites (ie, centers that do not administer any approved CAR T cell therapy for LBCL) at any point during their treatment journey, and rates were assessed in aggregate and stratified by individual LOT from second (2L) to fifth line (5L) depending on data availability. CAR T cell therapy treatment rates were analyzed for all referred patients, both overall and by LOT, and for patients who continually received care at CAR T sites across LOTs. Baseline patient characteristics were evaluated for eligible patients and compared between referred versus nonreferred and CAR T cell therapy–treated versus non-CAR T cell therapy–treated patients. Statistical significance of differences was assessed by Pearson's chi-square test, with a significance threshold of P<0.05.
Results: Of 8959 patients with R/R LBCL meeting eligibility criteria, 3068 (34%) began and remained at a CAR T site throughout their treatment journey, and 5891 (66%) received care at a non-CAR T site for ≥1 LOT. Of the 5891 who received care at a non-CAR T site, 1797 (31%) were referred to CAR T sites during the study period.
Overall, 1382 of 8959 (15%) patients received CAR T cell therapy at a CAR T site, including 689 patients who originated from CAR T sites (ie, 22% of the 3068) and 693 patients referred to CAR T sites during the treatment journey. By LOT, referral rates increased from 19% at 2L to 25% at third line (3L) and declined to 23% at fourth line (4L) and 13% at 5L. CAR T cell therapy treatment rates followed a similar pattern (6% at 2L, 12% at 3L, 11% at 4L, 4% at 5L).
Among the 5891 patients who received ≥1 treatment at a non-CAR T site, significant differences in age, sex, race/ethnicity, geographic region, insurance type, and distance to the nearest CAR T site were observed between referred and nonreferred patients. Mean ±SD age was 61.5±13.8 years for referred patients and 67.3±15.4 years for nonreferred patients, and the proportions of male patients were 63% and 59%, respectively. The proportions of patients composing racial and ethnic groups for referred versus nonreferred patients, respectively, were as follows: Asian or Pacific Islander (6% vs 5%), Black or African American (8% vs 8%), Hispanic or Latino (15% vs 13%), and White (66% vs 71%). Regional distribution was 19% versus 17% in the Northeast, 24% versus 22% in the West, and 34% versus 39% in the South. Insurance coverage varied by referral status, with a greater proportion of referred patients having commercial insurance (44% vs 27%) and fewer being covered by Medicare (44% vs 63%). Referred patients lived closer to CAR T sites, with a median (range) distance of 17 (0–1514) miles versus 24 (0–1430) miles for nonreferred patients. Within the referred population, no statistically significant differences in baseline demographic characteristics were observed between those treated with CAR T cell therapy and those who were not.
Conclusions: This analysis of comprehensive claims data shows that, although CAR T cell therapy offers curative potential as a new standard of care for 2L or later treatment of LBCL, approximately 80% of patients do not receive CAR T cell therapy due to significant barriers, particularly limited referral. These findings underscore the need to improve equitable access by expanding CAR T site availability and strengthening referral pathways from non-CAR T sites to ensure broader reach of innovative treatments across LBCL patient populations
