CAR-TUTILIZATION BEFORE AND AFTER THE APPROVAL AS A SECOND-LINE THERAPY FOR DIFFUSE LARGE B-CELL LYMPHOMA PATIENTS: AN INTERRUPTED TIME SERIES ANALYSIS

Author(s)

Yinan Wang, PhD, MPP, Jieni Li, PhD, MPH, Rajender R. Aparasu, PhD, FAPhA.
University of Houston, Houston, TX, USA.
OBJECTIVES: The Food and Drug Administration (FDA) approved axicabtagene ciloleucel, a chimeric antigen receptor T-cell (CAR-T) therapy, for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) as a second-line therapy in April 2022. Before this approval, CAR-T therapy was restricted to third-line or later stages. This study investigated the impact of second-line approval on the utilization of CAR-T therapy in DLBCL.
METHODS: We used 2019-2024 Merative MarketScan Commercial and Medicare claims data to identify the utilization rates of CAR-T therapy and chemoimmunotherapy among DLBCL patients with continuous enrollment. We conducted single-group interrupted time series (ITS) analyses involving two medication use patterns. The first outcome was utilization of CAR-T, measured by quarterly utilization per 100,000 DLBCL patients. We used an autoregressive model with a lag of 2 to assess the impact on CAR-T use. The second outcome was the utilization of first-line chemoimmunotherapy, measured by quarterly utilization per 100,000 DLBCL patients. We used an ordinary least squares model to examine the impact of chemoimmunotherapy utilization because no autocorrelation was detected.
RESULTS: The study identified 12,122 patients with DLBC, 6.17% received CAR-T therapy, and 21.59% received first-line therapy. We found that observations were significantly correlated with those two quarters earlier (p=0.02). The ITS model with a lag of 2 revealed an immediate level increase in quarterly CAR-T use after the policy change (mean estimate 63.22, p<0.01). The post-intervention trend did not differ significantly from the pre-intervention trend (1.03, p=0.59). The regression model found no significant change in level (12.99, p=0.66) or trend (-2.16, p=0.62) in the use of chemoimmunotherapy.
CONCLUSIONS: Approval of CAR-T therapy as second-line therapy significantly increased the immediate level of CAR-T use but did not change the underlying trend of CAR-T use or the level or trend of first-line chemoimmunotherapy use.

Conference/Value in Health Info

2026-05, ISPOR 2026, Philadelphia, PA, USA

Value in Health, Volume 29, Issue S6

Code

HPR115

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling

Disease

SDC: Oncology

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