Presentation (CTI)

OBJECTIVES: Objectives: Gene and cellular therapies have expanded in U.S. practice, yet adoption varies by therapy class, disease, and payer, with implications for coverage, care pathways, and center capacity. This study describes U.S. FDA-approved gene and cellular therapy adoption trends from 2010-2025 using deterministically linked medical and pharmacy claims with EHR data and summarizes uptake by therapy class, year, payer, age group, and region.
METHODS: Methods: We conducted a descriptive epidemiology of therapy initiation (patient level index = first observable administration/claim) in Optum Market Clarity. Therapies were identified using HCPCS/J codes and NDCs in medical and pharmacy claims, with ‑disease specific diagnosis confirmed within 90 days prior to index using claims and EHR data. Results are reported by year (2010-2025), therapy class (cellular immunotherapy, CAR T, and gene therapies), and selected patient/payer characteristics. Analyses are descriptive; no effectiveness or economic inferences were made.
RESULTS: Results: We observed 22,573 therapy administrations overall. Counts were highest for autologous cellular immunotherapy (n=15,314) and oncolytic viral therapy (n=2,887). Combined CAR‑T administrations totaled 4,126 across large B‑cell lymphoma, mantle cell lymphoma, and multiple myeloma, initiating in 2017 and rising through 2024, with a notable post‑2021 increase in myeloma. Gene therapies showed lower but growing uptake: retinal AAV (~117) and neuromuscular gene therapy (~129) with early use post‑2023. With confirmed disease diagnosis, 17,045 administrations were identified (e.g., cellular immunotherapy 11,159; oncolytic viral 2,432; combined CAR T 3,236; retinal gene therapy 110; neuromuscular gene therapy 108). Use was observed across commercial and Medicare Advantage populations (commercial ~40-50%; Medicare Advantage ~21-43% by therapy), with Medicaid smaller. 2025 counts reflect partial‑year data (through June)
CONCLUSIONS: Conclusions: In linked claims-EHR data, adoption of these therapies increased over time but varied substantially by class, disease, and payer. Early gene therapy uptake was modest, and real‑world use patterns inform coverage, contracting, and implementation needs.