Cost-effectiveness of Orca-T vs allo-HCT with conventional GVHD prophylaxis for the treatment of advanced hematologic malignancies in the United States.

AIMS: Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapy for patients with hematologic malignancies, but its success is limited by graft‑versus‑host disease (GVHD), which carries considerable clinical and economic burden. A cost-effectiveness model was developed to evaluate whether the higher upfront costs of allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq (Tregzi [Orca-T; Orca Bio, Menlo Park, CA, USA]) are offset by reductions in GVHD and associated healthcare costs compared with conventional allo-HCT using TAC/MTX or PTCy.

METHODS: A three-state partitioned survival model (relapse-free, relapsed, and dead) with a lifetime horizon and monthly cycles was developed. Overall survival and relapse-free survival data from the Phase 3 Precision-T study (ClinicalTrials.gov Identifier NCT05316701) were incorporated using a cure-mixture modeling approach to estimate long-term survival, relapse status, and cure fraction for patients. Costs included transplant procedure, GVHD management, infection management, and terminal care. Outcomes included life-years, quality-adjusted life-years (QALYs), and direct healthcare costs. Both costs and outcomes were discounted at 3% annually. A scenario analysis was conducted to determine the cost-effectiveness of Orca-T vs allo-HCT with PTCy for GVHD prophylaxis, and sensitivity analyses were conducted to test the uncertainty of the model inputs.

RESULTS: Orca‑T was associated with lower lifetime costs ($1,026,856 vs $2,170,875) and higher QALYs (15.28 vs 13.00) than conventional allo‑HCT with TAC/MTX, yielding cost savings of $1,144,019 and a gain of 2.28 QALYs per patient. GVHD-related costs were substantially lower with Orca‑T ($495,447 vs $1,998,621). Compared with PTCy, Orca‑T remained dominant, with cost savings of $158,144, a gain of 2.85 QALYs, and lower GVHD-related costs ($476,448 vs $999,945).

CONCLUSIONS: Orca‑T reduced costs and increased QALYs versus conventional allo‑HCT with TAC/MTX or PTCy, driven by lower GVHD and infection burden. These findings support Orca‑T as a high‑value treatment option.