COST-EFFECTIVENESS AND POTENTIAL VALUE OF T-REGULATORY CELL THERAPY IN THE TREATMENT OF MODERATE-SEVERE CROHN’S DISEASE
Author(s)
Eric Stone, MHS, Dulamjav Jadambaa, MD.
Johns Hopkins University, Baltimore, MD, USA.
Johns Hopkins University, Baltimore, MD, USA.
Presentation Documents
OBJECTIVES: To evaluate the cost-effectiveness of a hypothetical allogeneic T-regulatory cell therapy compared with infliximab and ustekinumab for moderate to severe Crohn’s disease, and to estimate its potential value as reflected in its economically justifiable price at a standard willingness-to-pay threshold.
METHODS: A hybrid decision tree-Markov model with 8-week cycles and a 6-year time horizon was constructed to estimate the costs and health outcomes of ustekinumab and infliximab compared to T regulatory (Treg) cells from the US healthcare sector perspective. Transition probabilities for infliximab (IFX) and ustekinumab (UST) were sourced from Aliyev et al (Pharmacotherapy 2019). As no clinical data exist for allogeneic Treg therapy in treating Crohn’s disease, we modeled a plausible incremental benefit scenario in which Treg therapy reduced the probability of surgery and moderate to severe disease by 20 percent relative to UST. Costs included drug acquisition, administration, monitoring, surgery and disease management. Outcomes reflected quality-adjusted life years (QALYs), total costs, incremental cost-effectiveness ratios (ICERs), net monetary benefit (NMB), and the economically justifiable price (EJP) at a willingness-to-pay (WTP) threshold of $150,000/QALY.
RESULTS: Treg therapy results in an ICER of $65,917/QALY versus IFX. IFX dominated UST. At a WTP of $150,000/QALY, Treg yielded the highest net monetary benefit of $529,388, demonstrating it was the most cost-effective option evaluated. The economically justifiable price for Treg therapy was $95,382, indicating the maximum cost at which it would remain cost effective under base case assumptions.
CONCLUSIONS: Based on the assumptions used in our model, allogeneic T regulatory cell therapy could be a cost-effective treatment for Crohn’s disease. Further analysis is needed to determine the real-world manufacturing costs and clinical outcomes as Treg therapies advance through development.
METHODS: A hybrid decision tree-Markov model with 8-week cycles and a 6-year time horizon was constructed to estimate the costs and health outcomes of ustekinumab and infliximab compared to T regulatory (Treg) cells from the US healthcare sector perspective. Transition probabilities for infliximab (IFX) and ustekinumab (UST) were sourced from Aliyev et al (Pharmacotherapy 2019). As no clinical data exist for allogeneic Treg therapy in treating Crohn’s disease, we modeled a plausible incremental benefit scenario in which Treg therapy reduced the probability of surgery and moderate to severe disease by 20 percent relative to UST. Costs included drug acquisition, administration, monitoring, surgery and disease management. Outcomes reflected quality-adjusted life years (QALYs), total costs, incremental cost-effectiveness ratios (ICERs), net monetary benefit (NMB), and the economically justifiable price (EJP) at a willingness-to-pay (WTP) threshold of $150,000/QALY.
RESULTS: Treg therapy results in an ICER of $65,917/QALY versus IFX. IFX dominated UST. At a WTP of $150,000/QALY, Treg yielded the highest net monetary benefit of $529,388, demonstrating it was the most cost-effective option evaluated. The economically justifiable price for Treg therapy was $95,382, indicating the maximum cost at which it would remain cost effective under base case assumptions.
CONCLUSIONS: Based on the assumptions used in our model, allogeneic T regulatory cell therapy could be a cost-effective treatment for Crohn’s disease. Further analysis is needed to determine the real-world manufacturing costs and clinical outcomes as Treg therapies advance through development.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE119
Topic
Economic Evaluation
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Gastrointestinal Disorders, STA: Biologics & Biosimilars, STA: Genetic, Regenerative & Curative Therapies