COST-EFFECTIVENESS OF REMIBRUTINIB FOR MODERATE TO SEVERE CHRONIC SPONTANEOUS URTICARIA IN THE U.S.
Author(s)
Janice Jang, PharmD, Kyu Lee, MS, PhD;
University of Washington, Seattle, WA, USA
University of Washington, Seattle, WA, USA
OBJECTIVES: Chronic spontaneous urticaria (CSU) is an inflammatory skin disease with a substantial impact on patient quality of life. Remibrutinib, a Bruton tyrosine kinase (BTK) inhibitor, was approved in September 2025 for chronic spontaneous urticaria for patients who remain symptomatic despite antihistamine treatment. This study aims to evaluate the cost-effectiveness of remibrutinib compared to the standard of care (SOC) second-generation antihistamine from a healthcare sector perspective in the U.S.
METHODS: We constructed a Markov model to estimate 10-year and 24-week outcomes among patients with moderate to severe CSU, with the interventions being either remibrutinib with cetirizine or cetirizine alone. We used the treatment efficacy estimates (transition probabilities from “moderate/severe urticaria” to “well-controlled urticaria”) from phase 3 remibrutinib clinical trials (REMIX-1 and REMIX-2). Outcomes included discounted costs, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay threshold (WTP) of $150,000 per QALY. Sensitivity analyses were performed to assess the robustness of the outcomes
RESULTS: In the base-case scenario, remibrutinib had higher costs and QALYs compared to the SOC. Remibrutinib had 0.12 and 0.01 more QALYs in the 10-year and 24-week time horizons, respectively. The ICER of the 10-year time horizon was $3,208,966 per QALY, and the ICER of the 24-week time horizon was $232,084 per QALY. Based on a WTP of $150,000 per QALY, remibrutinib was not cost-effective. Results are corroborated by the sensitivity analysis.
CONCLUSIONS: Based on this model, remimbrutinib is not cost-effective with a WTP of $150,000 per QALY.
METHODS: We constructed a Markov model to estimate 10-year and 24-week outcomes among patients with moderate to severe CSU, with the interventions being either remibrutinib with cetirizine or cetirizine alone. We used the treatment efficacy estimates (transition probabilities from “moderate/severe urticaria” to “well-controlled urticaria”) from phase 3 remibrutinib clinical trials (REMIX-1 and REMIX-2). Outcomes included discounted costs, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay threshold (WTP) of $150,000 per QALY. Sensitivity analyses were performed to assess the robustness of the outcomes
RESULTS: In the base-case scenario, remibrutinib had higher costs and QALYs compared to the SOC. Remibrutinib had 0.12 and 0.01 more QALYs in the 10-year and 24-week time horizons, respectively. The ICER of the 10-year time horizon was $3,208,966 per QALY, and the ICER of the 24-week time horizon was $232,084 per QALY. Based on a WTP of $150,000 per QALY, remibrutinib was not cost-effective. Results are corroborated by the sensitivity analysis.
CONCLUSIONS: Based on this model, remimbrutinib is not cost-effective with a WTP of $150,000 per QALY.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE288
Topic
Economic Evaluation
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)