The Cost of Managing Safety Events: Ozanimod Versus Tofacitinib – A UK Perspective

OBJECTIVES: To compare adverse event (AE) and malignancy management costs between treatments for moderate to severe ulcerative colitis (UC).

METHODS: A cost comparison was completed based on published pooled safety data in patients with moderate to severe UC. Data were utilized from pooled safety data from phase 2, phase 3, and open-label extension trials for ozanimod, and from two phase 3 induction trials, a maintenance study, and an ongoing, open-label, long-term extension study for tofacitinib. An analysis of the safety data calculated incidence rates (IR) of serious infection (SI) and malignancy, measured as the number of unique patients with events per 100 years (PY) of exposure in the active treatment arms for ozanimod and tofacitinib and their respective placebo arms. SI and malignancy were classified by ICD-10 codes and their assigned Healthcare Resource Group (HRG) codes were used to elicit costs from NHS National Cost Collection data.

RESULTS: The difference in SI IR for active treatment versus placebo was –1.52 (1.32 vs 2.84) for ozanimod and 0.32 (1.70 vs 1.38) for tofacitinib use. For malignancy (excluding non-melanoma skin cancers), the difference in IR versus placebo was –0.50 (0.31 vs 0.81) for ozanimod and 0.75 (0.75 vs 0) for tofacitinib. Costing each SI (for SI that occurred in ≥2 patients) versus placebo showed incremental costs per PY of –£637.41 (£1103.37 vs £1740.77) for ozanimod and –£864.29 (£1110.11 vs £1974.40) for tofacitinib. Incremental costs for malignancy per PY were –£530.98 (£523.05 vs £1054.03) for ozanimod and £1575.23 (£1575.23 vs £0) for tofacitinib. Per PY, estimated cost savings of investigated AEs with ozanimod versus tofacitinib was £1879.32 (–£1168.38 vs £710.93).

CONCLUSIONS: Ozanimod and tofacitinib use were associated with lower and higher IR of SI and malignancy versus placebo, respectively, and ozanimod use was associated with cost savings versus placebo, while tofacitinib was associated with cost increases.