OBJECTIVES: Dialysis patients are susceptible to hepatitis B virus (HBV) infection due to immunocompromised states and recurrent exposure to blood components. Traditional intramuscular HBV vaccination has demonstrated suboptimal seroprotection and durability in this population. Clinical trials have indicated that intradermal (ID) HBV Sci-B-Vac vaccination with imiquimod (a Toll-like receptor 7 agonist) pretreatment is safe and enhances seroprotection in dialysis patients. This study aimed to evaluate the cost-effectiveness of intradermal administration of HBV Sci-B-Vac plus imiquimod pretreatment for dialysis patients from the perspective of US healthcare provider.

METHODS: A lifetime Markov model was designed to estimate outcomes in a hypothetical cohort of serologically negative dialysis patients receiving (1) HBV Sci-B-Vac via intradermal administration with imiquimod pretreatment (IMQ+ID group) and (2) HBV Sci-B-Vac intramuscular injection alone (IM group). Model inputs were derived from literature and public database. Primary outcomes included hepatitis B-related events (acute infection, fulminant hepatitis, chronic hepatitis B, hepatocellular carcinoma, liver transplant and hepatitis B-related death), direct medical cost and quality-adjusted life-year (QALY).

RESULTS: Compared to the IM group, the IMQ+ID group reduced 273 acute infection cases, 3 fulminant hepatitis cases, 74 CHB cases , 24 HCC cases, 0.003 liver transplants cases, and 43 HBV-related deaths per 100,000 dialysis patients. The IMQ+ID group showed an incremental cost of USD 51.38 compared to the IM group and was more effective (0.0021 QALYs gained). The incremental cost-effectiveness ratio of IMQ+ID group was (24,584 USD/QALY) lower than the willingness-to-pay (WTP) threshold (50,000 USD/QALY). Results were robust to the variation of all model inputs in one-way sensitivity analysis. The probabilities of the IMQ+ID and IM group being cost-effective at the WTP threshold of 50,000 USD/QALY were 82.74% and 17.26%, respectively.

CONCLUSIONS: Intradermal administration of HBV Sci-B-Vac plus imiquimod pretreatment appears to be a cost-effective strategy for serologically negative dialysis patients.