OBJECTIVES: The novel 3-antigen hepatitis B vaccine was granted marketing authorization by the European Commission in April 2022. This analysis estimates the cost-effectiveness of the 3-antigen vaccine relative to the single-antigen vaccine to prevent hepatitis B virus (HBV) infection among adults in Germany.
METHODS: A cost-effectiveness model was developed using a combined decision tree and Markov structure to follow 100,000 adults over their remaining lifetimes after vaccination with either the 3-antigen or single-antigen vaccine. Seroprotection rates by dose were obtained from the pivotal, phase 3, head-to-head PROTECT trial (NCT03393754). Population demographics (Federal Statistics Office, 2021), HBV incidence (RKI, 2020), costs, and other parameters were obtained from published sources for Germany. Health and cost outcomes (2020 Euros) were discounted 3% annually and reported for the societal perspective for adults aged 18-44, 45-64, and ≥ 65 years; diabetic adults; and obese adults. One-way sensitivity and scenario analyses (≥ 100 mIU/ml seroprotection threshold) were conducted.
RESULTS: The 3-antigen vaccine resulted in fewer acute and chronic HBV infections, fewer complications and deaths, and more quality-adjusted life-years (QALYs) compared with the single-antigen vaccine due to higher seroprotection rates and faster onset of seroprotection. Reductions in HBV-related infections and costs were greatest in adults aged 18-44 years (−37% for 18-44 years; −27% for 45-64 years; −22% for ≥ 65 years; −18% for diabetic adults; −29% for obese adults). Given assumed price parity, the 3-antigen vaccine resulted in lower total costs and was the dominant strategy compared with single-antigen vaccine. The 3-antigen vaccine remained the dominant vaccination strategy in all scenarios conducted.
CONCLUSIONS: Compared with the single-antigen vaccine, the 3-antigen vaccine averted more infections, resulted in more QALYs, and had lower direct medical costs and total costs. The 3-antigen vaccine represents an additional meaningful tool for addressing the burden of hepatitis B among adults in Germany.
