OBJECTIVES: The first 3-antigen hepatitis B (HepB) vaccine was approved by the FDA in November 2021. This analysis estimates the cost-effectiveness of this 3-antigen vaccine relative to a 3-dose, single-antigen vaccine to prevent HepB infection among adults in the United States.

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 3-antigen or single-antigen vaccine. Societal and payer perspectives were modeled for adults aged 18-44, 45-64, and ≥ 65 years; diabetics (aged ≥18 years); and obese adults (aged ≥18 years).

Seroprotection rates were obtained from the pivotal, phase 3, head-to-head PROTECT trial (NCT03393754). Incidence, vaccine costs, vaccine adherence rates, direct and indirect costs, utilities, transition probabilities, and mortality were obtained from published sources. Health outcomes and costs (2020 USD) were discounted 3% annually. Total and incremental health and cost outcomes were reported by vaccine and population; the primary outcome was incremental cost per quality-adjusted life-year (QALY) gained (ICER). One-way sensitivity and scenario analyses were conducted.

RESULTS: The 3-antigen vaccine reduced cases and increased QALYs for all populations compared with single-antigen vaccine. The 3-antigen vaccine reduced disease-related costs and fully offset increased vaccination costs, making it dominant (cost-saving) compared with single-antigen vaccine for adults aged 18-64 years and adults with diabetes and obesity. For adults aged ≥65 years, the ICER was $26,237. In sensitivity analyses, ICERs in most modeled populations were sensitive to vaccine cost per dose and HepB incidence.

CONCLUSION: 3-antigen vaccine is estimated to lead to fewer HepB cases, complications, and deaths compared with single-antigen vaccine due to higher seroprotection rates. Compared with single-antigen vaccine, 3-antigen vaccine is dominant (cost-saving) from societal and payer perspectives in adults aged 18-64 years and adults with diabetes and obesity, and cost-effective in adults aged ≥65 years.