Abstract：
The first 3-antigen hepatitis B vaccine was approved by the United States (US) Food and Drug Administration in November 2021 and was recommended by the Centers for Disease Control and Prevention in 2022. We estimated the cost-effectiveness of this 3-antigen vaccine (PreHevbrio™) relative to the single-antigen vaccine, Engerix-BTM, to prevent hepatitis B virus (HBV) infection among US adults.
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. Outcomes from societal and healthcare sector perspectives were calculated for adults aged 18-44, 45-64, and ≥65 years; adults with diabetes; and adults with obesity. Seroprotection rates were obtained from the phase3, 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 (2020USD) were discounted 3% annually and reported by vaccine and population. One-way sensitivity and scenario analyses were conducted.
In the model, the 3-antigen vaccine led to fewer HBV infections, complications, and deaths compared with the single-antigen vaccine in all modeled populations due to higher rates and faster onset of seroprotection. Compared with the single-antigen vaccine, the 3-antigen vaccine had better health outcomes, more quality-adjusted life-years (QALYs), and lower costs in adults aged 18-64 years, adults with diabetes, and adults with obesity (dominant strategy). For adults aged ≥65 years, the 3-antigen vaccine was cost-effective compared with the single-antigen vaccine ($26,237/QALY gained) below common willingness-to-pay thresholds ($50,000-$100,000/QALY gained). In sensitivity analyses, results were sensitive to vaccine cost per dose, incidence, and age at vaccination.
The recently approved 3-antigen vaccine is a cost-saving or cost-effective intervention for preventing HBV infection and addressing the long-standing burden of hepatitis B among US adults.
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. Outcomes from societal and healthcare sector perspectives were calculated for adults aged 18-44, 45-64, and ≥65 years; adults with diabetes; and adults with obesity. Seroprotection rates were obtained from the phase3, 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 (2020USD) were discounted 3% annually and reported by vaccine and population. One-way sensitivity and scenario analyses were conducted.
In the model, the 3-antigen vaccine led to fewer HBV infections, complications, and deaths compared with the single-antigen vaccine in all modeled populations due to higher rates and faster onset of seroprotection. Compared with the single-antigen vaccine, the 3-antigen vaccine had better health outcomes, more quality-adjusted life-years (QALYs), and lower costs in adults aged 18-64 years, adults with diabetes, and adults with obesity (dominant strategy). For adults aged ≥65 years, the 3-antigen vaccine was cost-effective compared with the single-antigen vaccine ($26,237/QALY gained) below common willingness-to-pay thresholds ($50,000-$100,000/QALY gained). In sensitivity analyses, results were sensitive to vaccine cost per dose, incidence, and age at vaccination.
The recently approved 3-antigen vaccine is a cost-saving or cost-effective intervention for preventing HBV infection and addressing the long-standing burden of hepatitis B among US adults.
摘要：
目的：第一个3抗原乙型肝炎疫苗于2021年11月获得美国（美国）食品药品监督管理局的批准，并于2022年被疾病控制和预防中心推荐。我们估计了这种3抗原疫苗（PreHevbrio™）相对于单抗原疫苗的成本效益，Engerix-BTM,在美国成年人中预防乙型肝炎病毒（HBV）感染。
方法：使用组合决策树和马尔可夫结构开发了一个成本效益模型，以跟踪100,000名成年人在接种3抗原或单抗原疫苗后的剩余寿命。从社会和医疗保健部门的角度，对18-44岁、45-64岁和≥65岁的成年人、糖尿病成年人和肥胖成年人的结果进行了计算。血清保护率来自第3阶段，头对头PROTECT试验（NCT03393754）。发病率,疫苗费用,疫苗依从率，直接和间接成本，公用事业，转移概率，和死亡率是从公布的来源获得的。健康结果和成本（2020USD）每年折扣3％，并按疫苗和人群报告。进行了单向敏感性和情景分析。
结果：在模型中，3-抗原疫苗导致较少的HBV感染，并发症,与单抗原疫苗相比，在所有模型人群中，由于更高的比率和更快的血清保护起效，导致死亡。与单抗原疫苗相比,3-抗原疫苗有更好的健康结果，更多的质量调整寿命年(QALYs)，18-64岁成年人的成本较低，成人糖尿病患者,和成人肥胖（主导策略）。对于年龄≥65岁的成年人，与单抗原疫苗相比,3抗原疫苗的成本效益(增加$26,237/QALY)低于一般支付意愿阈值(增加$50,000-$100,000/QALY).在敏感性分析中，结果对每剂疫苗成本敏感，发病率,接种疫苗的年龄。
结论：最近批准的3抗原疫苗是一种节省成本或具有成本效益的干预措施，用于预防HBV感染和解决美国成年人乙型肝炎的长期负担。
方法：使用组合决策树和马尔可夫结构开发了一个成本效益模型，以跟踪100,000名成年人在接种3抗原或单抗原疫苗后的剩余寿命。从社会和医疗保健部门的角度，对18-44岁、45-64岁和≥65岁的成年人、糖尿病成年人和肥胖成年人的结果进行了计算。血清保护率来自第3阶段，头对头PROTECT试验（NCT03393754）。发病率,疫苗费用,疫苗依从率，直接和间接成本，公用事业，转移概率，和死亡率是从公布的来源获得的。健康结果和成本（2020USD）每年折扣3％，并按疫苗和人群报告。进行了单向敏感性和情景分析。
结果：在模型中，3-抗原疫苗导致较少的HBV感染，并发症,与单抗原疫苗相比，在所有模型人群中，由于更高的比率和更快的血清保护起效，导致死亡。与单抗原疫苗相比,3-抗原疫苗有更好的健康结果，更多的质量调整寿命年(QALYs)，18-64岁成年人的成本较低，成人糖尿病患者,和成人肥胖（主导策略）。对于年龄≥65岁的成年人，与单抗原疫苗相比,3抗原疫苗的成本效益(增加$26,237/QALY)低于一般支付意愿阈值(增加$50,000-$100,000/QALY).在敏感性分析中，结果对每剂疫苗成本敏感，发病率,接种疫苗的年龄。
结论：最近批准的3抗原疫苗是一种节省成本或具有成本效益的干预措施，用于预防HBV感染和解决美国成年人乙型肝炎的长期负担。
