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3 种抗原疫苗与单种抗原疫苗预防美国成人乙型肝炎的成本效益比较。

Cost-effectiveness of a 3-antigen versus single-antigen vaccine for the prevention of hepatitis B in adults in the United States.

机构信息

RTI Health Solutions, 3040 Cornwallis Rd., Durham, NC 27709, United States.

RTI Health Solutions, 3040 Cornwallis Rd., Durham, NC 27709, United States.

出版信息

Vaccine. 2023 May 26;41(23):3506-3517. doi: 10.1016/j.vaccine.2023.04.022. Epub 2023 May 3.

Abstract

OBJECTIVES

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-B, to prevent hepatitis B virus (HBV) infection among US adults.

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. 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.

RESULTS

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.

CONCLUSION

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

首款三抗原乙型肝炎疫苗于 2021 年 11 月获得美国食品药品监督管理局(FDA)批准,并于 2022 年被疾病控制与预防中心(CDC)推荐使用。我们评估了这款三抗原疫苗(PreHevbrioTM)相对于单抗原疫苗(Engerix-B)在预防美国成年人乙型肝炎病毒(HBV)感染方面的成本效益。

方法

采用决策树和马尔可夫结构相结合的成本效益模型,对 10 万名接种三抗原或单抗原疫苗的成年人在接种后的剩余寿命进行随访。从社会和医疗保健部门的角度计算了 18-44 岁、45-64 岁和≥65 岁成年人、糖尿病成年人和肥胖成年人的结果。从三抗原、头对头 PROTECT 试验(NCT03393754)获得血清保护率。从已发表的文献中获得了发病率、疫苗成本、疫苗接种率、直接和间接成本、效用、转移概率和死亡率。健康结果和成本(2020 年美元)按 3%的年率贴现,并按疫苗和人群进行报告。进行了单因素敏感性分析和情景分析。

结果

在模型中,与单抗原疫苗相比,由于血清保护率更高且更快出现,三抗原疫苗在所有建模人群中导致的 HBV 感染、并发症和死亡更少。与单抗原疫苗相比,三抗原疫苗在 18-64 岁成年人、糖尿病成年人和肥胖成年人(优势策略)中具有更好的健康结果、更多的质量调整生命年(QALY)和更低的成本。对于≥65 岁的成年人,与单抗原疫苗相比,三抗原疫苗在常见的支付意愿阈值(50000-100000 美元/QALY)以下具有成本效益(每获得一个 QALY 节省 26237 美元)。在敏感性分析中,结果对疫苗单价、发病率和接种年龄敏感。

结论

最近批准的三抗原疫苗是预防 HBV 感染和解决美国成年人乙型肝炎长期负担的一种节省成本或具有成本效益的干预措施。

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