Health Economics and Outcomes Research, PriceSpective, 2101 Rosecrans Ave, Suite 5280, El Segundo, CA 90245, United States.
Vaccine. 2013 Aug 20;31(37):4024-32. doi: 10.1016/j.vaccine.2013.05.014. Epub 2013 May 22.
HEPLISAV™ is an adult hepatitis B vaccine that requires fewer doses over a shorter period of time and elicits higher and earlier seroprotection compared to Engerix-B to reduce the risk of hepatitis B infection. The objective of this analysis was to evaluate the cost-effectiveness of vaccination with HEPLISAV vs. Engerix-B(®) to prevent hepatitis B infection in select populations.
Markov models were developed for the following populations: diabetics, patients with chronic or end stage kidney disease, healthcare workers and international travelers to countries with high HBV infection prevalence. Hepatitis B disease progression was modeled using 11 health states: seroprotected, susceptible, acute infection, chronic infection, fulminant hepatic failure, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplant, post-transplant care, and death. Seroprotection rates were obtained from two phase 3 clinical trials comparing HEPLISAV with Engerix-B and ranged across various populations from 89-96% for HEPLISAV and 62-81% for Engerix-B. Higher vaccination completion rates were assumed for HEPLISAV compared with Engerix-B given that fewer doses of HEPLISAV are required in a shorter period of time to achieve seroprotection for the evaluated populations. Each cycle length after the first year in the model was 1-year. All future costs and benefits were discounted at 3%. A lifetime analysis and a U.S. payer perspective were used.
HEPLISAV has a favorable cost-effectiveness profile with incremental cost effectiveness ratios <$25,000 across all populations studied. In the patients with chronic or end stage kidney disease, HEPLISAV was the dominant option and was cost-saving compared with Engerix-B. The cost of vaccine, regimen completion rates, and seroprotection rates were the sensitive variables in the models.
HEPLISAV is a cost-effective option to provide high rates of seroprotection and early seroprotection across a range of populations from health care workers to patients with chronic or end stage kidney disease.
HEPLISAV™ 是一种成人乙型肝炎疫苗，与 Engerix-B 相比，它需要更少的剂量和更短的时间就能产生更高和更早的血清保护作用，从而降低乙型肝炎感染的风险。本分析的目的是评估接种 HEPLISAV 与 Engerix-B（®）预防特定人群乙型肝炎感染的成本效益。
为以下人群开发了马尔可夫模型：糖尿病患者、慢性或终末期肾病患者、医护人员和前往乙型肝炎高流行国家的国际旅行者。使用 11 种健康状态对乙型肝炎疾病进展进行建模：血清保护、易感、急性感染、慢性感染、暴发性肝衰竭、代偿性肝硬化、失代偿性肝硬化、肝细胞癌、肝移植、移植后护理和死亡。HEPLISAV 与 Engerix-B 比较的两项 3 期临床试验获得了血清保护率，在不同人群中，HEPLISAV 的血清保护率为 89-96%，而 Engerix-B 的血清保护率为 62-81%。假设 HEPLISAV 比 Engerix-B 具有更高的疫苗接种完成率，因为在评估人群中，HEPLISAV 只需要更少的剂量和更短的时间就能达到血清保护。模型中第一年之后的每个周期长度为 1 年。所有未来的成本和效益均以 3%贴现。使用了终身分析和美国支付者视角。
在所有研究人群中，HEPLISAV 的增量成本效益比<25000 美元，具有良好的成本效益。在慢性或终末期肾病患者中，HEPLISAV 是首选方案，与 Engerix-B 相比具有成本效益。疫苗成本、方案完成率和血清保护率是模型中的敏感变量。
HEPLISAV 是一种在从医护人员到慢性或终末期肾病患者的各种人群中提供高血清保护率和早期血清保护率的具有成本效益的选择。
