Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc, Dublin, Ireland.
Clinical Development, Dynavax Technologies Corporation, Emeryville, CA, USA.
Vaccine. 2021 Jul 30;39(33):4733-4741. doi: 10.1016/j.vaccine.2021.05.020. Epub 2021 May 21.
The hepatitis B virus is highly infectious and can cause incurable liver disease, leading to high morbidity rates, increased healthcare utilization, and high mortality. Multiple preventative hepatitis B vaccine options have been available for decades, but adherence to the traditional 6-month vaccine schedule for the approved 3-dose series remains low in adult populations at risk of hepatitis B exposure. A 2-dose hepatitis B vaccine (HEPLISAV-B) approved by the US Food and Drug Administration in 2017 induces rapid seroprotection within 1 month and has a safety profile comparable to a commonly used 3-dose vaccine. In a previous cost-effectiveness study, HEPLISAV-B had a favorable cost-effectiveness profile for multiple at-risk populations. The goal of the current analysis was to update and extend previous findings by evaluating cost-effectiveness of HEPLISAV-B compared with a 3-dose vaccine (Engerix-B) in selected adult populations, including patients with diabetes, chronic liver or kidney disease, end-stage renal disease, healthcare personnel, travelers to countries with endemic hepatitis B, and a public health population. Cost-effectiveness was measured as incremental cost-effectiveness ratios using a health economics Markov model that accounts for adherence rates, seroprotection rates, healthcare costs, and current pricing considerations. Patients progressed between a series of health states, and the difference in lifetime spending and survival for individuals receiving either HEPLISAV-B or Engerix-B was estimated from the perspective of a US managed care payer, HEPLISAV-B had favorable cost-effectiveness profiles for patients with diabetes, healthcare personnel, travelers, and patients with chronic liver disease and dominant incremental cost-effectiveness ratios for patients with chronic kidney disease and end-stage renal disease. A probabilistic sensitivity analysis supported the robustness of the cost-effectiveness profiles, and an additional analysis indicated that HEPLISAV-B was cost-effective in the general adult population. Overall, HEPLISAV-B was cost-effective in multiple adult populations recommended for HBV vaccination in the United States.
乙型肝炎病毒具有高度传染性，可导致无法治愈的肝脏疾病，从而导致高发病率、增加医疗保健的利用以及高死亡率。几十年来，已有多种预防性乙型肝炎疫苗可供选择，但在有乙型肝炎暴露风险的成年人群中，仍有低比例人群能够坚持接受传统的 6 个月乙型肝炎疫苗接种方案，完成 3 剂系列接种。美国食品药品监督管理局于 2017 年批准的 2 剂乙型肝炎疫苗（HEPLISAV-B）在接种后 1 个月内可迅速产生血清保护，其安全性与常用的 3 剂疫苗相当。在之前的成本效益研究中，HEPLISAV-B 在多个高危人群中具有良好的成本效益比。本分析旨在通过评估 HEPLISAV-B 与 3 剂疫苗（Engerix-B）在选定的成年人群（包括糖尿病患者、慢性肝脏或肾脏疾病患者、终末期肾病患者、医护人员、前往乙型肝炎流行国家的旅行者以及一般公众）中的成本效益，更新和扩展之前的研究结果。使用健康经济学马尔可夫模型来衡量成本效益，该模型考虑了依从性、血清保护率、医疗保健成本以及当前定价因素。患者在一系列健康状态之间进展，根据美国管理式医疗支付方的观点，通过比较接受 HEPLISAV-B 或 Engerix-B 的个体的终生支出和生存情况来估计个人的差异。HEPLISAV-B 对糖尿病患者、医护人员、旅行者以及慢性肝脏疾病患者具有良好的成本效益比，对于慢性肾脏疾病患者和终末期肾病患者则具有优势增量成本效益比。概率敏感性分析支持了成本效益比的稳健性，并且另外一项分析表明，HEPLISAV-B 在一般成年人群中具有成本效益。总体而言，HEPLISAV-B 在多个美国推荐的乙型肝炎疫苗接种的成年人群中具有成本效益。
