Sohn Hyun Soon, Suh Dong-Churl, Jang Eunjin, Kwon Jin-Won
Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, 160 Frelinghuysen Rd., Piscataway, NJ 08854-8020, USA.
J Manag Care Pharm. 2010 Jan-Feb;16(1):32-45. doi: 10.18553/jmcp.2010.16.1.32.
Streptococcus pneumoniae (sp) is a leading cause of invasive and noninvasive bacterial disease in children. 7-valent pneumococcal conjugate vaccine (PCV-7) has been shown to significantly reduce the incidence of pneumococcal diseases, such as meningitis, bacteremia, pneumonia, and otitis media. Although PCV-7 was introduced in Korea in 2003, it is not yet included in the universal immunization program.
To evaluate the health outcomes, costs, and cost-effectiveness of universal vaccination with PCV-7 in Korean infants and to estimate the break-even price for PCV-7 from a societal perspective.
A decision analytic model was used to evaluate the cost-effectiveness of immunization with PCV-7 in a birth cohort of Korean infants born in 2006. A universal vaccination strategy was compared with no vaccination in terms of costs and life years gained (LYG) over a 5-year time horizon. The birth cohort size, incidence of disease, resource utilization, and associated costs were obtained from the Korea National Statistical Office, the Korean Centers for Disease Control and Prevention, the Korean National Health and Nutrition Examination Survey, and the Korean Ministry of Health and Welfare. Inputs on the probabilities of clinical treatment pathways (e.g., tympanostomy) were derived from international literature if data specific to Korea did not exist. To estimate the benefits of universal immunization, the serotype-specific efficacy of PCV-7 was derived from studies conducted by Northern California Kaiser Permanente and by the Finnish Otitis Media Vaccine Study and applied to the serotypes isolated in Korean children with sp infections. The effects of vaccination on quality of life, herd immunity, benefits after the first 5 years of life, and patient copayments were not considered. A 4-dose schedule was used in the base-case analysis. A 3-dose schedule was also evaluated. The assumed price per dose was Korean won (KW) 70,000 (approximately US$54; 2009 exchange rate US$1 = KW1,300). Univariate and probabilistic sensitivity analyses were performed.
Implementing a 4-dose universal PCV-7 vaccination strategy in a birth cohort of 451,514 infants in Korea would prevent 96,728 cases of pneumococcal-related infections (591 meningitis, 1,379 bacteremia, 43,950 pneumonia, and 50,808 otitis media cases) and 218 deaths (199 discounted deaths averted, 575 discounted LYG over 5 years). The medical and nonmedical cost burden of pneumococcal diseases offset with vaccination was KW44,033 million (US$33.87 million). The incremental discounted cost of universal vaccination was estimated to be KW86,384 million (US$66.45 million). The incremental cost per LYG was KW150.2 million (US$115,549) for the 4-dose schedule and KW103.91 million (US$79,955) for the 3-dose schedule. The break-even costs were KW22,100 and KW28,100 per dose for the 4- and 3-dose schedules, respectively.
Universal PCV-7 vaccination of infants in Korea could substantially reduce pneumococcal disease morbidity, mortality, and related costs by preventing pneumococcal infections. However, at current market prices for the vaccine, a universal vaccination strategy is not cost-effective. The literature suggests that factors not considered in this analysis, including vaccine price reduction and indirect effects on public health (e.g., herd immunity), have the potential to make the public health impact and cost-effectiveness of universal PCV-7 vaccination in Korea more favorable.
肺炎链球菌是儿童侵袭性和非侵袭性细菌性疾病的主要病因。7价肺炎球菌结合疫苗(PCV-7)已被证明可显著降低肺炎球菌疾病的发病率,如脑膜炎、菌血症、肺炎和中耳炎。尽管PCV-7于2003年在韩国引进,但尚未纳入国家免疫规划。
评估在韩国婴儿中普遍接种PCV-7的健康结局、成本和成本效益,并从社会角度估计PCV-7的收支平衡价格。
采用决策分析模型评估2006年出生的韩国婴儿队列接种PCV-7的成本效益。在5年时间范围内,将普遍接种策略与未接种策略在成本和获得的生命年数(LYG)方面进行比较。出生队列规模、疾病发病率、资源利用情况和相关成本数据来自韩国国家统计局、韩国疾病控制与预防中心、韩国国家健康与营养检查调查以及韩国卫生与福利部。如果没有韩国的特定数据,则临床治疗途径(如鼓膜造孔术)的概率输入来自国际文献。为估计普遍接种的益处,PCV-7的血清型特异性效力来自北加利福尼亚凯撒医疗集团和芬兰中耳炎疫苗研究进行的研究,并应用于在韩国感染肺炎链球菌的儿童中分离出的血清型。未考虑疫苗接种对生活质量、群体免疫、生命前5年后的益处以及患者自付费用的影响。基础病例分析采用4剂接种方案,也评估了3剂接种方案。假设每剂价格为70000韩元(约54美元;2009年汇率1美元=1300韩元)。进行了单因素和概率敏感性分析。
在韩国451514名婴儿的出生队列中实施4剂PCV-7普遍接种策略可预防96728例肺炎球菌相关感染(591例脑膜炎、1379例菌血症、43950例肺炎和50808例中耳炎)以及218例死亡(避免199例贴现死亡,5年期间575例贴现LYG)。接种疫苗抵消的肺炎球菌疾病的医疗和非医疗成本负担为4403.3亿韩元(3387万美元)。普遍接种的增量贴现成本估计为8638.4亿韩元(6645万美元)。4剂接种方案每LYG增量成本为1.502亿韩元(115549美元),3剂接种方案为1.0391亿韩元(79955美元)。4剂和3剂接种方案的收支平衡成本分别为每剂22100韩元和28100韩元。
在韩国对婴儿普遍接种PCV-7可通过预防肺炎球菌感染大幅降低肺炎球菌疾病的发病率、死亡率和相关成本。然而,按照目前疫苗的市场价格,普遍接种策略不具有成本效益。文献表明,本分析未考虑的因素,包括疫苗降价和对公共卫生的间接影响(如群体免疫),有可能使在韩国普遍接种PCV-7对公共卫生的影响和成本效益更有利。