PDF(Pubmed)
Abstract：
BACKGROUND: Since 2009, a pneumococcal conjugate vaccine (PCV) covering 13 serotypes (PCV13) has been included by Germany\'s Standing Committee on Vaccinations for infants, resulting in major reductions in pneumococcal disease (PD). Higher-valent vaccines may further reduce PD burden. This cost-effectiveness analysis compared 20-valent PCV (PCV20) under a 3+1 schedule with 15-valent PCV (PCV15) and PCV13, both under 2+1 schedule, in Germany\'s pediatric population.
METHODS: A Markov model with annual cycles over a 10-year time horizon was adapted to simulate the clinical and economic impact of pediatric vaccination with PCV20 versus lower-valent PCVs in Germany. The model used PCV13 clinical effectiveness and impact studies as well as PCV7 efficacy studies for vaccine direct and indirect effect estimates. Epidemiologic, utility, and medical cost inputs were obtained from published sources. Benefits and costs were discounted at 3% from a German societal perspective. Outcomes included PD cases, deaths, costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).
RESULTS: In the base case, PCV20 provided greater health benefits than PCV13, averting more cases of invasive pneumococcal disease (IPD; 15,301), hospitalized and non-hospitalized pneumonia (460,197 and 472,365, respectively), otitis media (531,634), and 59,265 deaths over 10 years. This resulted in 904,854 additional QALYs and a total cost saving of €2,393,263,611, making PCV20 a dominant strategy compared with PCV13. Compared to PCV15, PCV20 was estimated to avert an additional 11,334 IPD, 704,948 pneumonia, and 441,643 otitis media cases, as well as 41,596 deaths. PCV20 was associated with a higher QALY gain and lower cost (i.e., dominance) compared with PCV15. The robustness of the results was confirmed through scenario analyses as well as deterministic and probabilistic sensitivity analyses.
CONCLUSIONS: PCV20 3+1 dominated both PCV13 2+1 and PCV15 2+1 over 10 years. Replacing lower-valent PCVs with PCV20 would result in greater clinical and economic benefits, given PCV20\'s broader serotype coverage.
Pneumococcal diseases (e.g., ear infections, pneumonia, bloodstream infections) are among the leading causes of illness and death in children worldwide. The pneumococcal conjugate vaccine protects against pneumococcal diseases and has significantly reduced the number of newly diagnosed cases. Higher-valent vaccines (which provide coverage for a greater number of disease-causing serotypes) have recently received European Commission approval for use in adults and children. This study examined costs and health benefits associated with the 20-valent pneumococcal conjugate vaccine (PCV20) under a 3+1 (i.e., three primary doses and one booster dose) schedule in Germany’s childhood vaccination program compared with 13-valent pneumococcal conjugate vaccine (PCV13) and the 15-valent pneumococcal conjugate vaccine (PCV15), both under a 2+1 (two primary doses, one booster) schedule. PCV20 was estimated to result in greater health benefits from avoiding more cases in pneumococcal diseases and lower costs compared with both PCV13 and PCV15. PCV20, therefore, is considered the best option among the three vaccines for children in Germany.
METHODS: A Markov model with annual cycles over a 10-year time horizon was adapted to simulate the clinical and economic impact of pediatric vaccination with PCV20 versus lower-valent PCVs in Germany. The model used PCV13 clinical effectiveness and impact studies as well as PCV7 efficacy studies for vaccine direct and indirect effect estimates. Epidemiologic, utility, and medical cost inputs were obtained from published sources. Benefits and costs were discounted at 3% from a German societal perspective. Outcomes included PD cases, deaths, costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).
RESULTS: In the base case, PCV20 provided greater health benefits than PCV13, averting more cases of invasive pneumococcal disease (IPD; 15,301), hospitalized and non-hospitalized pneumonia (460,197 and 472,365, respectively), otitis media (531,634), and 59,265 deaths over 10 years. This resulted in 904,854 additional QALYs and a total cost saving of €2,393,263,611, making PCV20 a dominant strategy compared with PCV13. Compared to PCV15, PCV20 was estimated to avert an additional 11,334 IPD, 704,948 pneumonia, and 441,643 otitis media cases, as well as 41,596 deaths. PCV20 was associated with a higher QALY gain and lower cost (i.e., dominance) compared with PCV15. The robustness of the results was confirmed through scenario analyses as well as deterministic and probabilistic sensitivity analyses.
CONCLUSIONS: PCV20 3+1 dominated both PCV13 2+1 and PCV15 2+1 over 10 years. Replacing lower-valent PCVs with PCV20 would result in greater clinical and economic benefits, given PCV20\'s broader serotype coverage.
Pneumococcal diseases (e.g., ear infections, pneumonia, bloodstream infections) are among the leading causes of illness and death in children worldwide. The pneumococcal conjugate vaccine protects against pneumococcal diseases and has significantly reduced the number of newly diagnosed cases. Higher-valent vaccines (which provide coverage for a greater number of disease-causing serotypes) have recently received European Commission approval for use in adults and children. This study examined costs and health benefits associated with the 20-valent pneumococcal conjugate vaccine (PCV20) under a 3+1 (i.e., three primary doses and one booster dose) schedule in Germany’s childhood vaccination program compared with 13-valent pneumococcal conjugate vaccine (PCV13) and the 15-valent pneumococcal conjugate vaccine (PCV15), both under a 2+1 (two primary doses, one booster) schedule. PCV20 was estimated to result in greater health benefits from avoiding more cases in pneumococcal diseases and lower costs compared with both PCV13 and PCV15. PCV20, therefore, is considered the best option among the three vaccines for children in Germany.
摘要：
背景：自2009年以来，涵盖13种血清型（PCV13）的肺炎球菌结合疫苗（PCV）已被德国婴儿疫苗常设委员会纳入，导致肺炎球菌疾病（PD）的大幅减少。更高价的疫苗可以进一步降低PD负担。此成本效益分析比较了31时间表下的20价PCV（PCV20）与21时间表下的15价PCV（PCV15）和PCV13，在德国的儿科人群中。
方法：适用于10年时间范围内的年周期马尔可夫模型，以模拟PCV20与低价PCV在德国的儿科疫苗接种的临床和经济影响。该模型使用PCV13临床有效性和影响研究以及PCV7功效研究来进行疫苗直接和间接效果估计。流行病学，实用程序，医疗费用投入是从公布的来源获得的。从德国社会的角度来看，收益和成本折扣为3％。结果包括PD病例，死亡,成本,质量调整生命年(QALYs)，和增量成本效益比(ICER)。
结果：在基本情况下，PCV20比PCV13提供了更大的健康益处，避免了更多的侵袭性肺炎球菌疾病病例（IPD;15,301），住院和非住院肺炎（分别为460,197和472,365），中耳炎(531,634),和59,265人死亡超过10年。这导致了904,854个额外的QALY，并节省了2,393,263,611欧元的总成本，使PCV20成为与PCV13相比的主要战略。与PCV15相比，PCV20估计可避免额外的11,334IPD，704,948肺炎,和441,643例中耳炎,以及41,596人死亡。PCV20与更高的QALY增益和更低的成本相关(即，优势)与PCV15相比。通过情景分析以及确定性和概率敏感性分析证实了结果的稳健性。
结论：PCV203+1在10年内主导PCV132+1和PCV152+1。用PCV20替换低价PCV将带来更大的临床和经济效益，考虑到PCV20更广泛的血清型覆盖。
肺炎球菌疾病(例如，耳部感染,肺炎,血液感染）是全球儿童疾病和死亡的主要原因之一。肺炎球菌结合疫苗可预防肺炎球菌疾病，并大大减少了新诊断病例的数量。更高价的疫苗（覆盖更多的致病血清型）最近已获得欧盟委员会批准用于成人和儿童。这项研究检查了与3+1下的20价肺炎球菌结合疫苗（PCV20）相关的成本和健康益处（即，德国儿童疫苗接种计划中的三个主要剂量和一个加强剂量）时间表与13价肺炎球菌结合疫苗（PCV13）和15价肺炎球菌结合疫苗（PCV15）相比，都在2+1(两个主要剂量，一个助推器)时间表。据估计，与PCV13和PCV15相比，PCV20可避免更多肺炎球菌疾病病例，并降低费用，从而带来更大的健康益处。因此，PCV20被认为是德国三种儿童疫苗中的最佳选择。
方法：适用于10年时间范围内的年周期马尔可夫模型，以模拟PCV20与低价PCV在德国的儿科疫苗接种的临床和经济影响。该模型使用PCV13临床有效性和影响研究以及PCV7功效研究来进行疫苗直接和间接效果估计。流行病学，实用程序，医疗费用投入是从公布的来源获得的。从德国社会的角度来看，收益和成本折扣为3％。结果包括PD病例，死亡,成本,质量调整生命年(QALYs)，和增量成本效益比(ICER)。
结果：在基本情况下，PCV20比PCV13提供了更大的健康益处，避免了更多的侵袭性肺炎球菌疾病病例（IPD;15,301），住院和非住院肺炎（分别为460,197和472,365），中耳炎(531,634),和59,265人死亡超过10年。这导致了904,854个额外的QALY，并节省了2,393,263,611欧元的总成本，使PCV20成为与PCV13相比的主要战略。与PCV15相比，PCV20估计可避免额外的11,334IPD，704,948肺炎,和441,643例中耳炎,以及41,596人死亡。PCV20与更高的QALY增益和更低的成本相关(即，优势)与PCV15相比。通过情景分析以及确定性和概率敏感性分析证实了结果的稳健性。
结论：PCV203+1在10年内主导PCV132+1和PCV152+1。用PCV20替换低价PCV将带来更大的临床和经济效益，考虑到PCV20更广泛的血清型覆盖。
肺炎球菌疾病(例如，耳部感染,肺炎,血液感染）是全球儿童疾病和死亡的主要原因之一。肺炎球菌结合疫苗可预防肺炎球菌疾病，并大大减少了新诊断病例的数量。更高价的疫苗（覆盖更多的致病血清型）最近已获得欧盟委员会批准用于成人和儿童。这项研究检查了与3+1下的20价肺炎球菌结合疫苗（PCV20）相关的成本和健康益处（即，德国儿童疫苗接种计划中的三个主要剂量和一个加强剂量）时间表与13价肺炎球菌结合疫苗（PCV13）和15价肺炎球菌结合疫苗（PCV15）相比，都在2+1(两个主要剂量，一个助推器)时间表。据估计，与PCV13和PCV15相比，PCV20可避免更多肺炎球菌疾病病例，并降低费用，从而带来更大的健康益处。因此，PCV20被认为是德国三种儿童疫苗中的最佳选择。
