Department of Health Management and Policy, School of Public Health.
Susan B. Meister Child Health Evaluation and Research Center, University of Michigan, Ann Arbor, Michigan.
Pediatrics. 2024 Dec 1;154(6). doi: 10.1542/peds.2024-066461.
Respiratory syncytial virus (RSV) causes substantial hospitalization in US infants. The Advisory Committee on Immunization Practices recommended nirsevimab in infants younger than 8 months born during or entering their first RSV season and for children aged 8 to 19 months at increased risk of RSV hospitalization in their second season. This study's objective was to evaluate the cost-effectiveness of nirsevimab in all infants in their first RSV season and in high-risk children in their second season.
We simulated healthcare utilization and deaths from RSV with and without nirsevimab among infants aged 0 to 7 months and those 8 to 19 months old over a single RSV season. Data came from published literature, US Food and Drug Administration approval documents, and epidemiologic surveillance data. We evaluated societal outcomes over a lifetime discounting at 3% and reporting in 2022 US dollars. Sensitivity and scenario analyses identified influential variables.
We estimated that 107 253 outpatient visits, 38 204 emergency department visits, and 14 341 hospitalizations could be averted each year if half of the US birth cohort receives nirsevimab. This would cost $153 517 per quality-adjusted life year (QALY) saved. Nirsevimab in the second season for children facing a 10-fold higher risk of hospitalization would cost $308 468 per QALY saved. Sensitivity analyses showed RSV hospitalization costs, nirsevimab cost, and QALYs lost from RSV disease were the most influential parameters with cost-effectiveness ratios between cost-saving and $323 788 per QALY saved.
Nirsevimab for infants may be cost-effective, particularly among those with higher risks and costs of RSV.
呼吸道合胞病毒（RSV）在美国婴儿中导致大量住院治疗。免疫实践咨询委员会建议在出生于 RSV 季节期间或进入其首个 RSV 季节的不足 8 个月的婴儿以及在第二个 RSV 季节有较高 RSV 住院风险的 8 至 19 个月龄儿童中使用 nirsevimab。本研究的目的是评估 nirsevimab 在所有首季 RSV 婴儿以及第二季高危儿童中的成本效益。
我们通过模拟 0 至 7 个月龄婴儿和 8 至 19 个月龄婴儿在单个 RSV 季节中有无 nirsevimab 的情况下 RSV 导致的医疗保健利用和死亡情况。数据来自已发表的文献、美国食品和药物管理局批准文件以及流行病学监测数据。我们在整个生命周期内按 3%折现并以 2022 年美元报告社会结果。敏感性和情景分析确定了有影响力的变量。
如果美国出生队列的一半婴儿接受 nirsevimab，我们估计每年可避免 107253 次门诊就诊、38204 次急诊就诊和 14341 次住院治疗。这将使每 QALY（质量调整生命年）节省 153517 美元。对于面临 RSV 住院风险高 10 倍的儿童，在第二季使用 nirsevimab 将使每 QALY 节省 308468 美元。敏感性分析表明 RSV 住院费用、nirsevimab 成本以及因 RSV 疾病而失去的 QALYs 是最具影响力的参数，其成本效益比在成本节约和每 QALY 节省 323788 美元之间。
nirsevimab 对婴儿可能具有成本效益，尤其是对那些 RSV 风险较高且 RSV 成本较高的婴儿。
