Abstract

Aims: Respiratory syncytial virus (RSV) is a common cause of respiratory infection in infants and severe infection can result in hospitalisation. The passive immunisation, palivizumab, is used as prophylaxis against RSV, however, use in the UK is restricted to populations at high risk of hospitalisation. This study assesses the cost-effectiveness (CE) of palivizumab in premature infants with and without risk factors for hospitalisation (congenital heart disease [CHD], bronchopulmonary dysplasia [BPD]).

Methods: A decision tree model, based on earlier CE analyses, was updated using data derived from targeted literature reviews and advice gained from a Round Table meeting. All costs were updated to 2019 prices. One-way and probabilistic sensitivity analyses were performed to assess the degree of uncertainty surrounding the results.

Results: Palivizumab is dominant (i.e. clinically superior and cost saving) when used in premature infants born ≤35 weeks gestational age (wGA) without CHD or BPD and aged <6 months at the start of the RSV season, infants aged <24 months with CHD and infants aged <24 months requiring treatment for BPD within the last 6 months.

Limitations: One-way sensitivity analysis suggests that these results are highly sensitive to the efficacy of prophylaxis, number of doses, impact of long-term respiratory sequalae, rate of hospitalisation and mortality due to RSV. A conservative approach has been taken towards long-term respiratory sequalae due to uncertainty around epidemiology and aetiology and a lack of recent cost and utility data.

Conclusions: Palivizumab prophylaxis is cost-effective in preventing severe RSV infection requiring hospital admission in a wider population than currently recommended in UK guidelines. Prophylaxis in premature infants born <29 wGA, 29-32 wGA and 33-35 wGA without CHD or BPD aged <6 months at the start of the RSV season is not funded under current guidance, however, prophylaxis has been demonstrated to be cost-effective in this analysis.

摘要

目的：呼吸道合胞病毒 (RSV) 是婴儿呼吸道感染的常见原因，严重感染可导致住院治疗。被动免疫帕利珠单抗用于预防 RSV，然而，在英国使用仅限于住院高风险人群。本研究评估了帕利珠单抗在有和没有住院风险因素（先天性心脏病 [CHD]、支气管肺发育不良 [BPD]）的早产儿中的成本效益 (CE)。

方法：基于早期 CE 分析的决策树模型使用来自有针对性的文献综述和圆桌会议建议的数据进行更新。所有费用均更新为 2019 年价格。进行单向和概率敏感性分析以评估围绕结果的不确定性程度。

结果：帕利珠单抗在用于胎龄≤35 周（wGA）且无 CHD 或 BPD 且 RSV 季节开始时年龄 <6 个月的早产儿、<24 个月患有在过去 6 个月内需要接受 BPD 治疗的冠心病和年龄 <24 个月的婴儿。

局限性：单向敏感性分析表明，这些结果对预防效果、剂量数量、长期呼吸道后遗症的影响、住院率和 RSV 死亡率高度敏感。由于流行病学和病因学的不确定性以及缺乏最近的成本和效用数据，对长期呼吸道后遗症采取了保守的方法。

结论：帕利珠单抗预防在预防需要住院的严重 RSV 感染方面具有成本效益，比目前英国指南推荐的人群更广。在 RSV 季节开始时，出生 <29 wGA、29-32 wGA 和 33-35 wGA 且年龄 <6 个月且没有 CHD 或 BPD 的早产儿的预防在目前的指导下没有得到资助，但是，预防已被证明是成本-在这个分析中有效。