Violicom Medical Limited, Aldermaston, Berkshire, United Kingdom.
MA Provider, Milan, Lombardy, Italy.
PLoS One. 2023 Aug 10;18(8):e0289828. doi: 10.1371/journal.pone.0289828. eCollection 2023.
Since the last Italian cost-utility assessment of palivizumab in 2009, new data on the burden of respiratory syncytial virus (RSV) and an International Risk Scoring Tool (IRST) have become available. The objective of this study was to provide an up-to-date cost-utility assessment of palivizumab versus no prophylaxis for the prevention of severe RSV infection in otherwise healthy Italian infants born at 29-31 weeks' gestational age (wGA) infants and those 32-35wGA infants categorized as either moderate- or high-risk of RSV-hospitalization (RSVH) by the IRST. A decision tree was constructed in which infants received palivizumab or no prophylaxis and then could experience: i) RSVH; ii) emergency room medically-attended RSV-infection (MARI); or, iii) remain uninfected/non-medically attended. RSVH cases that required intensive care unit admission could die (0.43%). Respiratory morbidity was considered in all surviving infants up to 18 years of age. Hospitalization rates were derived from Italian data combined with efficacy from the IMpact-RSV trial. Palivizumab costs were calculated from vial prices (50mg: €490.37 100mg: €814.34) and Italian birth statistics combined with a growth algorithm. A lifetime horizon and healthcare and societal costs were included. The incremental cost-utility ratio (ICUR) was €14814 per quality-adjusted life year (QALY) gained in the whole population (mean: €15430; probability of ICUR being <€40000: 0.90). The equivalent ICURs were €15139 per QALY gained (€15915; 0.89) for 29-31wGA infants and €14719 per QALY gained (€15230; 0.89) for 32-35wGA infants. The model was most sensitive to rates of long-term sequelae, utility scores, palivizumab cost, and palivizumab efficacy. Palivizumab remained cost-effective in all scenario analyses, including a scenario wherein RSVH infants received palivizumab without a reduction in long-term sequelae and experienced a 6-year duration of respiratory morbidity (ICUR: €27948 per QALY gained). In conclusion, palivizumab remains cost-effective versus no prophylaxis in otherwise healthy Italian preterm infants born 29-35wGA. The IRST can help guide cost-effective use of palivizumab in 32-35wGA infants.
自 2009 年意大利最后一次进行帕利珠单抗成本效用评估以来，有关呼吸道合胞病毒（RSV）负担和国际风险评分工具（IRST）的新数据已经可用。本研究的目的是提供帕利珠单抗与无预防措施预防 otherwise healthy 意大利早产儿的严重 RSV 感染的最新成本效用评估，这些婴儿的胎龄为 29-31 周（wGA），并且根据 IRST 被归类为中度或高风险 RSV-住院（RSVH）的 32-35wGA 婴儿。构建了一个决策树，其中婴儿接受帕利珠单抗或无预防措施，然后可能会经历：i）RSVH；ii）急诊室因 RSV 感染而接受医疗护理（MARI）；或 iii）保持未感染/未接受医疗护理。需要入住重症监护病房的 RSVH 病例可能会死亡（0.43%）。在所有存活的婴儿中，直到 18 岁都考虑了呼吸道发病率。住院率是根据意大利的数据和 IMpact-RSV 试验的疗效得出的。帕利珠单抗的成本是根据小瓶价格（50mg：€490.37 100mg：€814.34）和意大利出生统计数据以及生长算法计算得出的。采用终生时间范围和医疗保健和社会成本。增量成本效用比（ICUR）在整个人群中每获得 1 个质量调整生命年（QALY）的成本为 €14814（平均值：€15430；ICUR 低于€40000 的概率：0.90）。29-31wGA 婴儿的等效 ICUR 为每获得 1 个 QALY 的成本为 €15139（€15915；0.89），32-35wGA 婴儿的等效 ICUR 为每获得 1 个 QALY 的成本为 €14719（€15230；0.89）。该模型对长期后遗症、效用评分、帕利珠单抗成本和帕利珠单抗疗效的比率最为敏感。在所有情景分析中，帕利珠单抗仍然具有成本效益，包括 RSVH 婴儿接受帕利珠单抗而不减少长期后遗症并经历 6 年呼吸道发病率的情况（ICUR：每获得 1 个 QALY 的成本为 €27948）。总之，帕利珠单抗在 otherwise healthy 意大利早产儿出生的 29-35wGA 中仍然具有成本效益。IRST 可以帮助指导 32-35wGA 婴儿中帕利珠单抗的成本效益使用。
