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Neonatal outcomes following new reimbursement limitations on palivizumab in Italy
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  • Published on: 21 April 2025
    Response to comments of Dr Andrea Dotta and Dr Renato Cutrera
    • Antonio Addis, Dr Department of Epidemiology, Lazio Regional Health Service, Roma 00147, Italy
    • Other Contributors:
      • Valeria Belleudi, Dr

    Dear Editor,

    We thank you for the opportunity to discuss our data with the two correspondents who raised some concerns regarding the selected population of our analysis on neonatal outcomes following new reimbursement criteria on palivizumab use. They also reported data collected during the same time period and apparently different from our main results.

    In response to the first correspondent, our analysis is based on children < 2 years of age because the candidate for palivizumab treatments are included within this subpopulation. In fact, the therapeutic indication (1) of palivizumab includes not only the preterm infants up to 1 year of age but also children up to 2 years of age and treated for bronchopulmonary dysplasia or born with a serious heart disease. Furthermore, our selected population is consistent with previous analysis (2) that measured the association between updated guidelines-based palivizumab administration and hospitalization for Respiratory Syncytial Virus (RSV).   Table 1 of our study reports children up to 6 months of age, both at risk of RSV and including hospitalization data. We agree that this is probably the subpopulation with the major impact of the palivizumab treatment and regulatory decision. However, also in this case no differences in hospitalization rate have been detected before-after the AIFA’ limitation for palivizumab: 1031/47.608 (21.7 ‰) and 436/22715 (19.2 ‰) hospitalizations, respectiv...

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    Conflict of Interest:
    None declared.
  • Published on: 20 November 2018
    Correct target population for Palivizumab cost-utility analysis
    • Andrea Dotta, Neonatologist; Chief of NICU - Bambino Gesù Children's Hospital - Rome Italy on behalf of Regional Session of Italian Society of Neonatology
    • Other Contributors:
      • Pietro Ferrara, Pediatrician; Institute of Pediatrics, Catholic University Medical School

    Dear authors,

    We are kindly observing that the study on hospitalizations for infection due to respiratory syncytial virus should be conducted on infants aged <1 year old [1], and not on infants aged <2 years old. Such a choice is motivated by medical literature and since the prescription of palivizumab on the general population of preterm infants is up to 1 year of age. Moreover, the study does not tightly classify the hospitalization depending on the gestational age, a lack of information that exclude the possibility of a punctual statistical analysis on the infants whose gestational age is between 29-35 weeks, population matter of the analysis, impacted by the AIFA reimbursement limitations.
    In the study infants aged <2 years old have been considered, the same subjects are statistically contributing to two consecutive seasons with different ages. The algebraic sum of the season 2014-2015 / 2015-2016 perpetuate the complexity of analysis of hospitalization for a specific season, if the infant is hospitalized in the season of his/her birth or next year.
    As reported by Medici et al. [2], respiratory syncytial virus infection has a 2-years evolution, with a less critical year following a year with more abundant virus diffusion. By algebraically summing the data from two consecutive years the seasonality, so the stochasticity, is lost. Eventually the season 2016-2017 appear to be the less critical season. Environmental and patient conditions such...

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    Conflict of Interest:
    None declared.
  • Published on: 20 November 2018
    Neonatal Outcome in Italy: a clinical point of view
    • Renato Cutrera, Director Pediatric Pulmonology Unit Pediatric Hospital Bambino Gesu' - IRCCS Rome, Italy
    • Other Contributors:
      • Simonetta Picone, Pediatrician
      • Fabio Midulla, Associate Professor

    Dear authors, dear editors,

    We are writing to respond with our data, that, in the same region (Lazio), indicate a different pattern.
    We have focused on the patients that were previously eligible for palivizumab treatment (only preterm infants, with gestational age>29 weeks), in three different hospitals located in Rome.
    Please consider that the time frame is the year before and the year after of the AIFA reimbursement limitations, the same years where in Figure 1 of your manuscript you show higher hospitalizations before and lower hospitalizations after AIFA limitations.
    At the NICU Casilino Hospital (ref.A) we have noticed an increase in the number of bronchiolitis from the year before (6 bronchiolitis/35 children with 30-32WGA; 17%) to the year after limitations (12/47; 26%).
    At the Sapienza University of Rome we have registered an increase in hospitalizations for bronchiolitis in children with 30-36 WGA from 14 out of 165 hospitalizations (8.5%) during the 2015/16 season to 21/141 hospitalizations in the subsequent season (14.9%, p =0.05). Of them, respectively 8 (14%) and 13 (18.3%) were due to RSV, although the difference is not statistically significant. The total number of VRS+ increased significantly in the second year (ref.B).
    At the OPBG we have analysed only the data from the 2016/17 season and we have noticed a higher incidence of bronchiolitis in the late preterm (13 VRS+/27 children 30-37WGA, not treated with palivizuma...

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    Conflict of Interest:
    RC and FM received grant for partecipation of advisory boards from Abbvie