Background The indication of palivizumab is the prevention of serious lower respiratory tract disease requiring hospitalisation caused by the respiratory syncytial virus (RSV) in children at high risk for RSV disease, but medication assessment in different conditions to the authorised ones is a fairly common situation in our environment, thus the hospital maintain a multidisciplinary pharmacy committee which evaluates this medication for personalised authorisation.
Purpose The purpose of this study is to evaluate palivizumab off-label use (2016–2017).
Material and methods Observational retrospective study of patients receiving palivizumab off-label use. The analysed variables were; base pathology, gestational age, hospitalisation number, costs and evidence degree according to the US Agency for Healthcare Research and Quality scale.
Results Eighteen children (22.2% repeated prophylaxis the second year) were treated with palivizumab with an average age of 24.76 (5–63 months), 44,4% girls. Palivizumab use of off label represented 8.7% of total patients treated with palivizumab (230 patients). 33.3% were diagnosed with cystic fibrosis, 33.3% congenital myopathy and 5.5% respiratory disorders (recurrent pneumonia, pulmonary hypoplasia and respiratory infections secondary to kidney dysplasia, esophageal atresia and interstitial lung disease). According to the evidence level, in children with cystic fibrosis it presents grade Ib, in myopathy prophylaxis the grade is II (cohorts) and for esophageal atresia, pulmonary malformations and serious respiratory diseases the grade is IV (expert opinion). 33.3% of patients had a gestational age under 37 weeks. 11.1% of hospitalisations by RVS infection required oxygen therapy (a patient after having received prophylaxis in previous years and another hospitalisation by VRS in 2016 that was not repeated after the palivizumab treatment in 2017) (7.7 hospitalisation days). Dosage was 15 mg/kg monthly during the 4–5 months of the risk season. The cost/patient/year: €6,255.75 to €7,807.5 (VAT included). The estimated economic impact was €112,603,5 to €1 40 535 (16.8%–21% of total palivizumab cost).
Conclusion Given the existing low degree of evidence, this study shows that there are no clear advantages of this medication in patients with cystic fibrosis and neuromuscular problems. Consequently, and given the high cost that palivizumab use implies, it would be necessary to establish protocols that define use condition and identification of patients that may benefit better from the treatment.
References and/or acknowledgements No conflict of interest.
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