In 2016 the Italian Medicines Agency (AIFA) decided to limit the coverage of the prophylaxis with palivizumab following the American Academy of Pediatrics guidelines. In 2017 as a consequence of the strong debate that involved scientific societies, patients' associations and governing authorities, AIFA took a step back on its decision and restored the initial criteria. The present study assessed the impact of such governing measures on hospitalisations for respiratory syncytial virus (RSV) and the concomitant number of prescriptions of palivizumab for children aged < 2. During the considered four weeks (2014-2018) in the Lazio region 7,042 hospitalisations for respiratory viruses were observed in children aged < 2, of which 35.2% (no. = 2,476) for RSV. Following 2016-AIFA restrictions a decrease in the number of hospitalisations for RVS from 6.3 / 1,000 (95% CI from 6.0 to 6.7) to 5.5 / 1,000 (CI 95% from 5.0 to 5.9) was observed. In the same period the number of prescriptions of palivizumab concomitantly decreased by 48% (a saving of 750,000 euro for the National Health System). Therefore, the implementation of the new criteria for the reimbursement of palivizumab did not reflect an increase in the hospitalisation rate for RVS for children aged < 2, despite a significant decrease in the number of prescriptions of palivizumab.
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