BackgroundThis study aimed at estimating the efficiency of palivizumab in the prevention of Respiratory Syncytial Virus (RSV) infection and its sequelae in preterm infants (32day 1-35day 0weeks of gestational age –wGA-) in Spain.MethodsA decision-tree model was developed to compare health benefits (Quality Adjusted Life Years-QALYs) and costs of palivizumab versus a non-prophylaxis strategy over 6 years. A hypothetical cohort of 1,000 preterm infants, 32day 1-35day 0 wGA (4.356 kg average weight) at the beginning of the prophylaxis (15 mg/kg of palivizumab; 3.88 average number of injections per RSV season) was analysed.The model considered the most recent evidence from Spanish observational and epidemiological studies on RSV infection: the FLIP II study provided hospital admission and Intensive Care Unit (ICU) admission rates; in-hospital mortality rate was drawn from an epidemiological study from 2004 to 2012; recurrent wheezing rates associated to RSV infection from SPRING study were adjusted by the evidence on the palivizumab effect from clinical trials. Quality of life baseline value, number of hospitalized infants and the presence of recurrent wheezing over time were granted to estimate QALYs.National Health Service and societal perspective (included also recurrent wheezing indirect cost) were analysed. Total costs (€, 2016) included pharmaceutical and administration costs, hospitalization costs and recurrent wheezing management annual costs. A discount rate of 3.0% was applied annually for both costs and health outcomes.ResultsOver 6 years, the base case analysis showed that palivizumab was associated to an increase of 0.0731 QALYs compared to non-prophylaxis. Total costs were estimated in €2,110.71 (palivizumab) and €671.68 (non-prophylaxis) from the National Health System (NHS) perspective, resulting in an incremental cost utility ratio (ICUR) of €19,697.69/QALYs gained (prophylaxis vs non-prophylaxis). Results derived from the risk-factors population subgroups analysed were in line with the total population results. From the societal perspective, the incremental cost associated to palivizumab decreased to an €1,253.14 (ICUR = €17,153.16€/QALYs gained for palivizumab vs non-prophylaxis). One-way and probabilistic sensitivity analyses confirmed the robustness of the model.ConclusionsThe prophylaxis with palivizumab is efficient for preventing from RSV infections in preterm infants 32day 1-35day 0 wGA in Spain.Electronic supplementary materialThe online version of this article (10.1186/s12879-017-2803-0) contains supplementary material, which is available to authorized users.
database including approximately 6.7 million insured anonymities originating from 63 statutory health insurances. Analyses were performed by the InGef institute. A sample with approximately 4 million insured persons was drawn and stratified by age and gender according to the official demographic structure of the German statutory health insured population (DeStatis, Dec 31st, 2013). Patient data from 2012 -2016 were included if they met the following conditions: Main diagnosis of PsO (ICD-10 code L40.-), and start / maintenance / switch of treatment with PsO approved biological agent(s) (at least for three months). The study evaluated hospital admission, change in medication and direct medical costs (drug, outpatient care, hospitalization). Results: Leading biological agents for 1st line treatment of PsO are adalimumab and apremilast, however, at a low level of share of prescriptions. Adalimumab and etanercept are administered mostly to patients already on treatment (in 2015 adalimumab 40.4 % vs. etanercept 26.6 %). The total costs of the included 2'041 patients add up to € 36'874'827 in 2015. The total number of patients, the number of hospital admissions and the total treatment costs including all individual cost items grew yearly on average between 1. 7% and 14.5 % (2012 -2015). Hospitalization per patient declined slightly from 0.8 to 0.7. ConClusions: Adalimumab, apremilast and etanercept are those biological agents mainly used for treating PsO. All cost items grew steadily over the last 4 years. Total costs in 2015 were € 36.9 million (on average € 18'067 per patient).
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