Palivizumab in the prevention of severe respiratory syncytial virus infection in children with congenital heart disease; a novel cost-utility modeling study reflecting evidence-based clinical pathways in Spain

Abstract

Background: Respiratory syncytial virus (RSV) infection remains one of the major reasons of re-hospitalization among children with congenital heart disease (CHD). This study estimated the cost-effectiveness of palivizumab prophylaxis versus placebo, in Spain, from the societal perspective, using a novel cost-effectiveness model reflecting evidence-based clinical pathways. Methods: A decision-analytic model, combining a decision tree structure in the first year and a Markov structure in later years, was constructed to evaluate the benefits and costs associated with palivizumab versus no prophylaxis among children with CHD. In the first year of the model, children were at risk of mild (i.e. medically attended, MA-RSV) and severe (hospitalized, RSV-H) RSV infection. The impact of delayed corrective CHD surgery due to RSV infection and the consequence of performed surgery despite severe infection were considered. In later years, patients were at risk of developing asthma and allergic sensitization as sequelae of RSV infection. Input data for the model were derived from the pivotal clinical trial and systematic literature reviews. Indirect costs included parental absence from work and nosocomial infections. In agreement with Spanish guidelines, costs and effects were discounted at 3%. Results: Over a lifetime horizon, palivizumab prophylaxis yielded 0.11 and 0.07 additional quality-adjusted life years (QALYs) and life years (LYs), respectively, at additional costs of € 1,693, resulting in an ICER of € 15,748 per QALY gained and € 24,936 per LY gained. Probabilistic sensitivity analyses demonstrated that the probability of palivizumab prophylaxis being cost-effective at a € 30,000 per QALY threshold was 92.7%. The ICER remained below this threshold for most extreme scenario analyses. Conclusions: The model demonstrated that palivizumab prophylaxis results in more QALYs than no prophylaxis in children with CHD. Palivizumab prophylaxis was shown to be a cost-effective health care intervention according to the commonly accepted standards of cost-effectiveness in Spain (ICER below the threshold of € 30,000 per QALY).

Population-based Respiratory Syncytial Virus Hospitalization Disease Burden and Cost Effectiveness of Palivizumab Prophylaxis in Infants with Hemodynamically Significant Congenital Heart Diseases

“…[26,[31][32][33][34][35][36][37][38][39][40] Unfortunately, only a few studies were focused on this group of patients alone in areas with a distinct RSV season, and none of which were population-based. [26,31,33,40,41] These studies were mainly based on either hypothetical patient cohorts or decision-analysis models using ICER/Quality Adjusted Life year (QALY) to assess cost-effectiveness with an exceedingly wide range reported from €9,259 to US$114,337/QALY. [33,40,41] Despite a very favorable ICER/QALY was reported by Nuijten et al, a scenario analysis excluding mortality from the model was reported to raise the ICER/QALY signi cantly from €9,259 to €123,439/QALY.…”

“…[26,31,33,40,41] These studies were mainly based on either hypothetical patient cohorts or decision-analysis models using ICER/Quality Adjusted Life year (QALY) to assess cost-effectiveness with an exceedingly wide range reported from €9,259 to US$114,337/QALY. [33,40,41] Despite a very favorable ICER/QALY was reported by Nuijten et al, a scenario analysis excluding mortality from the model was reported to raise the ICER/QALY signi cantly from €9,259 to €123,439/QALY. [41] Judging from the fact that the RSV related mortality in this group of patients reported from the REGAL series covers a wide range from 0 to 3.3%, we think using ICER/QALY in hypothetical model may result in signi cant inaccuracy.…”

Updated cost-effectiveness analysis of palivizumab (Synagis) for the prophylaxis of respiratory syncytial virus in infant populations in the UK

“…Three of these related to various iterations of the JCVI (West Midlands HTA) model carried out by Wang et al [24][25][26] A further study was an evolution of this approach, funded by AbbVie and published in 2013. 27 We also identified five other studies: one from the UK, 4 two from Spain, 28,29 one from the Netherlands 30 and one from Canada. 31 These publications used approaches that were either at odds at those adopted by JCVI or simply reinforced the conclusions of the two key models, therefore, we did not consider these models further and focused on the West Midlands HTA model carried out by Wang et al [24][25][26] and the updated Bentley et al 27 model.…”

Respiratory Syncytial Virus Infections among Children with Congenital Heart Disease

“…The model demonstrated that palivizumab prophylaxis results in more quality-adjusted life years (QALY) than placebo in children with CHD. Palivizumab prophylaxis was shown to be a cost-effective health-care intervention according to the commonly accepted standards of cost-effectiveness in Spain [35].…”