Budget impact and cost-utility analysis of universal infant rotavirus vaccination in Spain

Highlights

• Universal rotavirus vaccination: More advanced economic evaluation for Spain

• Vaccination was no cost-effective unless large variations in price, efficacy and/or utilities took place.

• The model was stable to changes for the rest of variables.

• Large health care budget increase, more than ten million euros per year.

Abstract

Rotavirus is not included in the Spanish mass infant vaccination schedule but has also not been economically evaluated for its inclusion. We analysed cost-utility of the universal infant rotavirus vaccination using RotaTeq® versus no vaccination in Spain. We also carried out a budget impact analysis and determined the effect on results of different variables introduced in the model. A deterministic Markov model was built considering loss of quality of life for children and their parents, and introducing direct and indirect costs updated to 2011.

The introduction of the vaccination using RotaTeq® as a universal infant vaccination would increase the annual health care budget in 10.43 million euro and would result in a gain of an additional Quality Adjusted Life Year at a cost of 280,338€ from the healthcare system perspective and 210,167€ from the societal perspective. The model was stable to variable modifications.

To sum up, according to our model and estimates, the introduction of a universal infant rotavirus vaccination with RotaTeq® in Spain would cause a large impact on the health care budget and would not be efficient unless significant variations in vaccine price, vaccine efficacy and/or utilities took place.

Introduction

Rotavirus is a major cause of acute gastroenteritis in children worldwide (CDC, 2011). Although deaths due to rotavirus occur mostly in less-developed countries (Parashar et al., 2009), a substantial burden of Rotavirus Gastroenteritis (RVGE) has been reported in European countries (Giaquinto et al., 2007). In Spain, RVGE entails important morbidity and considerable resource utilization across all health care settings, as well as for families of patients and their employers (Diez-Domingo et al., 2010). It has been estimated that 181,626 episodes of acute gastroenteritis occur per year among children under 5 years of age in Spain (Díez-Domingo et al., 2010), which translates into 14,342 hospitalizations, 41,701 emergency department visits and 48,320 primary care visits with important implications for families, and society as a whole. Spanish parents miss, on average, 4.6 workdays when their child is hospitalized due to a rotavirus infection (Giaquinto et al., 2007).

Vaccination has proven to be effective in preventing rotavirus infections and limiting their impact (Vesikari et al., 2006). Although there are two rotavirus vaccines authorized for use in the European market, RotaTeq® and Rotarix®, our study has focused only on RotaTeq®, as it is the only vaccine available in Spain (Agencia Española de Medicamentos y Productos Sanitarios, 2010a, Agencia Española de Medicamentos y Productos Sanitarios, 2010b, Agencia Española de Medicamentos y Productos Sanitarios, 2010c). Currently the rotavirus vaccination is not included within the Spanish universal infant vaccination schedule, so RotaTeq® has to be purchased at market prices, as an out of pocket expense, if so desired.

The introduction of a new vaccine into the public immunization schedule would require a high resource investment and significant costs, taking into account that public vaccination programmes are, currently, completely publicly funded.

Cost-utility studies have been performed in some European countries, though not in the Spanish setting, estimating the costs of adding a Quality Adjusted Life Year (QALY) with mass vaccination versus no vaccination and adopting time dependence models. The assessments have differed in their assumptions, choice of model, contextual information, and other parameters, but also in their results. Some of them have concluded in favour of the introduction of the universal rotavirus vaccination (Atkins et al., 2012, Jit et al., 2009). However, most of them have come to the conclusion that the introduction of the vaccine would not be efficient with the current conditions, although a lower vaccine price could achieve a cost-effective result(Bilcke et al., 2009, Mangen et al., 2010, Melliez et al., 2008, Rozenbaum et al., 2011, Tilson et al., 2011).

An economic evaluation of rotavirus vaccination has recently been published for a specific region in Spain, “Castilla y León” (Pérez-Rubio et al., 2011). The study estimates the cost–utility ratio based on a decision tree that does not take into account time evolution and second episodes. Our study tries to overcome these limitations, using a Markov model, to compare the cost–utility of the universal infant rotavirus vaccination in Spain using RotaTeq® versus no vaccination. In addition, we assessed the effect on these results of varying different variables that feed the model.