The Spanish Ministry of Health asked us about the efficiency of extending the current rotavirus vaccination strategy to all newborns. The current strategy is to vaccinate only to high-risk newborns (premature and those qualified as high-risk by a pediatrician). The objective of this research was to compare three strategies: no-vaccination, vaccination of high-risk newborns and universal vaccination, considering the two vaccines available in Spain: RotaTeq® and Rotarix®.

A cost-utility analysis, based on a de novo Markov model, was carried out both from a societal and a healthcare system perspective. The model follows a cohort of newborns during their life-course. The cycle length is annual and a half-cycle correction was applied. A discount rate of 3 percent was applied in the base case both to costs and utilities. Most of the incidence, probabilities and costs data were Spanish. The Quality Adjusted Life Year (QALY) data were taken from international literature. We assumed a willingness to pay threshold of EUR 25,000 per QALY gained. We performed deterministic one-way sensitivity analysis.

Compared to no-vaccination, the high-risk vaccination strategy is cost-effective assuming the above- mentioned threshold only with Rotarix® from a societal perspective (RotaTeq® EUR 32,008 per QALY; Rotarix® EUR 23,368 per QALY). Universal vaccination is not cost-effective either compared to no-vaccination or compared to the high-risk vaccination strategy and with both perspectives. Vaccine prices and efficacy data are highly sensitive variables. We find that universal vaccination would be cost-effective with a discount of 44.6 and 36.9 percent of the current price of RotaTeq® and Rotarix®, respectively.

Universal vaccination would not be a cost-effective strategy for Spain with either of the two vaccines at current prices. Vaccination of high-risk newborns would be cost-effective at current prices and from a societal perspective only with Rotarix®. Substantial vaccines price reductions could make the universal vaccination a cost-effective option in Spain.