Elsevier

Vaccine

Volume 26, Issue 5, 30 January 2008, Pages 706-715
Vaccine

Cost and cost-effectiveness of childhood vaccination against rotavirus in France

https://doi.org/10.1016/j.vaccine.2007.11.064Get rights and content

Summary

Objectives

To assess the effectiveness and cost-effectiveness of routine childhood vaccination by new vaccines against rotavirus in France.

Methods

We constructed a Markov decision tree to compare two alternatives: “no vaccination” and “vaccination”. A hypothetical birth cohort of 750,000 children was followed until 3 years of age. First, the disease burden without vaccine was estimated using data from French databases and medical literature. Incidence rates in unvaccinated children were modelled as a function of age and seasons. Next, using data from the medical literature, the vaccine's protective effect on rotavirus diarrhoea was considered.

Results

A routine universal rotavirus immunization programme was estimated capable of annually avoiding 89,000 cases of diarrhoea, 10,500 hospitalizations, and 8 deaths. At a vaccination cost of €150/course, assuming 75% vaccine coverage, the programme would cost €95 million and involve a net loss of €68 million to the health care system. The vaccination programme would cost €298,000/year of life saved, and €138,000/QALY saved. Key variables affecting the results were disease incidence, mortality rates and vaccine price.

Conclusion

In France, childhood rotavirus vaccination with new antirotavirus vaccines would reduce the morbidity burden of rotavirus infection, but would not be cost-effective unless the price of vaccine decreased considerably.

Introduction

Rotavirus has been recognized as the main cause of severe acute diarrhoea in young children [1]. In tropical countries, rotavirus infection is associated with high mortality [2]. In temperate countries rotavirus infection is associated with low mortality, but is responsible for high morbidity. In a previous study, we found that in France, rotavirus infection is responsible, annually, for 300,000 episodes of acute diarrhoea among children under 5 years of age [3].

To reduce the burden of rotavirus infection, huge efforts have been made to develop a vaccine. In 1998, the first oral reassortant tetravalent rotavirus vaccine was licensed in the United States [4], [5], [6], [7], [8]. However, its use was stopped after an association between the vaccine and the risk of intussusception was detected [9]. A monovalent vaccine based on an attenuated human rotavirus strain (RotaRix®) and a human-bovine reassortant rotavirus vaccine (RotaTeq®) were recently licensed in many countries throughout the world [10], [11]. Several randomized clinical trials have been conducted to evaluate and demonstrate the efficacy of these new vaccines [12], [13], [14], [15]. However, the decision whether or not to integrate a new vaccine into the routine immunization schedule increasingly requires cost and cost-effectiveness analysis, in order to optimize the allocation of limited financial resources and establish health intervention priorities on the basis of concrete evidence. The objective of this study was to compare the results of routine infant rotavirus vaccination versus no intervention, in terms of life years saved, costs and cost-effectiveness ratios. This study was performed as part of an “expert advice” provided by the French Advisory Board on Immunization to the Ministry of Health, in order to participate in the decision-making process regarding universal infant rotavirus vaccination in France.

Section snippets

Study design

We estimated the impact of rotavirus vaccination performed during the first 4 months of life [12], [13], [14], [15] as part of routine infant immunization, and compared this impact to that of the absence of rotavirus vaccination, which is the current situation in France. A Markov decision tree of the risk of various rotavirus-related outcomes was constructed to compare the two alternative strategies. The analysis was applied to a hypothetical French birth cohort of 750,000 children (the average

Model validation

To assess the internal validity of the model, we compared our estimates on the incidence of acute forms of diarrhoea related to rotavirus infection during the first 3 years of life with the incidences of these episodes respectively observed in cohorts and placebo arms of randomized controlled trials conducted in Europe and the United States, to evaluate the efficacy of each vaccine against rotavirus infection (Table 3). Overall, the incidence projected by the model was within 7% of those

Discussion

In this study, using a Markov decision tree and data for the natural history of rotavirus diarrhoea, in France, we estimated the annual incidence of rotavirus diarrhoea at 0.081 per person-year, and found that rotavirus infection is responsible for about 13 deaths and 18,000 hospitalizations annually. Using data from clinical trials designed to assess rotavirus vaccine efficacy, we found that a programme using these vaccines, with a coverage rate of 75%, would avoid 89,000 episodes of acute

Conflict of interest

None.

Acknowledgements

This study was supported by grants from the Fondation pour la Recherche Médicale (Medical Research Foundation), and the Institut de Veille Sanitaire (Health Monitoring Institute). We also acknowledge POLYMOD for their support.

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