Objective: To develop a complete economic evaluation on the use of bacterial lysates for upper recurrent respiratory infections (URRI) prevention in pediatric patients from the Mexican national public health system.

Methods: A cost- effectiveness analysis was performed considering the difference in frequency of URRI reported on a meta-analysis by Yin et al in 2018. The analysis was performed through a decision tree model with a 6-months temporal horizon. Additionally, a budget impact analysis was developed to validate the financial impact of treatment inclusion to Mexico’s health system. The clinical information was obtained through an exhaustive search of different databases for pediatric population with the objective of evaluating the efficacy and safety of the standard lyophilized bacterial lysates in comparison with routine therapy for the management of URRI validated through an expert panel based on the Delphi method.

Results: The standard lyophilized bacterial lysates showed a significant reduction on the frequency of URRI in pediatric patients (mean difference [MD] =-2.33, 95% CI) versus the comparator. In a 6-month period, the standard lyophilized bacterial lysates generated an average cost per patient of $22,966.36 MxN vs $43,879.26 MxN of the proposed comparator. When estimating the incremental cost-effectiveness ratio, it was observed that the standard lyophilized bacterial lysates is the dominating option due to its improved efficacy and a lower average cost per patient. The budget impact analysis showed that the inclusion of the standard lyophilized bacterial lysates would generate annual average savings of $582,378,921.10 MxN in 5 years for Mexico’s national health system.

Conclusions: When considering the difference in URRI frequency in the pediatric population as an outcome evaluator, the standard lyophilized bacterial lysates are a dominant and efficient option for Mexico’s national health system.