Relative cost-effectiveness of an extensively hydrolyzed casein formula containing the probiotic Lactobacillus rhamnosus GG in managing infants with cow’s milk allergy in Italy

Abstract

Objective

To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) containing the probiotic Lactobacillus rhamnosus GG, (eHCF + LGG; Nutramigen LGG) as first-line management for cow’s milk allergy (CMA) compared with eHCF alone, soy-based formulae (SBF), hydrolyzed rice formulae (HRF), and amino acid formulae (AAF) in Italy, from the perspective of the Italian National Health Service (INHS) and parents.

Methods

Decision modeling was used to estimate the probability of infants developing tolerance to cow’s milk by 18 months, based on an observational study dataset. The model also estimated the cost (at 2012/2013 prices) of health care resource use funded by the INHS and formulae paid for by parents over 18 months after starting a formula, as well as the relative cost-effectiveness of each of the formulae.

Results

The probability of developing tolerance to cow’s milk by 18 months was higher among infants with either IgE-mediated or non-IgE-mediated allergy who were fed eHCF + LGG compared to those fed one of the other formulae. The total health care cost of initially feeding infants with eHCF + LGG was less than that of feeding infants with one of the other formulae. Hence, eHCF + LGG affords the greatest value for money to both the INHS and parents of infants with either IgE-mediated or non-IgE-mediated CMA.

Conclusion

Using eHCF + LGG instead of eHCF, SBF, HRF, or an AAF for first-line management of newly diagnosed infants with CMA in Italy affords a cost-effective use of publicly funded resources, and is cost-effective from the parents’ perspective, since it improves outcome for less cost. A randomized controlled study showing faster tolerance development in children receiving a probiotic-containing formula is required before this conclusion can be confirmed.

Keywords:

• amino acid formula
• extensively hydrolyzed formula
• soy-based formulae
• hydrolyzed rice formulae

Acknowledgments

This study was supported with an unrestricted research grant from Mead Johnson Nutrition, Glenview, IL, USA. However, Mead Johnson Nutrition had no influence on: 1) the study design; 2) the collection, analysis, and interpretation of data; 3) the writing of the manuscript; and 4) the decision to submit the manuscript for publication.

The authors wish to thank Professor Roberto Berni Canani, Department of Translational Medical Science, Pediatric Section, University of Naples “Federico II”, Naples, Italy and co-workers for providing their observational study dataset in order to perform the health economic evaluation.

The authors also wish to thank the following clinicians for their contributions to this study: Dr Marina Govoni, pediatrician, Via Di Villa Pardò, Bologna; Dr Francesco Savino, pediatrician, Ospedale Infantile Regina Margherita, Torino; Dr Massimo Landi, pediatrician, Pediatria di Gruppo AslTo1, Torino; Dr Silvia Salvatore, pediatric allergist, Clinica Pediatrica di Varese, Varese; and Dr Silvia Caimmi, pediatric allergist, Università degli Studi di Pavia, Pavia.

Disclosure

The authors report no conflicts of interest in this work.