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Julian F Guest,1,2 Ariana C Yang,3 Jane Oba,4 Maraci Rodrigues,5 Rosane Caetano,6 Lilian Polster7 1Catalyst Health Economics Consultants, Northwood, Middlesex, UK; 2Faculty of Life Sciences and Medicine, King’s College, London, UK; 3Universidade de São Paulo, São Paulo & Universidade Estadual de Campinas, São Paulo, Brazil; 4Hospital Israelita Albert Einstein, São Paulo, Brazil & Hospital Municipal Menino Jesus, São Paulo, Brazil; 5Department of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil; 6General Pediatrician, Rio de Janeiro, Brazil; 7General Pediatrician, São Paulo, Brazil Objective: To estimate the cost-effectiveness of three alternative dietetic strategies for cow’s milk allergy in Brazil: 1) using an extensively hydrolyzed casein formula (eHCF; ­Nutramigen) as a first-line formula, but switching to an amino acid formula (AAF) if infants remain symptomatic; 2) using an AAF as a first-line formula and then switching to an eHCF after 4weeks once infants are symptom-free, but switching back to an AAF if infants become symptomatic; and 3) using an AAF as a first-line formula and keeping all infants on that formula. The analysis was conducted from the perspective of the Brazilian public health care system, Sistema Único de Saude.Methods: Decision modeling was used to estimate the probability of immunoglobulin E (IgE)-mediated and non-IgE-mediated allergic infants developing tolerance to cow’s milk by 12 months from starting a formula. The models also estimated the Sistema Único de Saude cost (at 2013/2014 prices) of managing infants over 12 months after starting a formula, as well as the relative cost-effectiveness of each of the dietetic strategies.Results: The probability of developing tolerance to cow’s milk by 12 months from starting a formula was higher among infants with either IgE-mediated or non-IgE-mediated allergy who were initially fed with an eHCF, compared with those who were initially fed with an AAF. The total health care cost of initially feeding an eHCF to cow’s milk allergic infants was less than that of initially feeding both IgE-mediated and non-IgE-mediated infants with an AAF.Conclusion: Within the study’s limitations, using an eHCF instead of an AAF for the first-line management of newly-diagnosed infants with cow’s milk allergy affords a cost-effective use of publicly funded resources, since it improves the outcome for less cost. Keywords: amino acid formula, Brazil, cost-effectiveness, cow’s milk allergy, extensively hydrolyzed formula

Julian F Guest,1,2 Diana Weidlich,1 Maciej Kaczmarski,3 Elzbieta Jarocka-Cyrta,4 Natalia Kobelska-Dubiel,5 Agnieszka Krauze,6 Iwona Sakowska-Maliszewska,7 Anna Zawadzka-Krajewska8 1Catalyst Health Economics Consultants, Northwood, Middlesex, 2Faculty of Life Sciences and Medicine, King’s College, London, UK; 3Department of Pediatrics, Gastroenterology, and Allergology, Medical University of Bialystok, Białystok, 4Uniwersytet Warmińsko‑Mazurski, Wydział Nauk Medycznych, Katedra Pediatrii Klinicznej, Olsztyn, 5Department of Pediatric Gastroenterology and Metabolic Diseases, Poznań University of Medical Sciences, Poznań, 6Klinika Pneumonologii i Alergologii Wieku Dziecięcego, Warsaw, 7Poradnia Gastroenterologiczna Centrum Pediatrii, Sosnowiec, 8Department of Pediatric Pneumonology and Allergology, Medical University of Warsaw, Warsaw, Poland 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 an initial treatment for cow’s milk allergy compared with eHCF alone and amino acid formulas (AAF) in Poland from the perspective of the Polish National Health Fund (Narodowy Fundusz Zdrowia [NFZ]) and parents. Methods: Decision modeling was used to estimate the probability of cow’s milk allergic infants developing tolerance to cow’s milk by 18 months. The model also estimated the cost to the NFZ and parents (Polish Zloty [PLN] at 2013–2014 prices) for managing infants over 18 months after starting one of the formulas as well as the relative cost-effectiveness of each of the formulas. Results: The probability of developing tolerance to cow’s milk by 18 months was higher among infants who were fed eHCF + LGG (0.82) compared with those fed eHCF alone (0.53) or an AAF (0.22). An infant who is initially managed with eHCF + LGG is expected to consume fewer health care resources than infants managed with the other formulas. Hence, the estimated total health care cost incurred by the NFZ for initially feeding infants with eHCF + LGG (PLN 5,693) was less than that of feeding infants with eHCF alone (PLN 7,749) or an AAF (PLN 24,333). However, the total cost incurred by parents for initially feeding infants with an AAF (PLN 815) was marginally less than that of feeding with eHCF + LGG (PLN 993), which was less than that of feeding with eHCF alone (PLN 1,226). Conclusion: Using eHCF + LGG instead of eHCF alone or an AAF for first-line management of newly diagnosed infants with cow’s milk allergy affords a cost-effective use of NFZ-funded resources, since it improves outcome for less cost. Whether eHCF + LGG would be viewed as being cost-effective by parents is dependent on their willingness to pay an additional cost for additional tolerance acquisition to cow’s milk. Keywords: amino acid formula, cost-effectiveness, cow’s milk allergy, extensively hydrolyzed formula, Lactobacillus Rhamnosus GG, Poland

Julian F Guest,1,2 Diana Weidlich,1JIgnacio Mascuñan Díaz,3 Juan J Díaz,4 Pedro Manuel Ojeda,5 J Pablo Ferrer-González,6 David Gil,7 Isabel Onrubia Vaquero,8 Pedro Rincón Victor9 1Catalyst Health Economics Consultants, Northwood, Middlesex, 2Faculty of Life Sciences and Medicine, King’s College, London, UK; 3Centro de Salud de Paterna, Valencia, Spain; 4Hospital Universitario Central de Asturias, Oviedo, 5Clínica de Asma y Alergia Doctores Ojeda, 6Hospital General de Requena, Valencia, 7Hospital Universitario Virgen de la Arrixaca, Murcia, 8Centro de Salud Valle de la Oliva, Majadahonda, 9Centro de Salud la Chopera, Alcobendas, Spain Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula containing the probiotic Lactobacillus rhamnosus GG (eHCF + LGG; Nutramigen LGG) as a first-line management for cow’s milk allergy compared with eHCF alone, and amino acid formulae in Spain, from the perspective of the Spanish National Health Service (SNS).Methods: Decision modeling was used to estimate the probability of immunoglobulin E (IgE)-mediated and non–IgE-mediated allergic infants developing tolerance to cow’s milk by 18 months. The models also estimated the SNS cost (at 2012/2013 prices) of managing infants 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 with 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 the SNS for managing both IgE-mediated and non–IgE-mediated cow’s milk allergy.Conclusion: Using eHCF + LGG instead of eHCF alone or amino acid formulae for first-line management of newly-diagnosed infants with cow’s milk allergy affords a cost-effective use of publicly funded resources because 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, cost-effectiveness, cow’s milk allergy, extensively hydrolyzed formula, Spain, Lactobacillus rhamnosus GG

Julian F Guest,1,2 Monica Panca,1 Olga Ovcinnikova,1 Rita Nocerino3 1CATALYST Health Economics Consultants, Northwood, Middlesex, UK; 2Faculty of Life Sciences and Medicine, King's College, London, UK; 3Department of Translational Medical Science, Pediatric Section, University of Naples 'Federico II', Naples, Italy 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

Olga Ovcinnikova,1 Monica Panca,1 Julian F Guest1,2 1CATALYST Health Economics Consultants, Northwood, London, 2Faculty of Life Sciences and Medicine, King’s College, London, UK Objectives: The aim was to estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) plus the probiotic Lactobacillus rhamnosus GG (eHCF + LGG; Nutramigen LGG) compared to an eHCF alone (Nutramigen) and an amino acid formula (AAF; Neocate) as first-line dietary management for cow’s milk allergy (CMA) in the US. Methods: Using a cohort study design, the analysis was based on the case records of 136 eHCF-fed, 59 eHCF + LGG-fed, and 217 matched AAF-fed infants extracted from the Truven Health MarketScan® Commercial Claims Database (a nationally representative database of the commercially insured population of the US). Clinical outcomes and health care resource use (with corresponding costs at 2012 prices), following first-line dietary management with each formula, were estimated over 12 months from the start of feeding. Differences in infants’ outcomes and resource use between groups were adjusted for any differences in baseline covariates. Results: Infants were