Out-of-pocket expenses and parent reported quality of life in children with cow's milk protein allergy in Bogotá, Colombia.

OBJECTIVE: To identify the out-of-pocket expenses and parent-reported quality of life (QoL) of children with a diagnosis of cow's milk protein allergy between the ages of 0 and 5 using the Food Allergy Quality of Life Questionnaire - Parent Form. METHODS: A cross-sectional study was conducted in two tertiary care centers in Bogotá. Demographic, medical information, and QoL scores were collected by parental interview. We carried out a cost-of-illness analysis based on self-reported out-of-pocket expenses attributed to the treatment as a whole and the family's monthly income. Exploratory analyses used the QoL scores and the percentage of out-of-pocket expenses attributable to treatment as outcomes. RESULTS: 122 families were analyzed. Median subject age was 17 months (Q1-Q3: 11-26.75 months) and female subjects made up 71% of the sample. The median QoL score was 3.21 points (Q1-Q3: 2.43-4.34) and only differed by age groups and personal history of other food allergies. The median out-of-pocket treatment related costs was 300,000 Colombian pesos (COP) (Q1-Q3: 280,000-340,000 COP). About 17% of the families had to pay over 15% of their monthly income to purchase food and dietary products. Out-of-pocket treatment related costs differed depending on whether the treatment included formulas (Mann-Whitney test p < 0.001). Out-of-pocket treatment expenses were uncorrelated with the QoL scores. CONCLUSION: Food allergy related QoL scores were not associated with out-of-pocket expenses as a whole or as a fraction of monthly income but were higher in children with additional food allergies and in older age groups, suggesting a lower QoL.

Milk allergy most burdensome in multi-food allergic children.

BACKGROUND: Food allergy is a substantial health burden, which disproportionately affects children. Among children with food allergy, as many as 70% have multiple food allergies. Whereas the overall burden of food allergy on quality of life has been described, little is known about the burden of individual allergens. We aimed to examine the perception of burden among families with multiple food-allergic children. METHODS: Parents of children with 1 + children with multiple food allergies including milk responded to online questions, including both open-ended and closed-ended questions on food allergy-related burdens of time, financial costs, social restrictions, and emotional demands. RESULTS: Overall, 64 children (69.8% boys) of whom (73.0%) most were aged 10 and younger were included. Most had been diagnosed with food allergy in infancy and by a (pediatric) allergist. Other common allergies included peanut (65.6%), tree nuts (57.8%), egg (76.6%), and sesame (31.3%). Quantitatively, milk allergy was reported as carrying the most burden, including most socially limiting (81.5%), requiring the most planning (75.9%), causing the most anxiety (68.5%), most challenging to find "safe" or allergy-friendly foods (72.2%), and costly (81.5%). Qualitatively, we identified five themes that captured burdens associated with costs, marketing of milk products to children, risk of cross-contamination, ubiquity of milk/dairy and public confusion with lactose intolerance, and an unwillingness of others to accommodate the allergy. CONCLUSION: Parents whose children have multiple food allergies, including milk, report milk as the allergy associated with the greatest time, financial, social, and emotional burdens.

Cost-effectiveness of using an extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG in managing infants with cow's milk allergy in the US.

OBJECTIVE: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula containing the probiotic Lactobacillus rhamnosus GG (eHCF + LGG; Nutramigen LGG) compared with an eHCF alone and an amino acid formula (AAF) in treating cow's milk allergy (CMA) in the US, from the perspective of third-party insurers and from parents. METHODS: A decision model 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 insurers and parents (US dollars at 2016 prices) of managing infants over 18 months after starting one of the formulae, as well as the relative cost-effectiveness of each of the formulae. RESULTS: The probability of developing tolerance to cow's milk was higher among infants who were fed eHCF + LGG compared with those fed an eHCF alone or an AAF. Infants who are initially fed with eHCF + LGG are expected to utilize fewer healthcare resources than those fed with one of the other formulae. Hence, the estimated total healthcare cost incurred by third-party insurers and parents of initially feeding infants with eHCF + LGG was less than that of feeding infants with an eHCF alone or an AAF. CONCLUSION: Initial management of newly-diagnosed cow's milk allergic infants with eHCF + LGG was found to afford a cost-effective strategy to both third-party insurers and parents when compared to an eHCF alone or an AAF.

Expert panel on practice patterns in the management of cow's milk protein allergy and associated economic burden of disease on health service in Turkey.

AIMS: To evaluate practice patterns in the management of cow's milk protein allergy (CMPA) and associated economic burden of disease on health service in Turkey. MATERIALS AND METHODS: This study was based on experts' views on the practice patterns in management of CMPA manifesting with either proctocolitis or eczema symptoms and, thereby, aimed to estimate economic burden of CMPA. Practice patterns were determined via patient flow charts developed by experts using the modified Delphi method for CMPA presented with proctocolitis and eczema. Per patient total 2-year direct medical costs were calculated, including cost items of physician visits, laboratory tests, and treatment. RESULTS: According to the consensus opinion of experts, 2-year total direct medical cost from a payer perspective and societal perspective was calculated to be $US2,116.05 and $US2,435.84, respectively, in an infant with CMPA presenting with proctocolitis symptoms, and $US4,001.65 and $US4,828.90, respectively, in an infant with CMPA presenting with eczema symptoms. Clinical nutrition was the primary cost driver that accounted for 89-92% of 2-year total direct medical costs, while the highest total direct medical cost estimated from a payer perspective and societal perspective was noted for the management of an exclusively formula-fed infant presenting either with proctocolitis ($US3,743.85 and $US4,025.63, respectively) or eczema ($US6,854.10 and $US7,917.30, respectively). The first line use of amino acid based formula (AAF) was associated with total direct cost increment $US1,848.08 and $US3,444.52 in the case of proctocolitis and eczema, respectively. LIMITATIONS: Certain limitations to this study should be considered. First, being focused only on direct costs, the lack of data on indirect costs or intangible costs of illness seems to be a major limitation of the present study, which likely results in a downward bias in the estimates of the economic cost of CMPA. Second, given the limited number of studies concerning epidemiology and practice patterns in CMPA in Turkey, use of expert clinical opinion of the panel members rather than real-life data on practice patterns that were used to identify direct medical costs might raise a concern with the validity and reliability of the data. Also, while this was a three-step study with six experts included in the first stage (developing local guidelines for diagnosis, treatment, and follow-up of infants with CMPA in Turkey) and 410 pediatricians included in the second stage (a cross-sectional questionnaire-survey to determine pediatricians' awareness and practice of CMPA in infants and children), only four members were included in the present Delphi panel, which allows a limited discussion. Third, lack of sensitivity analyses and exclusion of indirect costs and costs related to alterations in quality of life, behavior of infants, and general well-being of infants and their parents from the cost-analysis seems to be another limitation that may have caused under-estimation of relative cost-effectiveness of the formulae. Fourth, calculation of costs per local guidelines rather than real-life practice patterns is another limitation that, otherwise, would extend the knowledge achieved in the current study. Notwithstanding these limitations, the present expert panel provided practice patterns in the management of CMPA and an estimate of the associated costs, depending on the symptom profile at initial admission for the first time in Turkey. CONCLUSIONS: In conclusion, in providing the first health economic data on CMPA in Turkey, the findings revealed that CMPA imposes a substantial burden on the Turkish healthcare system from both a payer perspective and societal perspective, and indicated clinical nutrition as a primary cost driver. Management of infants presenting with eczema, exclusively formula-fed infants, and first line use of AAF were associated with higher estimates for 2-year direct medical costs.

The economic effect and outcome of delaying oral food challenges.

BACKGROUND: Food specific IgE (sIgE) is a useful marker to assess predictability of oral food challenge (OFC) outcome. A threshold of less than 2 kUA/L for peanut, egg, and milk has been proposed as a 50% negative predictive value at which patients may pass an OFC. OBJECTIVE: To assess the economic effect and outcome of delaying OFCs. METHODS: A retrospective analysis was performed for peanut, egg, and milk OFCs conducted between 2001 and 2012 at a tertiary food allergy referral center. Delayed OFC was defined as greater than 12 months from the time the sIgE level became less than 2 kUA/L. Time to OFC was explored in association with skin prick test result (wheal size), OFC outcome, and the economic effect of delay. RESULTS: Of 319 challenges, 173 OFCs were delayed (54.2%) by a mean time of 35.5 months (range, 13-123 months) vs a mean time of 4.2 months in the 146 challenges that were not delayed (P < .001). The overall OFC passage rate was 89.9%. There was no association between delayed OFC and history of anaphylaxis, type of allergen, age at OFC, or challenge outcome. Delay in OFC was associated with an estimated mean economic cost of $12,203 per patient ($4,184 per 12 months) and $1,951,487 total (total delay, 5,597 months) in this population. CONCLUSION: Despite a 50% negative predictive value, more than 50% of OFCs were delayed in this population by a mean time of nearly 3 years. Delaying OFC is associated with increased costs, and quality improvement is needed to help decrease time to OFC and reduce the economic burden of food allergy on families and the health care system.

Costs of allergic diseases from birth to two years in Finland.

OBJECTIVES: Costing studies are needed to identify the resources used for treatment and inform payers of the costs incurred. The objectives were to determine the costs of diagnosing and treating atopic dermatitis, food allergy and asthma, and to compare the share of costs to society and to the family during the first two years of life. STUDY DESIGN: The data were obtained from an ongoing mother-infant nutrition study. The sample comprised 60 infants who developed allergic disease by the age of 24 months and 56 healthy infants with no allergic disease. METHODS: The costs included diagnosis and treatment of the allergy, disability allowances, travel expenses and time spent by parents. RESULTS: The median costs per infant were €275 (range 94-1306) for atopic dermatitis, €1408 (163-5408) for asthma, €3182 (628-11195) for food allergy, and €10 (0-619) for the healthy infants due to the suspicion of allergic disease. The highest costs in atopic dermatitis were caused by primary care visits, topical treatments, travel costs and parents' time, and those for food allergy by hospital out-patient care, infant formulae for cow's milk allergy, disability allowances and travel costs. The families paid 43% of the costs arising from atopic dermatitis, 13.6% of those from food allergy and 16.5% of those from asthma. CONCLUSIONS: Cow's milk allergy emerged as the most expensive allergic disease, especially for the society, and concurrent asthma in particular further increased the costs.

Direct medical costs associated with atopic diseases among young children in Thailand.

OBJECTIVE: Allergic diseases are the most common childhood illness in Thailand. Their prevalence has been rising over time, with several studies having revealed substantial economic burden. However, no such study had yet been conducted for Thailand. The aim of this study was to estimate direct medical costs associated with atopic diseases among children aged 0-5 years in Thailand. RESEARCH DESIGN AND METHODS: A cost-of-illness model was constructed to estimate the total direct medical costs of atopic diseases comprising atopic dermatitis, chronic rhinitis, asthma (i.e., recurrent wheeze), and cow's milk allergy. The model employed a prevalence-based approach, considering a total number of atopic cases in 2010. Direct medical costs were estimated using a bottom-up analysis with the estimation of the quantity of healthcare resource use and the unit costs. Epidemiological data were obtained from literature and Thai surveys, whereas treatment unit costs were from either a hospital database or Thai standard cost list. Expert opinion informed type, frequency, and quantity of medical resources utilized. Key limitations included lack of data-driven evidences on severity distribution for this particular age group, indirect costs, and medical resource use associated with each condition. RESULTS: Total direct cost was estimated to be THB 27.8 billion (US$899 million). Treatments contributed largest to the total costs (46%), followed by inpatient care (37%), outpatient care (12%), and monitoring and labs (5%). Costs per treated patient were highest in cow's milk allergy (THB 64,383; US$2077), followed by rhinitis (THB 12,669; US$409), asthma (THB 9633; US$312), and atopic dermatitis (THB 5432; US$175). CONCLUSION: Atopic diseases in young children are associated with substantial burden in direct medical costs to Thailand. These costs can be diminished through nutritional intervention recognized to effectively decrease the incidence of atopic diseases.

Oral desensitization for milk allergy in children: state of the art.

PURPOSE OF REVIEW: The purpose of this review is to research current evidence on cow's milk oral immunotherapy for the treatment of cow's milk allergy (CMA). RECENT FINDINGS: The specific, active treatment for IgE-mediated food allergy included CMA, which is currently being investigated in human trials. Allergen-specific approaches include oral, sublingual and epicutaneous immunotherapy. Reports on oral immunotherapy (OIT) for the treatment of milk allergy have been more extensive and carried out mostly with native proteins. The aim of OIT with cow's milk is the achievement of desensitization or tolerance by patients suffering from CMA. Desensitization state can be achieved by approximately 36-92% of the children treated with specific immunotherapy; the rate of permanent tolerance is unknown. Longer duration of desensitization may result in permanent tolerance. The possibility of adverse events or reactions during OIT is quite frequent. Side-effects have been reported by patients in all published studies. SUMMARY: OIT as an active treatment for CMA represents an emerging reality. Before this treatment can be used in clinical practice, additional studies are needed. Currently, many issues remain unanswered: severity and type of food allergy responsive to specific immunotherapy, degree of protection, 'shared schedules' of desensitization(s) in research settings and well established risk-to-benefit ratio. However the field of specific, active treatment of food allergy is poised for clinically important advances.

Budget impact of managing cow milk allergy in the Netherlands.

OBJECTIVE: To assess the resource implications and budget impact of managing cow milk allergy (CMA) in the Netherlands from the perspective of the healthcare insurers. METHODS: A model was constructed depicting the management of CMA in the Netherlands using information obtained from interviews with youth healthcare doctors (n = 14), general practitioners (n = 6) and paediatricians (n = 11) with relevant clinical experience of managing CMA. The model was used to estimate the expected level of healthcare resource use and corresponding cost (at 2007/08 prices) attributable to managing 4,382 new CMA sufferers. RESULTS: The expected cost of healthcare resource use attributable to managing 4,382 new CMA sufferers up to 1 year of age following initial consultation with a community-based physician at a mean 3 months of age was estimated to be €11.28 (95% CI: €7.82; €14.33) million. Clinical nutrition preparations emerged as the primary cost driver accounting for 91% of the total cost and clinician visits collectively accounted for a further 5%. The time taken for CMA sufferers to be put on an appropriate diet and achieve symptom resolution was estimated to be 30 (95% CI: 27; 32) days. Sensitivity analysis showed that the costs would increase by approximately 16% if all new CMA sufferers were to undergo a double-blind placebo-controlled cow milk challenge in a hospital setting, as is currently being proposed. It is not clear how this proposal would affect time to symptom resolution since this would depend on the efficiency of hospitals being able to deal with the increased workload. LIMITATIONS: The intolerance rates were derived from a 1-year follow-up study among 1,000 infants with CMA in the UK, healthcare resource use was not collected prospectively and the study period was censured at 1 year of age and does not consider the impact of CMA in subsequent years. However, most children outgrow this form of allergy during their second year. CONCLUSION: Within the model's limitations, CMA imposes a substantial burden on the Dutch healthcare system. Moreover, initiating a double-blind placebo-controlled cow milk challenge for all CMA sufferers will potentially increase clinicians' workload and use of limited resources within paediatric hospital departments in the Netherlands.

Modelling the health economic impact of managing cow milk allergy in South Africa.

OBJECTIVE: To quantify the health economic impact of managing cow milk allergy (CMA) in South Africa, from the perspective of healthcare insurers in both the private and public sectors and parents/carers of CMA sufferers. METHODS: A decision model depicting the management of CMA in South Africa was constructed, using information obtained from interviews with paediatric specialists in the private and public sectors with relevant clinical experience. The model was used to estimate the expected 12-monthly levels of healthcare resource use and corresponding costs (at 2007/08 prices) attributable to managing CMA sufferers following an initial consultation with a paediatrician. RESULTS: The expected 12-monthly cost incurred by an insurer attributable to managing a CMA sufferer following an initial consultation with a paediatrician was estimated to be R2,430.4 (€202.0) and R1,073.7 (€89.0) in the private and public sector, respectively. The expected 12-monthly cost incurred by parents/carers following an initial consultation with a paediatrician was estimated to be R43,563.1 (€3,634.0) and R24,899.9 (€2,076.9) in the private and public sector, respectively. The time taken for a CMA sufferer to be put on an appropriate diet and achieve symptom resolution was estimated to be 24 days in the private sector and 18 days in the public sector. The total cost to manage an annual cohort of 18,270 newly diagnosed infants with CMA in South Africa in the first year following presentation to a paediatrician was estimated to be R22.1 (€1.8) million for healthcare insurers and R489.1 (€40.8) million for parents/carers. The expected costs to insurers were driven by visits to general paediatricians and prescriptions for dermatological drugs in both the private and public sectors. The expected costs to parents/carers were driven by over-the-counter (OTC) purchases of clinical nutrition preparations. LIMITATIONS: The intolerance rates were derived from a study among 1,000 infants with CMA in the UK, healthcare resource use was not collected prospectively and the study period was limited to 1 year following presentation to a paediatrician and does not consider the impact of CMA in subsequent years. However, most children outgrow this form of allergy by the time they reach 2 years of age. CONCLUSION: CMA imposes a substantial socio-economic burden in South Africa, especially on parents/carers of CMA sufferers. Any strategy that reduces this burden should potentially lead to higher compliance with clinicians' recommendations, thereby improving health outcomes associated with treatment and should also release healthcare resource use for alternative use.

Resource implications and budget impact of managing cow milk allergy in the UK.

AIM: To determine current treatment patterns for infants with cow milk allergy (CMA) and the associated resource implications and budget impact, from the perspective of the UK's National Health Service (NHS). METHODS: A computer-based model was constructed depicting current management of newly-diagnosed infants with CMA derived from patients suffering from this allergy in The Health Improvement Network (THIN) Database. The model spanned a period of 12 months following initial presentation to a general practitioner (GP) and was used to estimate the 12-monthly healthcare cost (at 2006/07 prices) of treating an annual cohort of 18,350 infants from when they initially present to their GP. RESULTS: Patients presenting with a combination of gastrointestinal and atopic symptoms accounted for 59% of all patients. From the initial GP visit for CMA it took a mean 2.2 months to be put on diet, although treatment varied according to presenting symptoms. A total of 60% of all infants were initially treated with soy, 18% with an extensively hydrolysed formula and 3% with an amino acid formula. A mean 9% of patients remained symptomatic on soy and 29% on an extensively hydrolysed formula. The total cost of managing CMA over the first 12 months following initial presentation to a GP was estimated to be £1,381 per patient and £25.6 million for an annual cohort of 18,350 infants. LIMITATIONS: Patients were not randomised to treatment and resource use was not collected prospectively. Nevertheless, 1,000 eligible patients have been included in the analysis, which should be a sufficiently large sample to accurately assess treatment patterns and healthcare resource use in actual clinical practice. The diagnosis of CMA may not be secure in all cases. Nevertheless, patients were diagnosed as having CMA by a clinician and have been managed by their GP as if they had CMA. CONCLUSION: CMA imposes a substantial burden on the NHS. Any strategy that improves healthcare delivery and thereby shortens time to treatment, time to diagnosis and time to symptom resolution should potentially decrease the burden this allergy imposes on the health service and release resources for alternative use.

Modelling the resource implications and budget impact of managing cow milk allergy in Australia.

OBJECTIVE: To estimate the resource implications and budget impact of current clinical practice for managing cow milk allergy (CMA) in Australia, from the perspective of the publicly funded healthcare system. METHODS: A decision model was constructed using published clinical outcomes and clinician-derived resource utilisation estimates. The model was used to estimate the expected 6-monthly levels of healthcare resource use and corresponding costs attributable to managing 6150 new CMA sufferers following referral to a specialist. RESULTS: The expected 6-monthly costs of managing 6150 newly-diagnosed infants with CMA following referral to a specialist was an estimated (Australian dollars, AU$) AU$6.5 million at 2006/07 prices. Clinical nutrition preparations were found to be the primary cost driver accounting for 62% of the total 6-monthly cost and clinician visits were the secondary cost driver accounting for up to a further 28% of the total 6-monthly cost. Sensitivity analysis showed there would be fewer visits to hospital-based paediatric gastroenterologists and paediatric immunologists/allergists if all newly-diagnosed patients were prescribed an amino acid formula (AAF) following referral to a specialist, instead of being managed according to current practice. CONCLUSION: CMA imposes a substantial burden on the publicly funded healthcare system in Australia. However, using an AAF as the initial treatment for CMA can potentially release limited hospital resources for alternative use within the paediatric healthcare system.