Smith Child Health Research Program, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois2Center for Healthcare Studies, Northwestern University Feinberg School of Medicine, Chicago, Illinois3Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
IMPORTANCE Describing the economic impact of childhood food allergy in the United States is important to guide public health policies. OBJECTIVE To determine the economic impact of childhood food allergy in the United States and caregivers' willingness to pay for food allergy treatment. DESIGN, SETTING, AND PARTICIPANTS A cross-sectional survey was conducted from November 28, 2011, through January 26, 2012. A representative sample of 1643 US caregivers of a child with a current food allergy were recruited for participation. MAIN OUTCOMES AND MEASURES Caregivers of children with food allergies were asked to quantify the direct medical, out-of-pocket, lost labor productivity, and related opportunity costs. As an alternative valuation approach, caregivers were asked their willingness to pay for an effective food allergy treatment. RESULTS The overall economic cost of food allergy was estimated at $24.8 (95% CI, $20.6-$29.4) billion annually ($4184 per year per child). Direct medical costs were $4.3 (95% CI, $2.8-$6.3) billion annually, including clinician visits, emergency department visits, and hospitalizations. Costs borne by the family totaled $20.5 billion annually, including lost labor productivity, out-of-pocket, and opportunity costs. Lost labor productivity costs totaled $0.77 (95% CI, $0.53-$1.0) billion annually, accounting for caregiver time off work for medical visits. Out-of-pocket costs were $5.5 (95% CI, $4.7-$6.4) billion annually, with 31% stemming from the cost of special foods. Opportunity costs totaled $14.2 (95% CI, $10.5-$18.4) billion annually, relating to a caregiver needing to leave or change jobs. Caregivers reported a willingness to pay of $20.8 billion annually ($3504 per year per child) for food allergy treatment. CONCLUSIONS AND RELEVANCE Childhood food allergy results in significant direct medical costs for the US health care system and even larger costs for families with a food-allergic child.
"Food allergies present a significant medical risk and have a negative impact on the quality of life for those affected by this condition. Annual costs associated with physician and ER visits associated with food allergies are estimated to be at around 25 billion dollars (Gupta et al. 2013), and recent studies indicate that the number of people with food allergies is increasing (Branum and Lukacs 2009; Sicherer et al. 2010; Gupta et al. 2011). Food allergen research has focused on the characterization of allergens in an effort to more clearly define the specific characteristics differentiating allergenic from nonallergenic food components, and to determine how food processing methods can enhance or reduce the ability of food allergens to cause food allergies. "
[Show abstract][Hide abstract] ABSTRACT: Ara h 1 is a major peanut allergen. Processing-induced modifications may modulate the allergenic potency of Ara h 1. Carboxymethyl lysine (CML) modifications are a commonly described nonenzymatic modification on food proteins. In the current study, we tested the ability of digestive and endolysosomal proteases to cleave CML-modified and unmodified Ara h 1 peptides. Mass spectrometric analyses of the digested peptides demonstrate that carboxymethylation of lysine residues renders these peptides refractory to trypsin digestion. We did not detect observable differences in the simulated gastric fluid or endolysosomal digestion between the parental and CML-modified peptides. One of the tested peptides contains a lysine residue previously shown to be CML modified laying in a previously mapped linear IgE epitope, but we did not observe a difference in IgE binding between the modified and parental peptides. Our findings suggest a molecular mechanism for the increased resistance of peanut allergens modified by thermal processing, such as Ara h 1, to digestion in intestinal fluid after heating and could help explain how food processing-induced modifications may lead to more potent food allergens by acting to protect intact IgE epitopes from digestion by proteases targeting lysine residues.
"Food allergies have a significant negative impact on participants’ quality of life [4-6]. The burden of FA on caregivers (buying special foods, limiting social encounters, foregoing full-time employment) has been reported to play a predominant role in the total annual economic burden of FA, $24.8 billion . Compared to those with single food allergies, those with multiple food allergies experience a greater decrease in quality of life [5,8], are more likely to suffer from dietary deficiencies  and are less likely to outgrow their food allergies . "
[Show abstract][Hide abstract] ABSTRACT: Background
Food allergy (FA) negatively affects quality of life in caregivers of food-allergic children, imposing a psychosocial and economic burden. Oral immunotherapy (OIT) is a promising investigational therapy for FA. However, OIT can be a source of anxiety as it carries risk for allergic reactions. The effect of OIT with multiple food allergens (mOIT) on FA-specific health-related quality of life (HRQL) has never been studied in participants with multiple, severe food allergies. This study is the first to investigate the effects of mOIT on FA-related HRQL in caregivers of pediatric subjects.
Caregiver HRQL was assessed using a validated Food Allergy Quality of Life – Parental Burden (FAQL-PB) Questionnaire (J Allergy Clin Immunol 114(5):1159-1163, 2004). Parents of participants in two single-center Phase I clinical trials receiving mOIT (n = 29) or rush mOIT with anti-IgE (omalizumab) pre-treatment (n = 11) completed the FAQL-PB prior to study intervention and at 2 follow-up time-points (6 months and 18 months). Parents of subjects not receiving OIT (control group, n = 10) completed the FAQL-PB for the same time-points.
HRQL improved with clinical (change < -0.5) and statistical (p < 0.05) significance in the mOIT group (baseline mean 3.9, 95% CI 3.4-4.4; 6-month follow-up mean 2.5, 95% CI 2.0-3.0; 18-month follow-up mean 1.8, 95% CI 1.4-2.1) and rush mOIT group (baseline mean 3.9, 95% CI 3.1-4.7; 6-month follow-up mean 1.7, 95% CI 0.9-2.6; 18-month follow-up mean 1.3, 95% CI 0.3-2.4). HRQL scores did not significantly change in the control group (n = 10).
Multi-allergen OIT with or without omalizumab leads to improvement in caregiver HRQL, suggesting that mOIT can help relieve the psychosocial and economic burden FA imposes on caregivers of food-allergic children.
"Up to 8% of the pediatric population suffers from food allergy and of those 30% have clinical reactivity to more than one food allergen [1-3]. The estimated cost of food allergies in the U.S. every year is approximately 25 billion U.S. dollars, with most of the burden (~$20 billion) borne by families themselves due to time lost from work, changing careers and emergency room visits . Compared to those with single food allergies, multi-sensitized subjects experience a greater decrease in quality of life , are more likely to suffer from dietary deficiencies  and are less prone to spontaneously outgrow their allergies . "
[Show abstract][Hide abstract] ABSTRACT: Up to 30% of patients with food allergies have clinical reactivity to more than one food allergen. Although there is currently no cure, oral immunotherapy (OIT) is under investigation. Pilot data have shown that omalizumab may hasten the ability to tolerate over 4 g of food allergen protein.
To evaluate the safety and dose tolerability of a Phase 1 Single Site OIT protocol using omalizumab to allow for a faster and safe desensitization to multiple foods simultaneously.
Participants with multiple food allergies received OIT for up to 5 allergens simultaneously with omalizumab (rush mOIT). Omalizumab was administered for 8 weeks prior to and 8 weeks following the initiation of a rush mOIT schedule. Home reactions were recorded with diaries.
Twenty-five (25) participants were enrolled in the protocol (median age 7 years). For each included food, participants had failed an initial double-blind placebo-controlled food challenge at a protein dose of 100 mg or less. After pre-treatment with omalizumab, 19 participants tolerated all 6 steps of the initial escalation day (up to 1250 mg of combined food proteins), requiring minimal or no rescue therapy. The remaining 6 were started on their highest tolerated dose as their initial daily home doses. Participants reported 401 reactions per 7,530 home doses (5.3%) with a median of 3.2 reactions per 100 doses. Ninety-four percent (94%) of reactions were mild. There was one severe reaction. Participants reached their maintenance dose of 4,000 mg protein per allergen at a median of 18 weeks.
These phase 1 data demonstrate that rush OIT to multiple foods with 16 weeks of treatment with omalizumab could allow for a fast desensitization in subjects with multiple food allergies. Phase 2 randomized controlled trials are needed to better define safety and efficacy parameters of multi OIT experimental treatments with and without omalizumab.
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