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The standardized diagnosis and treatment of food allergy in China begins with AAF
summary
Cow's milk allergy (CMA) is an important public health problem involving the health of infants and young children worldwide. Children often present with skin and gastrointestinal symptoms such as atopic dermatitis, milk refusal, diarrhea, and blood in the stool, and severe cases may have severe allergic reactions. The European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) has updated the 2012 application guide on Principles of Diagnosis and Treatment of Cow's Milk Protein Allergy in Children, based on the available evidence for the diagnosis, treatment and prevention of CMA, and published an updated position paper on the diagnosis, management and prevention of cow's milk allergy. It was mentioned in the paper that different countries have different options for alternative formulations during CMA treatment.
The practical experience of Australia, Brazil, Turkey and other countries has confirmed the absolute economic advantage of starting to use AAF for the management of children with CMA. Pharmacoeconomic studies on amino acid formula (AAF) and extensively hydrolyzed formula (eHF) based on the national conditions of the mainland found that the initial use of AAF replacement feeding was more cost-effective for the treatment of children with CMA in the mainland than that of eHF. The Chinese Expert Consensus on the Diagnosis and Management of Food Allergy-Related Digestive Tract Diseases and the Expert Consensus on the Diagnosis and Management of Food Allergy Related to Atopic Dermatitis in Children both recommend the use of AAF in the diagnosis of dietary avoidance in CMA, and the food allergy management program in China should start with AAF.
1. ESPGHAN's latest position paper notes that different countries have different options for alternative formulations during CMA care
In February 2024, ESPGHAN published a new position paper on the diagnosis, management, and prevention of cow's milk protein allergy (hereinafter referred to as the "position paper") [1]. The position paper was compiled by 13 leading paediatric nutrition experts from Belgium, Germany, Sweden, Italy, France, Romania, Spain, Israel, Poland, Norway and the United Kingdom, and represents the forefront of the field of cow's milk protein allergy in infants and young children in Europe.
The position paper states that AAF and eHF can be used as alternative foods for children with cow's milk protein allergy. Clinical studies have shown that AAF and eHF replacement feeding can alleviate allergy symptoms, improve comfort and promote tolerance to cow's milk proteins[2].
It is also made clear in the position paper that different countries have different considerations on which alternative feeding formulations to prefer, based on different practical experiences. Due to differences in population, medical environment, and living habits, food allergy management should be carried out in different countries and regions according to local conditions [3]. According to the latest guidelines of the International Allergy Organization (WAO) in 2022 [4], the selection of alternative formulations should fully consider their economic differences in different countries and their applicability in the context of medical insurance policies, and cost-effectiveness is one of the important considerations. Therefore, from the perspective of pharmacoeconomics, the evaluation of AAF and eHF treatment regimens is an important topic worthy of in-depth discussion.
2. From the perspective of pharmacoeconomics: China, Australia, Brazil, Turkey, and the initial use of AAF have more economic advantages
In the 2007 CMPA Expert Consensus, Professor Vandenplas mentioned that due to the different prices and medical insurance policies in different countries and regions, the cost-benefit of AAF and eHF is difficult to explain, and it is necessary to choose according to the actual situation of each region [5].
According to the NHS Cost Comparison Document for Special Purpose Infant Formula, AAF is 3 times more expensive in the UK than eHF[8]. In contrast, both the mainland AAF and eHF are self-paid products, and the market price difference is small. In addition, the medical environment, diagnosis and treatment process, and basic treatment are also quite different from those in Europe and the United States, so it is not possible to completely copy foreign experience to guide clinical practice in mainland China [2].
The "Expert Consensus on the Diagnosis and Management of Gastrointestinal Diseases Associated with Food Allergy" [9] and the "Expert Consensus on the Diagnosis and Management of Food Allergy Related to Atopic Dermatitis in Children" [10] recommend the use of AAF for 2-6 weeks during the period of dietary avoidance, and the food allergy management regimen in China should start with AAF.
In 2023, Zhou et al. for the first time comprehensively evaluated the economics of starting to use AAF or eHF in the dietary management of children with CMA from the aspects of cost and effect according to the national conditions of mainland China, and the results were published in the authoritative journal of pharmacoeconomics in China, China Health Resources [2]. The results of this study confirm the correctness of the consensus of Chinese experts to recommend AAF. The study targeted children under 2 years of age with CMA in mainland China, and the outcome measures included the economic cost of treatment and the evaluation of treatment effect.
The results showed that milk protein tolerance was achieved on average 7.15 months after initiation of AAF replacement feeding in children with continental CMA, compared with an average of 10.5 months for initiation of eHF. The total cost of milk powder, diagnosis and home care before the age of 2 years was on average 23 455 yuan for children receiving special medical formula, which was much lower than that for children treated with eHF (30 592 yuan for lactose-free and 31 337 yuan for lactose-containing eHF). It can be seen that the initial use of AAF in the treatment of CMA is cost-effective and effective compared with eHF, and is an advantageous option in economic evaluation [2].
Empirical experience in countries such as Australia, Brazil, and Turkey has also demonstrated the economic advantages of initiating AAF in the treatment of local children with CMA [2]. A 2009 Australian study showed that the use of AAF as the initial treatment for CMA resulted in savings in medical resources and use in other efforts within the pediatric health care system [6]. A 2016 Brazilian study demonstrated that the use of AAF in diagnostic food avoidance is a pharmacoeconomically compliant diagnostic modality that is less costly and may prolong the number of days a child remains asymptomatic [7]. The cost of AAF and eHF for treatment of children with CMA for two years is 9505 TL and 9582 TL, respectively, based on the Turkish monetary value in effect in March 2018, according to which the 2019 Turkish CMA guidelines recommend AAF as the first-line management of CMA [3].
3. Based on the actual national situation: China's food allergy management should start with AAF
The goals of food allergy management are sustained symptomatic relief and a return to a normal diet [11]. Stopping allergen stimulation and avoiding recurrence of symptoms is the basis for improving allergies, and the appropriate introduction of food antigens, inducing tolerance, and helping to return to a normal diet are ideal results.
Food allergies exist for a six-month period of hypersensitivity, and recurrent exposure to the allergen may result in recurrent symptoms [12]. Complete avoidance of allergens and symptoms is beneficial for intestinal barrier repair and immune system maturation [13-14]. AAF is a 100% food protein allergen-free formula that truly avoids allergens and helps provide rapid and sustained allergy relief [15]. However, eHF is still sensitized due to the presence of residual peptide chains, and nearly 30 percent of children with allergies are intolerant to eHF, and children with mild to moderate disease may also be intolerant to eHF, resulting in recurrent symptoms [16].
A return to a normal diet in children with allergies refers to the complete absence of clinical symptoms after the consumption of food antigens, known as oral tolerance [17]. Intake of whole food protein and gradually increasing doses can help promote immune development and induce tolerance formation [18]. The degradation of milk proteins results in a decrease in molecular weight and disruption of spatial structure, which leads to the loss of the ability of AAF and eHF to induce tolerance while reducing sensitization [19]. However, complementary foods contain a variety of whole proteins, which can promote the establishment of oral tolerance in infants and young children [20]. In a clinical study, 166 children with CMPA were fed with amino acid formula for 6 months and were successfully fed with complementary food, and the clinical allergy symptoms of the children were significantly improved, and 76.51% of the children achieved oral tolerance, indicating that AAF feeding enabled children with CMA to achieve good autoimmune development and maturation while effectively relieving symptoms [21].
In summary, AAF has three advantages in China that other formulations cannot match: completely allergenic, faster tolerable, and cost-saving. AAF is the best formula for Chinese food allergic babies and their families.
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