Cost-effectiveness Analysis of Hypoallergenic Milk Formulas for the Management of Cow’s Milk Protein Allergy in the United Kingdom

**Background:** Cow’s milk protein allergy (CMPA) is the most common food allergy in early childhood. In most children CMPA resolves by age 5 or 6; however, if not treated correctly can provoke nutritional deficiency resulting in poor growth. Management consists of excluding cow’s milk from the diet, with hypoallergenic formulas (or non-dairy alternatives) being introduced to meet nutritional requirements. **Objectives:** To compare the cost-effectiveness of hypoallergenic formulas in reducing allergic manifestations and promoting immune tolerance in infants with immunoglobulin E (IgE)-mediated symptoms of CMPA. **Methods:** A trial-based decision analytic cohort model was developed to simulate the occurrence of urticaria, eczema, asthma, rhinoconjunctivitis, or being symptom-free in infants with CMPA in the United Kingdom. Amino acid-based formula (AAF), extensively hydrolysed casein formula containing Lactobacillus rhamnosus Gorbach Goldin (EHCF+LGG), extensively hydrolysed whey formula (EHWF), and soy formula (SF) were compared using the National Health Service (NHS) perspective, 3-year time horizon and 3.5% discount rate for cost and health consequences. Hypoallergenic formulas comparative efficacy was sourced from a prospective cohort study. Resources required to manage allergic symptoms were sourced from published literature, validated by a UK clinician, and applied to UK cost resources. Results were reported as cost per additional child free from allergic manifestations at 3 years and cost per additional immune tolerant child at 3 years. **Results:** In the base case, infants receiving EHCF+LGG were associated with lower NHS resource use and improved CMPA tolerance. Over the 3-year treatment period, savings of £119, £476, and £1094 were achieved with EHCF+LGG compared to SF, EHWF and AAF, respectively. Infant formula accounted for the largest proportion of resource consumption averaging 44% for all comparators, with a minimum of 31% for SF and a maximum of 53% for AAF over 3 years. General practitioners’ visits constituted the second highest cost component, approximately 17% of total costs across comparators. The results were robust to deterministic and probabilistic sensitivity analyses. **Conclusions:** Compared to AAF, SF, and EHWF hypoallergenic formulas, EHCF+LGG was the most cost-effective, associated with lower total costs and contributing to a higher proportion of children being symptom-free and developing immune tolerance 3-years after diagnosis

Erratum: Cost-effectiveness Analysis of Hypoallergenic Milk Formulas for the Management of Cow's Milk Protein Allergy in the United Kingdom (JHEOR (2021) DOI: 10.36469/jheor.2021.26010)

We have identified an error in the cost of one of the comparators under evaluation which, despite not changing the conclusions of the cost-effectiveness analysis impacted some of its results. In the original publication we estimated treatment costs of amino acid-based formula (AAF) based on a price per 800 g tin, whilst the actual size of the container is only 400 g. In effect, the utilized price was half of what it should be. We have corrected this input and updated the sections of the manuscript and supplemental data file where the cost of AAF treatment was mentioned. As a consequence, based on changes to the cost of treatment with AAF, results from the deterministic and probabilistic analyses have changed. In conclusion, AAF remained dominated but its absolute and incremental costs increased. The original article has been updated online

Erratum: Cost-effectiveness Analysis of Hypoallergenic Milk Formulas for the Management of Cow's Milk Protein Allergy in the United Kingdom (Journal of Health Economics and Outcomes Research DOI: 10.36469/jheor.2021.26010)

We have identified an error in the cost of one of the comparators under evaluation which, despite not changing the conclusions of the cost-effectiveness analysis impacted some of its results. In the original publication we estimated treatment costs of amino acid-based formula (AAF) based on a price per 800 g tin, whilst the actual size of the container is only 400 g. In effect, the utilized price was half of what it should be. We have corrected this input and updated the sections of the manuscript and supplemental data file where the cost of AAF treatment was mentioned. As a consequence, based on changes to the cost of treatment with AAF, results from the deterministic and probabilistic analyses have changed. In conclusion, AAF remained dominated but its absolute and incremental costs increased. The original article has been updated online

BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: A Delphi consensus study

Background: Palforzia® enables the safe and effective desensitisation of children with peanut allergy. The treatment pathway requires multiple visits for dose escalation, up-dosing, monitoring of patients taking maintenance therapy and conversion onto daily real-world peanut consumption. The demand for peanut immunotherapy outstrips current National Health Service (NHS) capacity and requires services to develop a national consensus on how best to offer Palforzia® in a safe and equitable manner. We undertook a Delphi consensus exercise to determine guidance statements for the implementation of Palforzia®-based immunotherapy in the NHS. Methods: We undertook focus groups with children and young people who had received peanut immunotherapy to assess what was important for them and their carers. Common themes from patients formed the basis of creating draft statements. A panel of 18 multi-disciplinary professionals engaged in two rounds of anonymised voting to adapt the statements and score their importance. A final consensus workshop consolidated any variation in comments and scores to develop the final guidance statements. Results: the panel achieved consensus on 91% (29/32) of guidance statements, demonstrating strong consensus around pragmatic principles for assuring the integrity of consent, safety and conversion from Palforzia® to real-world peanut products. The greatest amount of feedback was generated from three broad issues; (i) whether eligibility assessment should include compulsory peanut challenges and whether these should be designed to assess the threshold at which patients react to peanut, (ii) the governance processes to best ensure that patients' interests are prioritised and (iii) how to safely transition young people to other services, or discharge them, while they are taking daily peanut. Conclusions: this consensus highlights the urgent need for the NHS to increase capacity for undertaking diagnostic food challenges as well as developing Palforzia® immunotherapy pathways. The voting panel agreed that families of peanut allergic children should be made aware of immunotherapy, that eligibility assessment should include how co-morbid conditions are managed and that services should monitor for adverse effects. The finalised statements are now published online for clinical practice in the UK. These guidance statements will be adapted in the coming years as more evidence is published and as the international experience of peanut immunotherapy evolves.</p