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

Author:

Marrs Tom12ORCID,Patel Nandinee34,Burrell Sarah34,Rampersad Anjali1ORCID,Minshall Eleanor5,Leech Susan6,Chandratilleke Dinusha7,Dempsey Justine3,Ludman Sian8,Roberts Graham9ORCID,Michaelis Louise Jane10ORCID,Brough Helen A.12ORCID,Karanam Surendra1112,Batt Rebecca1,Moulsdale Phoebe13,Steifel Gary14,Tiwana Kiran1,Smith Helen15ORCID,Knight Katherine16,Vazquez‐Ortiz Marta34,Vyas Deepan17,Turner Paul J.4ORCID,Makwana Nick1112

Affiliation:

1. Children's Allergies, Evelina London Guy's and St Thomas' NHS Foundation Trust London UK

2. Paediatric Allergy, Department of Women and Children's Health, Faculty of Life Course and Population Sciences King's College London Westminster UK

3. Paediatric Allergy Service, Imperial College NHS Foundation Hospitals St Mary's Hospital London UK

4. NIHR Imperial Biomedical Research Centre St Mary's Hospital London UK

5. Paediatric Department Sheffield Children's Hospital Sheffield UK

6. Paediatric Allergy Department King's College Hospital London UK

7. Royal Victoria Infirmary Newcastle upon Tyne UK

8. Royal Devon University Healthcare NHS Foundation Trust Exeter UK

9. Paediatric Allergy Department University of Southampton and Southampton NIHR Biomedical Research Centre Southampton UK

10. Great North Children's Hospital Victoria Wing, Royal Victoria Infirmary Newcastle upon Tyne UK

11. Sandwell and West Birmingham Hospitals Birmingham UK

12. Birmingham University Birmingham UK

13. Worcestershire Acute Hospitals NHS Trust Worcester UK

14. Leicester Royal Infirmary Leicester UK

15. Lee Kong Chian School of Medicine Nanyang Technological University Singapore City Singapore

16. Harris International Patient Centre London UK

17. Watford General Hospital Watford UK

Abstract

AbstractBackgroundPalforzia® 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.MethodsWe 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.ResultsThe 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.ConclusionsThis 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.

Publisher

Wiley

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