P16 Implications of nice guidance in england and wales on eligibility for treatment with mepolizumab and omalizumab – an ideal study analysis

Abstract

RationaleSevere asthma (SA) patients are a heterogeneous population with diverse clinical characteristics and biomarkers, including eosinophils and IgE. It is of clinical relevance to understand the relationship between different severe asthma phenotypes and thus eligibility for biologic therapies. The IDEAL study (Identification and Description of Severe Asthma Patients in a Cross-Sectional Study) aimed to define the proportion of patients in England and Wales who are eligible for anti IL-5 (mepolizumab) or anti-IgE (omalizumab) targeted therapy, and those who may be eligible for both, given current NICE guidance.MethodsIDEAL, an observational study, included SA subjects aged ≥12 years defined according to ATS/ERS guidelines by treatment with high-dose ICS plus additional controller(s) for ≥12 months. A post hoc analysis of IDEAL was conducted to identify eligibility to mepolizumab and omalizumab in accordance with current NICE guidance for each. Mepolizumab eligibility was defined as per NICE guidance: ‘severe refractory eosinophilic asthma patients who have eosinophils≥300 cells/microlitre (0.30 × 109/L) or more in the previous 12 months and have had ≥4 asthma exacerbations needing systemic corticosteroids in the previous 12 months, or have had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day for the previous 6 months’. Omalizumab eligibility defined as ‘evidence of severe persistent allergic asthma and need for continuous or frequent treatment with oral corticosteroids (defined as ≥4 courses in the previous year), and meeting bodyweight and IgE criteria for omalizumab treatment’.ResultsOf 748 SA subjects enrolled in the study, 670 met the analysis criteria and were included in this post-hoc analysis (mean age=50.9 years; 62% female). 90 subjects (13%) were eligible for mepolizumab and 184 (27%) were eligible for omalizumab. Of the 90 mepolizumab eligible patients, 31 (5%) were receiving omalizumab therapy, while of the remaining 59 (9%) patients not on a biologic 11 (2%) were also eligible for omalizumab.ConclusionsThis is the first cross-sectional study providing estimation of the proportion of SA patients eligible for biologic therapy in accordance with NICE guidance, indicating 13% mepolizumab-eligibility and 27% omalizumab-eligibility with limited overlap. (Funded by GSK; 2 01 722.)