Prevalence and cost implications of broadening asthma biologic eligibility criteria
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Rationale
Eligibility for biologic therapy in severe asthma varies internationally because government-funded schemes apply stricter criteria than pivotal trials. While relaxing eligibility thresholds may expand access, the effects on prevalence and healthcare costs remain uncertain.
Objective
To quantify how alternative biologic eligibility criteria affect prevalence, clinical characteristics, and budget impact in adults with asthma.
Methods
We studied adults with active asthma (2004-2021) using nationally representative primary care and hospital records. Biologic eligibility was assessed yearly using asthma severity (inhaled corticosteroid dose, additional controllers, rescue therapy) and exacerbations (oral corticosteroid prescriptions, emergency visits and hospitalisations). We assessed prevalence using UK criteria (severe asthma, ≥3 exacerbations), Global criteria (severe asthma, ≥1 or ≥2 exacerbations) and RCT criteria (moderate asthma, ≥1 or ≥2 exacerbations). Anti-IL-5/5Rα eligibility was evaluated using blood eosinophil counts. Budget impact was modelled over five years.
Results
Among 1,306,307 asthma patients, 7.2% had severe asthma. Under UK criteria, 19,093 patients were biologic-eligible (20.4% of severe asthma; 1.5% of all asthma). Global criteria increased eligibility to 2.4% (≥2 exacerbations) to 4.3% (≥1 exacerbation), while RCT criteria expanded eligibility to 4.7% (≥2 exacerbations) and 9% (≥1 exacerbation). Among patients with eosinophil data, 38-45% met anti-IL-5/5Rα criteria. UK-eligible patients had higher prevalence of lower respiratory tract infections, pneumonia, and bronchiectasis. Five-year costs were £261M under UK criteria, £436-767M under Global criteria, and £878M-1.6B under RCT criteria.
Conclusion
Only one-fifth of patients with severe asthma met UK biologic eligibility. Global criteria tripled eligibility and RCT criteria increased it sixfold, with substantial budget implications.
Eligibility for biologic therapy in severe asthma varies internationally because government-funded schemes apply stricter criteria than pivotal trials. While relaxing eligibility thresholds may expand access, the effects on prevalence and healthcare costs remain uncertain.
Objective
To quantify how alternative biologic eligibility criteria affect prevalence, clinical characteristics, and budget impact in adults with asthma.
Methods
We studied adults with active asthma (2004-2021) using nationally representative primary care and hospital records. Biologic eligibility was assessed yearly using asthma severity (inhaled corticosteroid dose, additional controllers, rescue therapy) and exacerbations (oral corticosteroid prescriptions, emergency visits and hospitalisations). We assessed prevalence using UK criteria (severe asthma, ≥3 exacerbations), Global criteria (severe asthma, ≥1 or ≥2 exacerbations) and RCT criteria (moderate asthma, ≥1 or ≥2 exacerbations). Anti-IL-5/5Rα eligibility was evaluated using blood eosinophil counts. Budget impact was modelled over five years.
Results
Among 1,306,307 asthma patients, 7.2% had severe asthma. Under UK criteria, 19,093 patients were biologic-eligible (20.4% of severe asthma; 1.5% of all asthma). Global criteria increased eligibility to 2.4% (≥2 exacerbations) to 4.3% (≥1 exacerbation), while RCT criteria expanded eligibility to 4.7% (≥2 exacerbations) and 9% (≥1 exacerbation). Among patients with eosinophil data, 38-45% met anti-IL-5/5Rα criteria. UK-eligible patients had higher prevalence of lower respiratory tract infections, pneumonia, and bronchiectasis. Five-year costs were £261M under UK criteria, £436-767M under Global criteria, and £878M-1.6B under RCT criteria.
Conclusion
Only one-fifth of patients with severe asthma met UK biologic eligibility. Global criteria tripled eligibility and RCT criteria increased it sixfold, with substantial budget implications.
Date Issued
2026-09-01
Date Acceptance
2026-07-28
Citation
World Allergy Organization Journal, 2026, 19 (9)
ISSN
1939-4551
Publisher
Elsevier
Journal / Book Title
World Allergy Organization Journal
Volume
19
Issue
9
Copyright Statement
© 2026 The Authors. Published by Elsevier Inc. on behalf of World Allergy Organization. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
License URL
Identifier
10.1016/j.waojou.2026.101449
Subjects
Biologic
Severe asthma
Exacerbations
Anti-TSLP
Anti-IL5
Publication Status
Published
Article Number
101449
Date Publish Online
2026-08-18