People with poorly controlled asthma despite conventional treatments may benefit from novel therapies known as biologics. Biologics reduce the number of asthma attacks and need for steroid treatment. This will improve patients’ quality of life and reduce side effects from steroids.
There are currently five asthma biologics available in the UK, but unfortunately patients need to be steroid dependent or have had at least 3 severe asthma attacks in one year to qualify for treatment. Clinical trials showed patients with fewer attacks and milder disease also benefit from treatment, but these patients do not have currently have access to biologics in the UK.
We will determine the current number of patients who qualify for biologics and whether they were appropriately referred for treatment. We will also estimate the potential increase in number of patients eligible for treatment in the future if criteria changed to include those with milder disease. We will calculate the cost savings from reduced hospital admissions and treatment of asthma attacks if criteria were changed.
This project will help policy makers understand how many patients currently qualify for biologic therapy but do not have access to treatment and the reasons why. Our estimation of potential increase in patient numbers and cost savings will help policy makers plan for asthma services over the next decade. We will highlight potential reasons for why patients currently eligible for biologics do not have access to treatment and the cost-effectiveness of giving access to biologics for those who have milder disease.
The objective is to determine the prevalence of asthma patients eligible for (but often do not receive) life-changing asthma biologics. First, we aim to identify the prevalence of biologic candidates by searching for all asthma patients who are eligible for omalizumab, mepolizumab, benralizumab, reslizumab and dupilumab according to current NICE criteria and determine potential causes for discrepancies, if any, in the number of patients eligible or receiving biologics. Second, we will determine the prevalence of potential future biologic candidates by searching for patients eligible for any of the five current biologics or tezepelumab according to licensing criteria. Third we will explore potential risk factors for eligible patients not being referred. Then we will estimate the number of avoidable exacerbations and hospital admissions if biologic eligibility criteria were changed from current NICE to drug licensing criteria. Finally, we will assess the influence of age of asthma diagnosis and duration of disease on eligibility for biologic treatments.
This is a cohort study using CPRD Aurum with linked Hospital Episode Statistics (HES) admission and outpatient data. The majority of statistical analyses are descriptive. We will identify the prevalence of biologic candidates using (1) inhaled corticosteroid prescriptions (2) oral corticosteroids prescriptions and (3) blood eosinophil count or atopic status. We will use logistic regression to estimate the effect of demographics and clinical characteristics on referral to secondary care (where biologics are instigated). We will use simple cost analyses and assumptions to calculate the healthcare cost implications of not commencing biologics.
Our findings will enable policymakers to plan future healthcare services to deliver biologic treatments to patients who meet eligibility criteria now and in the future, to reach the right demographic of patients, identify and address the barriers to accessing treatment and estimate the potential cost-savings from amendments of current biologic prescribing guidance.
Number of asthma patients eligible for any biologic, omalizumab, mepolizumab, benralizumab, reslizumab and dupilumab according to NICE criteria.
Number of asthma patients eligible for biologic according to NICE criteria but not referred to secondary care for respiratory review.
Number of asthma patients eligible for omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab and tezepelumab according to pivotal phase 3 clinical trial inclusion criteria ie drug licensing criteria.
Chloe Bloom - Chief Investigator - Imperial College London
Freda Yang - Corresponding Applicant - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation