National Institute for Health and Care Excellence, UK (NICE) guidance for omalizumab, mepolizumab and reslizumab
| Omalizumab for treating severe persistent allergic asthma |
| Omalizumab (Xolair, Novartis) is a monoclonal antibody that binds to IgE. It has a UK marketing authorisation as add-on therapy to improve control of asthma in adults and adolescents (those aged 12 years and over) and children (those aged 6–11 years) with severe persistent allergic asthma who have: |
| A positive skin test or in vitro reactivity to a perennial aeroallergen |
| Reduced lung function (FEV1 <80% in adults and adolescents) |
| Frequent daytime symptoms or night-time awakenings |
| Multiple documented severe exacerbations despite daily high-dose plus LABA |
| The marketing authorisation states that omalizumab treatment “should only be considered for patients with convincing IgE mediated asthma”. It also specifies that, 16 weeks after the start of omalizumab, physicians should assess how effective the treatment is, and should continue omalizumab only in patients whose asthma has markedly improved. It also specifies that omalizumab should be initiated and monitored in a specialist centre by a physician experienced in the diagnosis and treatment of severe persistent asthma. |
| Mepolizumab for treating severe refractory eosinophilic asthma |
| Mepolizumab, as an add-on to optimised standard therapy, is recommended as an option for treating severe refractory eosinophilic asthma in adults, only if: |
| The blood eosinophil count is ≥300 cells per μL or more in the previous 12 months, and |
| The person has agreed to and followed the optimised standard treatment plan, and |
| Has had four or more asthma exacerbations needing systemic corticosteroids in the previous 12 months, or |
| Has had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months, and |
| The company provides the drug with the discount agreed in the patient access scheme |
| At 12 months of treatment: |
| Stop mepolizumab if the asthma has not responded adequately, or |
| Continue treatment if the asthma has responded adequately and assess response each year |
| An adequate response is defined as: |
| At least 50% fewer asthma exacerbations needing systemic corticosteroids in those people with four or more exacerbations in the previous 12 months, or |
| A clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control |
| Reslizumab for treating eosinophilic asthma |
| Reslizumab, as an add-on therapy, is recommended as an option for the treatment of severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose ICS plus another drug, only if: |
| The blood eosinophil count has been recorded as ≥400 cells per μL |
| The person has had three or more asthma exacerbations in the past 12 months, and |
| The company provides reslizumab with the discount agreed in the patient access scheme |
| At 12 months: |
| Stop reslizumab if the asthma has not responded adequately, or |
| Continue reslizumab if the asthma has responded adequately and assess response each year |
| An adequate response is defined as: |
| A clinically meaningful reduction in the number of severe exacerbations needing systemic corticosteroids, or |
| A clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control |
For omalizumab, data from [17] (published in April 2013 and evidence reviewed again in March 2016 with no changes to the recommendations); for mepolizumab, data sourced from NICE (www.nice.org.uk/guidance/ta431; published January 2017) and for reslizumab, data sourced from NICE (www.nice.org.uk/guidance/gid-ta10036/documents/final-appraisal-determination-document). Ig: immunoglobulin; FEV1: forced expiratory volume in 1 s; LABA: long-acting inhaled beta-2 agonist; ICS: inhaled corticosteroid.