Title: Benralizumab for treating severe asthma [ID1129]
Funder: Department of Health and Social Care

Abstract: To appraise the clinical and cost effectiveness of benralizumab within its marketing authorisation for treating severe asthma with elevated blood eosinophils.

Lay abstract: Asthma is a chronic inflammatory disease associated with variable airflow obstruction and airway hyperresponsiveness. It is characterised by exacerbations associated with symptoms such as breathlessness, chest tightness, wheezing, sputum production and cough. Severe eosinophilic asthma is a subset of the condition that is associated with blood and sputum elevated eosinophils and recurrent exacerbations. Eosinophilic nasal polyps may also be present. Eosinophils are thought to play a major role in airway inflammation in asthma. People with severe asthma often have a severely impaired quality of life which can lead to fatigue, absence from school or work and psychological problems including stress, anxiety and depression. There were 1,242 deaths from asthma in the UK in 2012.1 Estimates suggest that around 5.4 million people in England and Wales currently receive treatment for asthma. Guidelines from the British Thoracic Society (BTS) and Scottish Intercollegiate Guidelines Network (SIGN)2 recommend a stepwise approach for treating asthma. Control is maintained by stepping up treatment as necessary and stepping down when control is good. The recommendations are summarised as follows (doses and treatments may differ for children and young people): - For all steps use an inhaled short-acting beta-2 agonist as required (consider moving up if using three doses a week or more). - Regular preventer: Use an inhaled corticosteroid as a regular preventer. - Initial add-on therapy: Add an inhaled long-acting beta-2 agonist to inhaled corticosteroid (normally as a combination inhaler). - Additional add-on therapies: If there is no response to long-acting beta-2 agonist, stop this treatment and consider an increased dose of inhaled corticosteroid. If control is inadequate from long-acting beta-2 agonist, continue treatment and increase inhaled corticosteroid to medium dose or continue treatment and consider a trial of other therapy (for example leukotriene receptor antagonist, slow-release theophylline or long-acting muscarinic agent). - High dose therapies: Consider trials of increasing the dose of inhaled corticosteroid up to a high dose. Consider adding a fourth drug (for example, a leukotriene receptor antagonist, slow-release theophylline, a beta-2 agonist tablet or long-acting muscarinic agent). Refer patients for specialist care. - Continuous or frequent use of oral steroids: Use daily steroid tablets at the lowest dose providing adequate control. Maintain high-dose inhaled corticosteroid. Consider other treatments to minimise the use of steroid tablets. Refer patients for specialist care. NICE technology appraisal guidance 431 recommends mepolizumab as an option for treating severe refractory eosinophilic asthma, as an add-on to optimised standard therapy, in adults only if the blood eosinophil count is 300 cells/microlitre or more in the previous 12 months and the person has agreed to and followed the optimised standard treatment plan and has had 4 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. NICE technology appraisal guidance 479 recommends reslizumab as an add-on therapy to treat severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids plus another drug, only if the blood eosinophil count has been recorded as 400 cells per microlitre or more and the person has had 3 or more severe asthma exacerbations needing systemic corticosteroids in the past 12 months. Technology appraisals 431 and 479 define optimised standard therapy as high-dose therapies (previously step 4 in the BTS and SIGN guidelines) or continuous or frequent use of oral steroids (previously step 5).

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: RESPIRATORY